2010/09/17

Almagel A

The composition and the form of

Combined medication. In 5 ml contains 0,3 g algeldrata (aluminum hydroxide), 0.1 g of magnesium hydroxide, 0.1 g Anaesthesinum, 0.8 g of sorbitol. Producing a suspension for oral administration - at 170 or 200 ml vial.

Medicinal properties

Has antacid, analgesic, enveloping and purgative action.

Indications

Peptic ulcer and 12 duodenal ulcer in acute, chronic gastritis in acute, hernia orifice food, accompanied by heartburn and pain.

Terms of use

Assign inside of 5-10 ml (1-2 teaspoons) of the suspension for half an hour before meals and at night just before bedtime.

If necessary, a single dose can be increased to 15 ml. Duration of appointment almagelya A is not more than 3-4 days.

Upon receipt of clinical effect can go to maintenance treatment antacid drug that does not contain a local anesthetic. Before use, should be vigorously shaking the vial.

Side effects

Nausea, vomiting, spastic pain in the stomach, constipation, exhaustion of phosphorus in the body, resorption of calcium from bones and increase its excretion in the urine.

Contraindications

Marked disorders of renal function, hypophosphataemia, increased sensitivity to the drug's components.

Pregnancy and lactation

Side effects were not described.

Interaction with alcohol

During treatment almagelem And should not drink alcoholic beverages.

Cautions

During the treatment should not eat lemons, vinegar and tartaric acid, as it reduces the effect anestezina. In the combined treatment of other drugs it is desirable to take 1-2 h after administration almagelya A. After taking the drug for admission of fluid - water, tea or fruit juice - but only in the number one drink. The product does not contain sugar, so it can assign patients with diabetes mellitus.

Storage conditions

Store in a cool, dry, dark place, a well ukuporennoy packaging. Shelf life - 5 years

Alka-Prim

Composition, structure and packing

Combined medication. Contains acetylsalicylic acid, glycine, sodium bicarbonate, anhydrous citric acid.

Alka-Prim released in the form of effervescent tablets of 2,8 g

Pharmacological action

Tablets Alka-note anti-inflammatory, antipyretic, analgesic effect. Prevents thrombosis. Neutralizes free hydrochloric acid in the stomach, which reduces the irritating effect of the drug on the mucous membranes of the gastrointestinal tract

Statement
pain syndrome is weak and medium intensity (headache, myalgia, arthralgia, etc.)
hyperthermia (including when "cold" diseases, viral infections),
dyspepsia (including heartburn, burning in the epigastrium, stomachalgia, including those caused by overeating or abuse of ethanol).

Dosage regimen

Adults appoint 1-2 tablets Alka-ca 3-4 times a day, with headache in combination with digestive disorders, caused by an error in the diet - a single dose 1-2 tablets.

Before taking a pill Alka-prima should be dissolved in 3 / 4 cup warm water.

Side effect

On the part of the SSA and the hemostatic system: bleeding, changes in the cellular composition of blood, collapse.

On the part of the digestive system: nausea, vomiting, decreased appetite, abdominal pain.

Allergic reactions: urticaria, angioedema, bronchospasm, shock (until loss of consciousness), tearing, allergic rhinitis.

Contraindications
predisposition to bleeding;
erosive and ulcerative lesions in the gastrointestinal stage of exacerbation;
deficiency of glucose-6-phosphate dehydrogenase;
marked disturbances of water-electrolyte metabolism and acid-base balance;
Hypersensitivity to the drug's components.

Pregnancy and lactation

The drug Alka-Prim contraindicated in pregnancy.

Do not take Alka-Prim and the postpartum period. If you want to use the drug for a long time and in high doses during lactation must decide whether to breast-feed.

Cautions

Do not give tablets Alka-note children under 14 years of pyretic disease. By combining this drug with drugs valproic acid (anticonvulsant), anticoagulants or cephalosporins increased risk of bleeding, with simultaneous application with gipoglikemiziruyuschimi drugs (derivatives sulfanilmocheviny) is increased hypoglycemic effect.

Overdose

Symptoms: noise and ringing in the ears.

Treatment: symptomatic.

Drug Interactions

Enhances the effect of oral anticoagulants and hypoglycemic drugs, insulin, methotrexate, other NSAIDs, GCS, valproic acid, ethanol. Reduces effect sulfinpirazon, diflunizala, fenoprofena, ibuprofen, indomethacin, piroxicam, naproxen, sulindaka, as well as drugs that block tubular secretion. Myelotoxic drugs increase the expression gematotoksichnosti drug.

Terms and Conditions of storage

Store in a dry place at temperatures not above 25 ° C.

Expiration date - 2 years.

Alka-seltzer

Composition, structure and packing

Effervescent tablets are white, round, flat, one side engraved "ALKA SELTZER" a presenter on the perimeter of a convex disc; reverse side has a chamfer.

1 tab. acetylsalicylic acid 324 mg
citric acid 965 mg
sodium bicarbonate 1,625 g

Excipients: povidone 25, siloxane / silicate, sodium benzoate Doss, sodium saccharinato, flavor, lemon lime flavor.

Clinico-pharmacological group

NSAIDs combined composition.

Pharmacological action

Combination drug whose action is due to its constituent active components.

Acetylsalicylic acid has analgesic, antipyretic, anti-inflammatory effect, which is caused by inhibition of cyclooxygenase enzymes involved in the synthesis of prostaglandins. Acetylsalicylic acid inhibits platelet aggregation by blocking the synthesis of thromboxane A2.

Sodium carbonate neutralizes free hydrochloric acid in the stomach, which reduces the irritating effect of the drug.

Citric acid promotes more rapid absorption of the drug.

Indications for use of the drug

Symptomatic treatment of pain:
headache (including after excessive alcohol consumption);
toothache;
sore throat;
back pain and muscle;
joint pain;
pain during menstruation.

Increased body temperature in cold and other infectious and inflammatory diseases (adults and children over 15 years).

Dosage regimen

The drug is intended for adults and children over 15 years.

Inside, adults and children over 15 years take 1 tablet up to 6 times when the strong pain and high temperature - 2-3 tablets, maximum daily dose should not exceed 9 tablets

Usage: Dissolve a pill / tablet in a glass (200 ml) of water.

The interval between doses of the drug should be at least 4 hours regular adherence of the drug to avoid a sharp rise in temperature and decrease the intensity of pain.

Duration of treatment (without consulting a doctor) must not exceed 5 days when administered as an analgesic, and more than 3 days - as a febrifuge.

Side effect
On the part of the digestive system: stomach pain, heartburn, nausea, vomiting, obvious (vomiting blood, tarry stools), or hidden signs of gastrointestinal bleeding, which can lead to iron deficiency anemia, erosive and ulcerative lesions (including those with perforation), gastrointestinal tract, in rare cases - violations of liver function (increased hepatic transaminases).
From the side of the central nervous system: dizziness, tinnitus (usually a sign of overdose).
On the part of the hemopoietic system: an increased risk of bleeding, due to the effects of aspirin on platelet aggregation.

Allergic reactions: skin rash, anaphylactic reactions, bronchospasm, edema Quincke. When these symptoms should stop taking the drug and immediately contact your doctor.

Contraindications to the use of the drug
Hypersensitivity to aspirin and other NSAIDs, or other components of the drug;
erosive-ulcerative lesions GIT (exacerbation);
bleeding diathesis;
combined use of methotrexate in doses of 15 mg per week or more;
asthma, caused by intake of salicylates or other NSAIDs;
pregnancy (I and III trimester);
breastfeeding.

The drug is not indicated for children under 15 years of age with acute respiratory diseases caused by viral infections, because of the risk of developing Reye syndrome (encephalopathy and acute fatty liver with development of acute liver failure).

Precautions: If concomitant therapy with anticoagulants, gout, gastric ulcers and / or duodenal ulcer (history), including chronic or recurrent course of ulcer disease, or episodes of gastrointestinal bleeding, kidney and / or liver failure, deficiency of glucose-6- phosphate.

Pregnancy and lactation

The drug is contraindicated in pregnancy (I and III trimesters).

If necessary, use during lactation breastfeeding should be discontinued.

Application for violations of liver function

Precautions: hepatic impairment.

Application for violations of renal function

Precautions: renal impairment.

Cautions

Acetylsalicylic acid may induce bronchospasm, bronchial asthma or other hypersensitivity reactions.

Risk factors are the presence of bronchial asthma, nasal polyps, fever, chronic broncho-pulmonary diseases, a history of allergy (allergic rhinitis, skin rash).

Acetylsalicylic acid can increase the propensity for bleeding, which is associated with its inhibitory effect on platelet aggregation. This should be considered when necessary surgeries, including small interfering as tooth extraction. Before surgery to reduce bleeding during surgery and the postoperative period should stop taking the drug for 5-7 days and notify the physician.

Children should not be prescribed drugs containing acetylsalicylic acid, as in the case of viral infection and increased risk of Reye syndrome. Symptoms of Reye syndrome are prolonged vomiting, acute encephalopathy, liver enlargement.

In the treatment of vascular diseases daily dose of aspirin is between 75 to 300 mg.

Acetylsalicylic acid reduces the excretion of uric acid from the organism that can cause an acute attack of gout in predisposed patients.

One effervescent tablet of Alka-Zelttsera contains 445 mg of sodium, which should be considered when diet, with controlled sodium intake.

Effects on ability to drive vehicles and management mechanisms

There were no effect of the drug to control a motor vehicle and other mechanisms.

Overdose

Symptoms: overdose of moderate severity: nausea, vomiting, tinnitus, hearing loss, headache, dizziness and confusion. These symptoms are at lower dose. Severe overdose: fever, hyperventilation, ketosis, respiratory alkalosis, metabolic acidosis, coma, cardiogenic shock, respiratory failure, marked hypoglycemia.

Treatment: hospitalization, lavage, activated charcoal method, monitoring the acid-alkaline balance, alkaline diuresis in order to achieve the level of urine pH between 7.5-8 (forced alkaline diuresis is achieved if the concentration of salicylate in plasma is more than 500 mg / l ( 3.6 mmol / l) in adults or 300 mg / L (2.2 mmol / l) in children), hemodialysis, loss of fluid, symptomatic therapy.

Drug Interactions

Joint application:
with methotrexate 15 mg per week or more: increased hemolytic cytotoxicity of methotrexate (decreased renal clearance of methotrexate and methotrexate replaced salicylates in relation to blood plasma proteins);
with anticoagulants such as heparin: increased risk of bleeding due to inhibition of platelet function, damage to the gastrointestinal mucosa, displacement of anticoagulants (oral) in relation to blood plasma proteins;
with other NSAIDs, as well as with large doses of salicylates (3 g per day or more): as a result of synergies and increased risk of ulcers and bleeding;
with urikozuratami such benzbromaron: reduces urikozurichesky effect;
with digoxin: the concentration of digoxin increased due to the reduction of renal excretion;
with antidiabetic drugs, such as insulin: increased hypoglycemic effect of antidiabetic agents due to hypoglycemic action of acetylsalicylic acid;
with thrombolytic therapy group: the risk of bleeding increases;
with diuretics at a dose of 3 mg per day and more: reduced glomerular filtration due to the reduction of synthesis of prostaglandins;
with systemic GCS, excluding hydrocortisone, used as replacement therapy in Addison's disease: the application of GCS reduced the level of salicylates in the blood by increasing the excretion of the latter;
with ACE inhibitors: a dose of 3 grams per day or more reduced glomerular filtration due to inhibition of prostaglandins and hence reduces the antihypertensive effect;
with valproic acid: increased toxicity of valproic acid;
with ethanol: increases the risk of damaging effect on the gastrointestinal mucosa and increases bleeding time.

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The drug is approved for use as a non-prescription medicines.

Terms and Conditions of storage

At temperatures below 25 ° C, the reach of children.

Shelf life - 3 years. Do not use a later date on the package.

Aldospray

Composition, structure and packing

Aerosol for external use only 10% of the foam as a homogeneous mass of white.

1 g mabuprofen 100 mg.

Excipients: dimethyl sulfoxide, cetyl alcohol, estearin Siegert L-2-SM, polyethylene 23 lauryl ether, sorbitana monostearate, monooleate sorbitana, triethanolamine, propylene glycol, polyvidone, benzyl alcohol, 1,1,1,2-tetrafluoroethane (propelent 134a) purified water. 90 g - aluminum cylinders (1) with a spray of polypropylene and caps - packs cardboard.

Clinico-pharmacological group: NSAID for topical use.

Mechanism of action of NSAIDs for topical use, a derivative of ibuprofen. Inflammatory and analgesic action.

The mechanism of action of the drug is associated with inhibition of COX activity - the main enzyme metabolism of arachidonic acid, which is a precursor of prostaglandins.

Pharmacokinetics

Absorption

For exterior use mabuprofen absorbed, hydrolyzed, and which releases ibuprofen. Systemic bioavailability - up to 18%.

Distribution and metabolism

The binding of ibuprofen to plasma proteins is 90%. In the process of biotransformation formed four metabolites: 2-p-(2-hydroxy-2-metilpropil) phenylpropionic acid, 2-p-(karboksipropil) phenylpropionic acid), 2-4 - (2-gidroksimetilpropil) phenylpropionic acid, 2-4 - (1-hydroxy-2-metilpropil) phenylpropionic acid.

Withdrawal

Urinary recovery up to 60%, about 9% - in the form of oxidized metabolites, to 17% - in the form of conjugated metabolites of oxidized, 16% - carboxylated metabolites, 19% - conjugated carboxylated metabolites.

Statement
inflammatory and degenerative diseases of the musculoskeletal system (including rheumatoid arthritis in remission, arthralgia rheumatism, gout / in the complex therapy / psoriatic arthritis, shoulder-scapular periarthritis, ankylosing spondylitis, osteoarthritis deformans, osteochondrosis with radicular syndrome , radiculitis, neuritis of the sciatic nerve, tendonitis, abscess, bursitis, pain in lower back);
injuries (including sports, industrial, household) without compromising the integrity of soft tissues (including sprains, strains or tears of muscles and ligaments, post-traumatic swelling of soft tissues);
myalgia (including rheumatoid genesis);
superficial phlebitis, periflebit (consisting of combined therapy).

Dosage regimen

The product should be applied to painful areas 2-3 times / day. Aerosol distribute to the painful area, ensuring full absorption foam, gently massaging the area, which caused the drug.

When applying the aerosol container should be kept in an upright position.

Side effect

Rare: erythema, burning sensation at the site of application of the drug. The drug is usually well tolerated.

Contraindications

Hypersensitivity to the drug's components.

Cautions

In applying the drug should be avoided contact with open wound surfaces and mucous membranes.

Overdose

For exterior use of the drug Aldosprey in connection with low systemic absorption of the active substance overdose is unlikely. If you accidentally taking the drug inside should consult with your doctor.

Treatment: If necessary, a symptomatic therapy.

Drug Interactions

Not found clinically significant drug interactions Aldosprey with other drugs.

Terms and Conditions of storage

The drug should be stored in a dark place at temperatures not above 30 ° C.

Shelf life - 3 years.

Aldecin

Composition, structure and packing

Nasal spray dose 1 dose - beclomethasone (in the form dipropionate) 50 mg

200 doses (8.5 g) - spray bottles (1) with a valve dispensing action - cartons.

Clinico-pharmacological group

SCS for inhalation and intranasal application

Pharmacological action

Beclometasone dipropionate - SCS has anti-inflammatory, antiallergic and immunosuppressive effect. Hinders the release of inflammatory mediators from mast cells, increases the production lipomodulina, is an inhibitor of phospholipase A, reduces the release of arachidonic acid inhibits the synthesis of metabolic products of arachidonic acid - Cyclic endoperekisey, prostaglandins. It reduces swelling and secretion of glands of the nasal mucosa, improves mucociliary transport. Virtually has no mineralocorticoid activity and resorptive effect after inhalation.

Pharmacokinetics

Absorption - low, an inhalation route of administration in recommended doses has no clinically significant systemic activity. After inhalation may ingestion of the administered dose with saliva. Most of the drug, got into the digestive tract, is inactivated at the first passage through the liver.

Relationship to plasma proteins - 87%. T1 / 2 - 15 h. The bulk of the drug (35-76%) is displayed for 96 h with fecal masses, mainly in the form of polar metabolites, 10-15% - the kidneys.

Indications for use of the drug
allergic rhinitis (seasonal or year-round);
vasomotor rhinitis;
polyposis of the nose (in a combination therapy).

Dosage regimen

Intranasal - in the form of inhalation.

Adults and teenagers 12 years: the recommended dose - 1-2 inhalations in each nostril 4, depending on the severity of symptoms. Children from 6 to 11 years: the recommended dose - 1-2 inhalations in each nostril 2, depending on the severity of symptoms. The maximum daily dose should not exceed 16 inhalations (0.8 mg) in adult and 8 inhalations (0.4 mg) in children aged 6 to 11 years. Upon reaching the therapeutic effect of the drug abolished, gradually reducing the dose.

Side effect

Allergic reactions (urticaria, pruritus, angioedema, skin redness), nose and throat infections caused by fungal flora, rhinorrhea, nasal bleeding, burning sensation or irritation of the mucous membrane of nose, dry nose, sneezing, a violation of smell, increased intraocular pressure, glaucoma, a violation of appetite, indigestion, nausea, diarrhea, headache, dizziness, hypertension, shortness of breath.

When using nasal GCS in large doses for a long time been cases perforation of the nasal septum. Side effects typical of systemic GCS may appear in the treatment of Aldetsinom if the drug is used in doses exceeding the recommended, or the patient has an increased sensitivity to the SCS, or have recently received systemic therapy of GCS. With the development of symptoms and side effects Aldetsin should be abolished, gradually reducing the dose.

Contraindications to the use of the drug
Hypersensitivity to any component of the drug;
tuberculosis (including latent) respiratory;
systemic infection (bacterial, fungal, viral, including infection caused by Herpes simplex eye affection);
recent surgery or trauma of the nose;
bleeding diathesis;
frequent nosebleeds;
Children up to age 6 (safety and efficacy of the drug in children under 6 years are not installed).

Pregnancy and lactation

Aldetsin can be used in pregnant and lactating women only if the possible benefits of treatment for women justifies the potential risk to the fetus or newborn. Infants of women who received SCS during pregnancy, should be explored to identify a possible reduction in adrenocortical function.

Application for violations of liver function

With care use in patients with severe hepatic insufficiency.

Cautions

Do not pierce the bottle nozzle needle or wire.

Need to protect the eyes from getting the drug.

Therapeutic effect Aldetsina, unlike the local vasoconstrictor agent for the treatment of rhinitis with intranasal application of slow onset. Relief of symptoms of rhinitis usually becomes apparent within a few days of starting treatment.

Patients in whom the therapy SCS may reduce immunity, it should warn about the dangers of contact with the patients of certain infections (eg chickenpox, measles) and the need for treatment to a doctor in case of such contact. This is especially important for children.

Because the drug slows the healing of wounds, patients who had recently undergone trauma or surgery of the nose, should not apply Aldetsin nasal spray to complete healing.

A guide for patients on the correct implementation of inhalation

Before the first use of nasal spray should be his "calibrated" by pressing the dispensing device 6-7 times. After the "calibration" set stereotyped presentation of the medicinal substance. If the spray is not used within 14 days or longer, before a new application is needed to double "calibration".

Prior to the inhalation of free nasal passages. Intensively shake flask. Insert the nasal applicator by holding it upright, into the nostril - in the direction of the inner corner of eye. In this second nostril should be closed, pressing a finger, and his head slightly tilted forward. Do not spray spray directly on the nasal septum.

Make a deep breath through your nose while pressing the spray and exhale through the mouth. Inhalation into the second nostril the same way.

To receive a single dose of 100 mg patients should make an inhalation by the above method twice.

Precautions

Opportunistic infections requiring antibiotics, hypertension, recent myocardial infarction, ulceration of the nasal septum, glaucoma, amebiasis, severe hepatic insufficiency, hypothyroidism, pregnancy, lactation.

Overdose

When used in very high doses can be observed systemic effects of GCS, including adrenal suppression and Cushing's symptoms. When these symptoms the dose should be reduced.

Drug Interactions

Clinically significant interactions of inhaled GCS with other drugs have been detected.

Phenobarbital, phenytoin, rifampicin and other inducers of microsomal oxidation of reduced efficiency.

Methandrostenolone, estrogens, beta 2-adrenostimulyatorov, theophylline, and oral appointed SCS reinforcing effect. Increases the effect of beta-adrenostimulyatorov.

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Drug prescription.

Terms and Conditions of storage

Keep out of reach of children, at a temperature not above 25 ° C.

Shelf life - 3 years. Do not use the drug after the expiry date.

Albumin human

Composition, structure and packing

Solution for infusion of 5% transparent, from nearly colorless to light yellow, yellow or light green.

1 ml - plasma proteins in human blood of 50 mg, including Human albumin is not less than 96%

Excipients: sodium chloride, atsetiltriptofan, caprylic acid, hydrochloric acid, sodium hydroxide, water d / and.

Solution for infusion 20% transparent, from nearly colorless to light yellow, yellow or light green.

1 ml - plasma proteins in human blood 200 mg, including Human albumin is not less than 96%.

Excipients: sodium chloride, atsetiltriptofan, caprylic acid, hydrochloric acid, sodium hydroxide, water d / and.

Clinico-pharmacological group

Preparation of human albumin.

Pharmacological action

Plazmozameschayuschy preparation obtained by fractionation of human plasma.

Albumin solution 5% is izoonkoticheskim plasma. 20% albumin solution is hyperoncotic, and its colloid-osmotic effect than that of the plasma at about 4 times. When i / v injection of the drug increased oncotic pressure in the intravascular space, which leads to an increase and maintenance of BCC. The duration of this effect in different patients may vary. Some patients have increased plasma volume may persist for several hours. Albumin is also a transport protein that binds and suffering in the vascular bed hormones, enzymes, drugs.

Pharmacokinetics

Distribution

Normally, the total exchange fraction of albumin is 4-5 g / kg body weight, so that the amount of 40-45% are located in the vascular bed, and 55-60% - in the extravascular space. In pathological conditions (severe burns or septic shock) albumin normal distribution is violated, which is associated with a significant increase in capillary permeability.

Metabolism and excretion

T1 / 2 of albumin is approximately 19 days. Withdrawal takes place intracellularly with the participation of lysosomal protease.

In healthy volunteers less than 10% in / imposed albumin is derived from the vascular bed during the first 2 h after infusion. However, patients are in critical condition and may lose significant amounts of albumin, the rate of loss from the vascular bed is unpredictable.

Indications for use of the drug
replenishment and maintenance of BCC in cases where there is lack of it, and shows the use of colloidal solutions, in particular, with hypovolemic and hemorrhagic shock;
Therapeutic plasmapheresis (plasma exchange replacement);
as an aid in operations with extracorporeal circulation;
hemodilution and preoperative autologous blood procurement of components;
swelling of the brain (hyperoncotic solution).

Dosage regimen

The concentration of the drug, dose and infusion rate should be chosen individually in each case.

The dose required for the introduction, depending on body weight, severity of injury or disease and the continued loss of fluid and protein. To determine the required dose should assess the adequacy of BCC, but not the level of albumin in plasma.

Albumin solution is introduced into / in the drip. Infusion rate should be chosen depending on the patient's condition and evidence.

For the 5% albumin solution average single dose of 200-300 ml, the maximum dose - 500-800 ml. The recommended rate of introduction - no more than 60 drops / min.

For 20% albumin solution single dose of 100 ml. The recommended rate of introduction - no more than 40 drops / min.

In exchange replacement of plasma infusion rate may be higher and should correspond to removal rate.

In children a dose of the drug set individually, taking into account the evidence of the clinical condition and body weight. The recommended single dose of 0.5-1 g / kg. The drug can be used in preterm infants.

The drug can be used in patients who are on hemodialysis.

Recommendations for the Treatment of drug

Before applying the solution of the drug should be carefully inspected. If the solution is cloudy or contains inclusions, it can not be used because Similar changes may be evidence of the decay of the protein or microbial contamination.

Before the introduction of the drug shall be stored at room temperature. The drug should be administered immediately after opening the vial. The unutilized balance of the drug to be eliminated.

20% albumin solution may be diluted if necessary with normal saline or 5% dextrose (glucose). For this purpose, can not use the water for injection.

Side effect

During the period of post-registration of the drug were observed following adverse reactions.

The frequency of adverse reactions are classified as follows: very common (> 1 / 10), frequently (> 1 / 100, <1> 1 / 1000, <1> 1 / 10 000 , <1 / 1000); very rarely (<1 / 10 000, including isolated reports).

In applying the drug adverse reactions are rare. They usually go alone with a decrease in the rate or discontinue the drug. In severe reactions the introduction should stop and start the appropriate treatment.
On the part of the immune system: rare - anaphylactic reaction, very rare - anaphylactic shock.
On the part of the nervous system and psyche: a very rare - headache, confusion.
Since the cardiovascular system: rarely - hypotension, very rarely - tachycardia, bradycardia, hypertension, flushing of the face.
On the part of the respiratory system: very rarely - shortness of breath.
On the part of the digestive system: very rarely - nausea.

Dermatological reactions: very rare - urticaria, angioedema, erythematous rash, increased sweating.

Other: very rarely - fever, shivering, pain in the lumbar region.

Contraindications to the use of the drug
Chronic heart failure in the stage of decompensation;
pulmonary edema;
severe anemia
hypervolemia;
hypersensitivity to albumin or other components of the drug.

Precautions should use the drug in patients with chronic renal failure, congestive heart failure in the compensation phase, the chronic compensated anemia, hypertension, varicose veins of the esophagus, a hemorrhagic diathesis, thrombosis, the ongoing internal bleeding.

In elderly patients to avoid overloading the cardiovascular system are advised to avoid the introduction of 20% solution, and the introduction of 5% solution to avoid the introduction of high speed.

Pregnancy and lactation

Safety of the drug in pregnant women in controlled clinical studies have not been studied. Experience of clinical application of albumin solution does not give grounds to expect any adverse effects on pregnancy, the fetus or newborn, because human albumin is a normal component of human blood plasma.

Effect on reproductive function in animals not studied.

Application for violations of renal function

The drug can be used in patients who are on hemodialysis.

Cautions

If you have any allergic or anaphylactic reactions should immediately stop the introduction of the drug and start appropriate treatment. In the case of shock should begin antishock treatment in accordance with current standards of treatment.

When an infusion is necessary to ensure a thorough and regular monitoring of blood parameters, including Blood pressure, heart rate, central venous pressure, "wedge" in the pulmonary artery, diuresis, electrolyte concentration in the plasma, hematocrit / hemoglobin.

With the introduction of albumin solution should monitor the concentration of sodium and potassium in the blood plasma of the patient and take appropriate measures to restore or maintain the balance of these electrolytes. It should be borne in mind that the concentration of sodium in 5% and 20% solutions of the same.

If necessary, replace the relatively large volumes of required monitoring parameters of blood coagulation and hematocrit. There should be an appropriate replacement of other blood components (coagulation factors, electrolytes, platelets and red blood cells).

Introduction albumin solution during dehydration is possible only after preliminary ensure sufficient revenue fluids (oral, parenteral).

Since 20% solution of albumin is able to effectively raise the colloid-osmotic pressure in the process of its introduction should monitor the patient for timely detection of circulatory overload and hyperhydration.

Albumin solution can be diluted with water for injection, since the introduction of such a solution to the patient may cause hemolysis.

Standard measures to prevent infections caused by the use of medicines made from human blood or plasma include selection of donors, testing of individual servings and plasma pools for specific markers of infection and integration into the production of effective measures to inactivation / elimination of viruses. Nevertheless, the application of medicines made from blood or human plasma, we can not completely exclude the probability of transmission of infections. This also applies to unknown or newly identified viruses and other pathogens.

There were no reports of transmission of viruses with solutions of albumin produced by standard methods in accordance with the specifications of the European Pharmacopoeia.

For each patient the introduction of the drug is recommended that the name of the drug and the number of series in the history of the disease or the medical records of patients in order to be able to trace the relationship between the patient's condition with the introduction of the preparation of the series.

Effects on ability to drive vehicles and management mechanisms

There were no effects of the drug's ability to drive vehicles and operate machinery.

Overdose

Symptoms: In cases where the dose and infusion rate too high or do not match the patient's circulatory system may develop hypervolemia and its typical symptoms of overloading the cardiovascular system (shortness of breath, swelling of the jugular veins, headache). It is also possible rise in blood and / or central venous pressure, the development of pulmonary edema.

Treatment: at the first appearance of symptoms of overloading the cardiovascular system should immediately stop the introduction of the drug and to establish a permanent monitoring of parameters of blood circulation. According to the testimony - the holding of symptomatic therapy. The specific antidote is available.

Drug Interactions

Specific interaction of human albumin with other drugs is unknown.

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Drug prescription.

Terms and Conditions of storage

The drug should be kept away from children, protected from light at 2 ° to 25 ° C Do not freeze. Shelf life - 3 years.

Albetor

Composition, structure and packing

Solution for i / in the introduction of transparent, colorless or slightly colored.

1 ml.

butilaminogidroksipropoksifenoksimetil metiloksadiazol (proksodolol) 10 mg.

Other ingredients: citric acid, sodium citrate, d / and the water d / and.

Clinico-pharmacological group: Alpha-, beta-blocker.

Pharmacological action

Non-selective alpha-and beta-blocker. Has antihypertensive, antianginal and antiarrhythmic effect refers to antiarrhythmic drugs of Class II. Slows heart rate, dilates blood vessels, reduces TPVR and reduces the minute volume of blood.

Pharmacokinetics

Data on the pharmacokinetics Albetor not available.

Statement
hypertensive crisis (docking).

Dosage regimen

The drug is introduced into / in the jet or drip.

V / a jet injected at a dose of 10-20 mg (1-2 ml of 1% solution / 10 mg / ml) for 1 min.

If necessary, repeat the introduction at intervals of 5 minutes prior to the development effect.

The maximum dose - 50-100 mg (5-10 ml 1% solution / 10 mg / ml).

In / in infusions at a dose of 50 mg (5 ml of 1% solution / 10 mg / ml) in 200 ml of isotonic (0.9%) sodium chloride solution or 5% dextrose (glucose) at a rate of 0.5 mg (2 ml infusion solution ) in the minutes before receiving a positive reaction.

Side effect

Since the cardiovascular system: bradycardia, excessive lowering of blood pressure, cold extremities, leg bundle branch block, AV-block.

On the part of the digestive system: nausea, dry mouth, stomachalgia.

From the side of the central nervous system: dizziness, headache. Allergic reactions: local or generalized rash, urticaria.

Other: weakness, bronchospasm, increased contractility of the myometrium.

Contraindications
pronounced bradycardia;
AV-block II-III degree;
Chronic heart failure in the stage of decompensation;
cardiogenic shock;
hypotension;
COPD;
asthma;
simultaneous reception of MAO inhibitors;
Pregnancy
Lactation (breastfeeding);
age of 18 years (effectiveness and safety have not been studied);
Hypersensitivity to the drug's components.

Precautions should be used with AV-blockade of I degree, chronic heart failure, gastric ulcer and duodenal ulcer, diabetes mellitus type 1 (insulin-dependent).

Pregnancy and lactation

The drug is contraindicated during pregnancy and lactation (breastfeeding).

Cautions

When i / v injection of the drug requires strict control of blood pressure, heart rate, ECG.

Overdose

Symptoms: marked reduction of blood pressure, bradycardia (runs 10-20 min after the administration), ventricular premature beats, increased symptoms of heart failure, bronchospasm.

Treatment: transfer the patient in position with raised upside down, an oxygen therapy. When bradycardia - atropine sulfate or dobutamine in / may / v introduction of glucagon or epinephrine, holding transvenous pacing.

In marked decrease in blood pressure - in / to the introduction plazmozameschayuschih solutions (in the absence of pulmonary edema) and under the control of blood pressure - vasoconstrictor agent (epinephrine, norepinephrine, dopamine or dobutamine). If bronchospasm - isoprenaline and theophylline. With heart failure - cardiac glycosides and / or glucagon and diuretics. When ventricular arrhythmia - lidocaine or phenytoin.

Drug Interactions

Other alpha-and beta-blockers increase the hypotensive effect Albetora. With simultaneous application of Albetora with cardiac glycosides, methyldopa, reserpine and guanfatsinom, blockers of slow calcium channels (verapamil, diltiazem), amiodarone and other antiarrhythmics increased risk of developing or worsening of bradycardia, AV-blockade, possible cardiac arrest.

With simultaneous use of the drug with nifedipine, diuretics, clonidine sympatholytic, hydralazine and other antihypertensive therapy may be an excessive blood pressure reduction.

Albetor increases the duration of nondepolarizing muscle relaxants and anticoagulant effect of coumarins.

With the simultaneous use of three-and tetracyclic antidepressants, antipsychotic drugs (neuroleptics), ethanol, sedatives and hypnotics increased the inhibitory effect on the CNS.

With the simultaneous use of MAO inhibitors observed significant increase in the hypotensive action (simultaneous use of contraindicated

Terms and Conditions of storage

The drug should be stored out of reach of children, protected from light at temperatures from 5 ° to 25 ° C.

Shelf life - 2 years.

Albarel

Composition, structure and packing

Tablets are round, biconvex, white, engraved on both sides of the symbol "I".

1 tab. rilmenidine dihydrogen 1.544 mg, which corresponds to the content of rilmenidine 1 mg

Excipients: sodium karboksimetilkrahmal, microcrystalline cellulose, lactose, wax, silicon dioxide, colloidal anhydrous, magnesium stearate, talc, white beeswax.

Clinico-pharmacological group: Selective imidazoline receptor agonists.

Antihypertensives.

Pharmacological action

Antihypertensive drug, a derivative oksazolina. Selectively interacts with imidazoline receptors (I1) of cortical and peripheral vasomotor centers, in particular renal centers. Linking rilmenidine with imidazoline receptors inhibits sympathomimetic activity in both cortical and peripheral centers, which leads to a decrease in blood pressure. Albarel provides a dose-dependent hypotensive effect on systolic and diastolic BP in the supine position and standing.

Shown that the use of the drug Albarel in therapeutic doses (1 or 2 mg / day) effective in treating mild to moderate hypertension. The action of the drug lasts for 24 hours, effective during exercise. Prolonged use of addictive is not developed. In therapeutic doses Albarel not affect the function of the heart, does not cause sodium and water retention, does not violate the metabolic balance. Albarel reduces TPVR without changes in cardiac output. Myocardial contractility and electrophysiological indices remain unchanged. Albarel not cause orthostatic hypotension (including elderly patients) does not violate the compensatory physiological responses of heart rate to physical exercise, no effect on renal blood flow, glomerular filtration and filtration fraction; no effect on carbohydrate and lipid metabolism (in m . hours in patients with insulin and insulin-dependent diabetes mellitus).

Pharmacokinetics

Absorption

After taking the drug inside rilmenidine is rapidly and completely absorbed from the gastrointestinal tract. After receiving a single assay in a dose of 1 mg Cmax in plasma achieved after 1.5-2 h and is 3.5 ng / ml. The absolute bioavailability is 100% not subject to the effect of "first pass" through the liver. Absorption is the same in different patients: interindividual changes are not marked. Simultaneous food intake does not affect the bioavailability.

Distribution

Plasma protein binding is less than 10%. Vd - 5 l / kg. After the repeated application of the equilibrium state is established with the third day of the regular treatment. In patients with hypertension receiving treatment within 2 years, the concentration assay in plasma remains stable. Provided with breast milk.

Metabolism

Albarel biotransformiruetsya slightly.

Metabolites detected in trace amounts in urine and are the result of hydrolysis or oxidation oksazolinovogo ring. These metabolites are not α2-adrenoceptor agonists.

Removing 65% of applied dose excreted unchanged in the urine. Renal clearance is 2 / 3 of the total clearance. T1 / 2 by 8 h does not change when re-appointment.

Pharmacokinetics in special clinical cases of T1 / 2 in persons aged 70 years and older is 13 ± 1 h.

Patients with hepatic insufficiency T1 / 2 was 12 ± 1 h. Since the elimination of the drug occurs mainly by the kidneys in patients with impaired renal function has slowed elimination of the drug, which correlates with the spacecraft. In patients with severe impaired renal function (CC less than 15 ml / min) T1 / 2 is about 35 hours

Statement
hypertension. Dosage regimen recommended dose assay is 1 mg / day (1 tab.) Morning. If blood pressure is reduced enough after one month of treatment, the dose may be increased to 2 mg / day in 2 divided doses (1 tab. In the morning and 1 tab. In the evening during meals). In patients with renal insufficiency mild to moderate severity (spacecraft more than 15 ml / min) did not require correction dose. Treatment is long.

Side effect
From the side of the central nervous system: possible asthenia, insomnia, drowsiness, increased fatigue during physical exertion, and in rare cases - anxiety, depression, convulsions.
Since the cardiovascular system: heart, in isolated cases - cold extremities, orthostatic hypotension.
On the part of the digestive system: epigastric pain, dry mouth, diarrhea, and in rare cases - nausea, constipation.

Dermatological reactions: seldom - skin rash, itching. Other: In isolated cases - peripheral edema, hot flushes, disturbed sexual function.

Side effects are rare, usually mild and are transient.

Contraindications
pronounced depression;
renal failure, severe (CC <15 ml / min);
Pregnancy
lactation (breastfeeding);
Hypersensitivity to the drug.

Pregnancy, Lactation

The drug should not be given during pregnancy and lactation (breastfeeding) because of the lack of sufficient clinical data. In experimental studies have not observed teratogenic and embryotoxic effects.

Application for violations of renal function

In patients with renal insufficiency mild to moderate severity (spacecraft more than 15 ml / min) did not require correction dose.

Contraindicated in severe renal insufficiency (CC <15 ml / min).

Cautions

Administration of these drugs to patients after a recent stroke, myocardial infarction requires periodic medical monitoring. Thanks to good assay can be assigned to the testimony of elderly patients and patients with concomitant diabetes mellitus.

If you want to stop treatment the dose should be reduced gradually, although it is unlikely that the removal of the drug will be accompanied by any side effects.

Avoid co-administration assay with MAO inhibitors. During the course of treatment is not recommended to drink alcohol. Use in pediatric clinical data on the safety and efficacy of the drug in children under the age of 18 years is not enough, so the drug should not be given this category of patients.

Effects on ability to drive vehicles and management mechanisms Albarel in therapeutic doses has no effect on psychomotor reaction.

If the drug is prescribed in doses exceeding the therapeutic or in combination with drugs, depressing the central nervous system activity, should notify patients - drivers and patients dealing with other potentially dangerous activities, to the possibility of drowsiness.

Overdose

Symptoms: marked hypotension, mental disorders.

Treatment: gastric lavage, then - sympathomimetic therapy. Rilmenidine bad output in hemodialysis.

Drug Interactions

Appointment assay with tricyclic antidepressants reduce its antihypertensive effect.

Effect of assay reinforce vasodilators, diuretics and antihistamines. When combined with the use of drugs, have a depressing effect on the CNS, possibly increased sleepiness.

Terms and Conditions of storage

The drug should be stored out of reach of children at or above 30 ° C. Shelf life - 2 years.

Alflutop

Composition, structure and packing

Solution for injection 1 amp. The bioactive concentrate shallow marine fish (sprat (Sprattus sprattus sprattus), whiting Black Sea (Odontogadus merlangus euxinus), Black Sea shad (Alosa tanaica nordmanni), Black Sea anchovy (Engraulis encrassicholus ponticus)) 100 ml

Excipients: Water d /, and phenol (max. 5 mg / 1 ml).

Clinico-pharmacological group: The drug, which improves the metabolism in cartilage.

Pharmacological action

The drug, which regulates the metabolism of cartilage tissue, chondroprotector. It is a concentrate of bioactive shallow marine fish containing mucopolysaccharides (chondroitin sulfate), amino acids, peptides, ions of sodium, potassium, calcium, magnesium, iron, copper and zinc. Alflutop prevents the destruction of macromolecular structures of normal tissues, stimulates regeneration processes in interstitial tissue and tissue of the articular cartilage, which explains its analgesic action.

Anti-inflammatory effect and tissue regeneration based on the inhibition of hyaluronidase activity and normalization of the biosynthesis of hyaluronic acid. These effects are synergistic and cause the activation of metabolic processes in tissues, particularly cartilage tissue, hindering the processes of degeneration.

Pharmacokinetics

Effects of extract of marine organisms is the combined effect of its active components, so the study of pharmacokinetic properties is not possible.

Statement
primary and secondary osteoarthritis of different localization (including coxarthrosis, gonarthrosis, arthrosis small joints);
spondylosis;
osteochondrosis.

Dosage regimen

The drug is prescribed for adults.

When poliosteoartroze and osteochondrosis Alflutop injected deep into the / m and 1 ml / day. The course of treatment - 20 injections - 1 injection per day for 20 days.

When a primary lesion of the large joints drug injected into the joint of 1-2 ml in each joint with an interval between injections of 3-4 days.

The course of treatment - 5-6 injections in each joint. Perhaps a combination of V / m and intraarticular injection. The course of treatment is advisable to repeat in 6 months.

Side effect

Rare: dermatitis, itching, redness, burning sensation at the injection site, short-myalgia. Very rare: anaphylactic reaction. In some cases: transient amplification of pain (when intraarticular injection).

Contraindications
Pregnancy
Lactation (breastfeeding);
childhood;
Hypersensitivity to the drug's components.

We do not recommend use of the drug in children because of lack of data from clinical studies in this patient.

Pregnancy and lactation

The drug is contraindicated during pregnancy and lactation.

Cautions

In the case of individual intolerance of seafood (sea fish) increases the risk of allergic reactions.

Overdose

Symptoms: in predisposed patients may be allergic reactions, sometimes severe course.

Treatment: removal of preparation, conduct of symptomatic therapy.

Drug Interactions

To date, drug interactions drug Alflutop not installed.

Terms and Conditions of storage

The drug should be stored out of reach of children, protected from light at temperature of 15 ° to 25 ° C.

Shelf life - 3 years.

Altacid

Composition, structure and packing

Chewable tablets are round, flat on both sides, white or white with a yellowish tint, with a smooth surface, with the smell of menthol.

1 tab. dried aluminum hydroxide gel 333.3 mg, corresponds to 167.5 mg of aluminum hydroxide magnesium oxide, 158.4 mg.

Excipients: mannitol, talc, povidone, macrogol 4000, mint flavor, magnesium stearate, sodium saccharin.

Oral suspension of white color, the smell of menthol.

5 ml of aluminum hydroxide gel 10% 2249.5 mg, corresponds to the aluminum hydroxide 225 mg of magnesium hydroxide paste 30% 425 mg, magnesium hydroxide corresponds to 127.5 mg.

Excipients: sorbitol 70% (non-crystalline), metilparagidroksibenzoat, mint flavor, propilparagidroksibenzoat, distilled water. Clinico-pharmacological group: antacid drug.

Pharmacological action

Combination antacid drug. Neutralizes free hydrochloric acid in the stomach, lowers peptic activity of gastric juice.

Is also absorbent and protective action by reducing the impact of damaging factors on the mucous membrane.

Statement
acute gastritis;
hyperacid gastritis;
Acute duodenitis;
stomach ulcer and duodenal ulcer exacerbation;
symptomatic ulcers of various origins;
erosion of the mucous membrane of the upper GIT;
hiatal hernia;
reflux esophagitis;
acute pancreatitis, exacerbation of chronic pancreatitis;
hyperphosphatemia;
epigastric pain and heartburn in some gaps in your diet, taking drugs, excessive use of coffee, alcohol, nicotine;
fermentation and putrefactive dyspepsia.

Dosage regimen

Adult drug appoint 1-2 pi. or 10-15 ml (2-3 teaspoons) of the suspension 4-6 times / day after 1 h after meals and at night.

Children aged 2 to 12 years half the dose prescribed for adults.

Tablets should be chewed thoroughly. The suspension was taken with sips of water or milk. Before you use a bottle with a suspension should shake.

Side effect

On the part of the digestive system: rarely - nausea, vomiting, changes in taste, constipation.

On the part of metabolism: long-term use in high doses - hypophosphataemia, hypocalcemia, hypercalciuria, osteomalacia, osteoporosis, gipermagniemiya, giperalyuminiemiya.

On the part of the urinary tract: long-term use in high doses - nephrocalcinosis, renal failure.

Other: encephalopathy, with concomitant renal failure - a thirst, blood pressure reduction, hyporeflexia.

Contraindications
chronic renal failure;
Alzheimer's disease;
hypophosphataemia;
Pregnancy
Hypersensitivity to the drug's components.

Pregnancy and lactation

Contraindicated use of the drug during pregnancy. During the period of lactation (breastfeeding) Altatsid should be used with caution.

Application for violations of renal function

Contraindicated in patients with chronic renal failure.

Cautions

It should comply with 2-hour interval between doses Altatsida and other medicines. Chronic administration Altatsida should ensure adequate intake of phosphorus.

Use in Pediatrics

Precautions should be appointed Altatsid children under the age of 12 years.

Overdose

Prolonged use of the drug in high doses can lead to intestinal dyskinesia, hypophosphataemia, osteomalacia, as well as the development of iron deficiency in the body, because aluminum phosphate binds iron.

Drug Interactions

At the same time receiving a Altatsidom decreases and slows absorption of indomethacin, salicylates, chlorpromazine, phenytoin, blockers of histamine H2-receptors, beta-blockers, diflunizala, isoniazid, tetracycline antibiotics, indirect anticoagulants, barbiturates.

M-holinoblokatory, slowing gastric emptying, enhance and prolong the action Altatsida.

Terms and Conditions of storage

The drug should be stored out of reach of children at or above 30 ° C. Shelf life - 2 years.

Alprostan

Composition, structure and packing

Concentrate for solution for infusion in the form of a transparent colorless liquid.

1 amp. alprostadil 100 mcg.

Excipients: ethanol - up to 0.2 ml.

Clinico-pharmacological group: preparation of prostaglandin E1, which improves peripheral circulation.

Pharmacological action

The preparation of prostaglandin E1. Has vasodilator and angioprotective action. It improves the microcirculation and peripheral circulation, causing vasodilation at the level of arterioles, precapillary sphincters, the arteries.

With the introduction intrakavernoznom relaxes smooth muscles of the corpora cavernosa, thereby increasing blood flow and improve microcirculation in them. When intra-arterial injection promotes the temporary preservation of a functioning ductus arteriosus in neonates. It improves the rheological properties of blood, increasing the flexibility of red blood cells.
Affect the process of blood clotting, reducing the adhesion and aggregation of platelets.
It has fibrinolytic effects and antiatherogenic properties, slowing the activation of neutrophils, excessive proliferation of cells of the vascular wall.
Reduces TPVR, blood pressure, reflex increases in heart rate, which leads to an increase in cardiac output.
It stimulates the smooth muscles of the intestine, bladder, uterus, suppresses the secretion of gastric juice.

Pharmacokinetics

Metabolism

Following in / introduction of alprostadil quickly biotransformiruetsya. For a single passage through the lungs is metabolized to 60-90%. When enzymatic oxidation formed three biologically active metabolite: 15-keto-PGE1, 15-keto-13 ,14-dihydro-PGE1 and 13,14-dihydro-PGE1. Keto-metabolites have a lower than alprostadilom pharmacological activity, and metabolite 13,14-dihydro-PGE1 - comparable. Pharmacodynamic effects of the drug is due mainly just that pharmacologically active metabolite.

Withdrawal

The main metabolites excreted in the urine (88%) and feces (12%). T1 / 2 alprostadil is about 10 seconds. T1 / 2 13,14-dihydro-PGE1 is about 1 min (α-phase) and 30 min (β-phase).

Statement
chronic obliterating peripheral arterial disease stage III-IV (Fontaine classification), accompanied by pain in the limbs at rest or trophic disturbances (occlusive disease with severe intermittent claudication, which is not shown surgery, atherosclerosis of arteries of extremities, Raynaud's syndrome with trophic ulcers, diabetic angiopathy , Berger disease, vasculitis in systemic sclerosis, violations of peripheral circulation as a result of exposure sverhpredelnymi vibration);
the need for temporary preservation of a functioning blood flow to the reconstructive cardiac surgery for congenital heart defects duktuszavisimyh newborns.

Dosage regimen

Adults with chronic obliterating arterial diseases Alprostan appointed in / infusion dose of 50-200 mg 1 time / day or in more severe states of 50-100 mg 2 times / day. The solvent used 200-500 ml of saline, 5% or 10% glucose solution. The duration of infusion - at least 2 h. The solution should be prepared immediately before administration.

Duration of therapy averaged 14 days, with the positive effect of treatment can continue for a further 7-14 days. The maximum duration of treatment - 4 weeks.

In the absence of a positive effect within 2 weeks of starting treatment continued use of the drug should be discontinued.

When congenital malformations in newborns duktuszavisimyh Alprostan injected by constant infusion through the large veins or through the umbilical artery directly into the mouth of the ductus arteriosus. The initial dose is 0.01-0.05 mg / kg / min.

If necessary, the dose may be increased to 0.1 mg / kg / min.

When the therapeutic effect of the dose is reduced to the minimum maintenance (0.01-0.02 mg / kg / min).

Terms of preparing infusion solution

At dilution of 1 mg (0.2 ml) of concentrate for infusion of 9.8 ml of solvent (5% or 10% glucose solution, saline solution) obtained a solution with a concentration of alprostadil mkg/10 100 ml.

The resulting solution can be further diluted with large amounts of solvent. Also note that the resulting infusion solution should be used immediately after preparation, probably deposited within 24 hours at a temperature of from 2 to 8 ° C.

Side effect

From the CNS: headache, dizziness, fatigue, feeling of malaise.

On the part of the digestive system: a feeling of discomfort, nausea, vomiting, diarrhea, increase in liver transaminases, hyperbilirubinemia.

Since the cardiovascular system: tachycardia, hypotension, seizures, angina, cardiac arrhythmias, AV-block, pulmonary edema, cardio-vascular insufficiency.

The part of the hemopoietic system: leucopenia, leukocytosis. Allergic reactions: urticaria.

Other: increased sweating, hyperthermia body, increasing the titer of C-reactive protein, prolonged treatment (from 4 or more weeks) - hyperostosis of tubular bones; hematuria. Local reaction: swelling of limbs, in the vein received infusions.

Babies: From CNS: irritability, convulsions, drowsiness.

On the part of the digestive system: peritoneal symptoms, hyperbilirubinemia, diarrhea.

Since the cardiovascular system: arterial hypotension, bradycardia, tachycardia, shock, acute heart failure, cardiac arrhythmias, AV-block.

The respiratory system: respiratory depression (up to apnea), lower respiratory function (bradypnea, tachypnea).

On the part of the hemopoietic system: DIC-syndrome, bleeding, thrombocytopenia, anemia.

From the urinary system: reduction of renal function, anuria, hematuria. Allergic reactions: skin rash, tachyphylaxis.

Other: hyper-or hypothermia of the skin, flushing of the skin, hypo-or hyperglycemia, hypertonicity of the neck muscles, hypercapnia. With long-term therapy (several weeks) may cause hyperostosis of the bones of the lower extremities. With the development of side effects dose should be reduced.

Contraindications
acute and subacute myocardial infarction;
severe or unstable form of angina pectoris;
bronchial obstruction with signs of severe respiratory failure, edema or infiltrative changes in the lungs;
marked disturbances of liver function;
state, characterized by risk of bleeding (peptic ulcer and duodenal ulcer in acute, severe carotid arteries, proliferative retinopathy with a tendency to bleeding, major trauma);
co-administration of vasodilator and anticoagulant funds;
Pregnancy
lactation (breastfeeding);
Hypersensitivity to alprostadilu;
the age of 18 years (except for the neonatal period) and over 75 years.

In neonatology:
inhibition of respiratory function;
respiratory distress syndrome;
state of spontaneous staunchly ductus arteriosus;
Hypersensitivity to alprostadilu.

Pregnancy and lactation

Alprostan contraindicated in pregnancy. If necessary, use during lactation should decide on the termination of breastfeeding.

Application for violations of liver function

Contraindications disturbancies liver function.

Application for violations of renal function

In patients on hemodialysis treatment for drug should be conducted in postdializnom period.

Cautions

Particular caution should be exercised when administering the drug to patients with arterial hypotension, cardiovascular disease (should take into account the volume of infusion solution, increased infusion should be limited to patients with severe heart failure due to the risk of developing pulmonary edema and possible heart failure), in elderly patients with insulin-dependent diabetes mellitus, especially in extensive vascular damage, with the appointment of newborns in the case bradypnea, arterial hypotension, tachycardia, hyperthermia.

During treatment Alprostanom need to monitor hemodynamic parameters, acid-base balance, blood biochemistry parameters of coagulation (disorders of blood coagulation system or while taking medications that affect blood clotting).

In order to avoid the onset of symptoms in these patients overhydration volume of fluid injected, if possible, should not exceed 50-100 mg / day. Need dynamic monitoring of the patient (control of blood pressure, heart rate), if necessary - control of body weight, fluid balance, the measurement of central venous pressure, or echocardiography.

In the appointment of the drug for the treatment of chronic obliterating arterial diseases should be aware that therapy Alprostanom is a necessary part of complex treatment.

Clinical effect of long-term nature and can occur with some delay after the end of treatment. In patients on hemodialysis treatment for drug should be conducted in postdializnom period. The newborn drug should be used under the constant supervision of blood pressure in the presence of conditions for mechanical ventilation.

Overdose

Symptoms: reduction of blood pressure, flushing of the skin, weakness.

Treatment: infusion should be slowed down or stopped. Necessary for the specific treatment, there is usually no. If you suspect depression of the respiratory center in newborns should resort to artificial ventilation.

Drug Interactions

With simultaneous application Alprostana with anticoagulants and antiagregantami increased risk of bleeding. With simultaneous application Alprostan intensifies the effect of antihypertensive agents and vasodilators.

Pharmaceutical interactions

Concentrate for infusion pharmaceutically incompatible with other solutions (except for normal saline, 5% and 10% dextrose).

Terms and Conditions of storage

The drug should be stored in a dry, dark place at temperatures from 1 ° to 5 ° C; not freeze. Shelf life - 2 years. The prepared solution should be stored no longer than 24 hours at a temperature of 2 ° to 8 ° C.

Allopurinol-Egis

Composition, structure and packing

Tablets are round, flat, white or grayish-white color.

Tablets are round, flat, white or grayish-white color.

1 tab. allopurinol 300 mg.

Clinico-pharmacological group: drugs affecting the exchange of uric acid.

Arthrifuge drug.

Pharmacological action

Arthrifuge drug. Allopurinol - an inhibitor of xanthine oxidase - an enzyme catalyzing the conversion of hypoxanthine to xanthine and xanthine to uric acid, an end product of purine metabolism in humans. Allopurinol inhibits the oxidation of endogenous purines xanthine oxidase, as a result of the concentration of uric acid in serum and urine decreased, and excretion of xanthine and hypoxanthine in the urine increases.

The drug reduces the content of uric acid in the blood and prevents the deposition of acid and its salts in the tissues and the kidneys.

This drug is effective both in primary (gout), and secondary hyperuricemia.

Pharmacokinetics

Absorption

After oral allopurinol is well and rapidly absorbed into the blood. Cmax of allopurinol in the blood plasma are usually achieved in 1-1.5 h after ingestion.

Distribution

Neither allopurinol nor oksipurinol not bind to plasma proteins and distributed in the tissue fluid.

Metabolism

Allopurinol is rapidly converted to oksipurinol - the active metabolite with a longer T1 / 2 - 15 h. The metabolic conversion of allopurinol under the influence of xanthine oxidase occurs at high speed and the ratio of allopurinol to oksipurinolu in plasma is rapidly changing.

Withdrawal

About 20% of the dose excreted in the feces. Allopurinol excreted mainly in urine. T1 / 2 allopurinol - about 2 hours

Renal clearance of high due to glomerular filtration.

After a 5-7-day oral administration of allopurinol 60-70% of the dose is determined in the urine in the form of oksipurinola. 6-12% is excreted in the urine as unchanged allopurinol. Only a very small portion (about 3% of the dose) is displayed in the form of allopurino-1-ribonucleoside or oksipurino-7-ribonucleosides.

Pharmacokinetics in special clinical situations

In patients with renal insufficiency and uric acid output oksipurinol bad. In gouty nephropathy dose of allopurinol should be reduced in order to maintain an adequate level oksipurinola for inhibiting xanthine oxidase. There are charts for calculating adequate doses of allopurinol in violation clearance oksipurinola.

Statement
gout;
treatment of primary hyperuricemia;
prevention and treatment of urate nephropathy with signs of gout or without them;
treatment of secondary hyperuricemia associated with blood diseases;
prevention and treatment of secondary hyperuricemia which develops during radio-and / or chemotherapy for leukemia, lymphoma and other malignant diseases;
prevention and treatment giperurikozurii.

Dosage regimen

Drugs are taken by mouth after meals, drinking plenty of water. Daily urine volume should be higher than 2 liters, and the reaction of urine - a neutral or slightly alkaline. For adults the initial dose is 100-300 mg 1 time / day.

If necessary, the daily dose can be gradually increased to 100 mg every 1-3 weeks to achieve the desired effect under the control of the content of uric acid in blood serum.

Maintenance dose is usually 200-600 mg / day, but if necessary it can be increased to 800 mg / day. If the daily dose exceeds 300 mg, it should be shared equally by 2-4 single admission.

The prevention of hyperuricemia in tumor therapy for 1-2 days before the beginning Allopurinol-Aegis administered in doses of 600-800 mg daily for 2-3 days.

Maintenance dose of allopurinol depend on the level of uric acid.

Children with secondary hyperuricemia in malignant blood diseases and tumors, as well as changes in enzymatic activity of the drug administered in daily doses at the rate of 10-20 mg / kg body weight. The choice of a daily dose is given the size of the tumor, the number of blast forms in the peripheral blood and bone marrow infiltration.

Side effect
On the part of the digestive system: nausea, vomiting, abdominal pain, diarrhea, rarely - granulomatous hepatitis, transient disturbances of liver function with increased levels of alkaline phosphatase, transaminases, blood.
On the part of the hemopoietic system: possible thrombocytopenia, eosinophilia, leukopenia, leukocytosis, aplastic anemia, hemolytic anemia, reticulocytosis, lymphocytosis.
On the part of metabolism: at the beginning of treatment may develop an acute attack of gout because of the mobilization of uric acid from gouty nodules and other tissue depots.
Since the cardiovascular system: rarely - vasculitis, pericarditis, bradycardia, thrombophlebitis.
From the side of the central nervous system: possible neuritis, sleep disorders, depression, amnesia.
On the part of the organ of vision: can katarkta, conjunctivitis, amblyopia.
On the part of the urinary system: rarely - interstitial nephritis, hematuria, proteinuria, peripheral edema. Allergic reactions: possible rash, fever, rarely - bronchospasm.

Patients with liver disease or kidney may itch, Makulo-papular lesions, purpura, rarely - exfoliative dermatitis, accompanied by fever, lymphadenopathy, arthralgia, and eosinophilia, similar to Stevens-Johnson syndrome and / or Lyell's syndrome.

These reactions require the discontinuation of the drug and treatment with corticosteroids.

Contraindications
severe liver problems;
severe renal dysfunction (azotemia);
Primary (idiopathic) hemochromatosis (or its presence in the family history);
acute attack of gout;
Pregnancy
lactation (breastfeeding);
Hypersensitivity to allopurinol.

Pregnancy and lactation

Allopurinol-Aegis is contraindicated in pregnancy and lactation (breastfeeding).

Cautions

In order to prevent acute attacks of gout, which can be triggered by the use of allopurinol, in addition to it within 1 month from the start of treatment should be prescribed NSAIDs or colchicine.

Elderly patients with hepatic or renal insufficiency the dose should be reduced in connection with an increased risk of intoxication.

In the first 6-8 weeks of treatment, regular liver function tests.

When blood diseases need regular monitoring of the laboratory parameters.

Precautions should be prescribed Allopurinol-Egis along with 6-mercaptopurine, azathioprine, methotrexate, cyclophosphamide, anticoagulants of indirect action, antipyrine, phenytoin, theophylline, hlorpropamidom, sulfinpirazon with iron preparations, thiazide diuretics, furosemide, ethacrynic acid, thiophosphamide.

Overdose

Symptoms: nausea, vomiting, diarrhea.

Treatment: Symptoms of intoxication are reduced by increasing the renal excretion of allopurinol and its metabolites with abundant fluid intake and consequently enhance diuresis. In the clinical setting can be used dialysis.

Drug Interactions
With simultaneous use of allopurinol with anti-Aegis means increased risk of hemopoietic system.
With the simultaneous use of allopurinol-Aegis with 6-mercaptopurine and azathioprine are the oppression of their metabolism and due to this increased toxicity.
With the simultaneous use of allopurinol-Aegis with methotrexate, cyclophosphamide, anticoagulants of indirect action, antipyrine, phenytoin, theophylline may enhance their effects (including side) in connection with the slowing of inactivation in the liver.
At simultaneous application with hlorpropamidom increased risk of persistent hypoglycemia in patients with impaired renal function.
At simultaneous application with sulfinpirazon decreases the effectiveness of allopurinol.
With simultaneous use of allopurinol-Aegis with iron supplementation may be the accumulation of iron in the liver.

Under the influence of thiazide diuretics, furosemide, ethacrynic acid, and thiotepa antigiperurikemicheskoe effects of allopurinol decreases, because These drugs increase levels of uric acid in blood serum.

Terms and Conditions of storage

The drug should be stored under normal conditions at room temperature (15 ° to 25 ° C). Shelf life - 5 years.

Allertec

Composition, structure and packing

Film-coated tablets: white to cream-colored, oblong, with one-sided separation mark.

1 tab. cetirizine dihydrochloride 10 mg.

Excipients: lactose, microcrystalline cellulose, corn starch, polyvinylpyrrolidone 25 magnesium stearate, oksipropilmetiltsellyuloza, sodium gluconate starch, silica gel, sodium lauryl sulfate, polyethylene glycol 6000.

Clinico-pharmacological group: blocker histamine H1-receptors.

Antiallergic drug.

Pharmacological action

Blocker of the peripheral histamine H1-receptors. Has anti-allergic effect. Does the early stage gistaminozavisimuyu allergic reactions, reduces the migration of eosinophils, restricts the release of inflammatory mediators in late, cell stage of allergic reactions. Prevents the development and facilitates during allergic reactions, has antipruritic effect.

Almost no anticholinergic and antiserotoninovogo action. In therapeutic doses does not cause a sedative effect. The maximum therapeutic effect is achieved within 4-8 hours after drug administration and lasts up to 24 hours

Pharmacokinetics

Absorption

After oral cetirizine rapidly and well absorbed from the gastrointestinal tract. Cmax plasma levels achieved after 30-60 min. Eating has no significant effect on the magnitude of absorption, but in this case the rate of absorption slightly reduced.

Distribution

Binding to plasma proteins is 93%. Vd is about 0.5 L / kg. Do not cross the BBB and into the cell. In applying the drug at a dose of 10 mg for 10 days accumulation of the drug is not observed.

Metabolism

Cetirizine poorly metabolized in the liver with the formation of an inactive metabolite.

Withdrawal

About 70% of applied dose cetirizine kidneys derived largely unchanged. After a single dose of a single dose of T1 / 2 is about 10 hours

Pharmacokinetics in special clinical situations

In children aged 2 to 12 years T1 / 2 of 5-6 h. The renal dysfunction (QA least 11-31 ml / min) and in patients on hemodialysis (CC less than 7 ml / min), T1 / 2 increased by 3 times, clearance is reduced by 70%.

In chronic diseases and elderly patients indicate an increase in T1 / 2 by 50% and a decrease in clearance by 40%.

Statement
seasonal and perennial allergic rhinitis;
allergic conjunctivitis;
pollinosis (hay fever);
urticaria (including chronic idiopathic);
pruritic allergic dermatitis (in t.ch atopic dermatitis, atopic dermatitis);
Quincke's edema.

Dosage regimen

Adults and children over 12 years prescribed 10 mg (1 tab.) / Day.

Children aged 6 to 12 years drug prescribed 5 mg (1 / 2 pi.) 2 times a day, morning and evening, or 10 mg (1 tab.) 1 times / day.

In renal insufficiency the dose should be reduced in 2 times.

When violations of the liver dose picked individually, especially when simultaneous kidney failure. Elderly patients with normal renal function, dose adjustment is required. The drug can be taken irrespective of food intake, preferably in the evening.

Tablets should be swallowed whole without chewing, drinking a small amount of water.

Side effect

On the part of the digestive system: dry mouth, and in some cases - indigestion, abdominal pain, flatulence. From the side of the central nervous system: in some cases - headache, drowsiness, dizziness, agitation.

Allergic reactions: In rare cases - urticaria, angioedema, dyspnea (the patient should be warned about the need for immediate cessation of the drug).

The drug is generally well tolerated.

Contraindications
Children under 6 years
Pregnancy
Lactation (breastfeeding);
Hypersensitivity to the drug's components.

Precautions should be prescribed the drug in patients with chronic renal failure, moderate and severe (requires correction dosing regimen), as well as elderly patients (possibly reducing the glomerular filtration).

Pregnancy and lactation

Allertek not recommend use during pregnancy. If necessary, use during lactation should decide on the termination of breastfeeding.

Application for violations of liver function

Patients with severe hepatic impairment dose is reduced.

Application for violations of renal function

Patients with severe impaired renal function reduce the dose.

Cautions

Be wary prescribers elderly and patients with impaired liver function and / or kidneys. Patients should notify the need to inform your doctor about any side effects occur against a background of the drug.

Patients should notify the need to avoid the simultaneous application of Allerteka with other drugs without a prescription.

Data on the interaction of cetirizine with ethanol has not yet been received, even though this use of alcohol during treatment with the drug Allertek not recommended.

Use in Pediatrics

The drug should not be administered to children under 6 years.

Effects on ability to drive vehicles and management mechanisms

Be wary prescribers to patients involved in potentially hazardous activities that require attention and quickness of psychomotor reactions.

Overdose

Symptoms: drowsiness (with the single dose of the drug in doses exceeding 50 mg) in children - anxiety, irritability, possible anticholinergic effects (urinary retention, dry mouth, constipation).

Treatment: gastric lavage, activated charcoal method, with the need to spend symptomatically. Hemodialysis is ineffective.

Drug Interactions

With simultaneous application Allerteka with theophylline may increase the frequency of side effects.

Terms and Conditions of storage

The product should be stored in a dry, dark place at a temperature of 15 ° to 25 ° C. Shelf life - 4 years.

Allergodil

Composition, structure and packing

Nasal spray dose

1 dose azelastina hydrochloride 140 mg.

Excipients: disodium salt of EDTA x 2H2O, hydroxypropylmethylcellulose, citric acid, sodium phosphate dibasic dvenadtsativodny, sodium chloride, purified water.

Clinico-pharmacological group: antiallergic drug for local use in ENT practice.

Pharmacological action

Blocker histamine H1-receptor, a derivative ftalazinona. Has a strong and prolonged anti-allergic effect. It inhibits the synthesis or release of mediators involved in the early and late stages of allergic reactions (including leukotrienes, serotonin, platelet activation factor / PAF /), inhibits the release of histamine from mast cells activated by allergen, preventing bronchospasm caused by leukotrienes and PAF, reduces the number of cells and molecular adhesion of eosinophils.

With prolonged use at high doses was not observed clinically significant effect on azelastina interval QT.

Pharmacokinetics

Absorption and distribution

After 2 h after intranasal application in a daily dose of 560 micrograms azelastina concentration in plasma is about 0.65 ng / ml, in a daily dose of 1.12 mg - 1.09 ng / ml. Thus, the concentration azelastina in blood plasma is proportional to the dose of the drug. Despite increasing doses of systemic bioavailability after intranasal application of about 8 times lower than with oral azelastina a daily dose of 4.4 mg (therapeutic dose for treatment of allergic rhinitis).

After repeated intranasal administration of the drug in a daily dose of 560 micrograms Css azelastina in the blood plasma of healthy volunteers at about 0.27 ng / ml.

Repeated use of the drug in patients with allergic rhinitis leads to increased concentrations azelastina in plasma compared with healthy volunteers, suggesting a more pronounced systemic absorption (most likely due to increased permeability of the inflamed mucosa of the nasal cavity).

Metabolism

The concentration of active metabolite N-dismetilatselastina located on the lower limit of quantification of content or does not reach it (0.12 ng / ml).

Statement
seasonal rhinitis, rhinoconjunctivitis.

Dosage regimen

Allergodil inject one dose (140 mkg/0.14 ml) in each nostril 2 times / day, which corresponds to a daily dose of 560 micrograms azelastina. Allergodil apply to the disappearance of symptoms. Perhaps the prolonged use, but not more than 6 months.

Rules of the drug Allergodil
Remove the protective cap.
Before first use, click on the spray 2-3 times.
Vprysnutr 1 time in each nostril, while holding his head straight.
Again, wear the protective cap.

Side effect

Local reactions: in some cases - irritation of inflamed mucous membranes of the nose, dryness, burning, itching, sneezing, and in rare cases - nosebleeds.

Contraindications
Children under 6 years
Hypersensitivity to the drug's components.

Pregnancy and lactation

Allergodil not recommended for use in the I trimester of pregnancy and during lactation. In experimental studies, when used in doses many times higher than the therapeutic range, data on the teratogenicity azelastina not received.

Cautions

Improper use of spray with tilting the head back can cause a bitter taste in the mouth.

Overdose

So far, cases of overdosing Allergodil not reported.

Drug Interactions

Drug Interactions drug Allergodil not revealed.

Terms and Conditions of storage

The drug in the form of nasal spray should not be stored at a temperature below 8 ° C. Shelf life - 3 years.

After opening a bottle of spray should be used for no more than 6 months.

Allapanin

Composition, structure and packing

Tablets are white, biconvex, ploskotsilindricheskie.

1 tab. allapinine (hydrobromic salt alkaloid lappaconitine derived from a fighter and a fighter northern beloustogo) 25 mg.

Excipients: sugar, potato starch, calcium stearate.

Clinico-pharmacological group: antiarrhythmic drugs.

Pharmacological action

Class I antiarrhythmic agent. Blocks "fast" sodium channels of membranes of cardiomyocytes. It was slow AV-and intraventricular conduction, shortens the effective and functional refractory periods of atrial, AV-node, bundle of His and Purkinje fibers, did not affect the duration of the interval QT, the conductivity of AV-node in the anterograde direction, heart rate, blood pressure, myocardial contractility (for the initial absence of effects of heart failure). Not depresses automaticity of sinus node. There is no negative inotropic and hypotensive effect. Has a moderate spasmolytic, koronarorasshiryayuschee, anticholinergic, mestnoanesteziruyuschee and sedative effect. When administered effect develops in 40-60 minutes, reaching a maximum after 4-5 h and lasts 8 hours or more.

Pharmacokinetics

Absorption

Bioavailability is 40%. The drug undergoes the effect of "first pass" through the liver.

Distribution and metabolism

When administered Vd is 690 liters. Penetrates through the BBB.

Withdrawal

T1 / 2 of 1-1.2 h. Write the kidneys.

Pharmacokinetics in special clinical situations

Prolonged use may increase in T1 / 2. In chronic renal failure, T1 / 2 increases by 2-3 times, with cirrhosis of the liver - in 3-10 times.

Statement
supraventricular premature beats;
ventricular premature beats;
paroxysms of fibrillation and atrial flutter;
paroxysmal supraventricular tachycardia (including the syndrome WPW);
paroxysmal ventricular tachycardia (in the absence of organic heart disease).

Dosage regimen

Assign inside of 25 mg (1 tab.) 3 times / day. In the absence of therapeutic effect appoint 50 mg (2 tab.) 3-4 times / day. The maximum single dose - 150 mg daily dose - 300 mg. Duration of treatment is determined by your doctor. In chronic renal failure, severe reduction of the dose required allapinine. The drug is taken as 30 minutes before eating, drinking warm water. Before taking pills recommended crush.

Side effect

From the central nervous system and peripheral nervous system: dizziness, headache, feeling of heaviness in the head, ataxia, diplopia.

Since the cardiovascular system: possible congestion of the skin, violations AV-and intraventricular conduction, the appearance of sinus tachycardia (with prolonged use), arrhythmogenic effect.

Contraindications
AV-block II and III degree (without pacemaker);
Chronic heart failure;
hypertrophy of left ventricular (more than 1.4 cm);
the presence of infarction atherosclerosis;
marked disturbances of liver function;
pronounced renal dysfunction;
Pregnancy
lactation;
childhood and adolescence to 18 years;
Hypersensitivity to the drug.

With caution and under close medical supervision, starting treatment in hospital, should be applied to AV-blockade of I degree, violation of intraventricular conduction, SSS, bradycardia, severe circulatory disorders.

Pregnancy and lactation

The drug is contraindicated during pregnancy and lactation.

Application for violations of liver function

Contraindications disturbancies liver function.

Application for violations of renal function

In chronic renal failure requires dose reduction allapinine.

Cautions

If you have a headache, dizziness, diplopia should reduce the dose of the drug. When sinus tachycardia against a background of prolonged administration of the drug illustrated the use of beta-blockers in low doses.

Overdose

Data on overdose allapinine not available.

Drug Interactions

When applied simultaneously with inducers of microsomal liver enzymes allapinine efficiency decreases. Antiarrhythmics, other classes increase the risk of arrhythmogenic action. Allapinine intensifies the effect of nondepolarizing muscle relaxants.

Terms and Conditions of storage

List B. The drug should be stored protected from light and the reach of children. Shelf life - 3 years.

Alkeran

Composition, structure and packing

Tablets, coated in white or almost white, round, biconvex, with the stigma of "GX EH3" on one side and "A" - on the other.

1 tab. melphalan 2 mg.

Excipients: microcrystalline cellulose, krospovidon, silica colloidal anhydrous, magnesium stearate.

The composition of the shell: gipromelloza, titanium dioxide, macrogol. 25 pcs. - Dark glass bottles (1) - packs cardboard. Lyophilized powder for solution for injection in white or nearly white; attached solvent transparent, colorless solution with an alcohol odor, dissolving in 10 ml solvent contains almost no visible particles. 1 vial. melphalan (in the form of hydrochloride) 50 mg

Excipients: povidone K12, hydrochloric acid. Solvent: sodium citrate, propylene glycol, ethanol, water, d / and. Glass Bottles (1) together with the solvent (10 ml - vials.) - Plastic Packaging (1) - bundle pasteboard.

Clinico-pharmacological group: The antitumor drug.

Pharmacological action

The antitumor drug, bifunctional alkylating agents. The process of alkylation is covalent formed from two bis-2-chloroethyl groups of carbon intermediate compounds with 7-nitrogen of guanine in DNA and cross-linking of the two strands of DNA that leads to disruption of cell replication. In / in the introduction Alkerana as monotherapy or in combination with other cytotoxic drugs is also effective in multiple myeloma, as well as oral Alkerana. In / in the introduction Alkerana in high doses (with transplantation of hematopoietic stem cells or not) as first-line treatment or for consolidation of remission after standard cytotoxic chemotherapy leads to complete remission in 50% of patients with multiple myeloma. Alkeran in high doses (with hematopoietic stem cell transplantation with or without) was used as a monotherapy and in combination with radiation therapy and / or other cytotoxic drugs for consolidation of remission after standard treatment for widespread neuroblastoma in children. In / in the introduction Alkerana as monotherapy and in combination with other cytotoxic drugs can achieve the objective effect of around 50% of patients with common adenocarcinoma of the ovary. Acceptance of the drug as monotherapy or in combination with other drugs has a significant therapeutic effect in some patients with widespread carcinoma of the breast, in addition, melphalan was used in the adjuvant therapy after surgery for breast carcinoma. It is effective in treating patients with polycythemia.

Pharmacokinetics

Absorption

In 13 patients treated with oral melphalan at a dose of 0.6 mg / kg body weight, absorption was characterized by high variability - both in time before the first appearance of the drug in plasma (range from 0 to 336 min) and for Cmax value in plasma (range from 70 to 63 ng / ml). In 5 patients who received an equivalent dose of melphalan was administered in / in, the average absolute bioavailability was was 56 ± 27%. The pharmacokinetics of melphalan in in / in the introduction of standard and high-dose corresponds to a bi-exponential dual-chamber model. . In 18 patients treated with oral melphalan in doses from 0.2 to 0.25 mg / kg, Cmax in plasma (range from 87 to 350 ng / ml) achieved within 0.5-2.0 h. When you receive melphalan tablets immediately after a meal time to achieve Cmax in plasma increased, and the AUC decreased by 39 - 45%.

Distribution

After injection of the drug in the form of two minutes infusion in doses ranging from 5 to 23 mg/m2 body surface (about 0.1-0.6 mg / kg body weight) 10 patients with ovarian cancer or multiple myeloma average Vd in the equilibrium state and the central compartment were 29.1 ± 13.6 l and 12.2 ± 6.5 l, respectively. In 28 patients with various malignant tumors, at doses ranging from 70 to 200 mg/m2 body surface in the form of 2-20-minute infusion, the average Vdv equilibrium state and the central compartment were equal, respectively, 40.2 ± 18.3 L and 18.2 ± 11.7 liters.

In Hyperthermia (39 ° C) perfusion of the lower extremity melphalan at a dose of 1.75 mg / kg of body weight in 11 patients with advanced melanoma Average Vdv equilibrium state and the central compartment, respectively, were equal to 2.87 ± 0.8 l and 1.01 ± 0.28 liters.

Metabolism

Data obtained in vivo and in vitro, suggest that the primary determinant of T1 / 2 of the drug in humans, is the spontaneous degradation, rather than enzymatic.

Withdrawal

13 patients after oral administration of melphalan at a dose of 0.6 mg / kg body weight average T1 / 2 final phase is 90 ± 57 min, while for 24 h in urine was detected 11% of the drug. 8 patients after a single bolus dose of 0.5-0.6 Alkerana mg / kg, T1 / 2 in primary and terminal phase were respectively 7.7 ± 3.3 and 108 ± 20.8 min. After parenteral administration of melphalan in plasma were determined by its metabolites - monogidroksimelfalan and digidroksimelfalan, whose concentration reached maximum levels at 60 and 105 min, respectively. T1 / 2 by adding to the serum of patients melphalan in vitro at 37 ° C was similar to that in vivo and was 126 ± 6 min. This suggests that the main factor determining the duration of T1 / 2 in the human body is, rather, its spontaneous degradation, rather than enzymatic metabolism. After injection of the drug in the form of two minutes infusion in doses ranging from 5 to 23 mg/m2 body surface (about 0.1-0.6 mg / kg body weight) 10 patients with ovarian cancer or multiple myeloma T1 / 2 in primary and terminal phase were respectively 8.1 ± 6.6 and 76.9 ± 40.7 minutes, and the average clearance - 342.7 ± 96.8 ml / min. In 15 children and 11 adults treated by high-(140 mg/m2 body surface area) in / melphalan therapy on the background of forced diuresis, mean T1 / 2 in primary and terminal phase were respectively 6.5 ± 3.6 and 41.4 ± 16.5 min. In 28 patients with various malignant tumors, at doses ranging from 70 to 200 mg/m2 body surface in the form of 2-20-min infusion average T1 / 2 in primary and terminal phase were respectively 8.8 ± .6 and 73.1 ± 45.9 min, and Average clearance - 564.6 ± 159.1 ml / min. In Hyperthermia (39oS) perfusion of the lower extremity melphalan at a dose of 1.75 mg / kg of body weight in 11 patients with advanced melanoma mean T1 / 2 in primary and terminal phase were respectively 3.6 ± 1.5 and 465 ± 17.2 min, respectively, while the average clearance - 55.0 ± 9.4 ml / min. In 18 patients treated with oral melphalan at a dose of 0.2-0.25 mg / kg of body weight, mean T1 / 2 left 1.12 ± 0.15 h.

Statement

For parenteral

The regional arterial perfusion is indicated for:
localized melanoma of the limbs;
localized soft tissue sarcoma of extremities. In / in the introduction to the standard doses used in:
multiple myeloma;
disseminated ovarian cancer in the / in the introduction to the high doses used to treat: - multiple myeloma;
widespread neuroblastoma in children.

For oral

Showed at:
multiple myeloma;
common adenocarcinoma of the ovary.

Can be used for:
carcinoma of the breast;
polycythemia vera.

Dosage regimen

Alkeran should be appointed only by doctors who have experience of cytostatic therapy of malignant neoplasms.

Adults with multiple myeloma for parenteral administration Alkerana solution for injection in the intermittent mode is assigned as a monotherapy and in combination with other cytotoxic drugs, in doses ranging from 8 to 30 mg/m2 body surface, at intervals ranging from 2 to 6 weeks.

In addition, some regimens included prednisolone. More detailed treatments are given in the literature.

When i / in monotherapy the usual dosing regimen Alkerana is 0.4 mg / kg (16 mg/m2) with repeated administration at appropriate intervals (eg once every 4 weeks), subject to recovery for the period of peripheral blood.

When used in the mode of high-therapy Alkeran injected once into / in a dose of 100 to 200 mg/m2 (approximately 2.5 to 5.0 mg / kg body weight).

In applying the drug in doses of 140 mg/m2 body surface is very important to the transplantation of hematopoietic stem cells.

In violation of renal function dose should be reduced to 50. Given the expressed mielosupressivnogo actions when in / therapy in high doses, this therapy should be conducted only in specialized centers under the supervision of experienced professionals.

Adults with multiple myeloma Oral is usually prescribed to 0.15 mg / kg of body weight in divided doses for 4 days, repeating cycles with intervals of 6 weeks. However, used, and many other modes, which can be found in detail in the literature.

Receiving melphalan inside with simultaneous appointment of prednisolone may be more effective than monotherapy with melphalan. Combination therapy is usually appointed by a broken diagram. Therapy longer than 1 year in patients responding to therapy, apparently not accompanied by higher efficiency.
In common with adenocarcinoma of the ovaries in / in the introduction as monotherapy Alkeran usually used in doses of 1 mg / kg body weight (approximately 40 mg/m2) with an interval of 4 weeks.
When used in combination with other cytotoxic drugs recommended doses Alkerana ranges from 0.3 to 0.4 mg / kg body weight (from 12 to 16 mg/m2) with an interval of 4-6 weeks.
If ingestion is usually prescribed for the 0.2 mg / kg body weight per day for 5 days, repeating the cycle every 4 - 8 weeks or after a pattern of peripheral blood.
In melanoma, hyperthermic regional perfusion solution Alkerana used as adjuvant therapy after removal of melanoma at an early stage of disease, as well as a palliative treatment of locally advanced stage.
When soft tissue sarcoma hyperthermic regional perfusion solution Alkerana applied at all stages of localized soft tissue sarcoma, usually in combination with surgical treatment. Alkeran also given in combination with actinomycin D.
In carcinoma of the breast Alkeran prescribe oral dose of 0.15 mg / kg of body weight or 6 mg/m2 body surface per day for 5 days, repeating the cycle every 6 weeks.
The toxic effect on bone marrow hemopoiesis lower dose.
In polycythemia vera for remission induction drug prescribe oral doses of 6 to 10 mg / day for 5-7 days and then transferred to a reception at a dose of 2 to 4 mg per day to achieve adequate control of the disease.

For maintenance therapy the drug is prescribed in doses of 2 to 6 mg once a week Because of the possibility of severe myelosuppression when receiving continuous melphalan, it is very important throughout the therapy on a regular basis to investigate the blood picture, if necessary, adjusting the dose or by making breaks in treatment to maintain good control of the picture blood.

With widespread neuroblastoma in children Alkerana solution for injections administered in doses ranging from 100 to 240 mg/m2 (sometimes this dose is divided into several equal parts and injected for three consecutive days) as a monotherapy and in combination with radiotherapy and / or with other cytotoxic drugs, in combination with transplantation of hematopoietic stem cells. Melphalan at conventional dose range is assigned to children only in rare cases, therefore, to give clear guidance on dosing is not possible. Alkeran is often used in patients of elderly in standard doses, information about the features of its use in this age subgroup no. Experience with Alkerana in high doses in patients of elderly is limited. Before starting of high-in / melphalan therapy in patients in this category must achieve adequate general condition.

In case of violation of renal function melphalan clearance can be reduced, although highly variable.

When i / v injection of the drug in standard doses (8-40 mg/m2) in patients with moderate or severe renal insufficiency is recommended to reduce initial dose by 50%, and further to select the dose depending on the degree of suppression of bone marrow function.

When i / v injection of the drug in high doses (100-240 mg/m2) the need for dose reduction depends on the degree of renal dysfunction, whether that asks whether the transplantation of hematopoietic stem cells, and the therapeutic necessity. Typically, during the treatment of high-melphalan without hematopoietic stem cell transplantation in patients with moderate renal insufficiency (CC 30-50 ml / min) dose reduced by 50%.

In severe renal failure of high-melphalan therapy without hematopoietic stem cell transplantation is not recommended. Of high-melphalan therapy combined with transplantation of hematopoietic stem cells successfully implemented even in patients with end stage renal failure who are on hemodialysis. Current data on the pharmacokinetics not allow us to recommend reducing the dose melphalan for oral administration in patients with impaired renal function, but at the beginning of therapy may be appropriate to reduce the dose to determine tolerability.

In the appointment of the drug inside should be aware that since drug absorption after oral administration varies, for guaranteeing the achievement of therapeutic concentrations may require careful dose increase to development myelosuppression. Terms of cooking solution for injection solution is prepared at room temperature by mixing the dried powder with solvent, which is attached to a bottle of Alkeranom. Into a vial containing the lyophilized powder Alkerana should add 10 ml of solvent (simultaneously) and shake vigorously until completely dissolved. The resulting solution contains 5 mg anhydrous melphalan in 1 ml and has a pH of about 6.5. Prepared solution for injection Alkerana not stable and should be prepared immediately before use. Unused solution should be destroyed. Prepared solution Alkerana be stored in the refrigerator, as it causes the formation of sediment. Alkerana solution for injection is introduced only in / except when shown the regional arterial perfusion. When i / in the application is recommended to introduce a solution Alkerana slowly through a special closed access to the infusion system against a background of rapid infusion of another solution. When injected directly into the rapidly introduced another solution is impossible, the solution can be diluted in Alkerana capacity for infusion. Solution Alkerana encouraged to grow only 0.9% solution of sodium chloride for injection and mixed with infusion solutions containing dextrose (glucose).

With further dilution of the solution Alkerana injection in infusion solutions and its stability decreases, and its rate of degradation increases rapidly with increasing temperature.

At room temperature (approximately 25 ° C) the total time from preparation of the solution Alkerana injection until the end of its infusion should not exceed 1.5 h. When cooked, or in a dilute solution Alkerana appear blurred or crystallization, it should be destroyed. Be careful to avoid the possible introduction of Alkerana not in a vein, and in the surrounding tissue. In case of difficulty of access to peripheral veins of the drug is introduced into the central vein. High doses Alkerana (with transplantation of hematopoietic stem cells or not) is recommended to enter into the central vein.

When using the drug for regional arterial perfusion are encouraged to review the details of methodology in the literature.

Side effect

Recent clinical data on the frequency of adverse reactions when using this drug available. The frequency of adverse reactions varies depending on the indications and doses, as well as the use of the drug in combination with other drugs.

To classify the frequency of adverse reactions used the following guidelines: very often - ≥ 0.1, is often - ≥ 0.01, but <0.1, sometimes - ≥ 0.001, but <0.01, rarely - ≥ 0.0001, but <0.001, very rarely - <0.00001.
On the part of the hemopoietic system and lymphatic system: very often - inhibition of bone marrow hematopoiesis with the development of leukopenia and thrombocytopenia, rarely - hemolytic anemia.
On the part of the immune system: Rarely - allergic reactions (hives, swelling, skin rash, itching and anaphylactic shock in the first and subsequent introduction of observed infrequently, mostly in in / therapy Alkeranom). There are reports of rare cases of heart failure in patients with allergic reactions to Alkeran.
On the part of the respiratory system: rarely - interstitial pneumonia and pulmonary fibrosis (including fatal).
On the part of the digestive system: very often - nausea, vomiting and diarrhea, the use of high-profile - stomatitis; rarely - liver damage, ranging from changes in the activity of functional liver tests before clinically manifest hepatitis and jaundice, veno-occlusive disease after high-therapy, stomatitis in use of standard doses.

For parenteral administration: diarrhea, nausea, vomiting are dozolimitiruyuschimi factors of toxicity in patients receiving to / in therapy of high-Alkeranom with transplantation of hematopoietic stem cells. Previous therapy cyclophosphamide, appears to reduce the severity of symptoms from the gastrointestinal tract, caused by high dose Alkerana.

When administered: the available data, up to 30% of patients receiving melphalan orally in standard doses, side effects noted by the digestive system, such as nausea and vomiting.

Dermatological reactions: very often - alopecia during treatment of high-often - alopecia in the appointment of the standard doses; rarely - Makulo-papular rash and itching.

From the urinary system: often - transient significant increase in the level of urea in the blood of patients with multiple myeloma with renal dysfunction.

Other: for parenteral administration is very often - the subjective transient sensation of heat and / or tingling.

Contraindications
sensitivity to melphalan.

Pregnancy and lactation

It should avoid the use of melphalan in pregnancy, especially in the I trimester. In each individual case, the potential risk to the fetus should be correlated with the expected benefit to the mother. Women receiving Alkeran should stop breastfeeding. If any of the partners gets Alkeran should use reliable methods of contraception.

Teratogenic potential Alkerana not been studied.

In view of its mutagenic properties and structural similarities to known teratogenic compounds, it is possible that Alkeran may cause congenital malformations in children born to patients treated with this drug. A considerable number of women who have not reached menopause, Alkeran suppresses ovarian function, causing amenorrhea.

Some data indicate the possibility of adverse effects on spermatogenesis Alkerana, therefore, in its application it is possible the development of transient or permanent sterility in men.

Application for violations of renal function

In case of violation of renal function melphalan clearance can be reduced, although highly variable.

When i / v injection of the drug in standard doses (8-40 mg/m2) in patients with moderate or severe renal insufficiency is recommended to reduce initial dose by 50%, and further to select the dose depending on the degree of suppression of bone marrow function.

When i / v injection of the drug in high doses (100-240 mg/m2) the need for dose reduction depends on the degree of renal dysfunction, whether that asks whether the transplantation of hematopoietic stem cells, and the therapeutic necessity. Typically, during the treatment of high-melphalan without hematopoietic stem cell transplantation in patients with moderate renal insufficiency (CC 30-50 ml / min) dose reduced by 50%.

In severe renal failure of high-melphalan therapy without hematopoietic stem cell transplantation is not recommended.

Cautions

Immunization with live vaccine can sometimes cause the development of infection in immunocompromised patients. For this reason, the use of live vaccines during therapy with melphalan is not recommended.

When extravasation Alkerana solution for injection may cause local damage to the surrounding vessel tissue, so it should not be injected directly into the peripheral vein.

It is recommended to enter solution Alkerana slowly against the background of rapid infusion through a special closed access to the infusion system or a central vein. Given the high risk and the need for complex maintenance therapy in the treatment of drug, in / in of high-Alkeranom therapy should be undertaken only in specialized centers, with appropriate conditions, under the supervision of experienced professionals. Patients receiving of high-in / therapy Alkeranom necessary to solve the issue of prophylaxis of antibacterial drugs and, if necessary, components of blood.

Before the therapy of high-melphalan necessary to ensure adequate general condition of the body and the function of organs. Alkeran should be used with caution in patients who have recently undergone a course of radiotherapy or chemotherapy, for the opportunity to enhance the toxic effects on bone marrow.

In applying Alkerana should follow the recommendations on the application of cytotoxic drugs.

Derivation of melphalan in patients with renal insufficiency may be reduced. In addition, renal failure may occur oppression kostnogomozgovogo blood uremic genesis. In such cases, you may need to decrease the dose, and patients should be under careful medical supervision.

In patients treated with Alkeran, detected chromosomal aberrations. Melphalan, like other alkylating agents, can cause the development of leukemia in humans.

There are reports of acute leukemia after long-term therapy melphalan about amyloidosis, melanoma, multiple myeloma, makroglobulinemii, cold agglyutininovogo syndrome and ovarian cancer. Comparative analysis of patients with ovarian cancer treated and not treated with alkylating agents, including melphalan, showed a significant increase in the incidence of acute leukemia in the first group. Before the appointment Alkerana to compare the risk of leukemia with potential therapeutic effects of the drug.

Monitoring of laboratory parameters

Since Alkeran is mielosupressivnym means, in the course of therapy is very important to regularly determine the number of blood cells, if necessary, adjusting the dose or temporarily postponing the introduction of the drug to avoid possible development of excessive myelosuppression and the risk of irreversible bone marrow aplasia. The number of blood cells may continue to decline after the cessation of the drug, so when the first signs of too sharp decline in the number of white blood cells or platelet therapy should be temporarily discontinued.

Rules of sound management of drug

When dealing with melphalan should follow guidelines for handling cytotoxic drugs in accordance with local recommendations and / or regulations. Solution Alkerana should be prepared under the supervision of an experienced pharmacist who owns the rules for safe handling of medication and familiar with its properties. Solution melphalan should be prepared in aseptic conditions on the special equipment (in a laboratory cabinet with vertical hatch), or, if that is not, in a special isolated room in the pharmacy or clinic.

Personnel who prepare solutions or gives an injection to wear special protective clothing: Disposable gloves surgical latex or PVC good quality (rubber is not suitable), a surgical mask of appropriate quality, safety glasses should be washed thoroughly with water after use, disposable apron.

When you work in aseptic conditions require other clothing.

When spraying or spill solution staff dressed in appropriate protective clothing should be immediately wiped with a damp paper towels, who then immediately be packed into a container for hazardous waste, and then destroyed in accordance with established procedure. The surface on which got the drug, should be washed with plenty of water.

After contact with melphalan solution to the skin immediately and thoroughly rinsed with cold water and soap in such cases it is advisable to see a doctor. In contact with mucous membranes of eyes, rinse immediately with a solution of sodium chloride to the eye and immediately seek medical attention.

In the absence of sodium chloride solution can use a large amount of water.

Rules of sound management of melphalan tablets

When dealing with melphalan dosage forms must comply with instructions on handling cytotoxic drugs available in local recommendations and / or appropriate regulations. If the outer shell tablet or damaged, then treatment with melphalan tablets do not pose a risk. Tablets melphalan should not be burst.

Terms of destruction of the drug

Solution Alkerana must be destroyed in accordance with the requirements. In the absence of such it is subject to the same procedure of destruction, as well as other toxic chemicals, such as high-temperature incineration and deep burial. Destruction of sharps (eg needles, syringes, infusion systems and ampoules) should be in rigid containers with a warning sign of danger. Staff carrying out the destruction, should be aware of the observance of all precautions. Procedures for destruction must comply with local regulatory requirements.

Tablets melphalan destroyed in accordance with local regulatory requirements for the destruction of cytostatics.

Overdose

Symptoms: the first manifestations of acute overdose Alkerana with a / in the introduction are nausea and vomiting, may develop blennosis gastrointestinal tract with diarrhea, sometimes hemorrhagic.

If ingestion is most likely the first symptoms of acute overdose are side effects from the gastrointestinal tract, including nausea, vomiting and diarrhea.

The main toxic effect of melphalan (such as ingestion or parenteral administration) is the suppression of bone marrow hemopoiesis to the development of leucopenia, thrombocytopenia and anemia.

Treatment: If necessary, conduct joint activities supporting character, along with blood transfusions and platelet, as well as solve the problem of hospitalization of patients for therapy against infectious and destination stimulant of hematopoiesis.

Specific antidote exists. We must carefully monitor the performance of peripheral blood for at least four weeks after the overdose, until there are signs of normalcy.

Drug Interactions

In / to the introduction of melphalan in high doses along with nalidixic acid resulted in children to death as a result of the development of hemorrhagic enterocolitis. Patients who prior to transplantation of hematopoietic stem cells in / melphalan was administered at high doses, and subsequently administered cyclosporine to prevent the reaction of the graft versus host ", describes cases of renal dysfunction.

Pharmaceutical incompatibilities

The solution of the drug is incompatible with infusion solutions containing dextrose (glucose). He recommended only in a solution of sodium chloride 0.9% for in / infusions.

Terms and Conditions of storage

Packaging with the drug in the form for parenteral administration should be stored protected from light and away from children at or above 30 ° C. Expiration lyophilized powder for solution - 3 years.

The drug in the form of tablets should be stored out of reach of small children at a temperature of from 2 to 8 ° C. Expiration tablets - 2 years. The drug should not be used after the expiry date stated on the packaging.