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.
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.
To the top
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.
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