2010/06/16

Humulin NPH

Composition, structure and packing

Suspension for injection sterile, white color, pH 6.9-7.5; storage stratified, forming a white precipitate and a transparent colorless or nearly colorless supernatant, sediment is easily resuspended in cautious shaking. 1 ml of human biosynthetic insulin izofana suspension of 100 IU. Excipients: m-cresol distilled (1.6 mg / ml), glycerol, phenol (0.65 mg / ml), protamine sulfate, sodium phosphate dibasic, zinc oxide, water d / and hydrochloric acid, sodium hydroxide.

Suspension for injection sterile, white color, pH 6.9-7.5; storage stratified, forming a white precipitate and a transparent colorless or nearly colorless supernatant, sediment is easily resuspended in cautious shaking. 1 ml of human biosynthetic insulin izofana suspension of 100 IU. Excipients: m-cresol distilled (1.6 mg / ml), glycerol, phenol (0.65 mg / ml), protamine sulfate, sodium phosphate dibasic, zinc oxide, water d / and hydrochloric acid, sodium hydroxide.

Clinico-pharmacological group: Insulin human average duration.

Pharmacological action

DNA-recombinant human insulin. Is insulin an average duration of action. The main action of the drug is the regulation of glucose metabolism. In addition, it has anabolic effects. In muscle and other tissues (except brain), insulin causes rapid intracellular transport of glucose and amino acids, accelerates protein anabolism. Insulin helps convert glucose into glycogen in the liver, inhibits gluconeogenesis and stimulates the conversion of excess glucose into fat.

Pharmacokinetics

Humulin NPH insulin is a average duration. The beginning of the drug - within 1 h after injection, the maximum effect of - between 2 and 8 h, duration - 18-20 hours Individual differences in the activity of insulin depends on factors such as dose, the choice of the injection site, physical activity, patient.

Statement
diabetes when indicated for insulin;
first identified diabetes mellitus;
pregnancy in diabetes mellitus type 2 (insulin-dependent).

Dosage regimen

The dose determines the doctor individually depending on the level of glycemia. The drug should be administered sc, possibly / m introduction.

In / in the introduction

Humulina contra NPH! N / a drug injected into the shoulder, hips, buttocks or abdomen. Injection site should be rotated so that the same place was not used more often about 1 times / month. When s / c administration should be careful to avoid falling into a blood vessel. After the injection should not massage the injection. Patients must be trained in the proper use of devices for insulin injection.

The rules of preparation and administration of the drug

Cartridges and vials Humulina NPH before using the laminate should be between your palms 10 times and shook his head, turning 180 ° and 10 times for resuspension of insulin to its state until it assumes the form of a homogeneous turbid fluid or milk. Do not shake vigorously, as This can lead to foam, which can interfere with the right set of doses. Cartridges and bottles should be carefully checked. You should not use the insulin if it has, after mixing flakes, if the bottom or sides of the bottle stuck solid white particles, creating the effect of frost.

The unit does not allow the cartridge to mix their contents with other insulin directly in the cartridge. Cartridges are not designed for refilling. The contents of the vial should be prepared in insulin syringe, the appropriate concentration of insulin, and introduce the necessary dose of insulin in accordance with an indication of a doctor.

When using cartridges manufacturer instructions should be followed with regard to filling the cartridge and attaching a needle. It should introduce the drug in accordance with the manufacturer's instructions syringe pens. Using the outer needle cap, immediately after the introduction unscrew the needle and secure way to destroy it. Removing the needle immediately after injection ensures sterility, prevents leakage of air from entering and possibly clogging the needle. Then put the cap on the handle. Needles should not be reused. Needle and syringe-pen should not be used by others. Cartridges and vials used for as long as they do not become empty, then they should be discarded. Humulin NPH can be administered in combination with Humulinom regular.

For this short-acting insulin should be recruited into the syringe first to prevent the entry into the vial of insulin over the long-lasting. Preferably cooked mixture to enter immediately after mixing. To enter the exact number of each type of insulin you can use a separate syringe for Humulina Regular and NPH Humulina. Always use the insulin syringe, the appropriate concentration of insulin.

Side effect

Adverse effects associated with the main action of the drug: hypoglycemia. Severe hypoglycemia may cause loss of consciousness and (in exceptional cases) to death. Allergic reactions: possible local allergic reactions - flushing, swelling or itching at the injection site (usually expire within a period of several days to several weeks), systemic allergic reactions (occur rarely, but are more serious) - generalized itching, difficulty breathing, shortness of breath , reduction of blood pressure, rapid pulse, increased sweating. Severe cases of systemic allergic reactions can be life-threatening. Other: probability of lipodystrophy is minimal.

Contraindications
hypoglycemia;
increased sensitivity to insulin or to one of the components of the drug.

Pregnancy and lactation

When pregnancy is particularly important to maintain good glycemic control in patients with diabetes mellitus. During pregnancy the need for insulin is usually reduced in the I trimester and increases in the II and III trimesters. Patients with diabetes should inform the doctor about the occurrence or planning pregnancy. In patients with diabetes mellitus during lactation (breastfeeding) may require dosage adjustment of insulin, diet or both. In studies of genetic toxicity in a series of in vitro and in vivo human insulin was not mutagenic action.

Application for violations of liver function

The need for insulin may decrease in hepatic failure.

Application for violations of renal function

The need for insulin may decrease in renal insufficiency.

Cautions

Transfer the patient to another type of insulin or insulin with another brand name should be under strict medical supervision. Changes in the activity of insulin, but its type (eg, Regular, M3), plant species (pig, human insulin, insulin analog human) or method of manufacture (recombinant DNA-insulin or insulin of animal origin) may lead to the need for dose adjustment. The need for dose adjustment may be necessary already at the first administration of the drug, after insulin, human insulin products of animal origin, or gradually over several weeks or months after the transfer. The need for insulin may decrease with insufficient adrenal, pituitary or thyroid, renal or hepatic insufficiency.
In some diseases or emotional stress the need for insulin may increase. Correction doses may also require an increase in physical activity or changing the normal diet.

Symptoms of hypoglycemia-precursors on the background of the introduction of human insulin in some patients may be less pronounced or different from those observed them on the background of insulin of animal origin.
With the normalization of blood glucose, for example as a result of intensive insulin therapy, may disappear all or some symptoms of hypoglycemia, harbingers of what patients should be informed. Symptoms of hypoglycemia-precursors may change or be less pronounced in the long course of diabetes mellitus, diabetic neuropathy, or when used with beta-blockers. In some cases, local allergic reactions may be caused by factors unrelated to the action of the drug, such as irritation of the skin cleansing agent or improper conduct of injections.

In rare cases of systemic allergic reactions requires immediate treatment. Sometimes you may need a change of insulin or the holding of desensitization.

Effects on ability to drive vehicles and management mechanisms

During hypoglycemia the patient may deteriorate the ability to concentrate and decrease the speed of psychomotor reactions. This can be dangerous in situations where these abilities are especially needed (driving or control mechanisms). Patients should be advised to take precautions to avoid hypoglycemia while driving. This is especially important for patients with mild or no symptoms, a precursor of hypoglycemia or part of the development of hypoglycemia. In such cases, the physician should assess the feasibility of driving the car the patient.

Overdose

Symptoms: hypoglycemia, accompanied lethargy, increased sweating, tachycardia, pale skin, headache, tremor, vomiting, confusion. Under certain conditions, such as long duration or with intensive control of diabetes, symptoms of hypoglycemia-precursors may change. Treatment: Light condition of hypoglycemia can usually be cut short oral glucose (dextrose), or sugar.

You may need correction dose of insulin, diet or physical activity. Correction of moderate hypoglycemia can be done using the / m or sc administration of glucagon, followed by ingestion of carbohydrates. Heavy state of hypoglycemia, accompanied by coma, convulsions or neurological disorders, docked in the / m or sc administration of glucagon or / in the introduction of concentrated solution of glucose (dextrose). After recovery of consciousness the patient should be given foods rich in carbohydrates to prevent recurrence of hypoglycemia.

Drug Interactions

Hypoglycemic effect Humulina NPH reduce oral contraceptives, corticosteroids, thyroid medications, thiazide diuretics, diazoxide, tricyclic antidepressants.

Hypoglycemic effect Humulina NPH reinforce oral hypoglycemic agents, salicylates (eg aspirin), sulfonamides, MAO inhibitors, beta-blockers, ethanol and etanolsoderzhaschie drugs. Beta-blockers, klofelina, reserpine may mask the manifestation of symptoms of hypoglycemia.

Pharmaceutical interactions

The effects arising from mixing human insulin to insulin, animal or human insulin, produced by other manufacturers, have not been studied. Terms and Conditions of storage products should be stored in a refrigerator at a temperature of 2 ° to 8 ° C, avoid freezing, protect from direct exposure to light. Shelf life - 2 years. Located in the use of medication in the vial or cartridge should be stored at room temperature (15 ° to 25 ° C) not more than 28 days.