Humulin M3 suspension d / p / k introduction. 100U / ml, 3ml # 5

• Diabetes mellitus in the presence of indications for insulin therapy;

• newly diagnosed diabetes mellitus;

• pregnancy with type 2 diabetes mellitus (non-insulin dependent).

The dose is determined individually, depending on the level of glycemia.

The drug should be administered subcutaneously, possibly intramuscularly. IV injection of Humulin M3 is contraindicated! Subcutaneous drug is injected into the forearm, thigh, buttocks or abdomen.

The injection site must be alternated so that the same site is used no more than about 1 time / month. When administered subcutaneously, care must be taken to avoid entering the blood vessel. After injection, do not massage the injection site.

Patients should be trained in the correct use of insulin delivery devices. Rules for preparation and administration of the drug Cartridges and bottles of Humulin M3 before use should be rolled between palms 10 times and shaken, turning 180 ? also 10 times to resuspend insulin until it acquires the appearance of a homogeneous cloudy liquid or milk. Do not shake vigorously. this can lead to foam, which can interfere with the correct dosage.

Check cartridges and vials carefully.

Insulin should not be used if it contains flakes after stirring, if hard white particles adhere to the bottom or walls of the bottle, creating a frosty pattern effect.

The design of the cartridges does not allow mixing their contents with other insulins directly in the cartridge itself. Cartridges are not refillable. The contents of the vial should be drawn into an insulin syringe corresponding to the concentration of insulin injected, and the required dose of insulin should be administered as directed by the doctor.

When using cartridges, follow the manufacturer's instructions for cartridge refilling and needle attachment. The drug should be administered in accordance with the instructions of the manufacturer of the syringe pen. Using the outer needle cap, unscrew the needle immediately after insertion and safely discard. Removing the needle immediately after injection ensures sterility, prevents leakage, air ingress and possible clogging of the needle. Then put the cap on the handle.

The needles should not be reused. Needles and pen pens must not be used by others. Use cartridges and vials until they become empty, after which they should be discarded.

Suspension for subcutaneous administration of white color, which stratifies, forming a white precipitate and a transparent colorless or almost colorless supernatant liquid; the precipitate is easily resuspended with gentle shaking.

1 ml

biphasic insulin human genetically engineered 100 IU

is a two-phase mixture:

soluble human insulin solution 30%

human isophane insulin suspension 70%

Excipients: metacresol - 1.6 mg, glycerol - 16 mg, liquid phenol - 0.65 mg, protamine sulfate - 0.244 mg, sodium hydrogen phosphate - 3.78 mg, zinc oxide - 0.011 mg, water d / i - up to 1 ml, hydrochloric acid p- p 10% - qs to pH 6.9-7.8, sodium hydroxide solution 10% - qs to pH 6.9-7.8.

• Hypoglycemia;

• hypersensitivity to insulin or to one of the components of the drug.

pharmachologic effect

DNA recombinant human insulin of medium duration. It is a two-phase suspension (30% Humulin Regular and 70% Humulin NPH). The main action of the drug is the regulation of glucose metabolism. In addition, it has an anabolic effect. In muscle and other tissues (with the exception of the brain), insulin causes rapid intracellular transport of glucose and amino acids, accelerates protein anabolism. Insulin promotes the conversion of glucose to glycogen in the liver, inhibits gluconeogenesis, and stimulates the conversion of excess glucose to fat.

Pharmacokinetics

Humulin M3 is a medium-acting insulin preparation. The onset of action of the drug is 30 minutes after administration, the maximum effect is between 1 and 8.5 hours, the duration of action is 14-15 hours. Individual differences in insulin activity depend on factors such as dose, choice of injection site, and physical activity of the patient.

Side effect

A side effect associated with the main effect of the drug: hypoglycemia. Severe hypoglycemia can lead to unconsciousness and (in exceptional cases) death. Allergic reactions: local allergic reactions are possible - hyperemia, swelling or itching at the injection site (usually stop within a period from several days to several weeks); systemic allergic reactions (occur less often, but are more serious) - generalized itching, difficulty breathing, shortness of breath, decreased blood pressure, increased heart rate, increased sweating. Severe cases of systemic allergic reactions can be life threatening. Others: the likelihood of developing lipodystrophy is minimal.

Application during pregnancy and lactation

During pregnancy, it is especially important to maintain good glycemic control in patients with diabetes mellitus. During pregnancy, the need for insulin usually decreases in the first trimester and increases in the second and third trimesters. Patients with diabetes mellitus are advised to inform their doctor about the onset or planning of pregnancy. In patients with diabetes mellitus during lactation (breastfeeding), it may be necessary to adjust the dose of insulin, diet, or both. In studies of genetic toxicity in vitro and in vivo, human insulin did not have a mutagenic effect.

Application for violations of liver function

Insulin requirements may decrease with liver failure.

Application for impaired renal function

Insulin requirements may decrease with kidney failure.

special instructions

The transfer of a patient to another type of insulin or to an insulin preparation with a different trade name should be carried out under strict medical supervision. Changes in insulin activity, type (eg, Regular, NPH), species (porcine, human insulin, human insulin analog) or production method (DNA recombinant insulin or animal insulin) may necessitate dose adjustments. The need for dose adjustment may be required as early as the first administration of a human insulin preparation after an animal insulin preparation, or gradually over several weeks or months after transfer. The need for insulin may decrease with insufficient function of the adrenal glands, pituitary gland or thyroid gland, with renal or hepatic insufficiency.With some diseases or emotional stress, the need for insulin may increase. Dose adjustments may also be required if you increase your physical activity or change your usual diet. Symptoms-precursors of hypoglycemia during the administration of human insulin in some patients may be less pronounced or differ from those observed during the administration of insulin of animal origin. With the normalization of blood glucose levels, for example, as a result of intensive insulin therapy, all or some of the symptoms, precursors of hypoglycemia, may disappear, and patients should be informed about this. Symptoms-precursors of hypoglycemia may change or be less pronounced with a prolonged course of diabetes mellitus, diabetic neuropathy, or with the simultaneous use of beta-blockers.In some cases, local allergic reactions can be caused by reasons not related to the action of the drug, for example, skin irritation with a cleansing agent or improper injections. In rare cases of the development of systemic allergic reactions, immediate treatment is required. Sometimes insulin changes or desensitization may be required.

Influence on the ability to drive vehicles and use mechanisms

During hypoglycemia, the patient's concentration of attention may weaken and the speed of psychomotor reactions may decrease. This can be dangerous in situations where these abilities are especially needed. Patients should be advised to take precautions to avoid hypoglycemia while driving. This is especially important for patients with mild or absent symptoms, predictors of hypoglycemia, or with frequent development of hypoglycemia. In such cases, the physician should assess the appropriateness of the patient's driving.

Overdose

Symptoms: hypoglycemia, accompanied by lethargy, increased sweating, tachycardia, pallor of the skin, headache, tremors, vomiting, confusion. Under certain conditions, for example, with a long duration or with intensive control of diabetes mellitus, the precursor symptoms of hypoglycemia may change. Treatment: Mild hypoglycemic conditions can usually be controlled by ingestion of glucose (dextrose) or sugar. Adjustments to your insulin dose, diet, or physical activity may be required. Correction of moderate hypoglycemia can be carried out using intramuscular or subcutaneous administration of glucagon, followed by ingestion of carbohydrates. Severe hypoglycemic conditions accompanied by coma, seizures or neurological disorders,stop by i / m or s / c by the introduction of glucagon or i / v by the introduction of a concentrated solution of glucose (dextrose). After the restoration of consciousness, the patient must be given food rich in carbohydrates in order to avoid the re-development of hypoglycemia.

Drug interactions

The hypoglycemic effect of Humulin M3 is reduced by oral contraceptives, corticosteroids, thyroid hormone preparations, thiazide diuretics, diazoxide, tricyclic antidepressants. The hypoglycemic effect of Humulin M3 is enhanced by oral hypoglycemic drugs, salicylates (for example, acetylsalicylic acid), sulfonamides, MAO inhibitors, beta-blockers, ethanol and ethanol-containing drugs. Beta-blockers, clonidine, reserpine can mask the manifestation of symptoms of hypoglycemia. Pharmaceutical interactions The effects of mixing human insulin with animal insulin or human insulin from other manufacturers have not been studied.