Humulin^® M3 (Suspension) Instructions for Use

ATC Code

A10AD01 (Insulin human)

Active Substance

Insulin human (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Intermediate-acting human insulin with rapid onset of action

Pharmacotherapeutic Group

Hypoglycemic agent – combination of short- and intermediate-acting insulins

Pharmacological Action

DNA-recombinant human insulin of intermediate duration of action. It is a biphasic 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 (except the brain), insulin causes rapid intracellular transport of glucose and amino acids, and accelerates protein anabolism. Insulin promotes the conversion of glucose into glycogen in the liver, inhibits gluconeogenesis and stimulates the conversion of excess glucose into fat.

Pharmacokinetics

Humulin M3 is an intermediate-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 the patient’s physical activity.

Indications

• Diabetes mellitus in the presence of indications for insulin therapy;
• Newly diagnosed diabetes mellitus;
• Pregnancy in type 2 diabetes (non-insulin-dependent).

ICD codes

Dosage Regimen

Suspension

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

The drug should be administered subcutaneously, intramuscular administration is possible. Intravenous administration of Humulin M3 is contraindicated!

The drug is administered subcutaneously into the forearm, thigh, buttock or abdomen. The injection site should be alternated so that the same site is used no more than approximately once a month.

When administering subcutaneously, care must be taken to avoid entry into a blood vessel. After the injection, the injection site should not be massaged. Patients should be trained in the correct use of insulin delivery devices.

Rules for preparation and administration of the drug

Humulin M3 cartridges and vials should be rolled between the palms 10 times and rocked, turning them 180°C (356°F) also 10 times to resuspend the insulin until it appears as a uniform cloudy liquid or milk. Do not shake vigorously, as this may cause foaming which may interfere with correct dose measurement.

Cartridges and vials should be inspected carefully. Do not use insulin if it contains clumps after mixing, or if solid white particles are stuck to the bottom or walls of the vial, creating a frosted effect.

The design of the cartridges does not allow their contents to be mixed with other insulins directly in the cartridge itself. Cartridges are not intended for refilling.

The contents of the vial should be drawn into an insulin syringe corresponding to the concentration of the insulin being administered, and the required dose of insulin should be administered as directed by the doctor.

When using cartridges, the manufacturer’s instructions for cartridge priming and needle attachment should be followed. The drug should be administered in accordance with the pen injector manufacturer’s instructions.

Using the outer needle cap, immediately after administration unscrew the needle and safely destroy it. Removing the needle immediately after injection ensures sterility, prevents leakage, air ingress and possible needle clogging. Then put the cap on the pen.

Needles should not be reused. Needles and pen injectors must not be used by other persons. Cartridges and vials are used until they are empty, after which they should be discarded.

Adverse Reactions

Side effect associated with the main action of the drug hypoglycemia.

Severe hypoglycemia can lead to loss of consciousness and (in exceptional cases) death.

Allergic reactions local allergic reactions are possible – redness, swelling or itching at the injection site (usually stop within a period of several days to several weeks); systemic allergic reactions (occur less frequently, but are more serious) – generalized itching, difficulty breathing, shortness of breath, decreased blood pressure, increased pulse rate, increased sweating. Severe cases of systemic allergic reactions can be life-threatening.

Other the likelihood of developing lipodystrophy is minimal.

Contraindications

• Hypoglycemia;
• Hypersensitivity to insulin or to one of the components of the drug.

Use in 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 are advised to inform their doctor about the onset or planning of pregnancy.

In patients with diabetes during lactation (breastfeeding), adjustment of the insulin dose, diet, or both may be required.

In studies of genetic toxicity in a series of in vitro and in vivo tests, human insulin did not have a mutagenic effect.

Use in Hepatic Impairment

The need for insulin may decrease in hepatic insufficiency.

Use in Renal Impairment

The need for insulin may decrease in renal insufficiency.

Special Precautions

Transfer of a patient to another type of insulin or to an insulin preparation with a different brand name should occur under strict medical supervision. Changes in insulin strength, type (e.g., Regular, NPH), species (porcine, human insulin, human insulin analogue) or method of manufacture (DNA-recombinant insulin or insulin of animal origin) may lead to the need for dose adjustment.

The need for dose adjustment may be required as early as the first administration of the human insulin preparation after the animal insulin preparation or gradually over several weeks or months after the transfer.

The need for insulin may decrease in cases of insufficient adrenal, pituitary or thyroid function, or in renal or hepatic insufficiency.

In some diseases or during emotional stress, the need for insulin may increase.

Dose adjustment may also be required with increased physical activity or changes in the usual diet.

Symptoms of impending hypoglycemia during administration of human insulin may be less pronounced or different from those observed during administration of animal insulin in some patients. When blood glucose levels normalize, for example as a result of intensive insulin therapy, all or some of the symptoms of impending hypoglycemia may disappear, and patients should be informed about this.

Symptoms of impending hypoglycemia may change or be less pronounced in long-term diabetes, diabetic neuropathy, or with simultaneous use of beta-blockers.

In some cases, local allergic reactions may be caused by reasons not related to the action of the drug, for example, skin irritation by a cleansing agent or improper injection technique.

In rare cases of systemic allergic reactions, immediate treatment is required. Sometimes a change of insulin or desensitization may be required.

Effect on ability to drive vehicles and mechanisms

During hypoglycemia, the patient’s concentration may be impaired and the speed of psychomotor reactions may decrease. This can be dangerous in situations where these abilities are especially necessary.

Patients should be advised to take precautions to avoid hypoglycemia while driving. This is especially important for patients with mild or absent symptoms of impending hypoglycemia or with frequent hypoglycemia. In such cases, the physician should assess the advisability of the patient driving a car.

Overdose

Symptoms hypoglycemia, accompanied by lethargy, increased sweating, tachycardia, pale skin, headache, tremors, vomiting, confusion.

Under certain conditions, such as long duration or intensive control of diabetes, the symptoms of impending hypoglycemia may change.

Treatment mild hypoglycemic conditions can usually be controlled by oral administration of glucose (dextrose) or sugar. Adjustment of the insulin dose, diet, or physical activity may be required.

Moderate hypoglycemia can be corrected by intramuscular or subcutaneous administration of glucagon, followed by oral carbohydrate intake.

Severe hypoglycemic conditions accompanied by coma, convulsions or neurological disorders are stopped by intramuscular or subcutaneous administration of glucagon or intravenous administration of concentrated glucose (dextrose) solutions. After regaining consciousness, the patient should be given a carbohydrate-rich meal to avoid recurrent 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 (e.g., acetylsalicylic acid), sulfonamides, MAO inhibitors, beta-blockers, ethanol and ethanol-containing preparations.

Beta-blockers, clonidine, reserpine may mask the manifestation of hypoglycemia symptoms.

Pharmaceutical interaction

The effects resulting from mixing human insulin with animal insulins or human insulin produced by other manufacturers have not been studied.

Storage Conditions

The drug should be stored in a refrigerator at a temperature from 2°C (35.6°F) to 8°C (46.4°F), avoid freezing, protect from direct exposure to light.

Shelf Life

Shelf life – 2 years.

The drug in use in a vial or cartridge should be stored at room temperature (from 15°C (59°F) to 25°C (77°F)) for no more than 28 days.

Dispensing Status

The drug is dispensed by prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.