Vozulim - 30/70 (Suspension) Instructions for Use

Marketing Authorization Holder

Wockhardt Ltd. (India)

Manufactured By

Wockhardt Ltd. (India)

Packaging and Quality Control Release

WOCKHARDT, Ltd. (India)

Or

DOBROLEK, LLC (Russia)

ATC Code

A10AD01 (Insulin human)

Active Substance

Insulin human (Rec.INN registered by WHO)

Dosage Form

Vozulim – 30/70

Subcutaneous suspension 100 IU/1 ml: 3 ml cartridge, 10 ml bottle

Dosage Form, Packaging, and Composition

3 ml – cartridges (1) – contour cell packs (1) – cardboard packs.
10 ml – bottles (1) – contour cell packs (1) – cardboard packs.

Clinical-Pharmacological Group

Intermediate-acting human insulin

Pharmacotherapeutic Group

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

Pharmacological Action

Vozulim 30/70 is a human recombinant insulin preparation of intermediate duration of action.

The preparation contains soluble insulin (30%) and insulin isophane (70%). It interacts with a specific receptor on the outer cytoplasmic membrane of cells and forms an insulin-receptor complex that stimulates intracellular processes, including the synthesis of a number of key enzymes (hexokinase, pyruvate kinase, glycogen synthase, etc.).

The decrease in blood glucose levels is due to increased intracellular transport, enhanced uptake and utilization by tissues, stimulation of lipogenesis, glycogenesis, and a decrease in the rate of glucose production by the liver, among other factors.

The duration of action of insulin preparations is mainly determined by the rate of absorption, which depends on several factors (e.g., dose, method and site of administration), and therefore the insulin action profile is subject to significant variations, both among different people and in the same person.

Onset of action after subcutaneous administration is within 30 minutes, maximum effect is within 2-8 hours, duration of action is up to 24 hours.

Pharmacokinetics

The completeness of absorption and onset of insulin effect depends on the method of administration (subcutaneously, intramuscularly), the injection site (abdomen, thigh, buttocks), the dose (volume of insulin administered), the concentration of insulin in the preparation, etc.

It is distributed unevenly in tissues; does not cross the placental barrier and into breast milk. It is destroyed by insulinase mainly in the liver and kidneys. It is excreted by the kidneys (30-80%).

Indications

Diabetes mellitus.

ICD codes

Dosage Regimen

The preparation is intended for subcutaneous administration.

The dose and time of administration of the preparation are determined by the doctor individually in each specific case based on blood glucose concentration. On average, the daily dose of the preparation ranges from 0.5 to 1 IU/kg of body weight (depends on the individual characteristics of the patient and blood glucose concentration).

The temperature of the administered insulin should correspond to room temperature. The preparation is usually administered subcutaneously into the thigh. Injections can also be made into the anterior abdominal wall, buttock, or shoulder in the projection of the deltoid muscle. It is necessary to change injection sites within the anatomical area to prevent the development of lipodystrophy.

Patients with type 2 diabetes mellitus can be treated either with monotherapy with Vozulim 30/70 (administered twice daily) or with combination therapy with oral hypoglycemic agents. The cartridge is to be used only with a pen-injector.

Adverse Reactions

Due to the effect on carbohydrate metabolism hypoglycemic conditions (pallor of the skin, increased sweating, palpitations, tremor, feeling of hunger, agitation, paresthesia of the oral mucosa, headache).

Severe hypoglycemia can lead to the development of hypoglycemic coma.

Allergic reactions skin rash, angioedema, extremely rarely – anaphylactic shock.

Local reactions hyperemia, swelling and itching at the injection site, with prolonged use – lipodystrophy at the injection site.

Other edema, transient refractive disorders (usually at the beginning of therapy).

Contraindications

• Hypersensitivity to insulin or other components of the preparation;
• Hypoglycemia.

Use in Pregnancy and Lactation

There are no restrictions on the treatment of diabetes mellitus with insulin during pregnancy, since insulin does not cross the placental barrier.

When planning pregnancy and during it, it is necessary to intensify the treatment of diabetes mellitus. The need for insulin usually decreases in the first trimester of pregnancy and gradually increases in the second and third trimesters.

During childbirth and immediately after them, the need for insulin may decrease sharply. Soon after childbirth, the need for insulin quickly returns to the level that was before pregnancy. There are no restrictions on the treatment of diabetes mellitus with insulin during breastfeeding. However, a reduction in the insulin dose may be required, so careful monitoring is necessary for several months until the insulin requirement stabilizes.

Use in Hepatic Impairment

The insulin dose must be adjusted in case of impaired liver function.

Use in Renal Impairment

The insulin dose must be adjusted in case of impaired renal function.

Geriatric Use

The insulin dose must be adjusted for diabetes mellitus in persons over 65 years of age.

Special Precautions

During insulin therapy, constant monitoring of blood glucose concentration is necessary.

Causes of hypoglycemia, in addition to insulin overdose, may include: changing the preparation, skipping a meal, vomiting, diarrhea, increased physical activity, diseases that reduce the need for insulin (impaired liver and kidney function, hypofunction of the adrenal cortex, pituitary gland or thyroid gland), changing the injection site, as well as interaction with other drugs.

Incorrect dosing or interruptions in insulin administration, especially in patients with type 1 diabetes mellitus, can lead to hyperglycemia. Usually, the first symptoms of hyperglycemia develop gradually, over several hours or days. They include the appearance of thirst, frequent urination, nausea, vomiting, dizziness, redness and dryness of the skin, dry mouth, loss of appetite, and the smell of acetone in the exhaled air. If left untreated, hyperglycemia in type 1 diabetes mellitus can lead to the development of life-threatening diabetic ketoacidosis.

The insulin dose must be adjusted in case of thyroid dysfunction, Addison’s disease, hypopituitarism, impaired liver and kidney function, and diabetes mellitus in persons over 65 years of age.

Adjustment of the insulin dose may also be required if the patient increases the intensity of physical activity or changes their usual diet. Concomitant diseases, especially infections and conditions accompanied by fever, increase the need for insulin.

Switching from one type of insulin to another should be carried out under the control of blood glucose concentration.

The preparation reduces tolerance to alcohol.

Due to the possibility of precipitation in some catheters, the use of the preparation in insulin pumps is not recommended.

Do not use the preparation if, after shaking, the suspension does not become white or uniformly cloudy.

Effect on the ability to drive vehicles and mechanisms

Due to the initial prescription of insulin, a change in its type, or in the presence of significant physical or mental stress, the ability to drive a car or operate various mechanisms, as well as engage in other potentially hazardous activities that require increased attention and speed of mental and motor reactions, may be reduced.

Overdose

Overdose may lead to the development of hypoglycemia.

Treatment mild hypoglycemia can be eliminated by the patient themselves by taking sugar or carbohydrate-rich foods orally. Therefore, patients with diabetes mellitus are recommended to always carry sugar, sweets, cookies, or sweet fruit juice with them.

In severe cases, if the patient loses consciousness, 40% dextrose (glucose) solution is administered intravenously; glucagon is administered intramuscularly, subcutaneously, or intravenously. After regaining consciousness, the patient is advised to eat a carbohydrate-rich meal to prevent the recurrence of hypoglycemia.

Drug Interactions

Pharmaceutically incompatible with solutions of other drugs.

There are a number of drugs that affect the need for insulin. The hypoglycemic effect of insulin is enhanced by non-selective beta-blockers, quinidine, quinine, chloroquine, MAO inhibitors, angiotensin-converting enzyme inhibitors, carbonic anhydrase inhibitors, octreotide, bromocriptine, sulfonamides, anabolic steroids, tetracyclines, clofibrate, ketoconazole, mebendazole, pyridoxine, theophylline, cyclophosphamide, fenfluramine, lithium preparations, preparations containing ethanol.

The hypoglycemic effect of insulin is weakened by glucagon, somatropin, estrogens, oral contraceptives, glucocorticosteroids, iodine-containing thyroid hormones, thiazide diuretics, loop diuretics, heparin, tricyclic antidepressants, sympathomimetics, danazol, clonidine, sulfinpyrazone, epinephrine, H1-histamine receptor blockers, slow calcium channel blockers, diazoxide, morphine, phenytoin, nicotine.

Reserpine and salicylates can either enhance or weaken the hypoglycemic effect of insulin.

Storage Conditions

In a light-protected place at a temperature from 2°C (35.6°F) to 8°C (46.4°F). Do not freeze. Keep out of reach of children. The preparation in use should be stored at a temperature of 15-25°C (59-77°F) for no more than 6 weeks.

Shelf Life

Shelf life. 2 years. Do not use after the expiration date stated on the packaging.

Dispensing Status

The preparation 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.