Gensulin M30 (Suspension) Instructions for Use

Marketing Authorization Holder

Pharmasintez-Nord, JSC (Russia)

Manufactured By

Pharmasintez-Nord, JSC (Russia)

ATC Code

A10AD01 (Insulin human)

Active Substance

Insulin human (Rec.INN registered by WHO)

Dosage Form

Gensulin M30

Subcutaneous suspension 100 IU/1 ml: cartridges 3 ml 5 pcs., bottle 10 ml 1 pc.

Dosage Form, Packaging, and Composition

Suspension for subcutaneous administration white in color, which upon standing forms a white precipitate and a clear, colorless or almost colorless supernatant; upon gentle shaking, the precipitate resuspends easily.

Excipients: metacresol – 1.5 mg, phenol – 0.65 mg, glycerol – 16 mg, protamine sulfate – 0.189 mg, zinc oxide – up to 40 µg Zn²⁺/100 IU, sodium phosphate dibasic dodecahydrate – 5.04 mg, hydrochloric acid q.s. to pH 7.0-7.6, water for injections – up to 1 ml.

3 ml – cartridges of colorless glass (5) – blister packs (1) – cardboard boxes.
10 ml – glass aerosol vials (1) – cardboard boxes.

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. It is an intermediate-acting insulin. It regulates glucose metabolism and has an anabolic effect. In muscle and other tissues (except the brain), insulin facilitates the intracellular transport of glucose and amino acids, and enhances protein anabolism. Insulin promotes the conversion of glucose into glycogen in the liver, inhibits gluconeogenesis, and stimulates the conversion of excess glucose into fat.

Indications

Diabetes mellitus when there are indications for insulin therapy; newly diagnosed diabetes mellitus; pregnancy in type 2 diabetes mellitus (non-insulin-dependent).

ICD codes

Dosage Regimen

Determine the dosage individually based on the patient’s metabolic needs, blood glucose levels, and glycemic control targets.

Administer by subcutaneous injection only. Do not administer intravenously or intramuscularly.

Inject into the abdominal wall, thigh, buttocks, or the upper arm. Rotate injection sites within the same region to reduce the risk of lipodystrophy.

Gently roll the cartridge or vial between your palms ten times and invert it ten times to ensure a homogeneous, milky suspension before use. Do not shake vigorously.

Inspect the suspension visually before use. Use only if it appears uniformly cloudy. Do not use if clear sediment remains at the bottom or if clumping or frosting occurs.

The total daily insulin requirement is often between 0.5 and 1.0 IU/kg body weight. Divide the total daily dose into two or more injections.

Typically administer twice daily, approximately 30-45 minutes before breakfast and before the evening meal.

Approximately two-thirds of the total daily dose may be given in the morning and one-third in the evening. Adjust this ratio based on individual patient response.

Adjust the dose based on regular self-monitoring of blood glucose. Titrate the dose gradually, typically by 2-4 IU, to avoid hypoglycemia.

Monitor for and educate the patient on the signs and symptoms of hypoglycemia.

During intercurrent illness, stress, or changes in physical activity or diet, more frequent monitoring and dose adjustments are necessary.

Adverse Reactions

From the endocrine system: 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 subside within a period from 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.

Contraindications

Hypoglycemia; hypersensitivity to insulin.

Use in Pregnancy and Lactation

During pregnancy, it is especially important to maintain good glycemic control in patients with diabetes mellitus. During pregnancy, the insulin requirement 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), 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 show a mutagenic effect.

Use in Hepatic Impairment

The insulin requirement may decrease in hepatic insufficiency.

Use in Renal Impairment

The insulin requirement may decrease in renal insufficiency.

Special Precautions

Transferring a patient to another type of insulin or to an insulin preparation with a different trade name should occur under strict medical supervision.

Changes in insulin strength, type, species (porcine, human insulin, human insulin analog), or manufacturing method (DNA-recombinant insulin or insulin of animal origin) may necessitate a dose adjustment.

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

The insulin requirement 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 insulin requirement may increase.

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

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

The warning symptoms of hypoglycemia may change or be less pronounced in cases of long-standing diabetes mellitus, diabetic neuropathy, or concurrent use of beta-blockers.

In some cases, local allergic reactions may be caused by reasons not related to the drug’s action, such as 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 necessary.

Effect on ability to drive vehicles and operate machinery

During hypoglycemia, the patient’s ability to concentrate and the speed of psychomotor reactions may deteriorate. This can be dangerous in situations where these abilities are especially necessary (driving a car or operating machinery). Patients should be advised to take precautions to avoid hypoglycemia while driving. This is particularly important for patients with mild or absent warning symptoms of hypoglycemia or with frequent episodes of hypoglycemia. In such cases, the physician should assess the advisability of the patient driving a car.

Drug Interactions

The hypoglycemic effect is reduced by oral contraceptives, corticosteroids, thyroid hormone preparations, thiazide diuretics, diazoxide, tricyclic antidepressants.

The hypoglycemic effect 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 symptoms of hypoglycemia.

When insulin preparations are used in combination with drugs of the thiazolidinedione group in patients with type 2 diabetes mellitus, fluid retention may occur, thereby increasing the risk of development and progression of chronic heart failure, especially in patients with cardiovascular diseases and risk factors for chronic heart failure. Patients receiving such therapy should be regularly examined for signs of heart failure. If heart failure occurs, therapy should be carried out in accordance with current treatment standards.

Storage Conditions

Store at 2°C (36°F) to 8°C (46°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

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.