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Manufacturers: ICN Jugoslavija
Active ingredients
- Insulin isophane [human semi-synthetic]
Disease class
- Insulin-dependent diabetes mellitus
- Non-insulin dependent diabetes mellitus
Clinical and pharmacological group
- Not indicated. See instructions
Pharmacological action
- Hypoglycemic
Pharmacological group
- Insulins
Release form, packaging and composition of the drug Humulin® M3
suspension for subcutaneous administration that separates, forming a white precipitate and a clear, colorless or almost colorless supernatant; the sediment is easily resuspended with gentle shaking.
| 1 ml | |
| biphasic insulin (human genetically engineered) | 100 IU |
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, liquid water - up to 1 ml, hydrochloric acid solution 10 % - qs to pH 6.9-7.8, sodium hydroxide solution 10% - qs to pH 6.9-7.8.
3 ml - cartridges (5) - blisters (1) - cardboard pack. 3 ml - cartridge built into the KwikPen™ syringe pen (5) - cardboard pack.
Clinical and pharmacological group: Human insulin of medium duration of action with rapid onset of action
Pharmacotherapeutic group: Hypoglycemic agent - a combination of short- and medium-acting insulins
Use during pregnancy and breastfeeding
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 mellitus during lactation (breastfeeding), adjustments in the dose of insulin, diet, or both may be required.
In in vitro and in vivo genetic toxicity studies, human insulin did not have a mutagenic effect.
Dosage regimen
The dose is determined individually depending on the glycemic level.
The drug should be administered subcutaneously, possibly intramuscularly. IV administration of Humulin M3 is contraindicated!
The drug is administered subcutaneously to the forearm, thigh, buttock or abdomen. The injection site must be alternated so that the same site is used no more than approximately 1 time per month.
When administered subcutaneously, care must be taken to avoid entering a blood vessel. After the 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
Before use, Humulin M3 cartridges and vials should be rolled between your palms 10 times and rocked, turning 180° also 10 times to resuspend the insulin until it takes the form of a homogeneous cloudy liquid or milk. Do not shake vigorously as this may cause foam to appear, which may prevent the dose from being delivered correctly.
Cartridges and bottles should be checked carefully. Do not use insulin if there are flakes in it after mixing, or if hard white particles have stuck 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 intended to be refilled.
The contents of the bottle should be drawn into an insulin syringe corresponding to the concentration of insulin administered, and the required dose of insulin should be administered as directed by the doctor.
When using cartridges, follow the manufacturer's instructions regarding refilling the cartridge and attaching the needle. The drug should be administered in accordance with the instructions of the syringe pen manufacturer.
Using the outer needle cap, immediately after insertion, unscrew the needle and safely destroy it. Removing the needle immediately after injection ensures sterility and prevents leakage, air entrapment, and possible needle clogging. Then put the cap on the pen.
Needles should not be reused. Needles and pens must not be used by others. Cartridges and bottles are used until they are empty, after which they should be discarded.
Overdose
Symptoms: hypoglycemia, accompanied by lethargy, increased sweating, tachycardia, pale skin, headache, trembling, vomiting, confusion.
Under certain conditions, such as long-term diabetes or intensive control of diabetes, the warning symptoms of hypoglycemia may change.
Treatment: Mild hypoglycemia can usually be treated with oral glucose (dextrose) or sugar. Adjustments to your insulin dose, diet, or physical activity may be necessary.
Correction of moderate hypoglycemia can be carried out using intramuscular or subcutaneous administration of glucagon, followed by oral carbohydrates.
Severe conditions of hypoglycemia, accompanied by coma, convulsions or neurological disorders, are treated with intramuscular or subcutaneous administration of glucagon or intravenous administration of a concentrated solution of glucose (dextrose). After regaining consciousness, the patient must be given food rich in carbohydrates to avoid re-development of hypoglycemia.
Side effect
Side effect associated with the main effect of the drug: hypoglycemia.
Severe hypoglycemia can lead to loss of consciousness and (in exceptional cases) death.
Allergic reactions: local allergic reactions are possible - hyperemia, swelling or itching at the injection site (usually disappear 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 heart rate, increased sweating. Severe cases of systemic allergic reactions can be life-threatening.
Other: the likelihood of developing lipodystrophy is minimal.
pharmachologic effect
DNA recombinant human insulin with an intermediate duration of action. It is a two-phase suspension (30% Humulin Regular and 70% Humulin NPH).
The main effect 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 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.
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 symptoms of hypoglycemia.
Pharmaceutical interactions
The effects that occur when human insulin is mixed with animal insulins or human insulin from other manufacturers have not been studied.
