Biosulin R suspension for subcutaneous injection 100 IU/ml vial 10 ml 1pc.

Composition

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1 ml of the injection solution contains:

Active ingredient:

isofan-human insulin 100 units;

excipients:

glycerol;

metacresol;

water for injection

Pharmacological action

Biosulin P, a short-acting insulin, is a human insulin produced using recombinant DNA technology.

It interacts with a specific receptor of 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 synthetase).

The decrease in blood glucose is caused by an increase in its intracellular transport, increased absorption and assimilation by tissues, stimulation of lipogenesis, glycogenogenesis, and a decrease in the rate of glucose production by the liver.

The duration of action of Biosulin P is mainly determined by the rate of absorption, which depends on several factors (for example, on the dose, method and place of administration), and therefore the profile of insulin action is subject to significant fluctuations, both in different people and in the same person. After subcutaneous administration, the onset of action of Biosulin P is observed in approximately 30 minutes, the maximum effect is between 2 and 4 hours, and the duration of action is 6-8 hours.

Pharmacokinetics

Suction

The completeness of absorption and the onset of the effect of insulin depends on the method of administration (subcutaneous or intramuscular) and the place of administration (abdomen, thigh, buttocks), the dose (volume of insulin administered), and the concentration of insulin in the drug.

Distribution

It is distributed unevenly in the tissues. It does not cross the placental barrier and is not excreted in breast milk.

Metabolism

It is destroyed by insulinase mainly in the liver and kidneys.

T1/2 withdrawal time is a few minutes. It is excreted in the urine — 30-80%.

Indications

• Type 1 diabetes mellitus (insulin-dependent);
• type 2 diabetes mellitus (non-insulin-dependent): stage of resistance to oral hypoglycemic agents, partial resistance to these drugs (during combination therapy), intercurrent diseases;
• emergency conditions in patients with diabetes mellitus, accompanied by decompensation of carbohydrate metabolism.

Use during pregnancy and lactation

Data on the use of the drug during pregnancy and lactation are not provided.

Contraindications

increased individual sensitivity to insulin or other components of the drug; hypoglycemia.

Side effects

From the side of metabolism: hypoglycemic conditions (pallor of the skin, increased sweating, palpitation, tremor, hunger, agitation, paresthesia in the mouth, headache). Severe hypoglycemia can lead to the development of hypoglycemic coma.

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

Allergic reactions: rarely-skin rash, angioedema; in isolated cases-anaphylactic shock.

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

Interaction

There are a number of drugs that affect the need for insulin.

The hypoglycemic effect of insulin is enhanced by oral hypoglycemic drugs, MAO inhibitors, ACE inhibitors, carbonic anhydrase inhibitors, non-selective beta-blockers, bromocriptine, octreotide, sulfonamides, anabolic steroids, tetracyclines, clofibrate, ketoconazole, mebendazole, pyridoxine, cyclophosphamide, fenfluramine, lithium preparations. containing ethanol.

The hypoglycemic effect of insulin is weakened by oral contraceptives, corticosteroids, thyroid hormones, thiazide diuretics, heparin, tricyclic antidepressants, sympathomimetics, danazol, clonidine, BCC, diazoxide, morphine, phenytoin, nicotine.

Under the influence of reserpine and salicylates, both a weakening and an increase in the effect of the drug is possible.

How to take, course of administration and dosage

Subcutaneously, intramuscularly, intravenously,30 minutes before a meal or light snack containing carbohydrates.

The dose of the drug is determined by the doctor individually, in each specific case, based on the level of glucose in the blood.

On average, the daily dose is from 0.5 to 1 IU/kg of body weight (depending on the individual characteristics of the patient and the level of glucose in the blood).

The temperature of the injected insulin should correspond to room temperature.

With monotherapy, the frequency of administration is 3 times a day (if necessary,5-6 times a day). If the daily dose exceeds 0.6 IU / kg, it should be administered in the form of 2 or more injections in different areas of the body.

Biosulin P is usually administered subcutaneously in the anterior abdominal wall. Injections can also be made in the thigh, buttock, or deltoid area of the shoulder. It is necessary to change the injection sites within the anatomical area to prevent the development of lipodystrophy.

Intramuscularly and intravenously, Biosulin P can only be administered under the supervision of a doctor.

Biosulin P is a short-acting insulin and is usually used in combination with a medium-acting insulin (Biosulin H).

Injection technique when using insulin in vials

If the patient uses only one type of insulin

If the patient needs to mix two types of insulin

Injection technique when using insulin in cartridges

The Biosulin P cartridge is intended for use only with the Biosulin Pen syringe pen. The patient should be warned about the need to carefully follow the instructions in the instructions for using the pen for injecting insulin.

Before use, make sure that the Biosulin P cartridge is free of any damage (such as cracks). Do not use the ink cartridge if there is any visible damage. After the cartridge is inserted into the pen, a colored strip should be visible through the window of the cartridge holder.

After the injection, the needle should remain under the skin for at least 6 seconds. Keep the button pressed until the needle is completely removed from under the skin, so that the correct dose is administered and the possibility of blood or lymph entering the needle or the insulin cartridge is limited.

The Biosulin P cartridge is intended for individual use only and cannot be refilled again.

Injection procedure

Overdose

Symptoms: hypoglycemia may occur.

Treatment: the patient can eliminate mild hypoglycemia by taking sugar or carbohydrate-rich foods inside. Therefore, people with diabetes are advised to carry sugar, sweet fruit juice or other sweets at all times.

In severe cases, when the patient loses consciousness, a 40% dextrose solution is administered intravenously; intramuscularly, subcutaneously, intravenously — glucagon. After regaining consciousness, the patient is advised to eat a carbohydrate-rich diet to prevent the recurrence of hypoglycemia.

Special instructions

Do not use Biosulin P if the solution has become cloudy, colored, or solid particles are detected.

During insulin therapy, it is necessary to constantly monitor the level of glucose in the blood.

The causes of hypoglycemia, in addition to an overdose of insulin, can be: drug replacement, skipping meals, vomiting, diarrhea, increased physical activity, diseases that reduce the need for insulin (liver and kidney disorders, hypofunction of the adrenal cortex, pituitary gland or thyroid gland), changing the injection site, as well as interaction with other drugs.

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

The dose of the drug should be adjusted for significant physical exertion, infectious diseases, fever, thyroid disorders, Addison’s disease, hypopituitarism, liver and/or kidney disorders, diabetes mellitus in persons over 65 years of age, increased intensity of physical activity or changes in the usual diet.

Concomitant diseases (especially infectious diseases) and conditions accompanied by fever increase the need for insulin.

Switching from one type of insulin to another should be done under the control of blood glucose levels.

The drug reduces tolerance to alcohol.

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

Influence on the ability to drive motor vehicles and manage mechanisms

Due to the initial administration of insulin, a change in its type, or significant physical or mental stressful effects on the body, it is possible to reduce the ability to drive a car or control various mechanisms, as well as engage in other potentially dangerous activities that require increased attention and speed of psychomotor reactions.

Form of production

Solution for injection

Storage conditions

Store in a dark place, at a temperature of 2-8 °C (do not freeze)

Shelf life

2 years

Active ingredient

Genetically Engineered Human Soluble Insulin

Conditions of release from pharmacies

By prescription

Dosage form

suspension for injection

Purpose

For pregnant women as prescribed by a doctor, For adults as prescribed by a doctor, For nursing mothers as prescribed by a doctor, For Children as prescribed by a doctor

Indications

Type 1 Diabetes, Type 2 Diabetes

Weight

Weight: 28 gr.