Biosulin N suspension for subcutaneous injection. 100IU / ml, cartridge 3ml No. 5

• Type 1 diabetes mellitus;

• type 2 diabetes mellitus: stage of resistance to oral hypoglycemic agents, partial resistance to these drugs (during combination therapy), intercurrent diseases.

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

The drug is intended for subcutaneous administration. The average daily dose varies 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 insulin injected should be at room temperature.

BiosulinЃ N is injected subcutaneously into the thigh; injections can also be made into the anterior abdominal wall, buttock, or the area of ??the deltoid muscle of the shoulder.

It is necessary to change injection sites within the anatomical region to prevent the development of lipodystrophies.

It is possible to administer BiosulinЃ N as only one drug, or in combination with short-acting insulin (BiosulinЃ R).

Injection technique when using insulin in vials

Do not use BiosulinЃ N if, when stirring the contents of the vial according to the instructions for use, the insulin does not become uniformly white and cloudy. Do not use BiosulinЃ N if it contains flakes after mixing. Do not use BiosulinЃ N if hard white particles have adhered to the bottom or walls of the bottle, creating the effect of a 'frosty pattern'.

If the patient is using only one type of insulin

1. Disinfect the rubber membrane on the vial.

2. Draw air into the syringe in a volume corresponding to the required dose of insulin. Introduce air into the insulin vial.

3. Turn the vial with the syringe upside down and draw the required dose of insulin into the syringe. Remove the needle from the vial and remove air from the syringe. Check that the insulin dose is set correctly.

4. Inject immediately.

If the patient needs to mix two types of insulin

1. The rubber membranes on the vials should be disinfected.

2. Immediately before the kit, roll the long-acting ('cloudy') insulin bottle between the palms of your palms until the insulin is uniformly white and cloudy.

3. Draw air into the syringe in a volume corresponding to the dose of 'cloudy' insulin. Introduce air into the vial with the 'cloudy' insulin and remove the needle from the vial (the 'cloudy' insulin should not be drawn at this stage for now).

4. Draw air into the syringe in a volume corresponding to the dose of short-acting ('clear') insulin. Introduce air into the vial with 'clear' insulin. Turn the syringe bottle upside down and draw up the required dose of 'clear' insulin. Remove the needle and remove air from the syringe. Check the correct dose.

5. Insert the needle into the vial with the 'cloudy' insulin, turn the vial with the syringe upside down and draw up the required dose of insulin. Remove air from the syringe and check the correct dose. Immediately inject the drawn insulin mixture.

6. The insulins should always be drawn in the same sequence as described above.

Injection technique when using insulin in cartridges

The cartridge with the BiosulinЃ N preparation is intended for use with the BiomaticPenЃ or BiosulinЃ Pen syringe pen. The patient should be warned about the need to carefully follow the instructions in the instructions for use of a syringe pen for administering insulin.

Before use, make sure that there are no damages (for example, cracks) on the cartridge with BiosulinЃ N. Do not use the cartridge if there is any visible damage. Do not use BiosulinЃ N if, when stirring the contents of the cartridge according to the instructions for use, the insulin does not become uniformly white and cloudy. Do not use BiosulinЃ N if it contains flakes after mixing. Do not use BiosulinЃ N if hard white particles have adhered to the bottom or walls of the bottle, creating the effect of a 'frosty pattern'.

After the cartridge is inserted into the pen, a colored strip should be visible through the window of the cartridge holder.

Before placing the cartridge in the pen, turn the cartridge up and down so that the glass ball moves from end to end of the cartridge. This procedure should be repeated at least 10 times until all the liquid is white and evenly cloudy. An injection must be given immediately after this.

If the cartridge is already inside the pen, turn it with the cartridge inside up and down at least 10 times. This procedure must be repeated before each injection.

After injection, the needle should remain under the skin for at least 6 seconds. The button should be held down until the needle is completely removed from under the skin, thus ensuring the correct dose delivery and limiting the possibility of blood or lymph getting into the needle or into the insulin cartridge.

The cartridge with the BiosulinЃ N preparation is intended only for individual use and cannot be refilled.

Injection procedure

1. With two fingers, collect a fold of skin, then insert the needle into the base of the fold at an angle of about 45 ? and inject insulin under the skin.

2. After injection, the needle should remain under the skin for at least 6 seconds, in order to ensure that the insulin is fully injected.

3. If blood appears at the injection site after removing the needle, lightly press the injection site with a swab moistened with a disinfectant solution (such as alcohol).

4. The injection sites should be changed.

Suspension for subcutaneous administration of white; when standing, the suspension settles, forming a white precipitate. The supernatant is clear, colorless, or nearly colorless. The precipitate is easily resuspended with gentle shaking.

1 ml insulin isophane (human genetically engineered) 100 IU

Excipients: zinc oxide - 11-17 ?g, sodium hydrogen phosphate dihydrate (disodium hydrogen phosphate dihydrate) - 2.4 mg, protamine sulfate - 270-400 ?g, metacresol - 1.6 mg, phenol (crystalline phenol) - 650 ?g, glycerol - 16 mg, water d / i - up to 1 ml, sodium hydroxide 10% solution or hydrochloric acid 10% solution (to maintain the pH level).

• Hypoglycemia;

• hypersensitivity to insulin or other components of the drug.

pharmachologic effect

Medium-acting insulin preparation. It is human insulin obtained using recombinant DNA technology.

Interacts with a specific receptor of the outer cytoplasmic membrane of cells and forms an insulin-receptor complex that stimulates intracellular processes, incl. synthesis of a number of key enzymes (including hexokinase, pyruvate kinase, glycogen synthetase). A decrease in blood glucose is due to an increase in its intracellular transport, increased absorption and assimilation by tissues, stimulation of lipogenesis, glycogenesis, and a decrease in the rate of glucose production by the liver.

The duration of action of insulin preparations is mainly determined by the rate of absorption, which depends on several factors (for example, on the dose, route and place of administration), and therefore the profile of insulin action is subject to significant fluctuations, both in different patients and in the same patient. ...

After subcutaneous administration, the onset of action is observed in about 1-2 hours, the maximum effect is between 6 and 12 hours, the duration of action is 18-24 hours.

Pharmacokinetics

Suction

The completeness of absorption and the onset of the effect of insulin depends on the injection site (abdomen, thigh, buttocks), dose (volume of insulin injected), and the concentration of insulin in the preparation.

Distribution

It is distributed unevenly in the tissues. Does not penetrate the placental barrier and is not excreted in breast milk.

Metabolism

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

Withdrawal

It is excreted in the urine - 30-80%.

Side effect

Due to the effect on carbohydrate metabolism: hypoglycemic conditions (pallor of the skin, increased sweating, palpitations, tremors, hunger, agitation, paresthesia in the mouth, headache). Severe hypoglycemia can lead to the development of hypoglycemic coma.

Allergic reactions: skin rash, Quincke's edema, anaphylactic shock.

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

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

Application during pregnancy and lactation

There are no restrictions on the treatment of diabetes mellitus with insulin during pregnancy. 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 and immediately after childbirth, the need for insulin can drop dramatically. Soon after giving birth, the need for insulin returns to pre-pregnancy levels.

There are no restrictions on the treatment of diabetes mellitus with insulin while breastfeeding. However, it may be necessary to reduce the dose of insulin, so close monitoring is necessary and for several months until the insulin requirement stabilizes.

Application for violations of liver function

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

Application for impaired renal function

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

Use in elderly patients

The dose of the drug must be adjusted in persons over 65 years of age.

special instructions

You can not use the drug BiosulinЃ N, if after shaking the suspension does not become white and evenly cloudy.

Against the background of insulin therapy, constant monitoring of blood glucose levels is necessary.

In addition to insulin overdose, hypoglycemia may be caused by drug replacement, skipping meals, vomiting, diarrhea, increased physical activity, diseases that reduce the need for insulin (liver and kidney dysfunction, hypofunction of the adrenal cortex, pituitary gland or thyroid gland), change of the injection site, and also interactions with other medicinal products.

An incorrect dosing regimen or interruptions in the administration of insulin, 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. These include thirst, increased urination, nausea, vomiting, dizziness, redness and dryness of the skin, dry mouth, loss of appetite, and acetone odor in exhaled air. If left untreated, hyperglycemia in type 1 diabetes can lead to life-threatening diabetic ketoacidosis.

The insulin dose must be corrected in case of thyroid dysfunction, Addison's disease, hypopituitarism, liver and / or kidney dysfunction, diabetes mellitus in persons over 65 years of age.

Insulin dose adjustment may also be required if the patient increases the intensity of physical activity or changes the usual diet.

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

The transition from one type of insulin to another should be carried out under the control of blood glucose levels.

The drug lowers alcohol tolerance.

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 vehicles and use mechanisms

With the primary appointment of insulin, a change in its type or with significant physical or mental stress 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 hazardous activities that require increased attention and speed of psychomotor reactions.

Overdose

Symptoms: hypoglycemia may develop.

Treatment: the patient can eliminate mild hypoglycemia himself by ingesting sugar or carbohydrate-rich foods (diabetics are advised to constantly carry sugar, sweets, cookies or sweet fruit juice with them). In severe cases, with loss of consciousness, a 40% dextrose solution is injected intravenously; i / m, s / c or i / v - glucagon. After regaining consciousness, the patient is advised to eat a carbohydrate-rich diet to prevent the recurrence of hypoglycemia.

Drug interactions

There are a number of medications that affect your insulin requirement.

The hypoglycemic effect of insulin is enhanced by oral hypoglycemic drugs, MAO inhibitors, ACE inhibitors, carbonic anhydrase inhibitors, nonselective beta-blockers, bromocriptine, octreotide, sulfonamides, anabolic steroids, tetracyclines, clofibazylamide, ketoconazole preparations containing ethanol.

The hypoglycemic effect of insulin is weakened by oral contraceptives, corticosteroids, thyroid hormones, thiazide diuretics, heparin, tricyclic antidepressants, sympathomimetics, danazol, clonidine, blockers of 'slow' calcium channels, diazoxide, morphine, phenytoin-blockers aminephrine nicotine, N1 ...

Under the influence of reserpine and salicylates, both weakening and strengthening of the drug's action are possible.