Biosulin R solution for injection 100IU / ml, 10ml No. 1

• Diabetes;

• emergency conditions in patients with diabetes mellitus, accompanied by decompensation of carbohydrate metabolism.

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

The drug is intended for subcutaneous, intramuscular, intravenous administration.

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

The drug is administered 30 minutes before a meal or snack containing carbohydrates.

The temperature of the insulin injected should be at room temperature.

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

BiosulinЃ R is usually injected subcutaneously into the anterior abdominal wall. It can also be injected into the thigh, buttock, or deltoid area of ??the shoulder. It is necessary to change injection sites within the anatomical region to prevent the development of lipodystrophy.

IM and IV BiosulinЃ R can be administered only under the supervision of a physician.

BiosulinЃ R is a short-acting insulin and is usually used in combination with intermediate-acting insulin (BiosulinЃ N).

Injection technique when using insulin in vials

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 R 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 R. Do not use the 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 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 R preparation is intended for individual use only 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, press the injection site with your finger.

4. The injection sites should be changed.

Solution for injection is colorless or almost colorless, transparent or almost transparent.

1 ml

insulin soluble (human genetically engineered) 100 IU

Excipients: glycerol - 16 mg, metacresol - 2.5 mg, water d / i - up to 1 ml, hydrochloric acid 10% solution or sodium hydroxide 10% solution (to maintain the pH level).

• Hypoglycemia;

• hypersensitivity to insulin or other components of the drug.

pharmachologic effect

Short-acting insulin. 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 site of administration), and therefore the profile of insulin action is subject to significant fluctuations, both in different people and in the same the patient.

After subcutaneous administration, the onset of action of the drug is observed after about 30 minutes, the maximum effect is in the interval between 2 and 4 hours, 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 route of administration (subcutaneous or intramuscular) and the site of administration (abdomen, thigh, buttocks), dose (volume of insulin injected), and 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

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

Side effect

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

Allergic reactions: rarely - skin rash, Quincke's edema; in isolated cases - 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

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

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

Do not use BiosulinЃ R if the solution becomes cloudy, colored or if solid particles are detected.

During insulin therapy, it is necessary to constantly monitor blood glucose levels.

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 dysfunction, hypofunction of the adrenal cortex, pituitary gland or thyroid gland), change of place injections, as well as interactions with other drugs.

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 (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 life-threatening diabetic ketoacidosis.

The dose of the drug must be adjusted in case of thyroid dysfunction, Addison's disease, hypopituitarism, liver and / or kidney dysfunction, diabetes mellitus in persons over 65 years of age, with an increase in the intensity of physical activity or a change in 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 reduces 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

In connection 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. Therefore, diabetics are advised to carry sugar, sweets, cookies or sweet fruit juice with them at all times.

In severe cases, when the patient loses consciousness, 40% dextrose solution is administered intravenously; i / m, s / c, i / v - glucagon. After regaining consciousness, the patient is advised to eat food rich in carbohydrates 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, GCS, thyroid hormones, thiazide diuretics, heparin, tricyclic antidepressants, sympathomimetics, danazol, clonidine, calcium channel blockers, diazoxide, morphine, phenytoin, nicotine.

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