BIOSULIN N (Solution for injection)

Active material: soluble insulin (human genetic engineering)
When ATH: A10AB01
CCF: Short-acting human insulin
ICD-10 codes (testimony): E10, E11
When CSF: 15.01.01.01
Manufacturer: OAO Pharmstandard-UfaVITA (Russia)

Pharmaceutical form, composition and packaging

Solution for injection colorless or near colorless, clear or almost clear.

Excipients: glycerol, cresol, hydrochloric acid or sodium hydroxide (10% solution, to maintain the pH level), water d / and.

10 ml – glass bottles (1) – packs cardboard.

Solution for injection colorless or near colorless, clear or almost clear.

Excipients: glycerol, cresol, hydrochloric acid or sodium hydroxide (10% solution, to maintain the pH level), water d / and.

3 ml – glass cartridges for use with pen Pen Biosulin® (5) – packings Valium planimetric (1) – packs cardboard.

Pharmacological action

Short-acting insulin. It represents human insulin, produced using recombinant DNA technology.

It interacts with a specific receptor cytoplasmic outer cell membrane to form insulin-receptor complex, stimulating intracellular processes, incl. Several key enzymes (incl. geksokinaza, pyruvate, glikogensintetaza). The decrease in blood glucose due to an increase of intracellular transport, increased absorption and assimilation tissue, stimulation of lipogenesis, glikogenogeneza, reducing the rate of hepatic glucose production.

The duration of action of insulin in preparations is due mainly absorption rate, which depends on several factors (eg, dose, method and place of introduction), in connection with which action profile of insulin fluctuate significantly, how different people, and at one and the same person.

After p / to the introduction of onset of action observed in approximately 30 m, maximum effect – of between 2 and 4 no, duration – 6-8 no.

Pharmacokinetics

Absorption

Weight absorption and onset of insulin effect depends on the method of administration (n / a or / m) and the injection site (life, hip, buttocks), dose (volume of insulin), Insulin concentration in the formulation.

Distribution

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

Metabolism

It destroyed insulinase mainly in the liver and kidneys.

Deduction

T_1/2 is several minutes. Excreted in the urine – 30-80%.

Testimony

- Caharnыy diabetes;

- Urgent conditions in patients with diabetes, accompanied by decompensation of carbohydrate metabolism.

Dosage regimen

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

The drug is intended for the n / a, / m, / in the.

The average daily dose is between 0.5 to 1 IU / kg body weight (It depends on the individual patient and blood glucose levels).

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

Temperature of insulin must correspond to room.

When monotherapy dose frequency is 3 times / day (if necessary – 5-6 time / day). At a daily dose of, exceeding 0.6 IU / kg, It must be administered in the form of 2 or more injections into different areas of the body.

Biosulin^® P typically administered s / c in the abdominal wall. Injections can be done also in the thigh, buttocks or the deltoid region of the shoulder. It is necessary to change the injection site within the anatomical region, to prevent the development of lipodystrophy.

V / m and in / Biosulin^® P can be administered only under medical supervision.

Biosulin^® P – and short-acting insulin is typically used in combination with an intermediate-acting insulin (Biosulin^® N).

The injection technique with insulin vials

If the patient is using only one type of insulin

1. Disinfect the rubber membrane on the bottle.

2. Type in an amount of air in the syringe, corresponding to the required dose of insulin. Enter the air into the vial of insulin.

3. Turn the bottle upside down with the syringe and dial the correct dose of insulin into the syringe. Remove the needle from the vial and remove the air from the syringe. Check the correctness of the set dose of insulin.

4. Immediately make an injection.

If the patient needs to mix two types of insulin

1. Disinfect the rubber membrane on the vials.

2. Just before entering the ride vial of long-acting insulin (“cloudy”) between your hands until, until insulin will not be uniformly white and turbid.

3. Type in an amount of air in the syringe, appropriate dose “cloudy” insulin. Enter the air into the vial with “cloudy” insulin and pull the needle out of the vial (“cloudy” insulin at this stage is not to be gaining).

4. Type in an amount of air in the syringe, the appropriate dose of short-acting insulin (“clear”). Enter the air into the vial with “clear” insulinom. Turn the bottle upside down with the syringe and dial the correct dose “clear” insulin. Remove the needle and remove the air from the syringe. Check the correct dose dialed.

5. Introduce the needle in the vial “cloudy” insulinom, turn the bottle with the syringe upside down and dial the desired dose of insulin. Remove air from the syringe and check the dose correctly typed. Immediately to inject insulin mixture typed.

6. Recruit insulin should always be in the same sequence, above.

The injection technique with insulin in cartridges

Cartridge preparation Biosulin^® P is for use with a syringe pen Biosulin^® And. Patients should be warned of the need to carefully follow the instructions in the instructions for use of the pen for insulin.

Before using, make sure, that on the cartridge with the drug Biosulin^® P there is no damage (eg, cracks). Do not use the cartridge, If there is any visible damage. After, as the cartridge is inserted into the pen, through the window of the cartridge holder must be visible colored stripe.

After injection, the needle must remain under the skin for at least 6 sec. Keep the button down until complete withdrawal of the needle from the skin, thus, ensures the correct dosing and limited the possibility of getting a blood or lymph in the needle or insulin cartridge.

Cartridge preparation Biosulin^® P is intended only for personal use and may not be re-filling.

Injection procedure

1. Two fingers should gather a fold of skin, then insert the needle into the base of the fold at an angle of about 45 ° C and introduce insulin into the skin.

2. After injection, the needle must remain under the skin for at least 6 seconds, for, To make sure, Insulin is fully input.

3. If after removing the needle at the injection site appears blood, you must press the injection site with your finger.

4. It should change injection sites.

Side effect

Metabolism: hypoglycemic states (pale skin, increased sweating, palpitations, tremor, hunger, excitation, paresthesia in the mouth, headache). Severe hypoglycemia may lead to the development of hypoglycemic coma.

Allergic reactions: rarely – skin rash, angioedema; in a few cases – anaphylactic shock.

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

Other: swelling, transient refractive error (usually at the beginning of therapy).

Contraindications

- Gipoglikemiâ;

- Improved insulin sensitivity or other ingredients.

Pregnancy and lactation

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

Cautions

You can not use Biosulin^® P, if the solution became cloudy, or if the detected colored solids.

Against the background of insulin therapy is necessary to constantly monitor the level of glucose in the blood.

The causes of hypoglycemia, apart from insulin overdose, can be: Replacement product, skipping meals, vomiting, diarrhea, increasing physical activity, disease, reducing the need for insulin (of the liver and kidneys, hypofunction of the adrenal cortex, pituitary or thyroid), change the injection site, as well as interaction with other drugs.

Wrong dosing regimen or interruptions in insulin delivery, especially in patients with diabetes mellitus type 1, may lead to hyperglycaemia. Usually the first symptoms of hyperglycaemia develop gradually, for a few hours or days (the appearance of thirst, increased urination, nausea, vomiting, dizziness, redness and dryness of the skin, dry mouth, loss of appetite, acetone odor breath). Without treatment, hyperglycemia in diabetes mellitus type 1 It can lead to life-threatening diabetic ketoacidosis.

The dose must be adjusted in the human thyroid gland, Addison's disease, gipopituitarizme, hepatic dysfunction and / or kidney, diabetes mellitus in persons over 65 years, with an increase in the intensity of physical activity or a change in dietary habits.

Comorbidities (particularly infectious) and state, accompanied by fever, increase the need for insulin.

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

The drug reduces the tolerance to alcohol.

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

Effects on ability to drive vehicles and management mechanisms

In connection with the primary destination insulin, change its kind or significant physical or mental stress on the body may reduce the ability to drive a car or to the management of the various mechanisms, as well as studies in other potentially dangerous activities, require increased attention and psychomotor speed reactions.

Overdose

Symptoms: may develop hypoglycemia.

Treatment: light hypoglycaemia the patient can resolve itself, taking into sugar or carbohydrate-rich foods. Therefore, patients with diabetes should always carry sugar, confection, biscuits or sugary fruit juice.

In severe cases, loss of consciousness in the patient / injected 40% Dextrose; / m, n / a, I / – glucagon. After regaining consciousness of the patient is recommended to take food, rich in carbohydrates, to prevent recurrence of hypoglycemia.

Drug Interactions

There are several drugs, that affect the demand for insulin.

Hypoglycemic effect of insulin increase the oral hypoglycemic drugs, MAO inhibitors, ACE inhibitors, carbonic anhydrase inhibitors, non-selective beta-blockers, bromocriptine, Octreotide, sulfonamides, anabolic steroid, tetracikliny, clofibrate, ketoconazole, meʙendazol, pyridoxine, theophylline, cyclophosphamide, fenfluramin, lithium preparations, preparations, containing ethanol.

Hypoglycemic effect of insulin impaired oral contraceptives, GCS, thyroid hormones, thiazide diuretics, Heparin, tricyclic antidepressants, sympathomimetic, danazol, klonidin, Calcium channel blockers, diazoksid, morphine, phenytoin, nicotine.

Under the influence of reserpine and possibly as a weakening of salicylates, and strengthening of the drug.

Conditions of supply of pharmacies

The drug is released under the prescription.

Conditions and terms

List B. The drug should be stored out of reach of children, dark place at a temperature of 2 ° to 8 ° C; Do not freeze. Shelf life – 2 year. Do not use after the expiry date, on the package.

Used vial of insulin kept at a temperature of 15 ° to 25 ° C for 6 weeks, cartridge – during 4 weeks.