Биосулин® P

General characteristics. Structure:

Active agent: insulin human genetically engineered – 100 ME;
Excipients: metacresol, глицерол, water for injections.

Note: for regulation рН solution of sodium hydroxide or 10% acid solution of hydrochloric is used.

Description. Colourless or almost colourless, transparent liquid.

Pharmacological properties:

Биосулин® P - the human insulin received with use of technology of recombinant DNA. Is drug of insulin of short action. Interacts with a specific receptor of an external cytoplasmic membrane of cells and forms insulin - the receptor complex stimulating intracellular processes, including synthesis of a number of key enzymes (a hexokinase, a pyruvatekinase, a glikogensintetaza, etc.). Decrease in content of glucose in blood is caused by increase in its intracellular transport, strengthening of absorption and assimilation by fabrics, stimulation of a lipogenesis, glikogenogenez, reduction of speed of products of glucose a liver, etc.

Duration of effect of drugs of insulin is generally caused by the absorption speed which depends on several factors (for example, on a dose, a way and injection site), in communication with what the profile of effect of insulin is subject to considerable fluctuations, both at various people, and at the same person.

Action profile at a subcutaneous injection (approximate figures): the beginning of action in 30 minutes, the maximum effect – in an interval between 2 and 4 hours, action duration - 6-8 hours.

Pharmacokinetics. Completeness of absorption and the beginning of effect of insulin depends on a way of introduction (subcutaneously, intramusculary), injection sites (a stomach, a hip, buttocks), doses (volume of the entered insulin), concentration of insulin in drug, etc. It is distributed on fabrics unevenly: does not get through a placental barrier and into breast milk. Collapses an insulinase generally in a liver and kidneys. The elimination half-life makes several minutes. It is removed by kidneys (30-80%).

Indications to use:

• Diabetes mellitus of type 1 (insulin-dependent)
• Diabetes mellitus of type 2 (non-insulin-dependent): a resistance stage to peroral hypoglycemic means, partial resistance to these drugs (when carrying out a combination therapy), intercurrent diseases
• The medical emergencies at patients with a diabetes mellitus which are followed by a decompensation of carbohydrate metabolism

Route of administration and doses:

Биосулин® P it is intended for hypodermic, intramuscular and intravenous administration.

The dose and way of administration of drug is defined by the doctor individually in each case on the basis of glucose level in blood.

On average the daily dose of drug fluctuates from 0,5 to 1 ME/kg of body weight (depends on specific features of the patient and level of glucose of blood).

The drug is administered in 30 minutes prior to meal or the light meal containing carbohydrates.

Temperature of the entered insulin has to correspond to room.

At monotherapy by drug frequency rate of introduction makes 3 times a day (if necessary - 5-6 times a day). At the daily dose exceeding 0,6 ME/kg it is necessary to enter in the form of the 2nd and more injections into various areas of a body.

Биосулин® P it is usually entered subcutaneously into a front abdominal wall. Injections can be done also in a hip, a buttock or area of a deltoid muscle of a shoulder. It is necessary to change places of injections within anatomic area to prevent development of lipodystrophies. Intramusculary and intravenously Biosulin® P can be entered only under control of the doctor.

Биосулин® P – insulin of short action is also usually used in a combination with insulin of average duration of action (Biosulin N).

Features of use:

It is impossible to use Biosulin® P if it became muddy, painted or if solid particles come to light.

Against the background of therapy by insulin constant control of level of glucose in blood is necessary.

In addition to insulin overdose, can be the hypoglycemia reasons: drug replacement, the admission of meal, vomiting, diarrhea, increase in physical activity, the diseases reducing the need for insulin (an abnormal liver function and kidneys, hypofunction of bark of adrenal glands, a hypophysis or thyroid gland), change of the place of an injection, and also interaction with other medicines.

The wrong dosing or breaks in administration of insulin, especially at patients with a diabetes mellitus of type 1, can lead to a hyperglycemia. Usually the first symptoms of a hyperglycemia develop gradually, for several hours or days. They include emergence of thirst, increase of an urination, nausea, vomiting, dizziness, reddening and a xeroderma, dryness in a mouth, appetite loss, an acetone smell in expired air. If not to carry out treatment, the hyperglycemia at a diabetes mellitus of type 1 can lead to development of life-threatening diabetic ketoacidosis.

The dose of insulin needs to be korrigirovat at dysfunction of a thyroid gland, Addison's disease, a hypopituitarism, abnormal liver functions and kidneys and a diabetes mellitus at persons 65 years are more senior.

Dose adjustment of insulin can be also required if the patient increases intensity of physical activity or changes a usual diet.

Associated diseases, especially the infections and states which are followed by fever increase the need for insulin.

Transition from one type of insulin to another should be carried out under control of level of glucose to blood.

Drug lowers tolerance to alcohol.

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

Influence on ability to driving of motor transport and to control of mechanisms

Due to primary purpose of insulin, change of its look or in the presence of considerable physical or mental stresses, decline in the ability to driving of the car or to control of various mechanisms, and also occupations other potentially dangerous types of activity requiring special attention and speed of mental and motor reactions is possible.

Side effects:

Caused by influence on carbohydrate metabolism: hypoglycemic states (pallor of integuments, sweating strengthening, heartbeat, a tremor, feeling of hunger, excitement, paresthesias in a mouth, a headache). The expressed hypoglycemia can lead to development of a hypoglycemic coma.

Allergic reactions: seldom – skin rash, a Quincke's edema, it is extremely rare – an acute anaphylaxis.

Local reactions: a hyperemia, puffiness and an itch in the place of an injection, at prolonged use – a lipodystrophy in the place of an injection.

Others - hypostases, passing disturbances of a refraction (usually at the beginning of therapy).

Interaction with other medicines:

There is a number of medicines which influence the need for insulin.

Hypoglycemic effect of insulin peroral hypoglycemic drugs, monoamine oxidase inhibitors, inhibitors of an angiotensin-converting enzyme, karboangidraza inhibitors, non-selective beta adrenoblockers, Bromocriptinum, октреотид strengthen, streptocides, anabolic steroids, tetracyclines, Clofibratum, кетоконазол, Mebendazolum, a pyridoxine, theophylline, cyclophosphamide, фенфлурамин, the lithium drugs, drugs containing ethanol. Hypoglycemic effect of insulin oral contraceptives, glucocorticosteroids, thyroid hormones, thiazide diuretics, heparin, tricyclic antidepressants, sympathomimetics, даназол weaken, a clonidine, blockers of calcium channels, diazoxide, morphine, Phenytoinum, nicotine. Under the influence of Reserpinum and salicylates perhaps both easing, and strengthening of effect of drug.

Contraindications:

• The increased individual sensitivity to insulin or any of drug components
• Hypoglycemia

Overdose:

At overdose development of a hypoglycemia is possible.

Treatment: the patient can eliminate an easy hypoglycemia itself, having accepted inside sugar or carbohydrate-rich food stuffs. Therefore the sick diabetes mellitus recommends to carry constantly with itself sugar, sweets, cookies or sweet fruit juice.

In hard cases, at loss by the patient of consciousness, intravenously enter 40% dextrose solution; intramusculary, subcutaneously, intravenously – a glucagon. After consciousness recovery to the patient recommend to eat food, carbohydrate-rich, for prevention of repeated development of a hypoglycemia.

Storage conditions:

List B. In the place protected from light at a temperature from 2 °C to 8 °C. Not to freeze.

To store the used bottle at a temperature from 15 °C to 25 °C within 6 weeks. To store the used cartridge at a temperature from 15 °C to 25 °C within 4 weeks.

To store in the place, unavailable to children.

Period of validity - 2 years. Not to use after the period of validity specified on packaging.

Issue conditions:

According to the recipe

Packaging:

Solution for injections of 100 ME/ml. On 5 ml or 10 ml in  bottles from colourless neutral glass, corked by the cap combined.

On 3 ml in картирижд from neutral glass, Biomatik corked by the cap combined for use about the syringe the handle ®Пен or Biosulin ®Пен.

On 1 bottle on 5 ml or 10 ml in a pack together with the application instruction.

2,3 or 5 bottles on 5 ml or 10 ml in a blister strip packaging.

On 1, 3 or 5 cartridges in a blister strip packaging.

On 1 in planimetric packaging with bottles or with cartridges in a pack together with the application instruction in a cardboard pack.