Vozulim-30/70

General characteristics. Structure:

Active ingredient: 100 ME (4 mg) insulin of human (genetically engineered).

Excipients: protamin sulfate, zinc oxide, metacresol, phenol, глицерол, sodium phosphate disubstituted anhydrous, sodium hydroxide, Acidum hydrochloricum, water for injections.

Pharmacological properties:

Pharmacodynamics. Vozulim-30/70 is drug of human recombinant insulin of average duration of action. Insulin soluble (30%) and insulin isophanes (70%) is a part of drug. 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 glikogensintaza, 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 an injection site) in this connection the profile of effect of insulin is subject to considerable fluctuations, both at various people, and at the same person. The beginning of action after hypodermic introduction – in 30 min., the maximum effect – in 2 - 8 h, action duration – to 24 h.

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. It is removed by kidneys (30-80%).

Indications to use:

Diabetes mellitus.

Route of administration and doses:

Drug is intended for hypodermic introduction. The dose and time of administration of drug are defined by the doctor individually in each case, on the basis of concentration of glucose 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 concentration of glucose of blood).

Temperature of the entered insulin has to correspond to room.

The drug is usually administered subcutaneously in a hip. Injections can be done the same in a front abdominal wall, a buttock or in a shoulder in a projection of a deltoid muscle.

It is necessary to change places of injections within anatomic area to prevent development of a lipodystrophy.

To patients with a diabetes mellitus of type 2 the combination therapy with peroral hypoglycemic means can be carried out as monotherapy by the drug Vozulim-30/70 (brevity of introduction 2 times a day), and.

To use a cartridge only about the syringe handle.

Features of use:

Use during pregnancy and feeding by a breast. There are no restrictions on treatment of a diabetes mellitus with insulin during pregnancy as insulin does not get through a placental barrier. When planning pregnancy and during it it is necessary to intensify treatment of a diabetes mellitus. The need for insulin usually decreases in the I trimester of pregnancy and gradually increases in II and III trimesters.

At the time of delivery and directly after them the need for insulin can sharply decrease. Soon after the delivery the need for insulin quickly is returned to the level which was before pregnancy. There are no restrictions on treatment of a diabetes mellitus with insulin during feeding with a breast. However, the insulin dose decline therefore careful observation within several months before stabilization of need for insulin is necessary can be required.

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

Can be the hypoglycemia reasons in addition to overdose of insulin: 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 1 type, 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 1 type 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 concentration of glucose to blood.

Drug reduces tolerance to alcohol.

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

It is impossible to use drug if after agitation suspension does not become white or evenly muddy.

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, tremor, feeling of hunger, excitement, paresthesias of a mucous membrane of an oral cavity, headache). The expressed hypoglycemia can lead to development of a hypoglycemic coma.

Allergic reactions: 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:

Pharmaceutical it is incompatible with solutions of other medicines.      

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

Hypoglycemic effect of insulin non-selective beta adrenoblockers, quinidine, quinine, chloroquinine, monoaminooxidase inhibitors, inhibitors of an angiotensin-converting enzyme, karboangidraza inhibitors, октреотид strengthen, Bromocriptinum, streptocides, anabolic steroids, tetracyclines, Clofibratum, кетоконазол, Mebendazolum, a pyridoxine, theophylline, cyclophosphamide, фенфлурамин, the lithium drugs, drugs containing ethanol.

Hypoglycemic effect of insulin weaken a glucagon, соматропин, are oestrogenic, oral contraceptives, glucocorticosteroids, iodinated thyroid hormones, thiazide diuretics, loopback diuretics, heparin, tricyclic antidepressants, sympathomimetics, даназол, a clonidine, Sulfinpyrazonum, Epinephrinum, blockers of H1-histamine receptors, blockers of "slow" calcium channels, diazoxide, morphine, Phenytoinum, nicotine.

Reserpinum, salicylates can both strengthen, and to weaken hypoglycemic effect of insulin.

Contraindications:

- Hypersensitivity to insulin or other components of drug;

- 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% solution of a dextrose (glucose); 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:

To store in the place protected from light, at a temperature from +2 °C to +8 °C. Not to freeze. To protect from children. The drug which is in the use should be stored at a temperature of 15-25 °C no more than 6 weeks. A period of validity - 2 years. Not to use after the expiry date specified on packaging.

Issue conditions:

According to the recipe

Packaging:

Suspension for hypodermic introduction of 100 ME/ml. On 3 ml in cartridges of neutral glass (type I). On a cartridge paste the label. On 1 or 5 cartridges place in the blister from PVC / aluminum foil.

On 10 ml in the bottles of colourless neutral glass corked by rubber bungs and which are pressed out by aluminum caps with a plastic safety cover.

Each bottle or each blister with a cartridge No. 1 or No. 5 place in a cardboard pack together with the application instruction.