Ринсулин® P

General characteristics. Structure:

Active agent: insulin human 100 ME; excipients: metacresol of 3 mg, глицерол 16 mg, water for injections to 1 ml.

Pharmacological properties:

Pharmacodynamics. Rinsulin P is the human insulin received using technology of recombinant DNA. 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 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, glycogenesis, 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. On average, after hypodermic introduction, Rinsulin P begins to act in 30 minutes, the maximum effect develops between 1 and 3 hours, action duration – 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 1 type.

• Diabetes mellitus 2 types: a resistance stage to peroral hypoglycemic means, partial resistance to these drugs (when carrying out a combination therapy), intercurrent diseases.

• A diabetes mellitus 2 types at pregnant women.

• The medical emergencies at patients with a diabetes mellitus which are followed by a decompensation of carbohydrate metabolism.

Route of administration and doses:

Drug is intended for hypodermic, intramuscular and intravenous administration. The dose and a way of administration of drug is 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).

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 to 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.

The drug is usually administered subcutaneously in a front abdominal wall. Injections can be done the same in a hip, 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 lipodystrophies. At hypodermic administration of insulin it is necessary to show care that at an injection not to get to a blood vessel. After an injection it is not necessary to mass an injection site. Patients have to be trained in the correct use of the device for administration of insulin.

Intramusculary and intravenously the drug can be administered only under control of the doctor.

Cartridges can be used only if their contents represent transparent colourless liquid without visible particles. It is impossible to use drug if in solution the deposit appeared.

The device of cartridges does not allow to mix their contents with other insulin directly in the cartridge. Cartridges are not intended for replenishment.

When using cartridges it is necessary to observe the instruction of the producer concerning gas station of a cartridge in the syringe handle and fastenings of a needle. It is necessary to administer the drug according to the instruction of the producer the syringe handle.

After introduction it is necessary to turn off a needle, using an external cap of a needle, and at once safely to destroy it. Removal of a needle right after an injection provides sterility, prevents leak, hit of air and a possible contamination of a needle. Then it is necessary to put on a cap the handle.

When using previously filled multidose one-time the syringe handles for repeated injections it is necessary to take out before the first use the syringe handle from the refrigerator and to allow drug to reach room temperature. It is necessary to follow exact indications of the instruction for use the syringe handle delivered with drug.

Rinsulin P, in the syringe handle it is impossible to use if it stopped being transparent and colourless or if it was frozen.

Rinsulin P in the syringe handle and needles are intended only for individual use. The cartridge refill the syringe handle is not allowed.

Needles should not be reused.

For protection against light the syringe handle should be closed a cap.

Not to store used the syringe handle in the refrigerator.

To store the drug which is in the use at the room temperature (from 15 °C to 25 °C) no more than 28 days, to protect from direct sunshine and heating.

Features of use:

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 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.

Side effects:

Caused by influence on carbohydrate metabolism: hypoglycemic states (pallor of integuments, sweating strengthening, heart consciousness, tremor, fever, feeling of hunger, excitement, paresthesias of a mucous membrane of an oral cavity, weakness, headache, dizziness, decrease in visual acuity). The expressed hypoglycemia can lead to development of a hypoglycemic coma.

Allergic reactions: skin rash, Quincke's edema, 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 decrease in visual acuity (usually at the beginning of therapy). If the patient noted at himself development of a hypoglycemia or in it the episode of a loss of consciousness was noted, he needs to tell about it to the doctor immediately.

At identification of any other side effects which are not described above the patient also should see a doctor.

Interaction with other medicines:

There is a number of medicines which influence the need for insulin. Hypoglycemic effect of insulin peroral hypoglycemic drugs, monoaminooxidase 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 weaken a glucagon, соматропин, are oestrogenic, oral contraceptives, glucocorticosteroids, iodinated thyroid hormones, thiazide diuretics, loopback diuretics, heparin, tricyclic antidepressants, sympathomimetics, даназол, a clonidine, Epinephrinum, blockers of H1-histamine receptors, blockers of "slow" 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 (symptoms – see possible side effects).

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:

In the place protected from light at a temperature from 2 °C to 8 °C.

Not to freeze.

To store in the place, unavailable to children.

Issue conditions:

According to the recipe

Packaging:

10 ml - bottles (1) - packs cardboard