Растан®

General characteristics. Structure:

Active agent: соматропин 5,0 mg (15 ME)
excipients: sodium chloride, citrate sodium a dihydrate, phenol, polysorbate-20, citric acid, water for injections. Description: the colourless or slightly painted, transparent or opalescent liquid.

Pharmacological properties:

Pharmacodynamics. Stimulates skeletal and somatic growth, and also exerts the expressed impact on metabolic processes. Stimulates growth of bones of a skeleton, influencing plates of an epiphysis of tubular bones, bone metabolism at children. Contributes to normalization of structure of a body by means of increase in muscle bulk and decrease in fatty body weight. At patients with deficit of the growth hormone (GH) and osteoporosis replacement therapy leads to normalization of mineral composition and density of bones. Increases number and the size of cells of muscles, a liver, a thymus, gonads, adrenal glands, a thyroid gland. Stimulates transport of amino acids in a cell and protein synthesis, reduces concentration of cholesterol, influencing a profile of lipids and lipoproteids. Suppresses insulin release. Promotes a delay of sodium, potassium and phosphorus. Increases the body weight, muscular activity and physical endurance.

Pharmacokinetics. Absorption of a somatropin after hypodermic introduction makes 80%, the maximum concentration in a blood plasma is reached in 3-6 hours. Gets into well perfusing bodies, especially into a liver and kidneys. The volume of distribution of a somatropin – 0,49 – 2,11 l/kg. The elimination half-life after hypodermic introduction makes 3-5 hours.

Indications to use:

Growth inhibition at children owing to insufficient secretion of GR, at Shereshevsky-Turner's syndrome, at a chronic renal failure (depression of function of kidneys more than for 50%) in the prepubertatny period.

At adults at the deficit of GR confirmed expressed inborn or acquired as replacement therapy.

Route of administration and doses:

Растан® enter subcutaneously, slowly, 1 time a day, usually for the night. It is necessary to change places of injections for prevention of development of a lipoatrophia.

Doses select individually taking into account expressiveness of deficit of GR, weight or surface area of a body, efficiency in the course of therapy.

At children at insufficient secretion of GR the dose of 25-35 mkg/kg/days is recommended (0,07 - 0,1 МЕ/кг/сут) that corresponds to 0,7 - 1 ^mg/sq.m/days

(2 - 3 ME/m ² / days). Treatment is begun as it is possible at earlier age and continue before puberty and/or before closing of regions of growth of bones. The termination of treatment at achievement of desirable result is possible.

At Shereshevsky-Turner's syndrome, at the chronic renal failure at children which is followed by a growth inhibition the dose of 45 - 50 mkg/kg/days (0,14 МЕ/кг/сут) is recommended that corresponds to 1,4 ^mg/sq.m/days (4,3 ME/m ² / days). At insufficient dynamics of growth dose adjustment can be required.

At deficit of GR at adults the initial dose makes 0,15-0,3 mg/days (that corresponds to 0,45 - 0,9 ME/days) with the subsequent its increase, depending on effect. At titration of a dose as a control indicator concentration of an insulinopodobny growth factor (IRF-I) in blood serum can be used. The maintenance dose is selected individually, but does not exceed, as a rule, 1 mg/days that corresponds to 3 ME/days.

Lower doses are recommended to elderly.

Features of use:

Against the background of treatment by Rastan correction of doses of hypoglycemic drugs perhaps will be required from patients with a diabetes mellitus, there can be manifestation latentno of the proceeding hypothyroidism, and the patients receiving sodium left thyroxine can have hyperthyroidism signs. During treatment it is necessary to control a condition of an eyeground, especially at symptoms of intracranial hypertensia. The papilledema demands drug withdrawal. Detection of lameness against the background of therapy somatropiny demands careful observation. It is necessary to change places of subcutaneous injections in connection with a possibility of development of lipoatrophias. During transplantation of a kidney treatment by drug should be cancelled.

On condition of lack of symptoms of increase in intracranial pressure (a headache, nausea, vomiting, a vision disorder), Rastan® does not exert impact on ability to manage vehicles and to be engaged in other potentially dangerous types of activity demanding the increased concentration of attention and speed of psychomotor reactions.

Side effects:

Increase in intracranial pressure (headache, nausea, vomiting, vision disorder), depression of function of a thyroid gland, hyperglycemia, leukemoid tests, femur head epiphysiolysis, liquid delay with development of peripheral hypostases. Symptoms carry, as a rule, tranzitorny, dozozavisimy character, can demand reduction of a dose. Allergic reactions: skin rash, itch. Local reactions: morbidity, numbness, a hyperemia, a swelling, a lipoatrophia in the place of an injection.

Attention! The following side effects are described in literature at drug use соматропин: weakness, fatigue, a gynecomastia, a papilledema (it is usually observed within the first 8 weeks of treatment, most often happen at patients to Shereshevsky-Turner's syndrome), pancreatitis (abdominal pains, nausea, vomiting), average otitis and a hearing disorder (at patients to Shereshevsky-Turner's syndrome), a hip incomplete dislocation at children (limping, hip and knee pain), a gynecomastia, acceleration of growth of the nevus existing earlier (the malignancy), progressing of scoliosis (at patients with excessive rapid growth is possible), increase in content in blood of inorganic phosphate, parathyroid hormone and activity of an alkaline phosphatase.

Contraindications:

Hypersensitivity, malignant new growths, urgentny states (including states after heart, abdominal cavity operations, acute respiratory insufficiency). Stimulation of growth at patients with the closed epiphyseal regions of growth.

Pregnancy and feeding by a breast (for the period of treatment it is necessary to refuse breastfeeding).

With care: a diabetes mellitus, intracranial hypertensia, a hypothyroidism, the accompanying therapy by glucocorticosteroids, a hypothyroidism (in т.ч when performing replacement therapy by hormones of a thyroid gland), Pradera-Willie's syndrome.

Overdose:

The acute overdose can bring in the beginning to a hypoglycemia, and then to a hyperglycemia. At long overdose the signs and symptoms characteristic of surplus of human GR – development of an acromegalia and/or giantism, and also development of a hypothyroidism, decrease in concentration of cortisol in blood serum can be noted.

Treatment: drug withdrawal, symptomatic therapy.

Storage conditions:

In the place protected from light at a temperature from 2 ºС to 8 ºС.
Not to freeze.
To store the used bottle (cartridge) at a temperature from 2 °C to 8 °C within 28 days.
To store in the place, unavailable to children.

Period of validity - 2 years. Not to use drug after a period of validity.

Issue conditions:

According to the recipe

Packaging:

Solution for hypodermic introduction of 5 mg/ml (15 ME/ml).

On 3 ml in the bottle of colourless neutral glass with a capacity of 5 ml corked by the cap combined.

On 3 ml in the cartridge of colourless neutral glass corked by the cap combined.

5 bottles place in a blister strip packaging from a polyvinyl chloride film, without foil.

1 bottle or 1 blister strip packaging together with the instruction on a medical use place in a pack from a cardboard.

1 or 5 cartridges place in a blister strip packaging from a polyvinyl chloride film and aluminum foil.

1 blister strip packaging together with the instruction on a medical use is placed in a pack from a cardboard.