RASTAN

General characteristics. Structure:

1 bottle of drug contains:

 

	4 ME	8 ME	16 ME	24 ME
Active ingredients
Somatropin	1,3 mg	2,6 mg	5,3 mg	8 mg
Excipients
Mannitol	41,0 mg	41,0 mg	41,0 mg	41,0 mg
Glycine	2,0 mg	2,0 mg	2,0 mg	2,0 mg
Sodium phosphate monosubstituted	1,5 mg	1,5 mg	1,5 mg	1,5 mg

Pharmacological properties:

Stimulates growth of bones of a skeleton, influencing plates of an epiphysis of tubular bones, bone metabolism. At patients with deficit of a growth hormone 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 cholesterol level, 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.
 
Bioavailability subcutaneously of the administered drug makes 80%. The maximum concentration in blood is reached in 4-6 hours. Time of semi-removal makes 3 hours.

Indications to use:

At children at a growth disorder because of insufficient secretion of a growth hormone, at a dysgenesis of gonads (Shereshevsky-Turner's syndrome). The chronic renal failure at children which is followed by a growth inhibition. At the children and teenagers suffering from different forms of a chondrodystrophia. At adults at deficit of a growth hormone as replacement therapy.

Route of administration and doses:

Rastan is entered subcutaneously, slowly, usually in the evening. To dissolve bottle contents with activity of 1,3 mg (4 ME) or 2,6 mg (8 ME) in 1 ml of solvent or contents of a bottle with activity of 5,3 mg (16 ME) or 8 mg (24 ME) in 2 ml of the enclosed solvent, proceeding from the calculated dose. For this purpose to select solvent the syringe and to enter into a bottle with drug through a stopper, carefully shaking before full dissolution of contents of a bottle. Sharp stirring at the same time is inadmissible.
 
Doses select individually taking into account expressiveness of deficit of a growth hormone, weight or surface area of a body, efficiency in the course of therapy.
 
At children at insufficient secretion of a growth hormone the dose of 0,025-0,035 mg/kg (0,07-0,1 ME/kg) or 0,7-1 mg/sq.m (2-3 ME/m ²) is recommended to a body surface of 1 times a day. Treatment is begun as it is possible at earlier age and continue before puberty and before closing of regions of growth of bones. The termination of treatment at achievement of desirable result is possible. At Shereshevsky's syndrome - Turner, at the chronic renal failure at children which is followed by a growth inhibition the dose 0,05mg/kg (0,14 ME/kg) or 1,4 mg/sq.m (4,3 ME/m ²) is recommended to a body surface of 1 times a day. Insufficient dynamics of growth can demand dose adjustment.
 
At treatment of children with different forms of a chondrodystrophia the dose at the rate of 0,33 mg/kg (1 ME/kg) a week is recommended, to enter subcutaneously 1 time a day in the evening, 7 days a week.
 
At deficit of a growth hormone at adults the initial dose makes 0,006 mg/kg (0,018 ME/kg) of 1 times a day with the subsequent, depending on effect, its increase up to 0,012 mg/kg (0,036 ME/kg) of 1 times a day. Elderly lower doses are recommended.

Features of use:

Injections of Rastan do subcutaneously, to those places where there is a hypodermic fatty tissue: in a stomach, the front surface of hips, the posterolateral surface of shoulders, an upper part of buttocks.
 
Against the background of treatment by Rastan correction of doses of glucose-lowering drugs perhaps will be required from patients with a diabetes mellitus, there can be manifestation latentno of the proceeding hypothyroidism, and the patients receiving thyroxine can have hyperthyroidism signs. During treatment it is necessary to control a condition of an eyeground, especially, at symptoms of intracranial hypertensia. Hypostasis of an optic nerve demands drug withdrawal. Detection of lameness against the background of therapy rastany demands careful observation. It is necessary to change places of subcutaneous injections in connection with a possibility of development of lipoatrophias.
 
Before use to get a bottle from the refrigerator and to leave at the room temperature.

Side effects:

Increase in intracranial pressure (headache, nausea, vomiting, vision disorder), depression of function of a thyroid gland, hyperglycemia, leukemia, epiphysiolysis, edematous syndrome. Local reactions: change of volume of fatty tissue, pain and itch in the place of an injection.

Interaction with other medicines:

Glucocorticosteroids inhibit a promoting effect of Rastan on growth processes.

Contraindications:

Hypersensitivity, malignant new growths, closing of an epiphysis, pregnancy, feeding with a breast (for the period of treatment it is necessary to refuse breastfeeding).

Overdose:

One-time leads to hypo - or a hyperglycemia. Long – to hyperfunction signs (giantism, an acromegalia).

Storage conditions:

Store in the place protected from light at a temperature from 2 °C to 8 °C. Solution, ready to use, can no more than 15 days are stored in a bottle at a temperature from 2 °C to 8 °C.

Issue conditions:

According to the recipe

Packaging:

On 1,3 mg (4 ME), or 2,6 mg (8 ME) complete with one bottle of solvent on 1 ml, either 5,3 mg (16 ME), or 8 mg (24 ME) of drug complete with one bottle of solvent on 2 ml.