Instruction for use: Rastan

ATX Code H01AC01 Somatropin

Active substance: Somatropin

Pharmacological group

Growth hormone [Hormones of the hypothalamus, pituitary gland, gonadotropins and their antagonists]

Nosological classification (ICD-10)

E34.3 Low-growth [dwarfism], not elsewhere classified

Growth retardation, Growth retardation in children, Dwarfism, Nanism hypophyseal, Inadequate endogenous growth hormone, Growth Hormone Deficiency, Pituitary Nanism, Low height, Growth disorder, Disturbance of the growth process, Pituitary dwarfism, Disruption of endogenous hormone secretion with growth retardation, Growth disorders, Naniz disproportionate, Nanism associated with external factors

N18.9 Chronic renal failure, unspecified

Edema of renal genesis

Q96 Turner Syndrome

Turner syndrome, Gonadal Dysgenesis, Mixed gonadal dysgenesis, Shereshevsky-Turner Syndrome

R62 Lack of expected normal physiological development

Genetic Disease, Delay in the child's physical development, Insufficient growth intensity, Growth lag

Composition

Solution for subcutaneous administration 1 ml

active substance:

Somatropin 5 mg (15 IU)

Auxiliary substances: sodium chloride - 8,7 mg; Sodium citrate dihydrate - 2.94 mg; Polysorbate 20 - 4 mg; Phenol - 2.5 mg; Citric acid (1M solution) - to pH 6.0-6.5; Water for injection - up to 1 ml

pharmachologic effect

Pharmacological action - somatotropic.

Dosing and Administration

P / to, slowly, 1 time per day, usually at night. It is necessary to change the injection site to prevent the development of lipoatrophy.

Doses are selected individually, taking into account the severity of growth hormone deficiency, mass or body surface area, the effectiveness in the therapy process.

In children with insufficient growth hormone secretion, a dose of 25-35 μg / kg / day (0.07-0.1 IU / kg / day) is recommended, which corresponds to 0.7-1 mg / m2 / day (2-3 IU / M2 / day). Treatment begins as early as possible and continues until puberty and / or until the bone growth zones are closed. It is possible to stop treatment when the desired result is achieved.

With Shereshevsky-Turner syndrome, a dose of 50 μg / kg / day (0.14 IU / kg / day) is recommended, which corresponds to 1.4 mg / m2 / day (4.3 IU / m2 / day). If the dynamics of growth is insufficient, a dose adjustment of up to 67 μg / kg / day (0.2 IU / kg / day) may be required, which corresponds to 2 mg / m2 / day (6 IU / m2 / day).

In chronic kidney failure in children accompanied by growth retardation, a dose of 45-50 μg / kg / day (0.14 IU / kg / day) is recommended, corresponding to 1.4 mg / m2 / day (4.3 IU / m2 / day) . If the dynamics of growth is insufficient, a dose adjustment may be required.

With a deficiency of growth hormone in adults, the initial dose is 0.15-0.3 mg / day (corresponding to 0.45-0.9 IU / day) with a subsequent increase depending on the effect. When titrating the dose, IGF-1 concentration in the blood plasma can be used as a reference. The maintenance dose is selected individually, but does not exceed, as a rule, 1 mg / day, which corresponds to 3 IU / day.

Elderly, lower doses are recommended.

Form of issue

Solution for subcutaneous administration, 5 mg / ml (15 IU / ml).

3 ml in a bottle of colorless neutral glass with a capacity of 5 ml, capped with a cap combined. For 5 fl. In the outline of the cell packaging of PVC film without foil; 1 fl. Or 1 contour acrylic package in a pack of cardboard.

For 3 ml in a cartridge of colorless neutral glass, capped with a cap combined. For 1 or 5 cartridges in a contour cell box made of PVC film and aluminum foil. 1 contour pack in a pack of cardboard.

For 3 ml in a cartridge of colorless neutral glass, capped with a cap combined. The cartridge is mounted in the BiomatikPen® 2 disposable syringe pen. By 5 syringe-pens BiomatikPen® 2 single-use with cartridges in contour cell packaging. 1 contour pack with syringe handles or 1 or 5 BiomatikPen® 2 disposable syringe handle with cartridges in a pack of cardboard.

Terms of leave from pharmacies

On prescription.

Storage conditions

In the dark place at a temperature of 2-8 ° C (do not freeze). The used vial (cartridge), disposable syringe-pen should be stored at a temperature of 2-8 ° C for 28 days.

Keep out of the reach of children.

Shelf life

2 years.

Do not use after the expiry date printed on the package.