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Instructions

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Instruction for use: Genotropin

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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)

E23.0 Hypopituitarism

Kalmann's syndrome, Infantilism pituitary, Dwarfism is cerebral-pituitary, Cachexia pituitary, Cachexia diencephalo-pituitary, Anovulatory disorders, Symmonds disease, Secondary hypogonadism in men, Secondary hypogonadotropic hypogonadism, Hypogenitalism, Hypogonadism, Hypogonadism hypogonadotropic, Hypogonadism of the pituitary, Hypogonadism in men, Hypogonadotropic hypogonadism, Hypopituitarism, Pituitary insufficiency, Lack of growth in children with hypopituitarism, Pangypopituitarism, Primary hypogonadism, Primary hypogonadotropic hypogonadism, Shihan Syndrome, Shihina's Syndrome, Symmonds-Glinsky disease, Laron's dwarfism, Sheena's Syndrome, Syndrome of a fertile eunuch

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

Q96 Turner Syndrome

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

Composition and form of release

Lyophilizate for the preparation of a solution for subcutaneous administration (per 1 ml of solution after mixing)

Recombinant somatotropin (somatropin) 16 IU (5.3 mg)

Glycine 2 mg

Mannitol 41 mg

Sodium dihydrophosphate anhydrous 0.29 mg

Disodium phosphate anhydrous 0.28 mg

M-cresol 3 mg

Water for injection up to 1 ml

In two-compartment cartridges (with lyophilizate in one section and solvent in the other) for generators Genotropin Pen; In a box of carton 1 or 5 cartridges.

pharmachologic effect

Pharmacological action - somatotropic.

It interacts with specific receptors of membranes, increases the intracellular content of cAMP, activates protein kinases and protein synthesis. Strengthens bone metabolism and accelerates the linear growth of the skeleton, supports the normal structure of the body, stimulates muscle growth, muscle strength, cardiac output, promotes fat mobilization. Increases serum concentration of insulin, insulin-like growth factor (IRP-1) and its binding protein (IRFSB-3). The number of receptors that bind LDL in the liver increases, the lipids and lipoprotein profile in the serum changes. It inhibits the release of sodium, potassium and phosphorus, increases physical endurance, regulates the balance of neurotransmitters in the brain, improves memory and increases vitality.

Pharmacodynamics

Stimulates growth and increases body weight.

Pharmacokinetics

With n / to the introduction absorbed about 80%. Cmax is 13-35 ng / ml. T1 / 2 - 20-25 minutes after IV and 3-6 hours after SC administration.

Indications

Growth disorders in children: a deficiency of growth hormone (pituitary nanism), gonadal dysgenesis (Shereshevsky-Turner syndrome), in the puberty period with chronic renal failure (with a decrease in function by more than 50%); Hypothalamic-pituitary insufficiency in adults (deficiency of pituitary hormones, except prolactin).

Contraindications

Hypersensitivity (including to the components of the solvent); Malignant neoplasms; Critical conditions due to open heart or abdominal operations, multiple trauma and acute respiratory failure; Appointment after kidney transplantation; pregnancy; Closing of the growth zones of the epiphyses of tubular bones in childhood.

pregnancy and lactation

Use during pregnancy is possible on strict indications in cases where the expected benefit for the mother exceeds the possible risk to the fetus.

Side effects

Symptoms of fluid retention (peripheral edema, arthralgia, myalgia, etc.) - these phenomena are moderately or weakly manifested during the first months of treatment and decrease spontaneously or after a dose reduction; Rarely - benign intracranial hypertension, myositis; Extremely rare - leukemia (<1/10000), transient skin reactions at the injection site.

Interaction

Reduces the level of cortisol in the serum (due to the possible effect of growth hormone on transport proteins).

Dosing and Administration

P / k (previously in the injector Genotropin Pen put the cartridge, where there is automatic dilution). The dose is selected individually depending on the mass or body surface area (take into account the clinical effect, undesirable reactions and the results of determination of IGF-1 in the blood serum).

Growth disorder with insufficient growth hormone secretion in children: usually 0.07-0.1 IU / kg (0.025-0.035 mg / kg) or 2.1-3 IU / m2 (0.7-1 mg / m2) in day.

Growth disorder in Shereshevsky-Turner syndrome: 0.14 IU / kg (0.045-0.05 mg / kg) or 4.3 IU / m2 (1.4 mg / m2) per day.

Dysplasia in chronic renal failure: at an initial dose of 4.3 IU / m2 (1.4 mg / m2) or about 0.14 IU / kg (0.045-0.05 mg / kg) per day, with insufficient growth rate, the dose Gradually increase (after 6 months of treatment, a new dose adjustment may be required).

With a deficiency of growth hormone in adults: at an initial dose of 0.018 IU / kg (0.006 mg / kg), gradually increasing the dose to a maximum of 0.036 IU / kg (0.012 mg / kg) per day (elderly - lower doses).

Precautionary measures

Caution is prescribed for diabetes mellitus (you may need to adjust the dose of insulin); Untreated hypothyroidism (periodic examination of thyroid function, appointment of thyroid hormones); Lameness in children, hypopituitarism (careful monitoring is recommended). During treatment, the fundus should be monitored (especially with symptoms of intracranial hypertension): edema of the optic disc requires withdrawal of the drug. The site of administration should be changed to prevent lipoatrophy.

special instructions

When diluted, the solution is not shaken.

Storage conditions

In the dark place at a temperature of 2-8 C (do not freeze). Before dilution it is allowed to store at room temperature (not above 25 C) for 1 month; Ready solution - in the refrigerator for 3 weeks. Freezing is not allowed.

Keep out of the reach of children.

Shelf life

3 years. After cooking - 4 weeks (at t 2-8 deg.)

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

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