Instruction for use: Biosoma

ATX Code H01AC01 Somatropin

Active substance: Somatropin

Pharmacological group

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

Q96 Turner Syndrome

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

Composition and form of release

1 bottle with lyophilized powder for the preparation of the injection contains recombinant human growth hormone 1.4 mg (Biosome 4 IU) or 2.8 mg (Biosome 8 IU); In pack 1 bottle with powder lyophilized for injection (4 or 8 IU) complete with 1 ampoule solvent (2.2 ml 0.9% benzyl alcohol), 2 syringes and 2 needles.

pharmachologic effect

Pharmacological action - stimulating growth.

Accelerates the growth of tubular bones, promotes the synthesis of protein.

Indications

Lack of growth in children with hypopituitarism (insufficiency of growth hormone); Turner syndrome.

Contraindications

Hypersensitivity, the closure of the epiphyses, cancer.

Side effects

Hypofunction of the thyroid gland.

Interaction

Antagonism with thyroxine. Glucocorticoids decrease effectiveness.

Dosing and Administration

In the evening. Doses are selected individually. At stunting, 0.6-0.7 IU / kg of weight or 18 IU / m2 of body surface per week (divided by 6-7 injections). With long-term treatment, older children (at puberty), with Turner's syndrome - up to 1 IU / kg / week or 30 IU / m2 / week (divided by 6-7 injections). Treatment begins as early as possible and continues until the bone growth zones are closed or until the desired growth is achieved.

Overdose

In the beginning - the symptoms of hypoglycemia, later - hyperglycemia.

Precautionary measures

Treatment is carried out under the strict supervision of an endocrinologist. In the presence of any trauma in the head area, as well as in cases when the occurrence of growth hormone deficiency is due to organic brain damage, a special study is needed. During treatment, it is recommended to periodically monitor the function of the thyroid gland and, if necessary, prescribe thyroid hormones. For patients with concomitant deficiency of ACTH, the dose of substitution therapy is very carefully selected. When diabetes is sometimes necessary to increase the dose of insulin. It is recommended to dissolve the contents of the vial only in the supplied solvent; Use syringes included in the package; Do not use the remains of the prepared solution stored for more than 6 days.

Storage conditions

In the dark place at a temperature of 2-8 ° C. The prepared solution is 6 days at a temperature of 2-8 ° C.

Keep out of the reach of children.

Shelf Life

2 years.

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