Instruction for use: Norditropin PenSet 12

ATX Code H01AC01 Somatropin

Active substance: Somatropin

Pharmacological group

Hormones of the hypothalamus, pituitary gland, gonadotropins and their antagonists

Nosological classification (ICD-10)

E30.0 Delay in puberty

Later sexual development, Sexual maturation later

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

1 bottle with lyophilized powder for the preparation of the injection solution contains somatropin 12 IU; Complete with a solvent, in cartridges PenSet for use in special syringes-handles Nordidjekt 12 and a needle for mixing, in a box 1 set.

Characteristic

A biosynthetic preparation of growth hormone produced using recombinant DNA and a non-pathogenic strain of E. coli. A polypeptide comprising 191 amino acids. The biological activity is approximately 3 IU / mg.

pharmachologic effect

Pharmacological action - somatotropic.

Activates the transport of amino acids into cells, accelerates intracellular protein synthesis; Stimulates the growth of the skeleton and weight gain; Causes a delay in the body of nitrogen, mineral salts (calcium, phosphorus, sodium) and liquid; Increases the sugar content in the blood.

Indications

Deficiency of growth hormone (pituitary nanism, pituitary dwarfism), Turner's syndrome, growth retardation in children with renal insufficiency.

Contraindications

Hypersensitivity (including the preservative, which is part of the drug), malignant neoplasms, pregnancy, breast-feeding.

Side effects

Possible oppression of thyroid function with the development of symptoms of hypothyroidism (or their increase in hypothyroidism); Increased titer antibodies to somatotropin, local allergic reactions (skin rash, itching).

Dosing and Administration

PC. If there is a deficiency in the body of growth hormone - 0.07-0.1 IU / kg 1 time per day, with Turner's syndrome and growth retardation in children with renal insufficiency - 0.14 IU / kg 1 time per day.

Precautionary measures

To prevent lipoatrophy, alternate injection sites.

Storage conditions

In the dark place. The dissolved preparation remains active for 2 weeks at a temperature of 2-8 ° C. Do not freeze.

Keep out of the reach of children.

Shelf life

3 years.

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