RASTAN

Active material: Somatropin
When ATH: H01AC01
CCF: Recombinant growth hormone
ICD-10 codes (testimony): E23.0, Q96, R62
When CSF: 15.06.01
Manufacturer: OAO Pharmstandard-UfaVITA (Russia)

PHARMACEUTICAL FORM, COMPOSITION AND PACKAGING

Valium for drug of a solution for s / c administration white or white with a yellowish tint; enclosed solvent – transparent, colorless or slightly colored liquid.

Excipients: mannitol (mannyt), glycine, sodium dihydrogen, Sodium hydroxide.

Solvent: cresol, water d / and (to 1 ml).

Glass Bottles capacity 5 ml (1) together with the solvent (fl. 1 PC.) – packs cardboard.
Glass Bottles capacity 5 ml (1) together with the solvent (fl. 1 PC.) – packings Valium planimetric (1) – packs cardboard.

Pharmacological action

Comatotropny hormone. Stimulates skeletal and somatic growth, and also has a pronounced effect on metabolic processes. It stimulates the growth of bones, affects epiphysis plates of long bones, bone metabolism. Promotes normalization of the structure of the body by increasing muscle mass and reducing body fat.

In patients with growth hormone deficiency and osteoporosis replacement therapy leads to normalization of the mineral composition and bone density.

Increases the number and size of muscle cells, liver, thymus, gonads, adrenal, Thyroid. It stimulates the transport of amino acids into the cell and protein synthesis, lowers cholesterol, acting on lipid and lipoprotein profile. Inhibits the release of insulin. It promotes sodium retention, potassium and phosphorus. Increases weight, muscle activity and physical endurance.

Pharmacokinetics

Absorption

After p / to the introduction of absorption of growth hormone 80%. C_max plasma levels achieved after 3-6 no.

Distribution

It penetrates into well perfused organs, especially in the liver and kidneys. V_d somatropin - 0.49-2.11 l / kg.

Deduction

T_1/2 after s / to the introduction of 3-5 no.

Testimony

- Growth retardation in children due to inadequate growth hormone secretion, when gonadal dysgenesis (Syndrome Shyeryeshyevskogo Ternera), in chronic renal failure (decreased kidney function over 50%) prepubertal;

- In adults with confirmed congenital or acquired deficiency of growth hormone replacement therapy.

Dosage regimen

Rastan^® introduced n / a, slowly, 1 time / day, usually at night. Injection sites should be changed to prevent the development of lipoatrophy.

Doses are selected individually depending on the severity of growth hormone deficiency, weight or body surface area, efficacy in therapy.

In children at insufficient growth hormone secretion recommended dose 25-35 ug / kg / day (0.07-0.1 IU / kg / day), corresponding 0.7-1 mg / m²/d (2-3 IU / m²/d). Treatment is initiated as soon as possible at an early age and continued until puberty and / or before the closing of growth zones bones. Perhaps the discontinuation of treatment in achieving the desired result.

At sindromye Shyeryeshyevskogo Ternera, chronic renal failure in children, accompanied by growth retardation, recommended dose 50 ug / kg / day (0.14 IU / kg) corresponding 1.4 mg / m²/d (4.3 IU / m²/d). In case of insufficient growth dynamics may require dose adjustment.

At growth hormone deficiency in Adult starting dose is 150-300 mg / day (corresponding 0.45-0.9 IU / day) with subsequent increase, depending on the effect. During dose titration as a benchmark can be used by the level of IGF-1 in the blood serum. Contributing dose picked individually, usually, it does not exceed 1 mg / day, corresponding 3 IU / day.

Elderly patients recommended lower dose.

Terms of solution for injection

Dissolve contents of a bottle is recommended 1 ml of the supplied solvent, based on the calculated dose. For gaining this solvent into a syringe and injected into the vial through the stopper. Gently shake to complete dissolution of the vial. Sudden shaking thus inadmissible. The prepared solution was stored in a vial at most 2 weeks at a temperature of from 2 ° to 8 ° C..

Side effect

CNS: intracranial hypertension (headache, nausea, vomiting, blurred vision).

On the part of the endocrine system: decreased thyroid function, giperglikemiâ.

From the hematopoietic system: leukemoid reaction.

On the part of the musculoskeletal system: epiphysiolysis femoral head.

Metabolism: fluid retention with the development of peripheral edema.

The above side reactions are, usually, transitory, dose-dependent, It may require dose reduction.

Local reactions: lipotrofiya, pain and itching at the injection site.

Side effects reported in the literature in the application of growth hormone: weakness, fatigue, gynecomastia, papilledema (typically occurs during the first 8 weeks of treatment, most often in patients with Turner's syndrome), pancreatitis (stomach ache, nausea, vomiting), otitis media, and hearing loss (in patients with Turner's syndrome), subluxation of the hip in children (lameness, pain in the hip and knee), gynecomastia, accelerating the growth of pre-existing nevus (possible malignancy), progressirovanie scoliosis (in patients with overgrowth), increase the blood levels of inorganic phosphate, parathyroid hormone, and alkaline phosphatase activity.

Contraindications

- Malignant neoplasms;

- Urgent conditions (incl. states after cardiac surgery, abdomen, acute respiratory failure);

- Pregnancy;

- Lactation (breast-feeding);

- Hypersensitivity to the drug.

FROM caution use in patients with diabetes, cranial hypertension, gipotireoze.

Pregnancy and lactation

The drug is contraindicated during pregnancy and lactation (breast-feeding).

Cautions

The treatment crease^® It may require dose adjustment of hypoglycemic agents in patients with diabetes; may occur manifestation of latent flowing hypothyroidism, and in patients, receiving thyroxine, may be signs of hyperthyroidism.

During treatment it is necessary to monitor the state of the fundus, especially, for symptoms of intracranial hypertension. When the optic nerve edema requires removal of the drug.

Detection of lameness during therapy with somatropin requires careful monitoring.

It is necessary to change the place s / c injection due to the possibility of development of lipoatrophy.

Overdose

Symptoms: Acute overdose could lead initially to hypoglycaemia, and then to hyperglycemia. With long-term overdose may experience signs and symptoms, characteristic of an excess of human growth hormone – development of acromegaly and / or gigantism, as well as the development of hypothyroidism, lowering serum cortisol.

Treatment: removal of the drug, simptomaticheskaya therapy.

Drug Interactions

Corticosteroids inhibit the stimulatory effect of growth hormone on the growth.

The effectiveness of the drug (in respect of finite growth) It can also affect other hormones concomitant therapy, eg, gonadotropin, anabolic steroids, estrogens and thyroid hormones.

Conditions of supply of pharmacies

The drug is released under the prescription.

Conditions and terms

List B. The drug should be stored out of reach of children, dark place at a temperature of 2 ° to 8 ° C; Do not freeze. Shelf life – 2 year. Do not use the drug after the expiry date.

The solvent should be stored at a temperature no higher than 25 ° C.

The prepared solution must be stored at 2 ° to 8 ° C. 2 weeks.