Composition, form of production and packaging
Lyophilizate for the preparation of a solution for administration of white or white with a yellowish hue; The solvent applied is a clear, colorless or slightly colored liquid.
1 f.
human somatropin 4 IU (1.33 mg)
[PRING] mannitol, glycine, sodium dihydrogen phosphate dihydrate, sodium hydroxide.
Solvent: metacresol (3 mg), water d / and (1 ml).
Glass bottles with a capacity of 5 ml (1) complete with a solvent (fl. 1 ml 1 pc.) - packs cardboard.
Glass bottles with a capacity of 5 ml (1) complete with a solvent (fl. 1 ml 1 pc.) - packings of cellular contour (1) - packs of cardboard.
Lyophilizate for the preparation of a solution for administration of white or white with a yellowish hue; The solvent applied is a clear, colorless or slightly colored liquid.
1 f.
human somatropin 16 IU (5.33 mg)
[PRING] mannitol, glycine, sodium dihydrogen phosphate dihydrate, sodium hydroxide.
Solvent: metacresol (3 mg), water d / and (1 ml).
Glass vials (1) complete with a solvent (1 ml 1 pc.) - packs of cardboard.
Glass vials (1) complete with a solvent (2 ml of 1 pack) - packs of cardboard.
Glass vials (1) complete with a solvent (1 ml of 1 pack) - packings of cellular outline (1) - packs of cardboard.
Glass vials (1) complete with a solvent (2 ml of 1 pack) - packings of cellular contour (1) - packs of cardboard.
Lyophilizate for the preparation of a solution for administration of white or white with a yellowish hue; The solvent applied is a clear, colorless or slightly colored liquid.
1 f.
human somatropine 20 IU (6.67 mg)
[PRING] mannitol, glycine, sodium dihydrogen phosphate dihydrate, sodium hydroxide.
Solvent: metacresol (3 mg), water d / and (1 ml).
Glass vials (1) complete with a solvent (1 ml 1 pc.) - packs of cardboard.
Glass vials (1) complete with a solvent (2 ml of 1 pack) - packs of cardboard.
Glass vials (1) complete with a solvent (1 ml of 1 pack) - packings of cellular outline (1) - packs of cardboard.
Glass vials (1) complete with a solvent (2 ml of 1 pack) - packings of cellular contour (1) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2012.
PHARMACHOLOGIC EFFECT
Somatotropic hormone. Stimulates skeletal and somatic growth, and also has a pronounced effect on metabolic processes. Stimulates the growth of the bones of the skeleton, affecting the plate epiphysis tubular bones, bone metabolism in children. Helps normalize body structure by increasing muscle mass and reducing body fat.
In patients with growth hormone deficiency and osteoporosis, substitution therapy results in normalization of the mineral composition and bone density.
Increases the number and size of cells of muscles, liver, thymus gland, gonads, adrenals, thyroid gland. Stimulates the transport of amino acids into the cell and the synthesis of proteins, reduces the level of cholesterol, affecting the profile of lipids and lipoproteins. Suppresses the release of insulin. Promotes the retention of sodium, potassium and phosphorus. Increases body weight, muscle activity and physical endurance.
PHARMACOKINETICS
Suction
After sc administration, absorption of somatropin is 80%. C max in blood plasma is achieved in 3-6 hours.
Distribution
Penetrates into well perfused organs, especially the liver and kidneys. V d of somatropin - 0.49-2.11 l / kg.
Excretion
T 1/2 after the SC administration is 3-5 hours.
INDICATIONS
- growth retardation in children due to inadequate growth hormone secretion, with Shereshevsky-Turner syndrome, with chronic renal failure (decreased kidney function by more than 50%) in the prepubertal period;
- in adults with confirmed congenital or acquired pronounced growth hormone deficiency as a substitute therapy.
DOSING MODE
Rastan В® is administered sc, slowly, 1 time / 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 Ојg / kg / day (0.07-0.1 IU / kg / day) is recommended, which corresponds to 0.7-1 mg / m 2 / day (2-3 IU / m 2 / 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 the Shereshevsky-Turner syndrome , chronic renal failure in children accompanied by growth retardation is recommended, the dose is 50 Ојg / kg / day (0.14 IU / kg), which corresponds to 1.4 mg / m 2 / day (4.3 IU / m 2 / 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 150-300 Ојg / day (corresponding to 0.45-0.9 IU / day), followed by an increase, depending on the effect. When titrating the dose, the level of insulin-like growth factor (IRP-1) in the blood serum can be used as a control parameter. The maintenance dose is selected individually, but, as a rule, it does not exceed 1 mg / day, which corresponds to 3 IU / day.
Older patients are recommended lower doses of the drug.
Rules for the preparation of solution for injection
Dissolve the contents of the vial is recommended in 1 ml of the supplied solvent, based on the calculated dose. To do this, dial the solvent into the syringe and inject it into the vial with the drug through a stopper. Gently shake until the contents of the vial are completely dissolved. Sharp shaking is unacceptable. The prepared solution is stored in the vial for no more than 2 weeks at a temperature of 2 В° to 8 В° C.
SIDE EFFECT
From the side of the central nervous system: increased intracranial pressure (headache, nausea, vomiting, impaired vision).
On the part of the endocrine system: a decrease in thyroid function, hyperglycemia.
On the part of the hematopoiesis system: leukemoid reactions.
From the musculoskeletal system: epiphysis of the head of the femur.
From the side of metabolism: fluid retention with the development of peripheral edema.
The above-mentioned adverse reactions are, as a rule, transient, dose-dependent, a dose reduction may be required.
Local reactions: lipotrophy, pain and itching at the injection site.
Side effects described in the literature with the use of somatropin: weakness, fatigue, gynecomastia, edema of the optic nerve (usually observed during the first 8 weeks of treatment, most often in patients with Shereshevsky-Turner syndrome), pancreatitis (abdominal pain, nausea, vomiting ), otitis media and hearing impairment (in patients with Shereshevsky-Turner syndrome), subluxation of the hip in children (limping, pain in the thigh and knee), gynecomastia, acceleration of the growth of the previously existing nevus (malignancy is possible), progression of scoliosis (in patients with overgrowth), elevated levels of inorganic phosphate in the blood, parathyroid hormone and alkaline phosphatase activity.
CONTRAINDICATIONS
- malignant neoplasms;
- Urgent conditions (including conditions after operations on the heart, abdominal cavity, acute respiratory failure);
- Pregnancy;
- the period of lactation (breastfeeding);
- Hypersensitivity to the components of the drug.
With caution should be used in diabetes mellitus, craniocerebral hypertension, hypothyroidism (including when carrying out substitution therapy with thyroid hormones), Prader-Willi syndrome.
PREGNANCY AND LACTATION
The drug is contraindicated for use in pregnancy and lactation (breastfeeding).
APPLICATION FOR CHILDREN
The application is possible according to the dosing regimen.
APPLICATION IN ELDERLY PATIENTS
Older patients are recommended lower doses of the drug.
SPECIAL INSTRUCTIONS
Against the backdrop of Rastan's treatment, it may be necessary to correct the dose of hypoglycemic drugs in patients with diabetes mellitus, manifestation of latent hypothyroidism may occur, and in patients receiving thyroxine, symptoms of hyperthyroidism may appear.
During treatment, it is necessary to monitor the condition of the fundus, especially with symptoms of intracranial hypertension. With edema of the optic nerve, it is necessary to cancel the drug.
Detection of lameness on the background of somatropin therapy requires careful observation.
It is necessary to change the location of SC injections in connection with the possibility of developing lipoatrophy.
OVERDOSE
Symptoms: acute overdose can lead to hypoglycemia first, and then to hyperglycemia. With prolonged overdose, signs and symptoms characteristic of excess human growth hormone - the development of acromegaly and / or gigantism, as well as the development of hypothyroidism, a decrease in the level of cortisol in the serum can be noted.
Treatment: withdrawal of the drug, symptomatic therapy.
DRUG INTERACTION
Somatropin increases the clearance of drugs metabolized by microsomal enzymes of the liver, especially sex hormones, glucocorticoids, anticonvulsants and cyclosporine.
GCS inhibits the stimulating effect of somatropin on growth processes.
The effectiveness of the drug (in terms of final growth) may also be affected by concomitant therapy with other hormones, for example, gonadotropin, anabolic steroids, estrogens and thyroid hormones.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
List B. The drug should be stored out of reach of children, protected from light at a temperature of 2 В° to 8 В° C; Do not freeze. Shelf life - 2 years.
The prepared solution should be stored at a temperature of 2 В° to 8 В° C for 2 weeks. Keep out of the reach of children.
