Rastan

Rastan – the drug of recombinant somatotropic hormone exerting the expressed impact on metabolic processes, the stimulating skeletal and somatic growth.

Form of release and structure

• Lyophilisate for preparation of solution for hypodermic introduction: white or white-yellowish color (in glass bottles, in a pack a cardboard 1 bottle with lyophilisate and 1 bottle with solvent (1 ml or 2 ml); in glass bottles, 1 bottle with lyophilisate and 1 bottle with solvent (1 ml or 2 ml) in a blister strip packaging, in a pack cardboard 1 packaging);
• Solution for hypodermic introduction: colourless or slightly painted, opalescent or transparent (on 3 ml in colourless glass cartridges or colourless glass bottles, 1 or 5 cartridges/bottles in a blister strip packaging, in a pack cardboard 1 packaging).

Active agent – соматропин human:

• 1 bottle with lyophilisate – 4 ME (1,33 mg), 16 ME (5,33 mg) or 20 ME (6,67 mg);
• 1 ml of solution – 15 ME (5 mg).

Auxiliary components of lyophilisate: dihydrophosphate sodium dihydrate, sodium hydroxide, Mannitolum, glycine.

Composition of solvent (transparent, colourless or poorly painted): metacresol – 3 mg, water for injections – 1 mg.

Solution excipients: citrate sodium a dihydrate, citric acid, polysorbate 20, sodium chloride, water for injections, phenol.

Indications to use

• At children: a growth inhibition owing to insufficient secretion of a growth hormone, Shereshevsky-Turner's syndrome, the chronic renal failure (depression of function of kidneys more than for 50%) in the prepubertatny period which is followed by a growth inhibition;
• At adults: the inborn or acquired expressed deficit of a growth hormone confirmed (replacement therapy).

Contraindications

Absolute:

• The closed epiphyseal regions of growth (in need of growth stimulation);
• Urgentny states (including acute respiratory insufficiency, states after heart and abdominal cavity operations);
• Malignant new growths;
• Period of pregnancy and lactation;
• Individual hypersensitivity to Rastan.

With care:

• Intracranial hypertensia;
• Diabetes mellitus;
• Hypothyroidism, including during performing replacement therapy by hormones of a thyroid gland;
• Pradera-Willie's syndrome;
• Simultaneous use of glucocorticosteroids.

Route of administration and dosage

Rastan is entered slowly subcutaneously 1 time a day, usually for the night, alternating places of injections (in order to avoid development of a lipoatrophia).

The doctor selects a dose individually depending on expressiveness of deficit of a growth hormone, weight of the patient or the area of his body surface, and also efficiency of drug in the course of therapy.

The recommended dosages:

• Insufficient secretion of a growth hormone at children: 0,07-0,1 ME/kg (0,025-0,035 mg/kg) a day that corresponds to 2-3 ^ME/sq.m (0,7-1 ^mg/sq.m) a day. Treatment should be begun as it is possible at earlier age and to continue it until closing of regions of growth of bones and/or puberty. Also the termination of therapy is possible after achievement of desirable result;
• Shereshevsky-Turner's syndrome, the chronic renal failure which is followed by a growth inhibition: 0,14 ME/kg (0,05 mg/kg) a day that corresponds to 4,3 ^ME/sq.m (1,4 ^mg/sq.m) a day. At insufficient dynamics of growth dose adjustment is required;
• Deficit of a growth hormone at adults: in an initiation of treatment – on 0,45-0,9 ME (0,15-0,3 mg) in days, further depending on effect the dose is raised. During titration of a dose as a control indicator it is possible to use data of level of an insulinopodobny growth factor (IRF-1) in blood serum. The maintenance dose is selected individually, but it usually does not exceed 3 ME (1 mg) in days.

Patients of advanced age are recommended to appoint Rastan in lower doses.

Rules of preparation of solution for injections from lyophilisate: to gather the solvent enclosed in a set in the syringe and through a stopper to enter it into a bottle with lyophilisate, to carefully shake a bottle before full dissolution of contents (without stirring up!).

The equipment of an injection at solution use Rastan in bottles:

• To disinfect a rubber membrane of a bottle an antiseptic agent (for example, alcohol) to prevent hit in microorganisms. It is especially important when carrying out repeated injections;
• To prepare sterile needles and syringes of sufficient volume;
• To gather in the syringe air in the volume which corresponds to the necessary dose of drug and to enter it into a bottle;
• Without taking out the syringe, to turn a bottle upside down and to gather the necessary dose of drug in the syringe;
• To take out a needle from a bottle;
• To remove air from the syringe;
• To check correctness of set of a dose;
• To make an injection.

The equipment of the injection at use of solution in cartridges with use the syringe handle intended for the corresponding cartridges (for example, Biomatikpen):

• To be convinced of absence of damage of a cartridge (for example, cracks) and changes of outward of solution (existence of a deposit, change of transparency and color, etc.);
• To process an antiseptic agent a rubber cap of a cartridge;
• To install a cartridge in the syringe handle according to the instruction to its use;
• To make an injection. Within at least 10 seconds the needle has to remain under skin. The button should be held the needle pressed before full withdrawal from under skin to provide the correct introduction of a dose and to limit risk of hit of a lymph or blood in a needle and a cartridge with drug.

Each cartridge should be used only to 1 person. It cannot be filled repeatedly. For each injection it is necessary to use the new replaced sterile needle.

For introduction of the dose of Rastan appointed by the doctor it is necessary to use the table of recalculation of indications of the indicator the syringe handle in a drug dose. The dosage measurement step the syringe handle Biomatikpen is designated by the letter "To." (cliques) and makes 0,05 mg. Thus, when using solution Rastan for hypodermic introduction in cartridges of 3 ml figure 1 will correspond to a dose of 0,05 mg, figure 2 – 0,1 mg, figure 3 – 0,15 mg, etc., figure 60 – 3 mg.

Side effects

• From endocrine system: hyperglycemia, depression of function of a thyroid gland;
• From a metabolism: delay of liquid and development of peripheral hypostases;
• From system of a hemopoiesis: leukemoid tests;
• From the central nervous system: increase in intracranial pressure (it is shown by a vision disorder, nausea, a headache, vomiting);
• From a musculoskeletal system: femur head epiphysiolysis;
• Allergic reactions: itch, skin rash;
• Local reactions: a swelling, morbidity, a hyperemia, numbness and a lipoatrophia in the place of an injection;
• The side effects described in literature: a papilledema (arises within the first 8 weeks of treatment more often, usually happens at patients to Shereshevsky-Turner's syndrome), a hearing disorder and average otitis (at patients to Shereshevsky-Turner's syndrome), fatigue, weakness, a gynecomastia, progressing of scoliosis (at patients with excessive rapid growth), a hip incomplete dislocation at children (knee and hip pain, limping), pancreatitis (nausea, vomiting, abdominal pains), acceleration of growth of the nevus existing earlier (the malignancy is possible), increase in activity of an alkaline phosphatase, content in blood of parathyroid hormone and inorganic phosphate.

Special instructions

Due to the probability of development of lipoatrophias it is necessary to change places of subcutaneous injections.

On condition of lack of symptoms of the increased intracranial pressure Rastan does not exert a negative impact on the speed of reactions and ability to the increased concentration of attention.

In case of lameness during therapy somatropiny careful observation of a condition of the patient is necessary.

Sick diabetes mellitus during treatment by Rastan dose adjustment of hypoglycemic drug can be required. It is necessary to consider probability of manifestation latentno of the proceeding hypothyroidism. Patients who receive sodium left thyroxine have a risk of development of symptoms of a hyperthyroidism.

During treatment it is necessary to control a condition of an eyeground, especially at development of symptoms of intracranial hypertensia. In case of hypostasis of an optic nerve drug needs to be cancelled.

Treatment by Rastan should be stopped during transplantation of a kidney.

Medicinal interaction

Glucocorticosteroids suppress a promoting effect of a somatropin on growth processes.

The accompanying therapy by other hormones, for example, estrogen, anabolic steroids, a gonadotrophin or hormones of a thyroid gland can exert impact on efficiency of Rastan concerning final growth also.

Somatropin increases clearance of medicines which are metabolized by microsomal enzymes of a liver, especially cyclosporine, glucocorticoids, sex hormones and anticonvulsants.

Terms and storage conditions

To store in the place, unavailable to children, with observance of temperature condition 2-8 ºС. Not to freeze.

Period of validity – 2 years.

The solution prepared from lyophilisate can be stored within 14 days at a temperature of 2-8 ºС.

The begun cartridge or bottle with solution can be stored within 28 days at a temperature of 2-8 ºС.