Somatropin Evalpharm (10 vials / 10 IU)
About product
Instruction for use:
Evalpharm™ Somatropin.
Active substance:
Somatropin
Pharmacological group:
Growth hormone [Hormones of the hypothalamus, pituitary gland, gonadotropins and their antagonists].
Description of dosage form:
Lyophilizate: mass or powder white or white with a yellowish hue.
Pharmachologic effect:
Pharmacological action - somatotropic.
Form of issue:
Liofilizate for the preparation of solution for p / c administration 10 IU.
Lyophilizate:
in a glass vial with 10 IU.
For 10 vial pack. With the lyophilizate is placed in a pack of cardboard.
For 20 vial pack. With the lyophilizate is placed in a pack of cardboard.
Composition:
Lyophilizate for the preparation of a solution for subcutaneous administration 1 vial.
Active substance:
Somatropine 3.33 mg (10 IU)
Auxiliary substances:
mannitol - 20/40 mg;
Glycine - 0.7 / 1.4 mg;
Sodium dihydrogen phosphate 1.5 / 1.5 mg;
Sodium chloride - 0.5 / 0.5 mg
Pharmacodynamics:
The drug Evalpharm™. Somatropin is a genetically engineered growth 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. Promotes the normalization of body structure by increasing muscle mass and reducing body fat. In patients with growth hormone deficiency and osteoporosis, substitution therapy results in normalization of 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. Suppress the release of insulin.
Promotes the retention of sodium, potassium and phosphorus. Increases body weight, muscle activity and physical endurance.
Pharmacokinetics:
Absorption of somatropin after SC administration is 80%, Cmax in blood plasma is reached after 3-6 hours. It penetrates into well perfused organs. Metabolized in the kidney and liver. Vd of somatropin - 0,49-2,11 l / kg. It is excreted by the kidneys and with bile (including 0.1% unchanged). T1 / 2 after the SC administration is 3-5 hours.
Indications:
Gonadal dysgenesis (Shereshevsky-Turner syndrome), chronic renal failure (decreased kidney function by more than 50%) in the prepubertal period.
In adults with confirmed congenital or acquired growth hormone deficiency as a substitute therapy.
Contraindications:
Hypersensitivity;
Malignant neoplasms;
Active brain tumors;
Urgent conditions (including conditions after operations on the heart, abdominal cavity, acute respiratory failure);
pregnancy;
Breastfeeding (at the time of treatment, you must stop breastfeeding).
With caution: diabetes, intracranial hypertension, hypothyroidism.
Side effects:
Increased ICP (headache, nausea, vomiting, impaired vision), decreased thyroid function, hyperglycemia, leukemoid reactions, epiphysis of the head of the femur, fluid retention with development of peripheral edema, arthralgia, myalgia, tunnel syndrome. Symptoms are, as a rule, transient, dose-dependent, may require a dose reduction.
Allergic reactions: skin rash, itching. Rarely - the formation of antibodies to the drug with a decrease in its effectiveness.
Local reactions: hyperemia, swelling, pain, tching, lipoatrophy at the injection site.
Dosing and Administration:
Evalpharm™ Somatropin is administered slowly, 1 time per day, usually at night. It is necessary to change the injection site to prevent the development of lipoatrophy.
Dissolve the contents of the vial is recommended in 1 ml of the supplied solvent, based on the calculated dose. To do this, take the solvent with a 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 to 8 ° C.
Doses are selected individually, taking into account the severity of growth hormone deficiency, mass or body surface area, the effectiveness in the therapy process.
With a deficiency of growth hormone in adults.
When titrating the dose, IGF-1 serum level can be used as a reference.
The maintenance dose is selected individually, but does not exceed, as a rule, 1 mg / day, which corresponds to 3 IU / day.
Overdose:
Symptoms: Acute overdose may 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.
Storage Conditions:
In the dark place at a temperature of 2-8 ° C (do not freeze).
The prepared solution should be stored at a temperature of 2 to 8 ° C for 2 weeks.
Keep out of the reach of children!
Shelf life: 4 years.
Do not use after the expiry date printed on the package.
Manufactured address:
Denmark, Viborg
Packer:
Denmark, Copenhagen
Distributors in the world:
Indicated on the official website evalpharm.com
Check the code on the package: evalpharm.info