International nonproprietary name:
Testosterone propionate 100mg.
Valium for drug of a solution for subcutaneous injection.
Active ingredient: testosterone propionate 100mg 1.33 mg (4 ME), Excipients: mannitol 20 mg, 0.7 mg glycine, monosodium phosphate 1.5 mg Sodium chloride 0.5 mg.
Active ingredient: testosterone propionate 100mg 3.33 mg (10 IU). Excipients: mannitol 40 mg, 1.4 mg glycine, monosodium phosphate 1.5 mg 0.5 mg sodium chloride. Solvent:water for injection 1 ml.
The drug Dzhintropin ® is a genetically engineered growth hormone. It stimulates skeletal and somatic growth, but also has a strong influence on the metabolic processes. It stimulates the growth of bones, affects epiphysis plates of long bones, bone metabolism. It promotes normalization of body composition by increasing lean muscle mass and reduce 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 gland, gonads, adrenal gland, thyroid gland. It stimulates the transport of amino acids into the cell and protein synthesis, reduces cholesterol levels, affecting the profile of lipids and lipoproteins. It suppresses the release of insulin. Promotes sodium retention, potassium and phosphorus. It increases body weight, muscle activity and physical endurance.
Absorption growth hormone after subcutaneous administration is 80%, the maximum plasma concentration is achieved in 3-6 hours. It penetrates into well perfused organs. It is metabolized in the kidneys and liver. The volume of distribution of testosterone propionate 100mg – 0,49-2,11 l / kg. Excreted by the kidneys and the bile (incl 0.1% unchanged). The half-life after subcutaneous administration is 3-5 hours.
Indications for use:
Growth retardation in children due to insufficient growth hormone secretion, gonadal dysgenesis with (Shersshevskogo-Turner syndrome), chronic renal failure (impaired renal function by more than 50%) in prepubertal.
In adults with confirmed congenital or acquired deficiency of growth hormone replacement therapy.
Giperchuvstvitelyyust, malignancies, active brain tumors, urgent conditions (including conditions after surgeries on the heart, the abdomen, acute respiratory distress), pregnancy and breast-feeding (at the time of treatment should abandon breastfeeding).
Diabetes mellitus, intracranial hypertension, hypothyroidism.
Dosing and Administration
Dzhintropin ® is administered subcutaneously, slowly, 1 times a day, usually at night. It is necessary to change the place of injection for the prevention of the development of lipoatrophy.
Dissolve contents of vial recommended supplied in 1 ml of solvent, calculated based on the dose. To this solvent was selected syringe and injected into the vial through the stopper. Gently shake the vial until complete dissolution of the content. Sudden shaking at the same time is unacceptable. The prepared solution is stored in the vial is not more than two weeks at 2 C to 8 C.
Doses are selected individually depending on the severity of growth hormone deficiency, weight or body surface area, the effectiveness of the therapy.
In children with insufficient growth hormone secretion recommended dose of 25-35 mg / kg / day (0.07-0.1 IU / kg / day), which corresponds to 0.7-1 mg / m 2 / day (2.3 IU / m 2 / day). Treatment starts as possible at an early age and continued until puberty and / or before the closing of bone growth zones. Perhaps the cessation of treatment in achieving the desired result.
When Shereshevsky – Turner syndrome, chronic renal failure in children, accompanied by growth retardation, recommended dose of 50 mcg / kg / day (0.14 IU / kg / day) corresponding to 1.4 mg / m 2 / day (4.3 IU / m 2 / day) In case of insufficient growth dynamics may require dose adjustment.
When growth hormone deficiency in adults initial dose is 0.15-0.3 mg / day (corresponding to 0.45 – 0.9 IU / day), followed by its increase, depending on the effect. In titration dose level of IGF I (IGF-I) in the blood serum can be used as a benchmark. The maintenance dose is adjusted individually, but does not exceed, as a rule, 1 mg / day, which corresponds to 3 IU / day. Older recommended lower doses.
Increased intracranial pressure (headache, nausea, vomiting, blurred vision), decreased thyroid function, hyperglycemia, leukemoid reaction epiphysiolysis femoral head, fluid retention with the development of peripheral edema, arthralgia, myalgia, carpal tunnel syndrome. The symptoms are usually transient, dose-dependent, may require dose reduction.
Allergic reactions: skin rash, pruritus.
Rarely – formation of antibodies to the drug with reduced efficiency.
Local reactions: redness, swelling, pain, itching, lipoatrophy at the injection site.
Attention! The following side effects have been described in the literature with the use of the drug testosterone propionate 100mg: weakness, fatigue, gynecomastia, optic disc edema (usually occurs within the first 8 weeks of treatment, most often in patients with Turner’s syndrome), pancreatitis (abdominal pain, nausea, vomiting), otitis media and hearing loss (in patients with Turner’s syndrome), subluxation of the hip in children (limping, pain in the hip and knee), the acceleration of the growth of pre-existing nevi (possible malignancy), the progression of scoliosis (in patients with overgrowth growth), elevated levels of inorganic phosphate in the blood, parathyroid hormone and alkaline phosphatase activity.
Acute overdose may lead initially to hypoglycemia, and then to hyperglycemia. With long-term overdose may experience signs and symptoms associated with excess human growth hormone – acromegaly development and / or gigantism, as well as the development of hypothyroidism, decreased levels of cortisol in the blood serum. Treatment: removal of the drug, symptomatic therapy.
Interaction with other drugs
Corticosteroids reduce the stimulating effect of growth hormone on the growth processes. The effectiveness of the drug (in respect of finite growth) may also affect other hormones related therapy, eg gonadotrophin, anabolic steroids, estrogen and thyroid hormone.
Against the background of treatment with Dzhintropin ® may require correction doses of hypoglycemic agents in patients with diabetes mellitus, may occur manifestation of latent flowing hypothyroidism, and in patients receiving thyroxine may be signs gipertirsoza, during treatment is necessary to monitor the state of the fundus, especially for symptoms of intracranial hypertension. Swelling of the optic nerve requires discontinuation of the drug. Detection of lameness on testosterone propionate 100mg therapy requires careful monitoring. It is necessary to change the place of subcutaneous injections in connection with the development of lipoatrophy.
Valium for drug of a solution for subcutaneous injection 4 ME, 10, ME.
Lyophilisate: 4 or 10 ME in a glass vial.
Solvent: 1 mL neutral glass vial with a colored mark.
5 vials lyophilisate 5 complete with solvent ampoules and disposable syringes 5, 1 mL, in a pack carton along with instructions for use.
On 10 vials with lyophilisate complete with 10 ampoules with the solvent in a cardboard pack together with instructions for use.
On 20 vials with lyophilizate in cardboard pack together with instructions for use.