Dzhintropin powder lyophilisate for solution for injections 10me N5
Condition: New product
1000 Items
Rating:
Be the first to write a review!
More info
Active ingredients
Somatropin
Release form
Lyophilisate
Composition
Somatropin (somatropin) 3.33 mg. Excipients: mannitol - 40 mg, glycine - 1.4 mg, sodium dihydrogen phosphate - 1.5 mg, sodium chloride - 0.5 mg.
Pharmacological effect
Drug Dzhintropin; is a genetically engineered somatotropic hormone. Stimulates skeletal and somatic growth, and also has a pronounced effect on metabolic processes. Stimulates the growth of bones of the skeleton, affecting the plates of the epiphysis of the tubular bones, bone metabolism. It contributes to the normalization of body structure by increasing muscle mass and reducing body fat mass. In patients with growth hormone deficiency and osteoporosis, replacement therapy leads to the normalization of the mineral composition and bone density. Increases the number and size of muscle cells, liver, thymus, sex glands, adrenal glands, 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 insulin release. Contributes to the retention of sodium, potassium and phosphorus. Increases body weight, muscle activity and physical endurance.
Pharmacokinetics
Absorption and distribution Absorption of somatropin after s / c injection is 80%, Cmax in the blood plasma is reached in 3-6 hours. It penetrates into well-perfused organs. Metabolism and elimination Metabolized in the kidneys and liver. Vd somatropin - 0.49-2.11 l / kg. Excreted by the kidneys and with bile (including 0.1% unchanged). T1 / 2 after s / c injection is 3-5 hours
Indications
Growth retardation in children due to insufficient secretion of growth hormone, with gonadal dysgenesis (Shereshevsky-Turner syndrome), with chronic renal failure (reduced renal function by more than 50%) in the prepubertal period; in adults with confirmed congenital or acquired growth hormone deficiency as replacement therapy.
Contraindications
Malignant neoplasms; active brain tumors; urgent conditions (including conditions after operations on the heart, abdominal cavity, acute respiratory failure); pregnancy; breastfeeding period (breastfeeding should be abandoned at the time of treatment); hypersensitivity to the drug.
Precautionary measures
Precautions should be prescribed the drug for diabetes, intracranial hypertension, hypothyroidism.
Use during pregnancy and lactation
Contraindicated in pregnancy and lactation.
Dosage and administration
Jintropin; enter n / a, slowly, 1 time / day, usually at night. It is necessary to change the injection site for the prevention of the development of lyoatrophy. It is recommended to dissolve the contents of the vial in 1 ml of the attached solvent, based on the calculated dose. To do this, select the solvent with a syringe and injected into the vial with the drug through the tube. Carefully shake until the vial contents dissolve. Shaking is not allowed. The prepared solution is stored in a bottle for no more than two weeks at a temperature of 2 ° C to 8 ° C. Doses are selected individually, taking into account the severity of growth hormone deficiency, body mass or surface area, and effectiveness in the treatment process. In children with insufficient secretion of growth hormone, a dose is recommended 25-35 mcg / kg / day (0.07-0.1 IU / kg / day), which corresponds to 0.7-1 mg / m2 / day (2-3 IU / m2 / day). Treatment begins as soon as possible at an earlier age 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. In Shereshevsky-Turner syndrome, in chronic renal failure in children with growth retardation, a dose of 50 mcg / kg / day (0.14 IU / kg / day) is recommended, which corresponds to 1.4 mg / m2 / day ( 4.3 IU / m2 / day). In case of insufficient growth dynamics, dose adjustment may be required. If there is a growth hormone deficiency in adults, the initial dose is 0.15–0.3 mg / day (which corresponds to 0.45–0.9 IU / day) with its subsequent increase, depending on the effect. When titrating the dose as a control indicator can use the level of insulin-like growth factor I (IGF-I) in serum. Maintenance dose is selected individually, but does not exceed, as a rule, 1 mg / day, which corresponds to 3 IU / day. Older patients are recommended lower doses.
Side effects
Possible: increased intracranial pressure (headache, nausea, vomiting, blurred vision), reduced thyroid function, hyperglycemia, leukemoid reactions, epiphysiolysis of the femoral head, fluid retention with the development of peripheral edema, arthralgia, myalgia, tunnel syndrome. Symptoms are usually transient, dose-dependent,Allergic reactions: skin rash, itching. Rarely: the formation of antibodies to the drug with a decrease in its effectiveness. Local reactions: hyperemia, swelling, pain, itching, lipoatrophy at the injection site. The following side effects are described in the literature when using the drug somatropin : weakness, fatigue, gynecomastia, optic nerve edema (usually observed during the first 8 weeks of treatment, most often in patients with Shsreshevsky-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 hip and knee), acceleration of the growth of a previously existing nevus (possible malignancy), progression of scoliosis (in patients with excessively rapid growth), increased blood levels of inorganic phosphate, parathyroid hormone and alkaline phosphatase activity.
Overdose
Acute overdose can lead to hypoglycemia first, and then to hyperglycemia. With prolonged overdose, there may be signs and symptoms characteristic of an excess of human growth hormone - the development of acromegaly and / or gigantism, as well as the development of hypothyroidism, a decrease in serum cortisol levels. Treatment: drug withdrawal, symptomatic therapy.
Interaction with other drugs
GCS reduces the stimulatory effect of somatropin on growth processes. The effectiveness of the drug (in relation to final growth) can also be influenced by concomitant therapy with other hormones, for example, gonadotropin, anabolic steroids, estrogens and thyroid hormones.
special instructions
Against the background of drug treatment Dzhintropin; may require correction of doses of hypoglycemic drugs in patients with diabetes mellitus, manifestations of latent hypothyroidism may occur, and patients receiving thyroxin may experience signs of hyperthyroidism. During treatment, it is necessary to monitor the state of the fundus, especially for symptoms of intracranial hypertension. Edema of the optic nerve requires the abolition of the drug. Detection of lameness during therapy with somatropin requires careful observation. It is necessary to change the location of s / c injections in connection with the possibility of the development of lipoatrophy.