Strombaject Aqua suspension for injection
International Common Name (ICN) of the active substance
1 ml of suspension for injection contains:
The active substance: stanozolol 50 mg;
Excipients: myristyl-γ-picolinium chloride, sodium chloride, water for injections.
Suspension for injection.
DESCRIPTION OF THE MEDICINAL PRODUCT
White or white suspension with yellowish color.
THE PHARMACOTERAPEUTICAL GROUP and the ATC Code
Anabolic steroids. Derivatives of androstan. A14A A02.
Stanozolol is an anabolic steroid. It stimulates the anabolic processes and inhibits the catabolic ones caused by glucocorticoids. It leads to increased muscle mass, reduces fat deposits, improves trophic tissue, favors calcium deposition in bone, retains nitrogen, phosphorus, sulfur, potassium, sodium and water in the body. Hematopoietic action is determined by the increase in erythropoietin synthesis.
The antiallergic action is determined by the increase in serum of the C1 fraction of the complement. Androgenic (moderate) action may contribute to the development of male secondary sexual characteristics.
Dysregulation of protein synthesis, cachexia of various genesis, trauma, burns, pre- and postoperative period, convalescence period after infectious diseases and irradiation, renal and adrenal insufficiency, gouty, angioedema, muscular dystrophy, osteoporosis, negative nitrate balance in corticosteroid therapy, hypo- and plastic. Adjuvant in the treatment of tuberculosis, osteomyelitis, bronchial asthma, hepatitis.
DOSES AND METHOD OF ADMINISTRATION
Adults – initial dose 10-20 mg / day.
The maintenance dose is 5-10 mg / day. The treatment is based on a high protein diet.
The side effects listed below are classified by frequency, apparatus, system and organ. Frequency groups according to the MedDRA Convention are as follows: very common (≥ 1/10), common (≥ 1/100 and <1/10), uncommon (≥ 1/1000 and <1/100), rare (≥1 / 10,000 and <1/1,000)
and very rare (<1 / 10,000), of unknown frequency (can’t be estimated from the available data).
Benign, malignant and unspecified disorders:
Common: in the elderly – hypertrophy and/or prostate carcinoma.
Blood and lymphatic disorders:
Uncommon: changes in the leukocyte formula.
Rare: hypocoagulation with haemorrhagic tendency.
Common: in women: symptoms of virilization, inhibition of ovarian function, menstrual disorders. In men: during the prepubertal period – symptoms of virilization, idiopathic skin pigmentation.
Uncommon: retention or cessation of growth (calcification of epiphyseal growth zones of tubular bones); in the post-graduate period – gynecomastia.
Metabolism and nutrition disorders:
Common: fluid retention with peripheral edema, hypercalcaemia.
Rare: in men and women – the progression of atherosclerosis.
Uncommon: dysregulation of liver function with jaundice.
Musculoskeletal and connective tissue disorders:
Uncommon: Pain in long tubular bones.
Renal and urinary disorders:
Rare: post-puberty – bladder irritation.
Reproductive system and breast disorders:
Hypersensitivity, prostate cancer, male breast cancer, breast cancer in women with hypercalcemia, ischemic cardiopathy, severe atherosclerosis, liver and kidney failure, acute and chronic prostatitis, pregnancy and lactation.
Cases of overdose have not been reported.
WARNINGS AND SPECIAL PRECAUTIONS FOR USE
When the first signs of virilization of the patients (voice thickening, hirsutism, acne, clitoromalgia) occur, administration should be stopped to avoid irreversible changes. Systemically control lipidemia and cholesterol.
Administration during pregnancy or lactation
Effects on ability to drive and use machines
It does not affect the ability to drive or use machines.
INTERACTIONS WITH OTHER MEDICINES, OTHER TYPES OF INTERACTION
Glucocorticoids, mineralocorticoids, corticotropin, sodium-containing preparations and foods rich in sodium potentiate fluid retention in the body, increase the risk of developing edema, intensify acne eruptions. Increases the action of antiaggregants, anticoagulants, insulin and oral antidiabetics, decreases the action of somatotropin and its derivatives.
Suspension for injection 50 mg/ml.
1 ml in ampoules. 5 ampoules together with the instructions for administration in individual cartons.
Keep at temperatures below 25 °C.
Store in the original package in order to protect from light and moisture.
Keep out of the reach and sight of children.
TERMS OF VALIDITY
3 years. Do not use after the expiry date stated on the pack.
CERTIFICATE OF REGISTRATION
SC Balkan Pharmaceuticals SRL N. Grădescu str., 4, MD-2002, or. Chisinau, Republic of Moldova.
SC Balkan Pharmaceuticals SRL Industrial Street, 7 / A, MD-2091, or. Singera, Republic of Moldova.
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