Primobol INJ

Primobol injectible solution

International Common Name (ICN) of the active substance
Methenolonum
COMPOSITION OF PREPARATION
1 ml solution contains:
The active substance: metenolone enanthate 100 mg;
Excipients: benzyl alcohol, benzyl benzoate, peach oil.
PHARMACEUTICAL FORM
Injectible solution.
DESCRIPTION
Oily, transparent solution of light yellow to yellow color.
THE PHARMACOTERAPEUTICAL GROUP and the ATC Code
Anabolic steroid, A14A A04.
PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties:

Metenolone is an anabolic steroid. By penetrating into the cell nucleus, it stimulates the cell’s genetic machinery, which leads to increased synthesis of DNA, RNA and structural proteins, activates tissue-chain enzymes and enhances tissue respiration, oxidative phosphorylation, ATP synthesis and intracellular macrocellular accumulation . It stimulates the anabolic processes and inhibits the catabolic ones caused by glucocorticoids. Increases muscle mass, reduces fat deposition, improves tissue trophic, favors calcium deposition in bones, retains sodium and water in the body. Hematopoietic action is determined by increased erythropoietin synthesis. Androgenic (moderate) action may contribute to the development of male secondary sexual characteristics.
Pharmacokinetic properties:
Metenolone absorbs slowly. The maximum plasma concentration is achieved over 72 hours after intramuscular administration. Duration – 2-4 weeks. In the blood, about 90% is coupled with a specific fraction of transporting globules. Biotransformation occurs in the liver up to various 17-ketosteroid, which after conjugation with glucuronic or sulfuric acid is eliminated with urine (about 90%). Approximately 6% of the absorbed preparation is cleared with the feces in free form.
THERAPEUTIC INDICATIONS
Dysregulation of protein synthesis, caseinia of various genesis; trauma, burns, post-infectious diseases and irradiation; muscular dystrophy, osteoporosis, negative nitrate balance in corticosteroid therapy, hypo- and aplastic anemia.
DOSES AND METHOD OF ADMINISTRATION
The product is administered deep intramuscularly 1 ml once every 2 weeks. To receive a favorable result, 1 ml is given once 3-4 weeks.
SIDE EFFECTS
Blood and lymphatic disorders: changes in the leukocyte formula.
Metabolism and nutrition disorders: growth retardation or cessation (calcification of epiphyseal growth zones of tubular bones); In men and women – the progression of atherosclerosis, peripheral edema, impaired liver function,
Musculoskeletal disorders: pain in long tubular bones.
Genital and breast disorders: In women – virilization symptoms, menstrual cycle disorders. In men: during the prepubertal period – symptoms of virilization, in the post-paternal period – gynecomastia, priapism, inhibition of spermatogenesis.
CONTRAINDICATIONS
Hypersensitivity to the preparation, prostate cancer, breast cancer in men, mammary carcinoma in women with hypercalcemia, CPI, severe atherosclerosis, nephrotic syndrome, acute and chronic liver disease including alcohol, nephritis, pregnancy, lactation period.
OVERDOSE
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. This medicine contains benzyl alcohol and should not be used in premature or newborn babies. May cause toxic and anaphylactoid reactions in infants and children under 3 years of age.
Use during pregnancy or lactation:
It is contraindicated in pregnancy and lactation.
Effects on ability to drive and to operate machinery:
The preparation does not affect the ability to drive or to operate machinery.
INTERACTIONS WITH OTHER MEDICINES AND OTHER TYPES OF INTRACTIONS
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.
PRESENTATION, PACKAGING
Solution for injection 100 mg/ml.
1 ml in ampoules. Five or ten (5, 10) vials in individual carton box.
STORAGE
Keep at temperatures below 25 °C.
Do not freeze.
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
5 years. Do not use after the expiry date stated on the pack!
LEGAL STATUS
It is issued with prescription.
CERTIFICATE OF REGISTRATION
SC Balkan Pharmaceuticals SRL N. Grădescu str., 4, MD-2002, or. Chisinau, Republic of Moldova.
The manufacturer
SC Balkan Pharmaceuticals SRL Industrial Street, 7 / A, MD-2091, or. Singera, Republic of Moldova.

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