Primobol Tablets

International Common Name (ICN) of the active substance
Methenolonum
THE COMPOSITION OF THE MEDICINAL PRODUCT
1 tablet contains:
The active substance: metenolone 50 mg as metenolone acetate;
Excipients: magnesium stearate, Ludipress® (lactose, polyvidone, crospovidone).
PHARMACEUTICAL FORM
Tablets.
PREPARATION DESCRIPTION
White or almost white tablets of square shape, compact and homogeneous structure with a “BP” dividing line and incrustation on one side, and the inscription “50” on the other side, with sharp edges, the side surface with rounded edges .
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 apparatus, which leads to increased synthesis of DNA, RNA and structural proteins, activates tissue-type enzymes and increased tissue respiration, oxidative phosphorylation, ATP synthesis and intracellular macrocellular accumulation . It stimulates the anabolic processes and inhibits the catabolic ones caused by glucocorticoids. It leads to increased muscle mass, reducing fat sedimentation, ameliorates the trophic of tissues, favors calcium deposition in the bones, retains sodium and water in the body. Hematopoietic action is determined by the increase in erythropoietin synthesis. Androgenic (moderate) action may contribute to the development of male secondary sexual characteristics.
Pharmacokinetic properties:
It is rapidly and completely absorbed in TGI, low bioavailability is determined by the presence of the first passage of the liver. It is attached to specific transport globulins in a ratio of 90%. It undergoes the final biotransformation in the liver with the formation of inactive metabolites. The preparation is illuminated from the body by renal urine (about 90%). Approximately 6% of the absorbed preparation is cleared with the feces in free form.
THERAPEUTICAL INDICATIONS
Dysregulation of protein synthesis, caseinia of various genesis; trauma, burns, after infectious diseases and irradiation; muscular dystrophy, osteoporosis, negative nitrate balance in corticosteroid therapy, hypo- and aplastic anemia.
DOSES AND METHOD OF ADMINISTRATION
Primobol is given to adults at a dose of 2-3 mg/kg/day. Duration of treatment is 3 months and can be extended based on results.
SIDE EFFECTS
Blood and lymphatic disorders: changes in the leukocyte formula.
Metabolism and nutrition disorders: retention or cessation of growth (calcification of epiphyseal growth zones of tubular bones); In men and women – progress of atherosclerosis, peripheral edema, liver function disorder.
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 hypercalcaemia, 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 patient (voice reduction, hirsutism, acne, clitoromalgia) occur, administration should be stopped to avoid irreversible changes. Systemically control lipidemia and cholesterol.
Primobol contains lactose.
Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency (Lapp), or glucose-galactose malabsorption should not take this medicine.
Using during pregnancy or lactation:
It is contraindicated in pregnancy and lactation.
Effects on ability to drive and use machines:
The medicine does not affect the ability to drive or 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 antiplatelets, anticoagulants, insulin and oral antidiabetic agents, decreases the action of somatotropin and its derivatives.
PRESENTATION, PACKAGING
50 mg tablets.
Twenty (20) tablets in blister, three (3) blister packs with administration instructions are placed in a cardboard 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
3 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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