International Common Name (ICN) of the active substance Trenbolonum
COMPOSITION
1 ml solution for injection contains:
the active substance: trenbolone hexahydrobenzyl carbonate – 100 mg;
auxiliary substances: benzyl alcohol, benzyl benzoate, peach oil.
PHARMACEUTICAL FORM
Injectible solution.
DESCRIPTION OF THE MEDICINAL PRODUCT
Transparent oily solution, from yellow to light yellow, with characteristic smell.
THE PHARMACOTERAPEUTICAL GROUP and the ATC Code
Anabolic steroid. ATC code: A14AB.
PHARMACOLOGICAL PROPERTIES
Parabolin is a steroid anabolic. Being a derivative of nandrolone, trenbolone differs significantly from the latter by its properties. Due to structural particulars, trenbolone does not undergo 5α-aromatase activity but can itself exhibit both estrogenic and progestagenic activity (the latter manifests itself through progesterone receptor stimulation capacity).
Trenbolone is the most potent steroidal anabolic anabolic agent – after the androgen receptor stabilization time, trenbolone exceeds not only testosterone (over 3 times more) but also nandrolone.
It stimulates the anabolic processes and inhibits the catabolic ones caused by glucocorticoids. It leads to increased muscle mass, reducing sedimentation fat, improves tissue trophic, favors deposits calcium in the bones, retains nitrogen, phosphorus, sulfur, potassium, sodium and water in the body.
It stimulates the synthesis of erythropoietin and activates the anabolic processes in the bone marrow, which during the concomitant administration of the iron preparations is manifested by antianemic action. Inhibits the synthesis of gonadotrophins and endogenous testosterone. In high doses it inhibits spermatogenesis. It can stop the growth and sexual development of children.
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-31%
Dragon Pharma
THERAPEUTICAL INDICATIONS
Parabolan as a predominantly anabolic remedy is administered as an adjunct in complex therapy of conditions due to protein metabolism disorders with negative nitrate balance (insufficient intake, increased need or loss):
– Various genesis cachexia;
– Widespread burns;
– Long-term administration of glucocorticoids;
– Hypo- and aplastic anemia;
– Muscular atrophy in patients with AIDS (acquired immune deficiency syndrome);
– Osteoporosis.
DOSES AND METHOD OF ADMINISTRATION
Intramuscularly deep.
The dosing regimen is individually selected.
Adults: 50-200 mg (women – 50-100 mg) once every 1-4 weeks.
The duration of parabolic administration depends on the clinical response of the patient and the degree of adverse reaction.
The treatment is based on a high protein diet.
SIDE EFFECTS
The side effects listed below are classified by frequency, apparatus, system and organ. Frequency groups according to MedDRA convention: very common (≥1 / 10), common (≥ 1/100 and <1/10), uncommon (≥ 1/1000 and <1/100), rare (≥1 / 10000 and <1 / 1,000) and very rare (<1 / 10,000), of unknown frequency (can’t be estimated from the available data).
Blood and lymphatic disorders:
Uncommon: changes in the leukocyte formula,
Very rare: hypocoagulation with tendency to haemorrhage.
Metabolism and nutrition disorders:
Common: retention or cessation of growth (calcification of epiphyseal growth zones of tubular bones);
Uncommon: In men and women – progress of atherosclerosis, peripheral edema, liver function disorder.
Musculoskeletal disorders:
Rare: pain in long tubular bones.
Reproductive system and breast disorders:
Uncommon: in women – virilization symptoms, inhibition of ovarian function, menstrual cycle disorders; in men in the prepubertal period – symptoms of virilization, idiopathic skin pigmentation; in the post-paternal period – gynecomastia, priapism, inhibition of spermatogenesis, bladder irritation.
Rare: in the elderly – hypertrophy and/or prostate carcinoma.
CONTRAINDICATIONS
Hypersensitivity, prostate cancer and adenoma, male breast cancer, breast cancer in women with hypercalcaemia, cancer ovarian, CPI (ischemic cardiopathy), severe atherosclerosis, nephritis, nephrotic syndrome, hepatic and renal failure, acute and chronic prostatitis, pregnancy, breastfeeding, children up to sexual maturation.
OVERDOSE
Cases of overdose have not been reported.
WARNINGS AND SPECIAL PRECAUTIONS FOR USE
When prescribing steroid anabolics, patients should be informed about possible side effects with immediate medical attention after their appearance. When the first signs of virilization of the patients (voice thickening, hirsutism, acne, clitoromalgia) occur, administration should be stopped to avoid irreversible changes.
Preparations in this group may cause suppression of coagulation factors II, V, VII, X requiring thorough monitoring, including concomitant use with indirect anticoagulants.
During treatment, monitoring of liver function parameters (transaminases, alkaline phosphatase, bilirubin) and lipid spectrum (cholesterol and low density lipoproteins) is required.
An increase in the incidence of hypertrophy and prostate carcinoma in the elderly may require a rigorous control.
In patients using high doses of steroid anabolic agents, it is necessary to periodically determine hemoglobin and hematocrit due to possible polycystitis.
Using during pregnancy or lactation:
It is contraindicated in pregnancy and lactation.
Effects on ability to drive and to operate machinery:
The medicine does not affect the ability to drive or to operate machinery.
INTERACTIONS WITH OTHER MEDICINES AND 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.
PRESENTATION, PACKAGING
Solution for injection 100 mg/ml
1 ml in ampoules.
Each five (5) or ten (10) ampoules with the administration instruction are placed in an individual cardboard box.
STORAGE
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!
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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