APR DETONATE

INFORMATION FOR THE USER

Nandrolone decanoate 50mgInjection

Read all of this information carefully before you start taking this medicine because it contains important information for you.
• Keep this information. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine is prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this information.

1. COMPOSITION:
Each vial contains:
Nandrolone decanoate –50mg/ml

For Intramuscular injection ONLY.

2. DESCRIPTION:
Nandrolone is an androgen & anabolic steroid. It is available in the form if ester such as nandrolone decanoate.

3. PHARMACOLOGICAL ACTION:
Nandrolone is chemically related to testosterone & shows enhanced anabolic & a reduced androgenic activity. It has been shown to positively influence calcium metabolism & to increase bone mass in osteoporosis.Androgenic effects (e.g. virilisation) are relatively uncommon at the recommended dosages. Nandrolone lacks the C17 alpha-alkyl group which is associated with the occurrence of liver dysfunction & cholestasis.

4. CLINICAL PHARMACOKINETICS:
Nandrolone decanoate is slowly released from the injection site into the blood with a half-life of 6 days.The ester is rapidly hydrolysed to nandrolone in the blood with a half-life of one hour or less. The half-life for the combined process of hydrolysis & of distribution & elimination is 4.3 hours. It is metabolised by the liver. 19-norandrosterone, 19-noretiocholanolone & 19-norepiandrosterone have been identified as metabolites in urine. It is not known whether these metabolites display a pharmacological action.
5. INDICATIONS:
Nandrolone decanoate is indicated for the following:

– For use in osteoporosis in post-menopausal women.
– Established osteoporosis should have been diagnosed by the following parameters:
i) crush/wedge fractures of the vertebrae
ii) other osteoporotic fractures
iii) established reduction in bone mineral content as measured by accepted BMC measurements.

6. CONTRAINDICATIONS:
Hydrocortisone is contraindicated in:

– Pregnancy
– Breast-feeding
– Porphyria
– Hypersensitivity to active substance/any of the excipients including arachis oil. Contraindicated in patients allergic to peanuts or soya.
7. WARNINGS AND PRECAUTIONS:
Physicians should consider monitoring patients before the start of treatment, at quarterly intervals for the first 12 months & yearly thereafter for the following parameters: Hematocrit/hemoglobin to exclude polycythemia.
Patients, especially the elderly, with the following conditions should be monitored for:
• Tumours – Mammary carcinoma, hypernephroma, bronchial carcinoma & skeletal metastases. In these patients hypercalcaemia/hypercalciuria may develop spontaneously & also during androgen therapy.
• Pre-existing conditions-In patients with pre-existing cardiac, renal/hepatic insufficiency/disease or epilepsy or migraine anabolic steroid treatment may cause complications characterized by oedema with/without congestive heart failure. In such cases treatment must be stopped immediately..
• Diabetes mellitus – Can improve glucose tolerance in diabetic patients.
• Anti-coagulant therapy – Can enhance the anti-coagulant action of coumarin-type agents.
• Liver dysfunction – caution should be used in patients with severe hepatic impairment .
Adverse events: If anabolic steroid-associated adverse reactions occur treatment should be discontinued & upon resolution of complaints treatment can be resumed.
Virilisation:Patients should be informed about the potential occurrence of signs of virilisation.
(Mis) use in sports: It is classified as a prohibited substance under OMAC 1999. The misuse of Nandrolone to enhance ability in sports carries serious health risks & is to be discouraged.
Drug abuse & dependence:Anabolic androgenic steroids have been subject to abuse, typically at doses higher than recommended for the approved indication(s) & in combination with testosterone. Abuse of anabolic androgenic steroids including testosterone can lead to serious adverse reactions.

8. ADVERSE EFFECTS:
Common side effects include:
– Virilism
– Increased libido
– Hypertension
– Dysphonia
– Nausea
– Abnormal hepatic function
– Acne
– Pruritis
– Hirsutism
– Enlarged clitoris
– Oedema
– Rise in Hb

9. DRUG INTERACTIONS:
Enzyme-inducing agents may decrease & enzyme-inhibiting drugs may increase nandrolone levels. Adjustment of the dose may be required.
Insulin & other anti-diabetic medicines: May improve glucose tolerance & decrease the need for insulin/other anti-diabetic drugs.
Anti-coagulant therapy: May enhance the anti-coagulant action of coumarin- type agents.
ACTH/corticosteroids: The concurrent administration with ACTH/corticosteroids may enhance edema formations.
Laboratory test interactions: May decrease levels of thyroxine-binding globulin resulting in decreased total T4 serum levels & increases resin uptake of T3 & T4.
Recombinant Human Erythropoietin: Combination with rhEPO, especially in females, may enable a reduction of the erythropoietin dose to reduce anemia.
10. DOSAGE:
Post-menopausal women:50mg every 3 weeks
The duration of treatment depends on the clinical response & the possible occurrence of side-effects.
Effectiveness of therapy should be monitored with the appropriate methods for osteoporosis on a 6-12 monthly basis.

11. ADMINISTRATION:
For intramuscular administration use only.
Administration to be done by a registered medical practitioner/nurse in a proper sterile & hospital setting only.
12. PRESENTATION:
13. STORAGE:
Store below 25°C in a cool & dry pace. Protect from direct sunlight. Keep away from the reach of children.

Do not freeze.

14. MANUFACTURED BY:
15. MARKETED BY:

This information was last revised on May 2019.