| Product Name: | Nandrolone Decanoate Injection USP |
| Brand Name: | (GENERICS) |
| Strength: | 50mg/ml, 200mg/5ml, 250mg/10ml |
| Dosage Form: | Liquid Injection (Sterile) |
| Packing: | 1ml Ampoule & 10ml Vial |
| Route of Administration: | For I.M. use only |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | Steroids |
| Indication: | Nandrolone belongs to the group of medicines called Anabolic steroids. It is used to treat osteoporosis in postmenopausal women, certain types of anemia, and breast cancer (in women). It can also be used to treat patients on long-term corticosteroids. |
| Storage: | Store at 20°C to 25°C (68° to 77°). See USP-controlled room temperature. |
GENERIC NAME OF MEDICINAL PRODUCT:
- Nandrolone Decanoate Injection USP 50mg/ml
- Nandrolone Decanoate Injection USP 200mg/5ml
- Nandrolone Decanoate Injection USP 250mg/10ml
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Nandrolone Decanoate Injection USP 50mg/ml
Each ml contains:
Nandrolone Decanoate USP.……………………………………….50 mg
Benzyl Alcohol USP. …………….. 0.1 ml
Oily base…………………………………….q.s. - Nandrolone Decanoate Injection USP 200mg/5ml
Each ml contains:
Nandrolone Decanoate USP.……………………………………….200 mg
Benzyl Alcohol USP. …………….. 0.1 ml
Oily base…………………………………….q.s. - Nandrolone Decanoate Injection USP 250mg/10ml
Each ml contains:
Nandrolone Decanoate USP.……………………………………….250 mg
Benzyl Alcohol USP. …………….. 0.1 ml
Oily base…………………………………….q.s.
THERAPEUTIC INDICATION:
Nandrolone belongs to the group of medicines called Anabolic steroids. It is used to treat osteoporosis in postmenopausal women, certain types of anemia, and breast cancer (in women). It can also be used to treat patients on long-term corticosteroids.
DIRECTION OF USE:
For I.M. use only.
Refer enclosed leaflet for further information.
CAUTION & Warning:
CAUTION:
Do not use it if any foreign particulate matter is visible.
DO NOT ACCEPT IF THE VIAL SEAL IS BROKEN.
KEEP OUT OF REACH AND SIGHT OF CHILDREN.
WARNING: Not to be used in newly born or premature infants & children up to 3 years old.
WARNING: Not to be sold by retail without the prescription of a Registered Medical Practitioner.
STORAGE & DOSAGE:
Storage: Store at 20°C to 25°C (68° to 77°). See USP-controlled room temperature.
Dosage: As directed by the Physician.