Ifosfamide for Injection 1gm (Coxan) Technical Specification:
| Product Name: | Ifosfamide for Injection 1gm |
| Brand Name: | Coxan |
| Strength: | 1gm, 3gm |
| Dosage Form: | Lyophilized Dry Powder for Injection |
| Packing: | SINGLE DOSE VIAL |
| Route of Administration: | For I.V. infusion 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: | Anti-Cancer |
| Indication: | Ifosfamide is a chemotherapy medication used to treat a number of types of cancer. This includes testicular cancer, soft tissue sarcoma, osteosarcoma, bladder cancer, small cell lung cancer, cervical cancer, and ovarian cancer |
| Storage: | Store at controlled room temperature 20°C to 25°C (68° to 77° F). Protect from temperature above 30°C (86° F) |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Ifosfamide for Injection 1gm
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Ifosfamide for Injection 1gm
Each vial contains:
Ifosfamide…………………………………….1000mg
Water for Injection………………………q.s.
THERAPEUTIC INDICATION:
Ifosfamide is a chemotherapy medication used to treat a number of types of cancer. This includes testicular cancer, soft tissue sarcoma, osteosarcoma, bladder cancer, small cell lung cancer, cervical cancer, and ovarian cancer
DIRECTION OF USE:
For Intravenous infusion only.
Reconstitution for 1gm: Add 20ml Sterile Water for Injection USP or Sterile Bacteriostatic Water for Injection USP (benzyl alcohol or parabens preserved) shaking to dissolve for a reconstituted concentration of 50mg per ml.
Please refer accompanying package insert for detailed dosage, directions for use and precautions.
CAUTION & WARNING:
CAUTION: This injection should not be used if it contains visible particulate matter after reconstitution.
WARNING: Cytotoxic Agent: To be sold by retail on the prescription of an Oncologist/ Cancer Hospital only.
Constituted solutions should be refrigerated and used within 24 hours.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Discard Unused portion.
Keep out of the reach of the children.
STORAGE & DOSAGE:
Storage: Store at controlled room temperature 20°C to 25°C (68° to 77° F). Protect from temperature above 30°C (86° F)
Dosage: As directed by an Oncologist.
GENERIC NAME OF THE MEDICINAL PRODUCT:
b) Ifosfamide for Injection 3gm
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each vial contains:
Ifosfamide…………………………………….1000mg
Water for Injection………………………q.s.
b) Ifosfamide for Injection 3gm
Each vial contains:
Ifosfamide…………………………………….3000mg
Water for Injection………………………q.s.
THERAPEUTIC INDICATION:
DIRECTION OF USE:
Reconstitution for 1gm: Add 20ml Sterile Water for Injection USP or Sterile Bacteriostatic Water for Injection USP (benzyl alcohol or parabens preserved) shaking to dissolve for a reconstituted concentration of 50mg per ml.
Please refer accompanying package insert for detailed dosage, directions for use and precautions.
CAUTION & WARNING:
WARNING: Cytotoxic Agent: To be sold by retail on the prescription of an Oncologist/ Cancer Hospital only.
Constituted solutions should be refrigerated and used within 24 hours.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Discard Unused portion.
Keep out of the reach of the children.
STORAGE & DOSAGE:
Dosage: As directed by an Oncologist.
