GENERIC NAME OF THE MEDICINAL PRODUCT:
Ifosfamide for Injection IP 2000mg with Mesna Injection
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Ifosfamide for Injection IP 2000mg with Mesna Injection
Each combi pack contains:
One vial of Ifosfamide for Injection 2000mg
Each sterile lyophilized vial contains:
Ifosfamide USP……….…………………….2000mg
6×2 ml Ampoules of Mesna
Each ml contains
Mesna BP….…………………………………….100mg
Water for Injection IP………………………q.s.
Each combi pack contains:
One vial of Ifosfamide for Injection 2000mg
Each sterile lyophilized vial contains:
Ifosfamide USP……….…………………….2000mg
6×2 ml Ampoules of Mesna
Each ml contains
Mesna BP….…………………………………….100mg
Water for Injection IP………………………q.s.
THERAPEUTIC INDICATION:
Ifosfamide injection is indicated for use in combination with certain other approved antineoplastic agents for third-line chemotherapy germ cell testicular cancer. It should be used in combination with mesna for prophylaxis of hemorrhagic cystitis.
DIRECTION OF USE:
For Intravenous infusion only.
Dissolve the contents of Coxan Fosrex in 50ml of Sterile Water for Injection IP and shake until dissolved. If dissolution does not take place immediately, allow to stand for few minutes. Shake again. Use the solution as soon as possible after preparation.
Please refer accompanying package insert for detailed dosage, directions for use and precautions.
Dissolve the contents of Coxan Fosrex in 50ml of Sterile Water for Injection IP and shake until dissolved. If dissolution does not take place immediately, allow to stand for few minutes. Shake again. Use the solution as soon as possible after preparation.
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.
Important: it is essential to use Mesna in conjunction with Coxan Fosrex to prevent urotoxic side effects.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Discard Unused portion.
Keep out of the reach of the children.
WARNING: Cytotoxic Agent: To be sold by retail on the prescription of an Oncologist/ Cancer Hospital only.
Important: it is essential to use Mesna in conjunction with Coxan Fosrex to prevent urotoxic side effects.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Discard Unused portion.
Keep out of the reach of the children.
STORAGE & DOSAGE:
Storage: Store at 20°C to 25°C (68° to 77° F)
Dosage: As directed by an Oncologist.
Dosage: As directed by an Oncologist.
Ifosfamide for Injection IP 2000mg with Mesna Injection (Coxan Fosrex) Technical Specification:
| Product Name: | Ifosfamide for Injection IP 2000mg with Mesna Injection |
| Brand Name: | Coxan Fosrex |
| Strength: | 2000mg |
| Dosage Form: | Lyophilized Dry Powder for Injection |
| Packing: | Combipack |
| Route of Administration: | For I.V. infusion only. |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet) |
| Documents: | COA, MOA, Stability Studies, GMP |
| Therapeutic use: | Anti-Cancer |
| Indication: | Ifosfamide injection is indicated for use in combination with certain other approved antineoplastic agents for third-line chemotherapy germ cell testicular cancer. It should be used in combination with mesna for prophylaxis of hemorrhagic cystitis. |
| Storage: | Store at 20°C to 25°C (68° to 77° F) |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Ifosfamide for Injection IP 2000mg with Mesna Injection
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Ifosfamide for Injection IP 2000mg with Mesna Injection
Each combi pack contains:
One vial of Ifosfamide for Injection 2000mg
Each sterile lyophilized vial contains:
Ifosfamide USP……….…………………….2000mg
6×2 ml Ampoules of Mesna
Each ml contains
Mesna BP….…………………………………….100mg
Water for Injection IP………………………q.s.
THERAPEUTIC INDICATION:
Ifosfamide injection is indicated for use in combination with certain other approved antineoplastic agents for third-line chemotherapy germ cell testicular cancer. It should be used in combination with mesna for prophylaxis of hemorrhagic cystitis.
DIRECTION OF USE:
For Intravenous infusion only.
Dissolve the contents of Coxan Fosrex in 50ml of Sterile Water for Injection IP and shake until dissolved. If dissolution does not take place immediately, allow to stand for few minutes. Shake again. Use the solution as soon as possible after preparation.
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.
Important: it is essential to use Mesna in conjunction with Coxan Fosrex to prevent urotoxic side effects.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Discard Unused portion.
Keep out of the reach of the children.
STORAGE & DOSAGE:
Storage: Store at 20°C to 25°C (68° to 77° F)
Dosage: As directed by an Oncologist.
