Ifosfamide for Injection 3gm (Coxan) Technical Specification:

Product Name:Ifosfamide for Injection 3gm
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 3gm

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Ifosfamide for Injection 3gm
    Each vial contains:
    Ifosfamide…………………………………….3000mg
    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 3gm: Add 60ml 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:

a) Ifosfamide for Injection 1gm
b) Ifosfamide for Injection 3gm

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) Ifosfamide for Injection 1gm
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:

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 3gm: Add 60ml 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.