Vincristine Sulphate for Injection USP 1mg (Vratucan) Technical Specification:
| Product Name: | Vincristine Sulphate for Injection USP 1mg |
| Brand Name: | Vratucan |
| Strength: | 1mg |
| Dosage Form: | Lyophilized Dry Powder for Injection |
| Packing: | SINGLE USE 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: | Vincristine sulphate is used for the treatment of Leukaemias including acute lymphocytic leukaemia, chronic lymphocytic leukaemia, acute myelogenous leukaemia and blastic crisis of chronic myelogenous leukaemia. |
| Storage: | Store the vials in the original carton between 2°C to 8°C (36° F to 46° F). Protect from light. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Vincristine Sulphate for Injection USP 1mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Vincristine Sulphate for Injection USP 1mg
Each sterile lyophilized vial contains:
Vincristine Sulphate USP…….……1mg
Mannitol USP ………………………….100mg
Sodium Hydroxide USNF…………. q.s.
Sulfuric Acid USNF…………………… q.s.
THERAPEUTIC INDICATION:
Vincristine sulphate is used for the treatment of Leukaemias including acute lymphocytic leukaemia, chronic lymphocytic leukaemia, acute myelogenous leukaemia and blastic crisis of chronic myelogenous leukaemia.
DIRECTION OF USE:
For Intravenous infusion only.
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. Fatal if given Intrathecally, for Intravenous use only.
WARNING: Cytotoxic Agent: To be sold by retail on the prescription of an Oncologist/ Cancer Hospital only.
Cytotoxic special handling procedures see insert
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Discard Unused portion.
Keep out of the reach of the children.
STORAGE & DOSAGE:
Storage: Store the vials in the original carton between 2°C to 8°C (36° F to 46° F). Protect from light.
Dosage: As directed by an Oncologist.
GENERIC NAME OF THE MEDICINAL PRODUCT:
Vincristine Sulphate for Injection USP 1mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Vincristine Sulphate for Injection USP 1mg
Each sterile lyophilized vial contains:
Vincristine Sulphate USP…….……1mg
Mannitol USP ………………………….100mg
Sodium Hydroxide USNF…………. q.s.
Sulfuric Acid USNF…………………… q.s.
Each sterile lyophilized vial contains:
Vincristine Sulphate USP…….……1mg
Mannitol USP ………………………….100mg
Sodium Hydroxide USNF…………. q.s.
Sulfuric Acid USNF…………………… q.s.
THERAPEUTIC INDICATION:
Vincristine sulphate is used for the treatment of Leukaemias including acute lymphocytic leukaemia, chronic lymphocytic leukaemia, acute myelogenous leukaemia and blastic crisis of chronic myelogenous leukaemia.
DIRECTION OF USE:
For Intravenous infusion only.
Please refer accompanying package insert for detailed dosage, directions for use and precautions.
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. Fatal if given Intrathecally, for Intravenous use only.
WARNING: Cytotoxic Agent: To be sold by retail on the prescription of an Oncologist/ Cancer Hospital only.
Cytotoxic special handling procedures see insert
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.
Cytotoxic special handling procedures see insert
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Discard Unused portion.
Keep out of the reach of the children.
STORAGE & DOSAGE:
Storage: Store the vials in the original carton between 2°C to 8°C (36° F to 46° F). Protect from light.
Dosage: As directed by an Oncologist.
Dosage: As directed by an Oncologist.
