Vinorelbine Injection USP 50mg/5ml Technical Specification:
Product Name: | Vinorelbine Injection USP 50mg/5ml |
Brand Name: | Vinorelbine |
Strength: | 10mg/ml, 50mg/5ml |
Dosage Form: | Liquid Injection |
Packing: | SINGLE-USE VIAL |
Route of Administration: | For I.V. use only – Must be diluted before |
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: | Vinorelbine is used alone and in combination with other medications to treat non-small cell lung cancer (NSCLC) that has spread to nearby tissues or to other parts of the body. |
Storage: | Store the vials in the original cartons between 2°C to 8°C (36° F to 46° F) |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Vinorelbine Injection USP 50mg/5ml
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Vinorelbine Injection USP 50mg/5ml
Each ml contains
Vinorelbine tartrate USP
Equivalent to Vinorelbine………….10mg
Water for Injection USP………………q.s.
THERAPEUTIC INDICATION:
Vinorelbine is used alone and in combination with other medications to treat non-small cell lung cancer (NSCLC) that has spread to nearby tissues or to other parts of the body.
PACKING:
10mg/ml
- 10mg/1ml
- 50mg/5ml
DIRECTION OF USE:
For I.V. use only – Must be diluted before
Must be diluted before use.
See package insert for complete prescribing information.
CAUTION & WARNING:
CAUTION: This injection should not be used if it contains visible particulate matter.
WARNING: Cytotoxic Agent – To be sold by retail on the prescription of an Oncologist/ Cancer Hospital/ Institution.
The vial stopper is not made with natural rubber latex.
Sterile, Nonpyrogenic, Preservative free.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Discard any unused solution.
Keep out of reach of children
STORAGE & DOSAGE:
Storage: Store the vials in the original cartons between 2°C to 8°C (36° F to 46° F)
Dosage: As directed by the Oncologist.
GENERIC NAME OF THE MEDICINAL PRODUCT:
A. Vinorelbine Injection USP 10mg/ml (10mg/1ml, 50mg/5ml)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
a. Vinorelbine Injection USP 10mg/ml (10mg/1ml, 50mg/5ml)
Each ml contains
Vinorelbine tartrate USP
Equivalent to Vinorelbine………….10mg
Water for Injection USP………………q.s.
Each ml contains
Vinorelbine tartrate USP
Equivalent to Vinorelbine………….10mg
Water for Injection USP………………q.s.
THERAPEUTIC INDICATION:
Vinorelbine is used alone and in combination with other medications to treat non-small cell lung cancer (NSCLC) that has spread to nearby tissues or to other parts of the body.
PACKING:
10mg/ml
1) 10mg/1ml
2) 50mg/5ml
1) 10mg/1ml
2) 50mg/5ml
DIRECTION OF USE:
For I.V. use only – Must be diluted before
Must be diluted before use.
See package insert for complete prescribing information.
Must be diluted before use.
See package insert for complete prescribing information.
CAUTION & WARNING:
CAUTION: This injection should not be used if it contains visible particulate matter.
WARNING: Cytotoxic Agent - To be sold by retail on the prescription of an Oncologist/ Cancer Hospital/ Institution.
The vial stopper is not made with natural rubber latex.
Sterile, Nonpyrogenic, Preservative free.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Discard any unused solution.
Keep out of reach of children
WARNING: Cytotoxic Agent - To be sold by retail on the prescription of an Oncologist/ Cancer Hospital/ Institution.
The vial stopper is not made with natural rubber latex.
Sterile, Nonpyrogenic, Preservative free.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Discard any unused solution.
Keep out of reach of children
STORAGE & DOSAGE:
Storage: Store the vials in the original cartons between 2°C to 8°C (36° F to 46° F)
Dosage: As directed by the Oncologist.
Dosage: As directed by the Oncologist.