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Vinorelbine Injection 50mg/5ml USP Vinorelbine Injection USP 50mg/5ml Vinorelbine Injection USP 50mg/5ml Vinorelbine Injection USP 50mg/5ml Vinorelbine Injection USP 50mg/5ml Vinorelbine Injection USP 50mg/5ml Vinorelbine Injection USP 50mg/5ml Vinorelbine Injection USP 50mg/5ml Vinorelbine Injection USP 50mg/5ml
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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.

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

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.