Vinblastine Sulphate Injection 1mg/ml (10mg/10ml) (Veluterin) Technical Specification:    

Product Name:Vinblastine Sulphate Injection
Brand Name:Veluterin
Strength:1mg/ml (10mg/10ml)
Dosage Form:Liquid Injection
Packing:MULTIPLE USE VIAL
Route of Administration:For I.V. use 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: Vinblastine Sulphate to treat a number of types of cancer. This includes Hodgkin’s lymphoma, non-small cell lung cancer, bladder cancer, brain cancer, melanoma, and testicular cancer.
Storage:Store between 2°C to 8°C (36° F to 46° F) in a refrigerator. Do not freeze. Protect from light.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Vinblastine Sulphate Injection 1mg/ml (10mg/10ml)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Vinblastine Sulphate Injection 1mg/ml (10mg/10ml)
    Each ml contains
    Vinblastine Sulphate USP………..1mg
    Sodium Chloride USP………………9mg
    Benzyl Alcohol USP………………….0.9% v/v
    Water for Injection USP………….q.s.

THERAPEUTIC INDICATION:

Vinblastine Sulphate to treat a number of types of cancer. This includes Hodgkin’s lymphoma, non-small cell lung cancer, bladder cancer, brain cancer, melanoma, and testicular cancer.

PACKING:

1mg/ml (10mg/10ml)

DIRECTION OF USE:

For I.V. use only

See package insert for complete prescribing information.

CAUTION & WARNING:

CAUTION: This injection should not be used if it contains visible particulate. Fatal if given Intrathecally for Intravenous use only.

CAUTION: Cytotoxic agent – Special Handling.

CAUTION: This is a potent Cytotoxic agent. Use only after reading the directions on the pack insert.

WARNING: Cytotoxic Agent – To be sold by retail on the prescription of an Oncologist/ Cancer Hospital/ Institution.

FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.

Discard any unused solution.

Contains no antibacterial preservatives.

Keep out of reach of children.

STORAGE & DOSAGE:

Storage: Store between 2°C to 8°C (36° F to 46° F) in a refrigerator. Do not freeze. Protect from light.

Dosage: As directed by the Oncologist.

GENERIC NAME OF THE MEDICINAL PRODUCT:

Vinblastine Sulphate Injection 1mg/ml (10mg/10ml)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

Vinblastine Sulphate Injection 1mg/ml (10mg/10ml)
Each ml contains
Vinblastine Sulphate USP………..1mg
Sodium Chloride USP………………9mg
Benzyl Alcohol USP………………….0.9% v/v
Water for Injection USP………….q.s.

THERAPEUTIC INDICATIONS:

Vinblastine Sulphate to treat a number of types of cancer. This includes Hodgkin's lymphoma, non-small cell lung cancer, bladder cancer, brain cancer, melanoma, and testicular cancer.

PACKING:

1mg/ml (10mg/10ml)

DIRECTION OF USE:

For I.V. use only
See package insert for complete prescribing information.

CAUTION AND WARNING:

CAUTION: This injection should not be used if it contains visible particulate. Fatal if given Intrathecally for Intravenous use only.
CAUTION: Cytotoxic agent – Special Handling.
CAUTION: This is a potent Cytotoxic agent. Use only after reading the directions on the pack insert.
WARNING: Cytotoxic Agent - To be sold by retail on the prescription of an Oncologist/ Cancer Hospital/ Institution.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Discard any unused solution.
Contains no antibacterial preservatives.
Keep out of reach of children.

STORAGE AND DOSAGE:

Storage: Store between 2°C to 8°C (36° F to 46° F) in a refrigerator.
Do not freeze.
Protect from light.
Dosage: As directed by the Oncologist.