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Vinblastine Sulphate for Injection USP 10mg (Veluterin) Vinblastine Sulphate for Injection USP 10mg Vinblastine Sulphate for Injection USP 10mg

GENERIC NAME OF THE MEDICINAL PRODUCT:

Vinblastine Sulphate for Injection USP 10mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

Vinblastine Sulphate for Injection USP 10mg
Each vial contains:
Vinblastine Sulphate USP…….10mg
Excipients…………………………….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.

DIRECTION OF USE:

For Intravenous infusion only.
Add sterile water for injection USP. Shake to dissolve, if product does not dissolve immediately allow to stand at room temperature until solution is obtained.

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 vials at 20°C to 25°C (68° to 77° F); excursions permitted between 15°C to 30°C (59° to 86° F) [See USP Controlled Room Temperature]. Protected from light. Avoid excessive heat, over 40°C [104° F].
Dosage: As directed by an Oncologist.

Vinblastine Sulphate for Injection USP 10mg (Veluterin) Technical Specification:

Product Name:Vinblastine Sulphate for Injection USP 10mg
Brand Name:Veluterin
Strength:10mg
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: 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 for Injection USP 10mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Vinblastine Sulphate for Injection USP 10mg
    Each vial contains:
    Vinblastine Sulphate USP…….10mg
    Excipients…………………………….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.

DIRECTION OF USE:

For Intravenous infusion only.

Add sterile water for injection USP. Shake to dissolve, if product does not dissolve immediately allow to stand at room temperature until solution is obtained.

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 vials at 20°C to 25°C (68° to 77° F); excursions permitted between 15°C to 30°C (59° to 86° F) [See USP Controlled Room Temperature]. Protected from light. Avoid excessive heat, over 40°C [104° F].

Dosage: As directed by an Oncologist.