GENERIC NAME OF THE MEDICINAL PRODUCT:

Vincristin Sulfate Injection USP 1mg/ml (1mg/1ml, 2mg/2ml)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

Vincristin Sulfate Injection USP 1mg/ml (1mg/1ml, 2mg/2ml)
Each ml contains
Vincristin Sulfate USP………………….1mg
Mannitol………………………………………….100mg
Water for Injection USP……………………q.s.
Sulfuric acid or Sodium Hydroxide has been added for PH adjustment Sealed under nitrogen. Solution contains no preservative.

THERAPEUTIC INDICATIONS:

Vincristin sulfate is used for the treatment of Leukaemias including acute lymphocytic leukaemia, chronic lymphocytic leukaemia, acute myelogenous leukaemia and blastic crisis of chronic myelogenous leukaemia.

PACKING:

1mg/ml
1) 1mg/1ml
2) 2mg/2ml

DIRECTION OF USE:

For I.V. use only. Fatal if given by other routes.
See package insert for complete prescribing information.

CAUTION AND WARNING:

CAUTION: This injection should not be used if it contains visible particulate matter.
CAUTION: DOSAGE MAY BE CRITICAL
Be certain of vial strength and dosage calculation before administering.
WARNING: Cytotoxic Agent - To be sold by retail on the prescription of an Oncologist/ Cancer Hospital/ Institution.
WARNING: THIS IS A POTENT DRUG.
Do not administer without reading directions in package insert for dosage and method of administration.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Discard any unused solution.
Keep out of reach of children

STORAGE AND DOSAGE:

Storage: Refrigerate between 2°C to 8°C (36° F to 46° F).
Protect from light.
Store upright.
Dosage: As directed by the Oncologist.

Vincristin Sulfate Injection USP 1mg/ml (2mg/2ml) (Vratucan) Technical Specification:   

Product Name:Vincristin Sulfate Injection USP (2mg/2ml)
Brand Name:Vratucan
Strength:1mg/ml (1mg/1ml, 2mg/2ml)
Dosage Form:Liquid Injection
Packing:SINGLE-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: Vincristine sulphate is used to treat Leukaemias including acute lymphocytic leukaemia, chronic lymphocytic leukaemia, acute myelogenous leukaemia and a blastic crisis of chronic myelogenous leukaemia.
Storage:Refrigerate between 2°C to 8°C (36° F to 46° F). Protect from light. Store upright.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Vincristin Sulfate Injection USP 1mg/ml ( 2mg/2ml)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Vincristin Sulfate Injection USP 1mg/ml (2mg/2ml)
    Each ml contains
    Vincristin Sulfate USP………………….1mg
    Mannitol………………………………………….100mg
    Water for Injection USP……………………q.s.
    Sulfuric acid or Sodium Hydroxide has been added for PH adjustment and Sealed under nitrogen. The solution contains no preservatives.

THERAPEUTIC INDICATION:

Vincristin sulfate is used for the treatment of Leukaemias including acute lymphocytic leukaemia, chronic lymphocytic leukaemia, acute myelogenous leukaemia and a blastic crisis of chronic myelogenous leukaemia.

PACKING:

 1mg/ml

  • 1mg/1ml
  • 2mg/2ml

DIRECTION OF USE:

For I.V. use only. Fatal if given by other routes.

See package insert for complete prescribing information.

CAUTION & WARNING:

CAUTION: This injection should not be used if it contains visible particulate matter.

CAUTION: DOSAGE MAY BE CRITICAL

Be sure of vial strength and dosage calculation before administering.

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

WARNING: THIS IS A POTENT DRUG.

Do not administer without reading directions in the package insert for dosage and method of administration.

FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.

Discard any unused solution.

Keep out of reach of children

STORAGE & DOSAGE:

Storage: Refrigerate between 2°C to 8°C (36° F to 46° F). Protect from light. Store upright.

Dosage: As directed by the Oncologist.