VINBLASTINE SULFATE Solution for injection Ref.[8715] Active ingredients: Vinblastine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Hospira UK Limited, Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, UK

Product name and form

Vinblastine Sulfate 1 mg/ml solution for injection.

Pharmaceutical Form

Solution for injection.

A clear, colourless sterile solution.

Qualitative and quantitative composition

Each 1 ml contains 1.0 mg of vinblastine sulfate.

Each 10 ml presentation contains 10 mg of vinblastine sulfate.

Excipient with known effect: Each 10 ml vial contains approximately 35 mg (1.5 mmol) sodium.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Vinblastine

Vinblastine appears to bind to or crystallise critical microtubular proteins of the mitotic spindle, thus preventing their proper polymerisation and causing metaphase arrest. In high concentrations, vinblastine also exerts complex effects on nucleic acid and protein synthesis.

List of Excipients

Sodium chloride
Water for injections

Pack sizes and marketing

10 ml, Type I clear conventional glass vial, West Type 1888 rubber closure, aluminium spun cap ring, in packs of 5 vials.

10 ml, Type I clear Onco-Tain vials, West Type 1888 rubber closure, aluminium spun cap ring, in packs of 5 vials.

Not all above presentations and pack sizes may be marketed.

Marketing authorization holder

Hospira UK Limited, Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, UK

Marketing authorization dates and numbers

PL 04515/0051

25th September 2003

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