GEMCITABINE / HOSPIRA Concentrate for solution for infusion Ref.[7878] Active ingredients: Gemcitabine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Hospira UK Limited, Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, UK

Product name and form

Gemcitabine 38 mg/ml Concentrate for Solution for Infusion.

Pharmaceutical Form

Concentrate for solution for infusion.

A clear, colourless or light straw-coloured solution, practically free from visible particles.

pH: 2.0-3.0

Osmolarity: 266 mOsmol/L

Qualitative and quantitative composition

One ml of Gemcitabine Concentrate for Solution for Infusion contains gemcitabine hydrochloride, equivalent to 38 mg gemcitabine.

The quantitative composition of each presentation is provided in the table below:

PresentationStrengthQuantity of gemcitabine (as hydrochloride)Volume of Solution
200mg/5.3 ml38 mg/ml200 mg5.3 ml
1g/26.3 ml38 mg/ml1 g26.3 ml
2g/52.6 ml38 mg/ml2 g52.6 ml

Excipients with known effect: Each ml of concentrate contains up to 0.46mg sodium.

For a full list of excipients, see section 6.1.

Active Ingredient Description
Gemcitabine

Gemcitabine (dFdC), which is a pyrimidine antimetabolite, is metabolised intracellularly by nucleoside kinase to the active diphosphate (dFdCDP) and triphosphate (dFdCTP) nucleosides. The cytotoxic effect of gemcitabine is due to inhibition of DNA synthesis by two mechanisms of action by dFdCDP and dFdCTP.

List of Excipients

Water for injections
Hydrochloric acid (E507) (for pH adjustment)
Sodium hydroxide (E524) (for pH adjustment)

Pack sizes and marketing

200 mg/5.3 ml presentation:

A 10ml, Type I clear glass vial, stoppered with a chlorobutyl closure and sealed with an aluminium seal and flip-off top.

Each vial of the 200mg presentation contains 5.3ml concentrate. Each pack contains 1 vial.

1 g/26.3 ml presentation:

A 30ml, Type I clear glass vial, stoppered with a chlorobutyl closure and sealed with an aluminium seal and flip-off top.

Each vial of the 1g presentation contains 26.3ml concentrate. Each pack contains 1 vial.

2 g/52.6 ml presentation:

A 100ml, Type I clear glass vial, stoppered with a chlorobutyl closure and sealed with an aluminium seal and flip-off top.

Each vial of the 2g presentation contains 52.6ml concentrate. Each pack contains 1 vial.

Marketing authorization holder

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

Marketing authorization dates and numbers

PL 04515/0224

First Authorisation: 23rd December 2010

Date of latest renewal: 14th December 2015

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