Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Hospira UK Limited, Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, UK
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 |
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:
| Presentation | Strength | Quantity of gemcitabine (as hydrochloride) | Volume of Solution |
|---|---|---|---|
| 200mg/5.3 ml | 38 mg/ml | 200 mg | 5.3 ml |
| 1g/26.3 ml | 38 mg/ml | 1 g | 26.3 ml |
| 2g/52.6 ml | 38 mg/ml | 2 g | 52.6 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 |
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.
Hospira UK Limited, Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, UK
PL 04515/0224
First Authorisation: 23rd December 2010
Date of latest renewal: 14th December 2015
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