CYTARABINE Solution for injection Ref.[7212] Active ingredients: Cytarabine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: Hospira UK Ltd, Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, United Kingdom

Product name and form

Cytarabine 20 mg/ml Injection.

Pharmaceutical Form

Solution for injection.

Clear, colourless solution.

Qualitative and quantitative composition

Each 1 ml contains 20 mg of cytarabine.

Presentations100 mg/5 ml500 mg/25 ml1 g/50 ml
Amount cytarabine present100 mg500 mg1 g

Excipient with known effect:

Cytarabine 100 mg/5 ml (20 mg/ml) Injection contains 13.25 mg of sodium in each vial.

Cytarabine 500 mg/25 ml (20 mg/ml) Injection contains 66.75 mg of sodium in each vial.

Cytarabine 1 g/50 ml (20 mg/ml) Injection contains 133.5 mg of sodium in each vial.

For the full list of excipients see 6.1.

Active Ingredient Description
Cytarabine

Cytarabine (ARA-C) is metabolised in vivo to ARA-CTP phosphorylated compound. This competitively inhibits DNA polymerase and may also inhibit certain acid kinase enzymes.

List of Excipients

Sodium chloride
Water for injections
Hydrochloric acid (for pH adjustment)
Sodium hydroxide (for pH adjustment)

Pack sizes and marketing

Clear Type I glass vials, rubber stopper.

Clear Type I Onco-Tain Vials, rubber stopper.

Pack sizes 5’s, 25’s and 50’s.

Not all presentations and pack sizes may be marketed.

Marketing authorization holder

Hospira UK Ltd, Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, United Kingdom

Marketing authorization dates and numbers

PL 04515/0040

Date of first authorisation: 7th July 1992
Date of last renewal: 10th October 2006

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