ALEXAN Solution for injection Ref.[51134] Active ingredients: Cytarabine

Source: Medicines Authority (MT)  Revision Year: 2015  Publisher: 1 A Pharma GmbH, Keltenring 1+3, 82041 Oberhaching, Germany

Product name and form

Alexan, Solution for injection 50 mg/ml.

Pharmaceutical Form

Solution for injection.

The solution is a clear and colourless solution.

Qualitative and quantitative composition

1 ml contains 50.0 mg Cytarabine.

For a 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 lactate
Lactic acid
Water for injections

Pack sizes and marketing

500mg/10ml (box of 1 vial)
1000mg/20ml (box of 1 vial)
2000mg/40ml (box of 1 vial)

Not all pack sizes may be marketed.

Marketing authorization holder

1 A Pharma GmbH, Keltenring 1+3, 82041 Oberhaching, Germany

Marketing authorization dates and numbers

MA939/04101

14th May 2012

Drugs

Drug Countries
ALEXAN Austria, Hong Kong, Israel, Malta, Poland, Tunisia, Turkey, South Africa

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