CARBOPLATIN Solution for infusion

Active ingredients: Carboplatin

Product name and form

Carboplatin 10 mg/ml concentrate for solution for infusion.

Pharmaceutical Form

Concentrate for solution for infusion.

A clear, colourless to slightly pale yellow solution free from particles.

Qualitative and quantitative composition

1 ml of concentrate for solution for infusion contains 10mg of Carboplatin.

Each 5 ml vial contains 50 mg carboplatin.
Each 15 ml vial contains 150 mg carboplatin.
Each 45 ml vial contains 450 mg carboplatin.
Each 60 ml vial contains 600 mg carboplatin.

For a full list of excipients, see section 6.1.

Active Ingredient
Description

Carboplatin interferes with DNA intrastrand and interstrand crosslinks in cells exposed to the drug. DNA reactivity has been correlated with cytotoxicity.

List of Excipients

Water for injections

Pack sizes and marketing

Carboplatin infusion is supplied in 5 ml/15 ml/50 ml/100 ml type I amber glass vial containing 5 ml/15 ml/45 ml/60 ml concentrate for solution respectively. Vials are closed using grey chlorobutyl rubber stopper/Grey Westar prewashed rubber stopper with an aluminium flip off seal.

1 glass vial in one monocarton
5 ml vial, containing 50mg of carboplatin, 10mg/ml.
15 ml vial, containing 150 mg of carboplatin, 10mg/ml.
50 ml vial, containing 450 mg carboplatin, 10mg/ml.
100 ml vial, containing 600 mg carboplatin, 10mg/ml.

Not all pack sizes may be marketed.

Marketing authorization holder

Accord Healthcare Limited, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom

Marketing authorization dates and numbers

PL 20075/0028

09/12/2008