CISPLATIN Concentrate for solution for infusion

Active ingredients: Cis-Diaminedichloroplatinum

Product name and form

Cisplatin 1mg/ml Injection BP.

Cisplatin 1 mg/ml Concentrate for solution for infusion.

Pharmaceutical Form

Concentrate for solution for infusion.

The concentrate is a clear and colourless to yellowish solution.

Qualitative and quantitative composition

1 ml contains 1 mg cisplatin.

1 vial of 10 ml concentrate for solution for infusion contains 10 mg cisplatin.
1 vial of 20 ml concentrate for solution for infusion contains 20 mg cisplatin.
1 vial of 50 ml concentrate for solution for infusion contains 50 mg cisplatin.
1 vial of 100 ml concentrate for solution for infusion contains 100 mg cisplatin.

Excipient(s) with known effect:

Each ml concentrate for solution contains 3,54 mg sodium.

1 vial of 10 ml concentrate for solution for infusion contains 35 mg sodium.
1 vial of 20 ml concentrate for solution for infusion contains 71 mg sodium.
1 vial of 50 ml concentrate for solution for infusion contains 177 mg sodium.
1 vial of 100 ml concentrate for solution for infusion contains 354 mg sodium.

For the full list of excipients, see section 6.1.

Active Ingredient
Description

Cisplatin is an anorganic substance containing a heavy metal [cis-diamminedichloroplatinum(II)]. This substance inhibits the DNA synthesis by realising transverse connections within and between the DNA strings. The protein and RNA synthesis is inhibited to a lesser extent.

List of Excipients

Sodium chloride
Hydrochloric acid, dilute
Water for injections

Pack sizes and marketing

Amber type I glass vial with chlorobutyl rubber stopper with aluminium overseal.

Packs of 1, 5 or 10 vial(s) containing 10ml, 20 ml, 50 ml or 100 ml concentrate for solution for infusion each.

Not all pack sizes may be marketed.

The vials are packed with or without a protective plastic overwrap (OncoSafe).

Marketing authorization holder

Sandoz Ltd, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, UK

Marketing authorization dates and numbers

PL 04416/1597

Date of first authorisation: 12.07.2002