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CISPLATIN Concentrate for solution for infusion (2019)

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.

Chemical substance
Description
Cis-Diaminedichloroplatinum

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
Authorization dates

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

Date of first authorisation: 12.07.2002

Marketing authorization number:

PL 04416/1597