Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Sandoz Ltd, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, UK
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. |
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 |
|---|
|
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 |
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).
Sandoz Ltd, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, UK
PL 04416/1597
Date of first authorisation: 12.07.2002
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