Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK
CAMPTO 20 mg/ml concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
|
Concentrate for solution for infusion. |
The concentrate contains 20 mg/ml irinotecan hydrochloride, trihydrate (equivalent to 17.33 mg/ml irinotecan).
One vial of 2 ml contains 34.66 mg of irinotecan as 40 mg of irinotecan hydrochloride, trihydrate (40 mg/2 ml).
One vial of 5 ml contains 86.65 mg of irinotecan as 100 mg of irinotecan hydrochloride, trihydrate (100 mg/5 ml).
One vial of 15 ml contains 259.95 mg of irinotecan as 300 mg of irinotecan hydrochloride, trihydrate (300 mg/15 ml).
Excipient(s) with known effect: Sorbitol
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Irinotecan |
Irinotecan is a semi-synthetic derivative of camptothecin. It is an antineoplastic agent which acts as a specific inhibitor of DNA topoisomerase I. |
| List of Excipients |
|---|
|
Sorbitol E420 |
Single amber-coloured medical-grade polypropylene vial closed with halobutyl rubber stopper. Vials contain 40 mg/2 ml; 100 mg/5ml or 300 mg/15 ml of solution.
Not all pack sizes may be marketed.
Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK
PL 00057/0627
Date of first authorisation: 05 May 1995
Date of latest renewal: 26 August 2014
| Drug | Countries | |
|---|---|---|
| CAMPTO | Cyprus, Estonia, France, Hong Kong, Israel, Japan, Malta, Nigeria, Poland, Singapore, Tunisia, United Kingdom, South Africa |
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