CAMPTO Concentrate for solution for infusion Ref.[8066] Active ingredients: Irinotecan

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK

Product name and form

CAMPTO 20 mg/ml concentrate for solution for infusion.

Pharmaceutical Form

Concentrate for solution for infusion.

Qualitative and quantitative composition

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
Lactic acid
Sodium hydroxide (to adjust to pH 3.5)
hydrochloride acid (for pH adjustment)
Water for injections

Pack sizes and marketing

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.

Marketing authorization holder

Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK

Marketing authorization dates and numbers

PL 00057/0627

Date of first authorisation: 05 May 1995

Date of latest renewal: 26 August 2014

Drugs

Drug Countries
CAMPTO Cyprus, Estonia, France, Hong Kong, Israel, Japan, Malta, Nigeria, Poland, Singapore, Tunisia, United Kingdom, South Africa

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