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CANCIDAS Powder for solution for infusion (2018)

Active ingredients: Caspofungin

Product Name and Form

CANCIDAS 50 mg powder for concentrate for solution for infusion.

CANCIDAS 70 mg powder for concentrate for solution for infusion.

Pharmaceutical form

Powder for concentrate for solution for infusion.

Before reconstitution, the powder is a white to off-white-compact, powder.

Qualitative and Quantitative Composition

CANCIDAS 50 mg powder for concentrate for solution for infusion: Each vial contains 50 mg caspofungin (as acetate).

Excipients with known effect: Each 50 mg vial contains 35.7 mg of sucrose.

CANCIDAS 70 mg powder for concentrate for solution for infusion: Each vial contains 70 mg caspofungin (as acetate).

Excipients with known effect: Each 70 mg vial contains 50.0 mg of sucrose.

For the full list of excipients, see section 6.1.

Chemical substance
Description
Caspofungin

Caspofungin acetate is a semi-synthetic lipopeptide (echinocandin) compound synthesised from a fermentation product of Glarea lozoyensis. Caspofungin acetate inhibits the synthesis of beta (1,3)-D-glucan, an essential component of the cell wall of many filamentous fungi and yeast. Beta (1,3)-D-glucan is not present in mammalian cells.

List of excipients

Sucrose
Mannitol
Glacial acetic acid
Sodium hydroxide (to adjust the pH)

Pack sizes and Marketing

CANCIDAS 50 mg powder for concentrate for solution for infusion: 10 ml Type I glass vial with a grey butyl stopper and a plastic cap with a red aluminium band.

CANCIDAS 70 mg powder for concentrate for solution for infusion: 10 ml Type I glass vial with a grey butyl stopper and a plastic cap with an orange aluminium band.

Supplied in packs of 1 vial.

Marketing authorization holder
Authorization dates

Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands

Date of first authorisation: 24 October 2001

Date of latest renewal: 07 September 2011

Marketing authorization number:

EU/1/01/196/001

EU/1/01/196/003