CASPOFUNGIN ZENTIVA Powder for solution for infusion Ref.[49678] Active ingredients: Caspofungin

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: Zentiva Pharma UK Limited, 12 New Fetter Lane, London, EC4A 1JP, United Kingdom

Product name and form

Caspofungin Zentiva 50 mg powder for concentrate for solution for infusion.

Pharmaceutical Form

Powder for concentrate for solution for infusion.

White to off-white lyophilized powder.

Qualitative and quantitative composition

Each 50 mg vial contains 50 mg caspofungin (as acetate).

After reconstitution in 10.5 ml of water for injection, 1 ml of the concentrate contains 5.2 mg caspofungin.

For the full list of excipients, see section 6.1.

Active Ingredient 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 (for pH adjustment)

Pack sizes and marketing

10 ml transparent Type I glass vial with grey bromobutyl rubber stopper and aluminium band with red PP flip-off cap.

Supplied in packs of 1 vial.

Marketing authorization holder

Zentiva Pharma UK Limited, 12 New Fetter Lane, London, EC4A 1JP, United Kingdom

Marketing authorization dates and numbers

PL 17780/0769

11/01/2017 / 30/04/2021

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