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CUBICIN Powder for concentrate for solution for injection or infusion (2019)

Active ingredients: Daptomycin

Product Name and Form

Cubicin 350 mg powder for solution for injection or infusion.

Cubicin 500 mg powder for solution for injection or infusion.

Pharmaceutical form

Powder for solution for injection or infusion

A pale yellow to light brown lyophilised powder.

Qualitative and Quantitative Composition

Cubicin 350 mg powder for solution for infusion or injection: Each vial contains 350 mg daptomycin.

One ml provides 50 mg of daptomycin after reconstitution with 7 ml of sodium chloride 9 mg/ml (0.9%) solution.

Cubicin 500 mg powder for solution for infusion or injection: Each vial contains 500 mg daptomycin.

One ml provides 50 mg of daptomycin after reconstitution with 10 ml of sodium chloride 9 mg/ml (0.9%) solution.

For the full list of excipients, see section 6.1.

Chemical substance
Description
Daptomycin

Daptomycin is a cyclic lipopeptide natural product that is active against Gram positive bacteria only. The mechanism of action involves binding to bacterial membranes of both growing and stationary phase cells causing depolarisation and leading to a rapid inhibition of protein, DNA, and RNA synthesis.

List of excipients

Sodium hydroxide

Pack sizes and Marketing

Cubicin 350 mg powder for solution for injection or infusion: Single use 10 ml type I clear glass vials with type I rubber stoppers and aluminium closures with yellow plastic flip off caps.

Cubicin 500 mg powder for solution for injection or infusion Single use 10 ml type I clear glass vials with type I rubber stoppers and aluminium closures with blue plastic flip off caps.

Available in packs containing 1 vial or 5 vials. Not all pack sizes may be marketed.

Marketing authorization holder
Authorization dates

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

Date of first authorisation: 19 January 2006
Date of latest renewal: 29 November 2010

Marketing authorization number:

Cubicin 350 mg powder for solution for injection or infusion:

EU/1/05/328/001
EU/1/05/328/003

Cubicin 500 mg powder for solution for injection or infusion:

EU/1/05/328/002
EU/1/05/328/004