Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands
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. |
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.
| Active Ingredient | 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 |
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.
Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands
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
Date of first authorisation: 19 January 2006
Date of latest renewal: 29 November 2010
| Drug | Countries | |
|---|---|---|
| CUBICIN | Austria, Brazil, Canada, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, United Kingdom, United States, South Africa |
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