Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Astellas Pharma Europe B.V., Sylviusweg 62, 2333 BE Leiden, Netherlands
Mycamine 50 mg powder for solution for infusion.
Mycamine 100 mg powder for solution for infusion.
| Pharmaceutical Form |
|---|
|
Powder for solution for infusion. White compact powder. |
Mycamine 50 mg: Each vial contains 50 mg micafungin (as sodium).
After reconstitution each ml contains 10 mg micafungin (as sodium).
Mycamine 100 mg: Each vial contains 100 mg micafungin (as sodium).
After reconstitution each ml contains 20 mg micafungin (as sodium).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Micafungin |
Micafungin non-competitively inhibits the synthesis of 1,3-β-D-glucan, an essential component of the fungal cell wall. 1,3-β-D-glucan is not present in mammalian cells. Micafungin exhibits fungicidal activity against most Candida species and prominently inhibits actively growing hyphae of Aspergillus species. |
| List of Excipients |
|---|
|
Lactose monohydrate |
10 ml Type I glass vial with an isobutylene-isoprene (PTFE-laminated) rubber stopper and a flip-off cap. The vial is wrapped with an UV-protective film.
Pack size: packs of 1 vial.
Astellas Pharma Europe B.V., Sylviusweg 62, 2333 BE Leiden, Netherlands
EU/1/08/448/001
EU/1/08/448/002
Date of first authorisation: 25 April 2008
Date of latest renewal: 19 February 2018
| Drug | Countries | |
|---|---|---|
| MYCAMINE | Austria, Brazil, Canada, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, United States, South Africa |
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