Source: European Medicines Agency (EU) Revision Year: 2025 Publisher: Insmed Netherlands B.V., Stadsplateau 7, 3521 AZ Utrecht, Netherlands
ARIKAYCE liposomal 590 mg nebuliser dispersion.
| Pharmaceutical Form |
|---|
|
Nebuliser dispersion. White, milky, aqueous, nebuliser dispersion. |
Each vial contains amikacin sulfate equivalent to 590 mg amikacin in a liposomal formulation. The mean delivered dose per vial is approximately 312 mg of amikacin.
For the full list of excipients, see section 6.1.
| Active Ingredient |
|---|
|
Amikacin is an antibiotic used for a number of bacterial infections. Amikacin works by blocking the function of the bacteria's 30S ribosomal subunit, making it unable to produce proteins. |
| List of Excipients |
|---|
|
Cholesterol |
Glass vial with bromobutyl rubber stopper and aluminium seal with plastic flip-off cap.
Pack-size of 28 vials. The carton also contains the Lamira Nebuliser Handset and 4 aerosol heads.
Insmed Netherlands B.V., Stadsplateau 7, 3521 AZ Utrecht, Netherlands
EU/1/20/1469/001
Date of first authorisation: 27 October 2020
| Drug | Countries | |
|---|---|---|
| ARIKAYCE | Austria, Estonia, Finland, Croatia, Ireland, Japan, Lithuania, Netherlands, Poland, United Kingdom, United States |
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