ARIKAYCE Nebuliser dispersion Ref.[115484] Active ingredients: Amikacin

Source: European Medicines Agency (EU)  Revision Year: 2025  Publisher: Insmed Netherlands B.V., Stadsplateau 7, 3521 AZ Utrecht, Netherlands

Product name and form

ARIKAYCE liposomal 590 mg nebuliser dispersion.

Pharmaceutical Form

Nebuliser dispersion.

White, milky, aqueous, nebuliser dispersion.

Qualitative and quantitative composition

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
Dipalmitoylphosphatidylcholine (DPPC)
Sodium chloride
Sodium hydroxide (for pH adjustment)
Water for injections

Pack sizes and marketing

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.

Marketing authorization holder

Insmed Netherlands B.V., Stadsplateau 7, 3521 AZ Utrecht, Netherlands

Marketing authorization dates and numbers

EU/1/20/1469/001

Date of first authorisation: 27 October 2020

Drugs

Drug Countries
ARIKAYCE Austria, Estonia, Finland, Croatia, Ireland, Japan, Lithuania, Netherlands, Poland, United Kingdom, United States

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