RELENZA Inhalation powder, pre-dispensed Ref.[8276] Active ingredients: Zanamivir

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Glaxo Wellcome UK Ltd trading as GlaxoSmithKline UK, 980 Great West Road, Brentford, Middlesex, TW8 9GS

Product name and form

Relenza 5mg/dose, inhalation powder, pre-dispensed.

Pharmaceutical Form

Inhalation powder, pre-dispensed.

White to off-white powder.

Qualitative and quantitative composition

Each pre-dispensed quantity of inhalation powder (one blister) contains 5 mg zanamivir. Each delivered inhalation (the amount that leaves the mouthpiece of the Diskhaler) contains 4.0 mg zanamivir.

Excipients with known effect: Lactose monohydrate (approximately 20 mg which contains milk protein).

For the full list of excipients, see section 6.1.

Active Ingredient Description
Zanamivir

Zanamivir is a selective inhibitor of neuraminidase, the influenza virus surface enzyme. Neuraminidase inhibition occurred in vitro at very low zanamivir concentrations (50% inhibition at 0.64nM–7.9nM against influenza A and B strains).

List of Excipients

Lactose monohydrate (which contains milk protein)

Pack sizes and marketing

Relenza inhalation powder is packed in a circular aluminium foil disk (a Rotadisk) with four regularly distributed blisters. An inspiration driven inhaler made of plastic (a Diskhaler) is used for administration of doses (the contents of 2 blisters constitute a dose) from these foil disks, and is provided in the pack.

The pack contains 1 or 5 foil disks and a Diskhaler.

Marketing authorization holder

Glaxo Wellcome UK Ltd trading as GlaxoSmithKline UK, 980 Great West Road, Brentford, Middlesex, TW8 9GS

Marketing authorization dates and numbers

PL 10949/0327

Date of first authorisation: 24 June 1999
Date of last renewal: 02 October 2008

Drugs

Drug Countries
RELENZA Austria, Brazil, Canada, Ecuador, Estonia, Spain, Finland, Hong Kong, Ireland, Japan, Lithuania, Malta, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, United States, South Africa

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