DECTOVA Solution for infusion Ref.[27672] Active ingredients: Zanamivir

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: GlaxoSmithKline UK Limited, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom

Product name and form

Dectova 10 mg/mL solution for infusion.

Pharmaceutical Form

Solution for infusion.

A clear, colourless solution for infusion.

Qualitative and quantitative composition

Each mL of solution contains 10 mg of zanamivir (as hydrate).

Each vial contains 200 mg of zanamivir (as hydrate) in 20 mL.

Excipients with known effect:

Each vial contains 3.08 mmol (70.8 mg) sodium.

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

Sodium chloride
Water for injections

Pack sizes and marketing

26 mL clear vial (type I glass) with a stopper (coated chlorobutyl rubber), an over-seal (aluminium) and a plastic flip-off cap.

Pack size: 1 vial.

Marketing authorization holder

GlaxoSmithKline UK Limited, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom

Marketing authorization dates and numbers

PLGB 19494/0292

Date of first authorisation: 01/01/2021

Drugs

Drug Countries
DECTOVA Austria, Estonia, Finland, France, Croatia, Ireland, Lithuania, Netherlands, Poland, United Kingdom

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