FLIXONASE Nasal drops Ref.[27691] Active ingredients: Fluticasone

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

Product name and form

Flixonase Nasule Drops 400 micrograms (1 mg/ml), nasal drops suspension.

Pharmaceutical Form

Nasal drops.

Single dose aqueous suspension.

Qualitative and quantitative composition

Each single dose of Flixonase Nasule Drops contain:

Fluticasone propionate 400 micrograms (1 mg/ml).

For the full list of excipients, see section 6.1.

Active Ingredient Description
Fluticasone

Fluticasone has anti-inflammatory and vasoconstrictive features. Fluticasone given by inhalation at recommended doses has a potent glucocorticoid anti-inflammatory action within the lungs, resulting in a reduction of both symptoms and exacerbations of asthma, with a lower incidence and severity of adverse effects than those observed when corticosteroids are administered systemically.

List of Excipients

Polysorbate 20
Sorbitan laurate
Sodium dihydrogen phosphate dihydrate
Disodium phosphate anhydrous
Sodium chloride
Water for injections

Pack sizes and marketing

Strips of polyethylene single dose (400 micrograms) containers, within foil wrapping are available in the following pack sizes:

28 containers (4 strips of 7 Nasules)

84 containers (12 strips of 7 Nasules)

Not all pack sizes may be marketed.

Marketing authorization holder

Glaxo Wellcome UK Limited, trading as Allen & Hanburys, 980 Great West Road, Brentford, Middlesex, TW8 9GS

Marketing authorization dates and numbers

PL 10949/0323

27 January 1999 / 04 December 2008

Drugs

Drug Countries
FLIXONASE Austria, Brazil, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Lithuania, Malta, Mexico, Nigeria, Netherlands, New Zealand, Poland, Singapore, Tunisia, Turkey, United Kingdom, South Africa

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