GENEMIST Nasal spray, suspension Ref.[115274] Active ingredients: Fluticasone furoate

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2021  Publisher: GlaxoSmithKline South Africa (Pty) Ltd, 39 Hawkins Avenue, Epping Industria 1, 7460

Product name and form

GENEMIST 27,5 μg/spray, nasal spray suspension.

Pharmaceutical Form

Nasal spray, suspension.

A white uniform suspension.

Qualitative and quantitative composition

Each 50 μl spray contains 27,5 μg of fluticasone furoate.

Preservatives: benzalkonium chloride 0,015% m/m and disodium edetate 0,015% m/m.

Excipient with known effect:

Benzalkonium chloride.

For the full list of excipients, see section 6.1.

Active Ingredient

Fluticasone furoate is a synthetic trifluorinated corticosteroid that possesses a very high affinity for the glucocorticoid receptor and has a potent anti-inflammatory action.
List of Excipients

Glucose anhydrous
Dispersible cellulose
Polysorbate 80
Purified water
Benzalkonium chloride
Disodium edetate

Pack sizes and marketing

The nasal spray container consists of an inner container within an outer device. The inner container consists of a Type I or Type III amber glass bottle, closed with a metering spray pump. The outer device is a predominantly off-white side-actuated plastic delivery system with a light blue lever and lid containing a stopper. The outer plastic cover has a window for viewing the bottle contents.

GENEMIST is available in three pack sizes:

  • 30 sprays with a target net content of 4,5 g
  • 60 sprays with a target net content of 6,5 g
  • 120 sprays with a target net content of 10 g.

Not all pack sizes may be marketed.

Marketing authorization holder

GlaxoSmithKline South Africa (Pty) Ltd, 39 Hawkins Avenue, Epping Industria 1, 7460

Marketing authorization dates and numbers

41/21.5.1/0967

12 June 2009

Drugs

Drug Countries
GENEMIST South Africa
 
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