NASACORT Nasal Spray suspension Ref.[6451] Active ingredients: Triamcinolone

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Aventis Pharma Limited, One Onslow Street, Guildford, Surrey, GU1 4YS, UK or trading as: sanofi-aventis or Sanofi, One Onslow Street, Guildford, Surrey, GU1 4YS, UK

Product name and form

Nasacort Allergy 55 micrograms/dose Nasal Spray suspension.

Pharmaceutical Form

Nasal Spray suspension.

It is an unscented, thixotropic suspension of microcrystalline triamcinolone acetonide in an aqueous medium.

Qualitative and quantitative composition

The active component of Nasacort Allergy or Triamcinolone Nasal Spray is triamcinolone acetonide. Each bottle of Nasacort Allergy or Triamcinolone Nasal Spray contains 3.575 mg triamcinolone acetonide and provides at least 30 actuations each containing 55 micrograms of active compound after initial priming (see section 4.2).

For a full list of excipients, see section 6.1.

Active Ingredient Description
Triamcinolone

Triamcinolone acetonide is a more potent derivative of triamcinolone and is approximately 8 times more potent than prednisone. Although the precise mechanism of corticosteroid anti-allergic action is unknown, corticosteroids are very effective in the treatment of allergic diseases in man. Also, local injections are thought to have an anti-inflammatory effect.

List of Excipients

Microcrystalline cellulose
Carmellose sodium (Avicel CL-611)
Polysorbate 80
Purified water
Anhydrous glucose
Benzalkonium chloride
Edetate sodium
Hydrochloric acid or sodium hydroxide (for pH adjustment)

Pack sizes and marketing

Nasacort Allergy or Triamcinolone Nasal Spray is contained in a 20 ml high density polyethylene (HDPE) bottle fitted with a metered-dose spray pump unit. Each bottle of Nasacort Allergy or Triamcinolone Nasal Spray contains 6.5 g of suspension and provides at least 30 actuations.

Marketing authorization holder

Aventis Pharma Limited, One Onslow Street, Guildford, Surrey, GU1 4YS, UK

or trading as: sanofi-aventis or Sanofi, One Onslow Street, Guildford, Surrey, GU1 4YS, UK

Marketing authorization dates and numbers

PL 04425/0605

17 October 1997

Drugs

Drug Countries
NASACORT Brazil, Canada, Germany, Estonia, Spain, Finland, France, Ireland, Malta, Mexico, Netherlands, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, South Africa

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