SUPREFACT Nasal spray

Active ingredients: Buserelin

Product name and form

Suprefact Nasal Spray.

Pharmaceutical Form

Nasal spray.

Qualitative and quantitative composition

Suprefact nasal spray contains 100 micrograms buserelin as buserelin acetate in 1 spray dose of aqueous solution containing benzalkonium chloride as preservative.

100 micrograms buserelin is equivalent to 105 micrograms buserelin acetate.

Active Ingredient
Description

Buserelin is a synthetic peptide. It is a superactive analogue of natural gonadotrophin releasing hormone (gonadorelin, LHRH or GNRH). After an initial stimulation of gonadotrophin release, it down-regulates the hypothalanic-pituitary-gonadal axis.

List of Excipients

Sodium chloride
Citric acid monohydrate
Sodium citrate dihydrate
Benzalkonium chloride
Water for injections

Pack sizes and marketing

Box of 4 bottles each containing 10g solution and 4 spray pumps.

Marketing authorization holder

Aventis Pharma Limited, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK

Trading as: Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK

Marketing authorization dates and numbers

PL 04425/0279

16 June 2006

Drugs

Drug
Countries
Austria, Brazil, Canada, Spain, Netherlands, Singapore, United Kingdom