Firmagon 80mg Injection (2012)
Active ingredients: Degarelix
Product Name and Form
FIRMAGON 80 mg powder and solvent for solution for injection.
Powder and solvent for solution for injection (Powder for injection and solvent).
Powder: White to off-white powder
Solvent: Clear, colourless solution
Qualitative and Quantitative Composition
Each vial contains 80 mg degarelix (as acetate). After reconstitution, each ml of solution contains 20 mg of degarelix.
For a full list of excipients, see section 6.1.
Degarelix is a selective gonadotrophin releasing-hormone (GnRH) antagonist that competitively and reversibly binds to the pituitary GnRH receptors, thereby rapidly reducing the release of the gonadotrophins, luteinizing hormone (LH) and follicle stimulating hormone (FSH), and thereby reducing the secretion of testosterone (T) by the testes.
Water for injections
Pack sizes and Marketing
Vials of glass Type I with bromobutyl rubber stopper and aluminium flip-off seal.
1 vial containing 80 mg powder for solution for injection
1 vial containing 6 ml solvent
1 syringe (5 ml with dual-line marking 4.0 and 4.2 ml)
2 vial adapters
1 injection needle (25G 0.5 × 25 mm)
1 pack containing 1 powder vial, 1 solvent vial, 1 syringe, 2 vial adapters and 1 needle.
3 pack containing 3x (1 powder vial, 1 solvent vial, 1 syringe, 2 vial adapters and 1 needle).
Not all pack sizes may be marketed.
Ferring Pharmaceuticals A/S
Kay Fiskers Plads 11
DK-2300 Copenhagen S
Tel: +45 88 33 88 34