País: Australia
Idioma: inglés
Fuente: Department of Health (Therapeutic Goods Administration)
Degarelix; Water for injections
Ferring Pharmaceuticals Pty Ltd
Medicine Registered
FIRMAGON ® _Degarelix (as acetate)_ POWDER AND SOLVENT FOR INJECTION, DEPOT CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Firmagon. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking/being given Firmagon against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT FIRMAGON IS USED FOR Firmagon contains degarelix. Degarelix is a synthetic hormone that reduces the level of the male hormone, testosterone. Firmagon is used to treat: • prostate cancer Firmagon may slow or stop the growth of cancer. Firmagon should only be taken by men. It should not be taken by women or children. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY FIRMAGON HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed Firmagon for another reason. Firmagon is not addictive. This medicine is available only with a doctor's prescription. BEFORE YOU ARE GIVEN FIRMAGON _WHEN YOU MUST NOT BE GIVEN_ _IT_ FIRMAGON WILL NOT BE GIVEN IF YOU HAVE AN ALLERGY TO: • degarelix, the active ingredient in Firmagon or any similar drugs, known as GnRH antagonists (blockers) • any of the other ingredients of Firmagon listed at the end of this leaflet. Symptoms of an allergic reaction may include: • shortness of breath, wheezing or difficulty breathing • swelling of the face, lips, tongue or other parts of the body • rash, itching or hives on the skin. YOU MUST NOT BE GIVEN FIRMAGON AFTER THE EXPIRY DATE (EXP) PRINTED ON THE PACK. YOU MUST NOT BE GIVEN FIRMAGON IF THE PACKAGING IS TORN OR SHOWS SIGNS OF TAMPERING. If it has expired or is damaged, return it to your pharmacist for disposal. _BEFORE YOU ARE GIVEN IT_ TELL YOUR DOCTOR IF YOU HAVE ALLERGIES TO: • any other medi Leer el documento completo
1 #22606-v11A FIRMAGON ® degarelix (as acetate) FIRMAGON 120 mg, powder and solvent for injection, depot FIRMAGON 80 mg, powder and solvent for injection, depot NAME OF THE MEDICINE Degarelix (as acetate). Degarelix is a third generation gonadotrophin releasing hormone (GnRH) antagonist (blocker). It is a synthetic decapeptide, which forms a depot following subcutaneous injection; this depot formation results in a sustained release of degarelix. The structural formula of degarelix is N H H N N H H N N H O O O HN O NH O NH H N O O H N N H O OH O N CL O H N O NH N O N H NH 2 O O NH 2 O 2 4 5 6 7 8 9 10 1 3 It has an empirical formula of C 82 H 103 N 18 O 16 Cl and a monoisotopic mass of 1630.75 Da. CAS Number: 214766-78-6. DESCRIPTION FIRMAGON is a sterile, off-white powder plus a clear, colourless solvent for reconstitution. The sterile powder is a freeze-dried product containing degarelix (as the acetate) and mannitol. The solvent consists of sterile water for injections. FIRMAGON delivers degarelix acetate, equivalent to 120 mg of degarelix for the starting dose, and 80 mg of degarelix for the maintenance dose. The 80 mg vial contains 200 mg mannitol and the 120 mg vial contains 150 mg mannitol. Degarelix has a natural propensity to gel in aqueous media by its inherent physicochemical characteristics. At concentrations above ca. 1 mg/mL, aqueous degarelix aggregates and cross-links in a gel-forming network, resulting in the formation of a hydrogel. While the process does not take place visibly in the reconstituted product, the depot formation happens instantaneously following subcutaneous administration. PHARMACOLOGY PHARMACODYNAMICS Degarelix is a selective GnRH receptor antagonist (blocker) that competitivel Leer el documento completo