PaÃs: Jordania
Idioma: inglés
Fuente: JFDA (Jordan Food & Drug Administration - المؤسسة العامة للغذاء والدواء)
Degarelix 80 mg
مستودع البتراء للمواد الطبية - Petra Drug Store
L02BX02
Degarelix 80 mg
80 mg
1 powder vial , 1 solvent pre-filled syrige , 1 vial adaptor and 1 injection needle
RENTSCHLER BIOTECHNOLOGIC GMBH & CO.KG/GERMANY (المانيا)
-- -- --- '~Ii ~"""' ~ ':" fli) p r 1 11 r = FoL .JlnQ --- .. - -- -!:. f-l f> f t D I· dt 10 1'1 --- -- [' II ! 11 ft ' l ! -t-t Ph..! t· !JI ., l 'lIjl I' IJ~ I tJ" j II ( t' f f '.1 ~) _I, _ mil' 'r ') ITI t " , ' - - FIRMAGON® 80 mg t -  - Powder & solvent for solution (),' I WI" nl~ IE-~S - .'.U3 for Injection :3 1 ~~E.AlilLQUANTITAIIVE CQ]ol~ Each vial contains 80 mg degarelix (as acetate). After reconslitution,each ml of solution contains 20 mg 01 degarelix, 'tOOjll,201l11' I o '" 1J CIJ ..0 PHARMACEUII~ Powder and solvent for solution for injection (powder for injection and solvent) Powder. White to off-white powder Solvent: Clear, colourless solution !;:LlNICAL PARTI!;:ULARS: Therapeutic indications FIRMAGON is a gonadotrophin releasing hormone (GnRH) antagonist indicated for treatment of adult male patients with advanced hormone-dependent prostate cancer. Posology and method of administration ~ Starting dose Maintenance dose - monthly administration 240 mg administered as two 80 mg administered as one subcutaneous subcutaneous injections of 120 mg each injection The first maintenance dose should be given one month aher the starting dose. The therapeutic eHect of degarelix should be monitored by clinical parameters and prostate specific antigen (PSA) serum levels. Clinical studies have shown that testosterone (T) suppression occurs immediately after administration of the (}a:~§ ~~~J)~ge~~~~ ~ae~~~~n~s03~Xi~~trl~~~~:~tt~ . sL:~~~~~~~~~::~f~~~i~~et~~~~!~~n~~S~~~p to 1 year shows that 97"10 of the patients have sustained suppressed testosterone levels (T:s: 0.5 ng/ml). ~r~:~:~i~;~~~;i~~~~~~~~:~.~~:~~~a~:I~u~~':fst:~'i ' n~~::~e~~o~~::~~ee~~~ga~ ~~~u:tt~~~~~~~~~e:~~s an anti-androgen as surge protection at initiation of therapy. Special patient populations _Elderly. _ hepatically or renalty impaired patients: There is no need to adjust the dose for the eldel1y or in patients with mild or moderate liver or kidney function impairment Patients with severe liver or kidney impairment have not been studied a Leer el documento completo