国家: 马来西亚
语言: 英文
来源: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
DEGARELIX
Ferring Sdn. Bhd.
DEGARELIX
2units Units
FERRING GMBH
Not Applicable 阅读完整的文件
MY FIRMAGON 120mg proposed insert for COS to FGmbh (#77074) 5 3-I -MY -0 4.0 1 drafted by JIWO : 29- Jul-2016 ; LAC approval: NA FIRMAGON ® 120mg Powder and solvent for solution for injection QUALITATIVE AND QUANTITATIVE C OMPOSITION Each vial contains 120 mg d egarelix (as acetate). After reconstitution, each ml solution contains 40 mg of degarelix. List of excipients : Powder: Manni tol (E421). Solvent: Water for injection s. PHARM ACEUTICAL FORM Powder and solvent for solution for injection Powder: W hite to off-white powder. Solvent : C lear, colourless sol ution. 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 Posology Starting dose Maintenance dose – monthly administration 240 mg administered as two consecu tive subcutaneous injections of 120 mg each 80 mg administered as one subcutaneous injection The first maintenance dose should be given one month after the starting dose. The therapeutic effect 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 starting dose with 96% of the patients having serum testosterone levels corresponding to medical c astration (T≤0.5 ng/ml) after three days and 100% after one month. Long term treatment with the maintenance dose up to 1 year shows that 97% of the patients have sustained suppressed testosterone levels (T ≤0.5 ng/ml). In case the patient's clinical response appears to be sub- optimal, it should be confirmed that serum testosterone levels are remaining sufficiently suppressed. Since degarelix does not induce a testosterone surge it is not necessary to add an anti -androgen as surge protection at initiation of therapy . Method of administration FIRMAGON ® must be reconstituted prior to administration. For instructions on rec 阅读完整的文件