国: マレーシア
言語: 英語
ソース: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
TRABECTEDIN
ZUELLIG PHARMA SDN BHD
TRABECTEDIN
1Units Units
BAXTER ONCOLOGY GMBH
1 PRODUCT NAME YONDELIS 1 mg for Injection DOSAGE FORMS AND STRENGTHS Powder for concentrate for solution for infusion. YONDELIS drug product is provided as a sterile lyophilized white to off-white powder. Each vial contains 1 mg of trabectedin. 1 mL of reconstituted solution contains 0.05 mg of trabectedin (see _Instructions for Use and _ _Handling and Disposal_ ). INN: Trabectedin; CAS Registry No.: 114899-77-3 Chemical Name: (CAS): (1' _R_ ,6 _R_ ,6a _R_ ,7 _R_ ,13 _S_ ,14 _S_ ,16 _R_ )-5-(acetyloxy)-3',4',6,6a,7,13,14,16- octahydro-6',8,14-trihydroxy-7',9-dimethoxy-4,10,23-trimethyl-spiro[6,16 (epithiopropanoxymethano)-7,13-imino-12 _H_ -1,3-dioxolo[7,8]isoquino[3,2- _b_ ][3]benzazocine- 20,1'(2' _H_ )-isoquinolin]-19-one. Molecular Formula: The molecular formula is C 39 H 43 N 3 O 11 S. Molecular Weight: The molecular weight of trabectedin is 761.84 g/mol. Solubility: Trabectedin is hydrophobic, and has a low solubility in water. Trabectedin solubility is enhanced in acidic media. For excipients, see _List of Excipients._ CLINICAL INFORMATION INDICATIONS YONDELIS is indicated for the treatment of adult patients with advanced soft tissue sarcoma (STS), after failure of anthracyclines and ifosfamide, or who are unsuited to receive these agents. Efficacy data are based mainly on liposarcoma and leiomyosarcoma patients. YONDELIS in combination with pegylated liposomal doxorubicin hydrochloride (PLD) is indicated for the treatment of patients with relapsed platinum-sensitive ovarian cancer. DOSAGE AND ADMINISTRATION YONDELIS must be administered under the supervision of a physician experienced in the use of chemotherapy. Its use should be confined to qualified oncologists or other health professionals specialized in the administration of cytotoxic agents. _POSOLOGY _ For the treatment of soft tissue sarcoma (STS), the recommended starting dose is 1.5 mg/m 2 body surface area, administered as an intravenous infusion over 24 hours with a three-week interval between cycles. 2 For the treatment of 完全なドキュメントを読む