GEFTINAT吉非替尼片剂说明书全文(中英对照翻译).docx

$ $)edai PeiUon$: In populalion based data analyses no rclatioiuhips wre identified bciwocn predicted steady state irough concentrution and patent age. body urighr gender ethnicity or crc^ininc clearance. Fediatne; There arc nopharnucokincuc data in pcduiric patients. [For (he use only of a Canocr SpccuUrt or 2 Hospital of 汕 lnsutulion| GEFTINAT*(Ccniinib Tablets IPi Compo sition Each film coated ubici conums: Gcliiinib IP 250 mg DESCRIPTION GKFTINAT (gcfltinib ubicis IP) contain 250 mg of gcliiinib IP and arc availaUc as reddish brown film-voaicd tablets cngra^cd with GEFTINAT 0(1 one side and 250 on another side lor daity orul administrution, Gdllinib i an anilinoquinazoliiK with the cbcmicat name 4-Quinazotin ami IK. N-Jhlofo-muorDphcnyl7-mcihoxy-6-|3-l-inopholml propoxy). Il has ihc molecular formula C22H24C1F4O3?a relative molecular mass of 446,9 and u a white-colored powder. Gefitinib b a free base. CLINICAL PHARMACOLOGY Mcclunism of Action: The mechanism of ihc cUnicat antiiumor acdoti of gefitinib is not fully charMlcrized. Ccliiinib inhibits the iiMraccItular phosphorylation of numerous tyrosine kinases associaicd wiih traiumcmtvanc cell surface nxxpior^ including ihc lyroinc kinases associMcd with ihc cpidcnnal powih factor rcccpiof (EGFRTK). EGFR Is expressed on the cell surface of many normal celts and cancer cells. No clinical studies have been perform^ tiui demonstrate a cotTcUUon between EGFR rcccpior expression and response to gcfiimih. PharmacokiiKdcs: Gcfltinib k absorbed slowly aficroral adminisiraiion with mean bioavditabiljty of 60%, Elimination is by metabolism primarily CYP3A41 and excretion in feces. The Emin独iai bathlife is about 48 hours. Daily oral adminisiraiion of jcfiliiUb 10 cancer paiients resulted in a 2? fold accumulation compared 10 single dose ddministrution, Steady stale plasma conccmrations arc achieved within IObys. Absorpdon and Disiribuiion: Cdiiinib is slowly dMorbed. with peak plasma levels occurring 3?7 hciuni after dotin