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1) NHAN HOP A) Mat 1 B) Mat2 HOP 20 Vi x 10 VIEN NEN BAO PHIM | Ry Thuse ké dan w JE THAMBUTOL 400 Ethambutol hydraclorid 400mg I Co sb sin xuat: CONG TY CO PHAN HOA-DUGC PHAM MEKOPHAR 297/5 Ly Thuong Kigt - P.15 - 0.11 - TP.HCM - Viét Nam I 91 0 865 YI AY ‘THANH PHAN: thambutol hydrockei..40dma TA Of i nd VBR xi BINH, CAcH DUNG, ‘CHENG col mH VA che THONG TiN KHAC: Xam trong 18 hutng cB si oun tute kar theo ‘0 xa Thm TAY TRE EM. 0c Ky HUONG oAw st oun ‘TRUE HHI OOH. “ity edn et ng: DON Ble aud: ct ro, teanh am sing, - | a B) Mat 2 | Box of 20 blisters x 10 film-coated tablets ETHAMBUTOL 0 Ethambutol hydrochloride 400mg | 4k Manufacturer: Mekophar Chemical Pharmaceutical Joint-Stock Co. 297/5 Ly Thuong Kiet St. - W.15 - Dist.11- HCMC - Vietnam Ethambetol tyrochlore...400m9 | Bxcpints as 1 tabiet | INDICATIONS, DOSAGE, ‘CONTRA-INDICATIONS AND (OTHER INFORMATION See enclosed lett. soWeg Wo 56 See sy Sc om ‘Ge Dow ID NHAN Vi (S16 SX, HD duve dap ndi trén vi) A. Mat trude B. Mat sau Viti dat s6 16 SX va han ding TI) NHAN CHAI (60 VIEN) Rmewen (5) Waele sen 4a ro ‘soe aso” EMA@UOLe 255 TV) NHAN CHAI (200 VIEN) who ade Ry mate weer 6 Th Ta Ta hands yee... A000 00 if 00 on 8 00a ‘Té chase vin itn ‘CHAI 200 VIEN NEN BAO PHIM ‘TRUE hot DOS, (cul OYRH, CACH DUNG, ‘Titu ena cht tang: ODYN nn 9 E L shale mene Fecha THAMBUTOL 400 Sesccsse en bow ng ae 3 deg tne th. frame tyro cm ssnex xa nt: s0K tna of rad n-cuge Podm mecoPHA 2S Tong Hk P.5, 011. TPM Maen 0 HUONG DAN SU DUNG Rx ETHAMBUTOL 400 Vien nén bao phim Dé xa tm tay tré em Doc ky hwéng dan sir dung trude khi ding ‘Thude nay chi ding theo don thude Thanh phan, ham long eiia thude: Cho 1 vién nén bao phim Thanh phan hoat chat: - Ethambutol hydrocloris 400 mg Thanh phan ta duge: povidon K29/32. manitol, dicalci phosphat khan, crospovidon, colloidal silicon dioxyd, magnesi stearat, microcrystalin cellulose 101, hydroxypropylmethylcellulose, titan dioxyd, tale, macrogol 6000, mau tartrazi Dang bao ché cia thudec: Vien nén bao phim. M6 ta sin phim: Vien nén tron bao phim mau vang, m6t mat cé vach ngang. Chi dinh: ~ Ethambutol duge ding phéi hop véi cée thude chéng lao khée dé diéu tri bénh lao (lao phdi va ngoai phdi) thé hoat dong va lao phdi khing thuéde. + Nhigm tring phie hop Mycobacterium avium (MAC) (sir dung phéi hop voi cde thude khang lao kha). ~ Dy phong lao trong trutmg hgp lao tiém an hoge c6 ving phan img duong tinh rng voi tuberculin test. u ding, edieh ding: Cich ding: Phai u6ng ethambutol mdt Lin duy nhat trong ngay, Néu bj kich img during tiéu hoa, c6 thé uéng thude cing véi thite an. C6 thé nghién vién thude thanh bét, tron vai nude ép tao: khong tron vei cic mune ép Khée hoge si khae vi khéng kim mat vj dang hoae khéng én dinh. | Ding digu ti bénh lao hoae nhiém tring phite hop Mycobacterium avium, phOi hop voi cae thude chéng lao khac theo phe dé diéu ti dé tinh phat trién khang thude, Liéu ding: Liéu dé nghi - Ngudi lon: +Bénh nhan lao mdi: 15 mg/kg thé trong/ngiy, ti da 1,6 g/ngay. | +Bénh nhan lao tai phat: 25 mg/kg thé trong/ngay trong 60 ngay dau, sau dé udng 15 mg/kg thé trong/ngay, ti da 1,6 g/ngay. + Dy phng: 15 mg/kg thé trong/ngay, mét ligu duy nhat, nhiing thuéc phéi hgp nén duge duy tri & iéu khuyén edo. - Tré em: +Bénh nhan lao méi va lao t4i phat: 25 mg/kg thé trong/ngay trong 60 ngay dau, sau dé ung 15 mg/kg thé trong/ngay, 161 da 1 g/ngay. +Du phong: 15 mg/kg thé trong/ngay, mot liéu duy nhat ligu khuyen cdo. ~ Ngurbi bénh suy than: gidm ligu va thay déi khong dua liéu tay theo mire 46 suy than. Can higu chinh liu theo ndng d6 ethambutol trong mau Xi Ij thuéc tribe va sau khi sit dung: = Khong c6 yéu edu dic biét vé xtr ly thudc true va sau khi sir dung. Chong chi dinh: - Man cam vai bat ky thanh phan nao cua thudc. - Viém day than kinh thi gide, Canh bao va thin trong khi dig thudc: nhiing thudc phdi hgp nén duge duy tri 4 ~ Voi ngwoi bénh gidm chite ning than phai giam lieu, dya vo nong dO ethambutol trong huy than, Nén dinh gid chite nang thin trade khi diéu tri, néu d9 thanh thai creatinin < 30 ml/phut nén theo déi nong d6 ethambutol huyét tong trong qua trinh dicu tr} - Than trong khi digu tr} ethambutol v6i ngudi c6 bgnh 6 mat (nhu dye thiy tinh thé, ede tinh trang tai phat viém mat, bgnh ly ving mec do dai thio dudmg), ngudi gid va tré em, nhdt la tré em dudi 6 tudi vi khé phat hign va dinh gid cdc bién déi vé chite nang thi gi Sir dung ethambutol thin trong v6i tré em, chi diimg khi chic chin hoe nghi ngoy ching vi khuin ao khiing isoniazid hoe rifampicin, hoge tré c6 thé lao giéng ngudi Lén (tham nhiém dinh phdi, ©6 kiém tra thj lye truée khi diéu tri va trong qué trinh digu ti, kiém tra hing thing d6i voi nhing bénh nhan ding liéu hang ngay > 15 mg/kg thé trong. Neung thude néu xudt hién dau higu r6i Joan tam nhin, ~ Dinh ky xét nghigm kiém tra chite nding thin, gan va huyét hoe. = Ché pham chita tartrazin 1 chat tg0 mau c6 the gay ra phan img di img nhu do bimg, may day, kho tho, ué oai hoge giam huyét dp. Str dung thude cho phy ni 6 thai va cho con bi: Théi kj mang thais Mie di ethambutol qua duge nhau thai va e6 thé way quai thai khi dig ligu cao 6 dng vat thye nghiém nhung cho dén nay chua cé théng bao vé nguy co ding thudc trong thoi ky mang thai & ngudi, Tuy nhién, chi chi dinh ethambutol cho phy ni mang thai khi xac dinh duge loi ich ding thudc Ién hon nguy co. Thoi kj cho con bit: Ethambutol vao trong siia me v6i nding d6 twong duong ndng d wong huyét tuong, tuy nhién chia €6 bao céo nio duoe ghi nan bidu hign ddc tinh 6 tré bi me diéu tr bing ethambutol. Chi sir dung ethambutol cho ngudsi me khi di can nhac Igi ich di vai ngudi me va nguy eo véi tré bi mg. Anh huéng cia thude lén kha xe, van hanh may mée ee Ché phim gay gidm thj Iye, dau dau, chéng mgt, mét s6 tru’ng hgp té bi va di cém dau chi da duge ahi nid; than trong khi sit dung cho ngudy lai tu xe, van hainh méy, ngudi Lam vige trén eao va ede 8 trudng hop khie. ‘Tuong tic, twong ky cia thude: Tuong tic ctia thud: . - Véi isoniazid va cae thuée déc thin kinh khée (vi du disulfiram, cloroquin, hydralazin...) ding thoi ethambutol véi ede thude dé ¢6 thé ting nguy eo dée than kinh, nhur viém diy thin thj gide va ngoai bién. - Véi cic antacid: nhém hydroxyd Lam giém hp thu ethambutol & m6t s6 ngudi bénb. Tuong ky; ctia thube: Do khong ¢6 ede nghién extu vé tinh tuemg ky eta thude, khOng trén lin thude nay véi cde thude khée. . Tae dung khong mong muén: ht gap1/1000

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