LPD Title : Clindamycin Phosphate LPD Date : 18 Jul, Country : Vietnam Reference CDS version 6.0 Reference CDS Date : 16 Jul 2013 \ DALACIN T Rx

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$0 Reference CDS Date : 16 Jul 2013 \ DALACIN T Rx CANH BAO BAC BIET: Chi sir dung thuoc nay theo don. Doc ky huong dan sir dung trunc khi dung. Khong dung qua lieu chi dinh.$ Hay thong bao cho bac si biet neu xay ra bat ky tac dung ngoai y nao. Hay tham khao y kien bac si de co them thong tin. Khong su* dung thuoc da qua han dimg. Be thuoc ngoai tarn voi ciia tre em. 1.

Hay thong bao cho bac si biet neu xay ra bat ky tac dung ngoai y nao. Hay tham khao y kien bac si de co them thong tin. Khong su* dung thuoc da qua han dimg. Be thuoc ngoai tarn voi ciia tre em. 1.

1 (4Danh muc ta dugc ) 3. Dang bao che Dung dich boi tai cho. Dung dich nuoc trong suot khong mau. 4. Cac dac tinh lam sang 4.1. Chi dinh dieu tr{ Dung dich boi tai cho Dalacin T (clindamycin) dugc chi dinh trong dieu tri mun trung ca.

1 LPD Title : Clindamycin Phosphate LPD Date : 18 Jul, Country : Vietnam Reference CDS version 6.0 Reference CDS Date : 16 Jul 2013 \ DALACIN T Rx CANH BAO BAC BIET: Chi sir dung thuoc nay theo don. Doc ky huong dan sir dung trunc khi dung. Khong dung qua lieu chi dinh. Hay thong bao cho bac si biet neu xay ra bat ky tac dung ngoai y nao. Hay tham khao y kien bac si de co them thong tin. Khong su* dung thuoc da qua han dimg. Be thuoc ngoai tarn voi ciia tre em. 1. Ten san pham DalacinKT 2. Thanh phan dinh tinh va dinh lurong Mot ml dung dich boi tai cho Dalacin T chira Clindamycin phosphate voi nong do tuomg ung 10 mg Clindamycin. Ta dugc: Xem muc 6.1 (4Danh muc ta dugc ) 3. Dang bao che Dung dich boi tai cho. Dung dich nuoc trong suot khong mau. 4. Cac dac tinh lam sang 4.1. Chi dinh dieu tr{ Dung dich boi tai cho Dalacin T (clindamycin) dugc chi dinh trong dieu tri mun trung ca Lieu dimg va each dung Boi mot lop mong Dalacin T (clindamycin) len viing da benh hai lan moi ngay. 4.3 Chong chi dinh Chong chi dinh clindamycin boi tai cho o nhung nguoi co tien su qua man voi clindamycin hoac lincomycin. Chong chi dinh clindamycin boi tai cho o nhung nguoi co tien sir benh viem dai trang lien quan den dimg khang sinh Canh bao va than trong dac biet khi sir dung Clindamycin dimg duong uong hoac ngoai dubng tieu hoa, cung nhu hau het cac khang sinh khac, dugc phat hien co lien quan toi tieu chay va viem ket trang gia mac nghiem trong. Sir dung clindamycin boi tai cho lam hap thu khang sinh tren be mat da (xem muc 5.2 Cac tinh chat dugc dong hgc). Da co nhung bao cao tieu chay va viem ruot ket khong thuong xuyen cimg voi clindamycin boi tai cho. Do do, bac sy nen dugc canh bao co the xuat hien tieu chay va viem ruot ket lien quan den dimg khang sinh. Neu tieu chay nang hoac keo dai xay ra, nen dimg dimg thuoc va co quy trinh chan doan phir hgp va dieu tri neu can thiet. Dalcin T PI VN Page 1 of 5

LPD Title : Clindamycin Phosphate LPD Date: 18 Jul, 2013. Country : Vietnam Reference CDS version 6.0 Reference CDS Date : 16 Jul.

Dung dich clindamycin boi tai cho chua alcol baza la chat co the gay rat, kich ung mat, mang nhay va lam tray da.. 4.5.

Do vay, can than trgng tren cac benh nhan dang dung cac thuoc nay. 4.6.

2 LPD Title : Clindamycin Phosphate LPD Date: 18 Jul, Country : Vietnam Reference CDS version 6.0 Reference CDS Date : 16 Jul Tieu chay, viem ruot ket, va viem ket trang gia mac da dugc quan sat bat dau trong vong vai tuan sau khi dung dieu tri bang clindamycin dung duong uong va dung ngoai duong tieu hoa. Dung dich clindamycin boi tai cho chua alcol baza la chat co the gay rat, kich ung mat, mang nhay va lam tray da Ttrong tac voi cac thuoc khac va cac dang tirong tac khac Clindamycin dugc thay co dac tinh chen than kinh co nen co the lam tang tac dung cua cac thuoc chen than kinh ca khac. Do vay, can than trgng tren cac benh nhan dang dung cac thuoc nay Phu nu* co thai va cho con bu Su dung trong thai ki: Cac nghien cuu ve doc tinh hoc sinh san b chuot va tho theo duong uong va duong duoi da cua clindamycin khong cho thay bang chung nao lam suy giam kha nang sinh san hay gay hai cho thai nhi do clindamycin, ngoai trir b cac lieu lugng gay doc cho me. Nghien cuu tren kha nang sinh san cua dong vat khong phai luc nao cung dir doan dugc dap ung tren nguoi. Trong cac thu nghiem lam sang voi phu nu dang mang thai, viec dung clindamycin theo duong mau trong suot ba thang thu hai va ba thang cuoi cua thai ky khong lien quan den viec tang tan suat xuat hien di tat bam sinh. Clindamycin dugc dung trong ba thang dau cua thai ky khi thuc su can thiet. Chua co cac nghien cuu day du va dugc kiem soat tot tren phu nu mang thai trong ba thang dau cua thai ky. Su dung b phu nu cho con bu: Chua biet lieu clindamycin co bai tiet vao sua hay khong sau khi dung clindamycin boi tai cho. Tuy nhien, clindaymycin dung duong uong va ngoai duong tieu hoa da dugc bao cao xuat hien trong sua me. Do cac nguy co tiem tang ve cac tac dung khong mong muon b tre bu me, can quyet dinh xem nen dung viec cho bu hay dimg dung thuoc, dua tren tarn quan trgng cua thuoc doi vbi nguoi me Anh huong len kha nang lai xe va van hanh may moc Anh hubng cua clindamycin tren kha nang lai xe va van hanh may moc chua dugc danh gia mot each co he thong Tac dung khong mong muon Kho da la tac dung ngoai y thubng gap nhat khi su dung thuoc. Cac tac dung ngoai y sau day dugc bao cao them khi su dung che pham dung tai cho co chua clindamycin bao gom:. Roi loan mat: nhuc mat. Roi loan tieu hoa: dau bung, cac bat thubng tieu hoa, viem dai trang gia mac. Nhiem trung va nhiem ky sinh trung: viem nang long gram am. Roi loan da va mo dubi da: kich ung da, viem da tiep xuc, da nhbn, may day. Dalcin T PI LV Page 2 of 5

LPD Title : Clindamycin Phosphate LPD Date : 18 Jul, 2013. Country : Vietnam Reference CDS version 6.0 Reference CDS Date : 16 Jul. 2013 4.9.

3 LPD Title : Clindamycin Phosphate LPD Date : 18 Jul, Country : Vietnam Reference CDS version 6.0 Reference CDS Date : 16 Jul Qua lieu Clindamycin boi tai cho co the hap thu voi luong dii de gay ra tac dung toan than.trong truong hop qua lieu, cac bien phap dieu tri trieu chung va ho tro can dugc chi dinh khi can thiet. LH Ui. Cac dac tinh duoc ly hoc.1. Cac dac tinh duoc lire hoc Vi sinh hoc: Du clindamycin phosphate bat hoat trong ong nghiem, sir thuy phan nhanh trong moi truong in vivo chuyen hop chat nay thanh chat co hoat tinh uc che vi khuan clindamycin. Clindamycin duoc thay la co tac dung chong cac chung phan lap cua cac vi sinh vat sau trong ong nghiem: Cac cau khuan gram duong ai khi, gom: Tu cau vang (,Staphylococcus aureus) (cac chung sinh men penicillinase va khong sinh penicillinase). Khi thu nghiem trong ong nghiem, mot so chung tu cau khang voi erythromycin ban dau da nhanh chong khang voi clindamycin. Tu cau da (,Staphylococcus epidermidis) (cac chung sinh men penicillinase va khong sinh penicillinase). Khi thu nghiem trong ong nghiem, mot so chung tu cau khang voi erythromycin ban dau da nhanh chong khang voi clindamycin. Lien cau (Streptococci, ngoai trir Enterococcus faecalis) Phe cau (Pneumococci) Cac true khan gram am ky khi, gom: Loai Bacteroide (gom nhom Bacteroides fragilis va nhom Bacteroides melaninogenicus) Loai Fusobacterium Cac true khuan gram duong ky khi khong tao nha bao, gom: Propionibacterium Eubacterium Loai Actinomyces Cac cau khuan gram duong ky khi va vi ai khi, gom: Loai Peptococcus Loai Peptostreptococcus Lien cau vi ai khi Clostridia: Clostridia khang voi clindamycin nhieu hon hau het cac vi khuan ky khi. Hau het cac Clostridium perfringens nhay cam nhung cac loai khac nhu C. sporogenes va C. tertium thi thubng khang voi clindamycin. Can lam xet nghiem ve kha nang nhay cam. Khang cheo giua lincomycin va clindamycin da duoc chung minh. Doi khang nhau giua clindamycin va erythromycin duoc chung minh trong ong nghiem. Y nghta lam sang cua tuong tac nay chua duoc biet den. Dalcin T PI VN Page 3 of 5

LPD Title : Clindamycin Phosphate LPD Date : 18 Jul, 20

4 LPD Title : Clindamycin Phosphate LPD Date : 18 Jul, Country: Vietnam Reference CDS version 6.0 Reference CDS Date : 16 Jul Cac dac tinh dirge dong hoc Sau khi boi tai cho nhieu lan clindamycin phosphate voi nong do tirong duong 10 mg/ml clindamycin trong dung dich nude va isopropyl alcohol, nong do clindamycin tim thay trong huyet thanh rat thap (0-3 ng/ml) va dudi 0.2% lieu dung xuat hien lai trong nude tieu dudi dang clindamycin. Hoat tinh clindamycin dugc chung minh tren mun trung ca d nhung benh nhan co mun trung ca. Nong do khang sinh co hoat tinh trung binh lay tu mun trung ca sau khi su dung clindamycin boi tai cho trong 4 tuan la 597 meg/g (thay doi tu ). Trong moi trudng in vitro, Clindamycin uc che tat ca mun trung ca do Propionibacterium trong 16 vi khuan thu nghiem (MIC 0,4 mcg/ml). Luang acid beo tu do tren be mat da giam tu xap xi 14% xuong 2% sau khi boi clindamycin. Su dung d benh nhan cao tuoi Khong co du so luong benh nhan tir 65 tuoi trd len trong cac nghien cuu lam sang ve clindamycin boi tai cho de ket luan lieu dap ung d nhom doi tuong nay co khac vdi cac nhom doi tuong tre hon hay khong Dur lieu an toan tien lam sang Doc tinh gay ung thu: Cac nghien cun dai han d dong vat chua dugc tien hanh vdi clindamycin de danh gia kha nang gay ung thu tiem tang. Doc tinh gay quai thai: Cac thu nghiem doc tinh vdi he gen dugc tien hanh bao gom thu nghiem nhan nho d chuot cong va thu nghiem Ames Salmonella dao ngugc. Ca 2 thu nghiem deu cho ket qua am tinh. Suy giam kha nang sinh san: Cac nghien cuu ve kha nang san d chuot cong cho uong tdi lieu 300mg/kg/ngay (khoang 1,1 lan lieu khuyen cao cao nhat d ngudi trudng thanh tinh theo mg/m2) cho thay khong co anh hudng len kha nang sinh san hoac giao phoi. Trong cac nghien cuu ve phat trien phoi thai qua duong uong d chuot va phat trien phoi thai qua duong tiem dudi da d chuot va tho, khong quan sat thay doc tinh tien trien nao, ngoai trir d cac lieu lugng gay doc cho me. 6. Cac dac tinh dugc hoc 6.1. Danh muc ta dugc Alcol isopropyl, propylene glycol, nude cat, acid hydrochloric va natri hydroxyd Tuong ki Khong ap dung Han dung 24 thang ke tir ngay san xuat. Dalcin T PI VN Page 4 of 5

LPD Title : Clindamycin Phosphate LPD Date: 18 Jul, 2013. Country': Vietnam Reference CDS version 6.0 Reference CDS Date : 16 Jul, 2013 6.4.

6 Hucrng dan sir dung/cach dung Thuoc dugc dong trong chai, co dung cu boi va nap rieng. Sir dung dung cu boi: 1) Thao nap ra khoi chai va bo di. 2) An chat dung cu boi vao chai.

5 LPD Title : Clindamycin Phosphate LPD Date: 18 Jul, Country': Vietnam Reference CDS version 6.0 Reference CDS Date : 16 Jul, Than trong dac biet khi bao quan Bao quan a nhiet do khong qua 30 C Tinh chat va dung lirong cua bao bi dong goi Hop 1 chai 30 ml 6.6 Hucrng dan sir dung/cach dung Thuoc dugc dong trong chai, co dung cu boi va nap rieng. Sir dung dung cu boi: 1) Thao nap ra khoi chai va bo di. 2) An chat dung cu boi vao chai. 3) Van chat bang each siet chat nut hinh vom. Dugc si co the co chai da dugc lap rap cho ban, trong truong hgp do, dung cu boi da dugc lap san d dau chai. Tieu chuan thuoc thanh pham: Nha san xuat Nha san xuat va dong goi: Zoetis P&U LLC, 2605 E, Kilgore Road, Kalamazoo, MI , My. Nha xuat xuotig: Pharmacia & Upjohn Company, Kalamazoo, MI 49001, My. Dalcm T PI VN Page 5 of 5

BO YTE cu e q u An l y d ito c CONG HOA XA HOI CHU NG H IA VIET NAM Doc lap - Tir do - Hanh phuc S6: /QLD-BK Ha Noi, ngay c&f- thang 5 nam 2015 V/v cap nhat noi dung td hircrng dan su dung Kinh gui:

, Floor 36, 37, 38 United Center Building, 323 Silom Road, Silom, Bangrak, Bangkok 10500, Thailand Ngay 06/03/2015, Cue Quan ly Dugc nhan dugc dan de nghi de ngay 26/02/2015 va cac tai lieu lien quan

6 BO YTE cu e q u An l y d ito c CONG HOA XA HOI CHU NG H IA VIET NAM Doc lap - Tir do - Hanh phuc S6: /QLD-BK Ha Noi, ngay c&f- thang 5 nam 2015 V/v cap nhat noi dung td hircrng dan su dung Kinh gui: Dia chi: Pfizer (Thailand) Ltd., Floor 36, 37, 38 United Center Building, 323 Silom Road, Silom, Bangrak, Bangkok 10500, Thailand Ngay 06/03/2015, Cue Quan ly Dugc nhan dugc dan de nghi de ngay 26/02/2015 va cac tai lieu lien quan cua cong ty ve viec cap nhat noi dung to hudng dan su dung doi voi thuoc nude ngoai da duoc cap so dang ky luu hanh; Can cu Thong tu so 44/2014/TT-BYT ngay 25/11/2014 cua Bo trudng Bo Y te quy dinh viec dang ky thuoc; Thong tu so 04/2008/TT-BYT ngay 12/5/2008 cua Bo trudng Bo Y te hudng dan ghi nhan thuoc; Can cu Bien ban tham dinh ho so thay doi/bo sung, Cue Quan ly Dugc co y kien nhu sau: Dong y de cong ty dugc cap nhat noi dung td hudng dan su dung doi vdi thuoc Dalacin T, so dang ky VN Bang so sanh noi dung thay doi cua td hudng din su dung dugc dong dau xac nhan cua Cue Quan ly Dugc. Ngoai noi dung dugc thay doi tren, tit ca cac noi dung khac giu nguyen nhu ho so dang ky thuoc luu tai Cue Quan ly Dugc. Cong ty dang ky, nha san xuat phai chiu trach nhiem ve chat lugng doi vdi thuoc luu hanh tren thi truong, noi dung ghi tren nhan thuoc, quy dinh ve so hu'u tri tue lien quan den nhan hieu hang hoa cua thuoc va co trach nhiem thong bao su thay doi nay den cac co quan lien quan va khach hang. Sau 03 thang ke tir ngay ky cong van nay cong ty khong dugc nhap khau thuoc tren vdi noi dung cu da thay doi cua td hudng din sir dung. Cue Quan ly Dugc thong bao de cong ty biet va thuc hien dung cac quy \ r dinh cua Viet Nam ve luu hanh thuoc./. Noi nhan: - Nhir tren; - Liru: VT, BK (Li). L

BO Y T E CU C QUAN LY Dl/O'C DA FHE D l^ ^ y x T U B S ngay ^.

$VAN PHONG DAI DIEN PHO TC> HUONG DAN SIT DUNG MOT \ CHI (Phan them vao/ thay doi dugc danh dau vang) LPD Date : 30 Dec, 2014; Reference CDS Date : 02 Jul, 2014 Rx CANH BAO DAC BIET: Thuoc nay chi$ dung theo don cua bac si. Ha^thong bao cho bac si biet neu xay ra bat ky tac dung ngoai y nao. Hay tham khao y kien bac si de ed them thong tin.

dung theo don cua bac si. Ha^thong bao cho bac si biet neu xay ra bat ky tac dung ngoai y nao. Hay tham khao y kien bac si de ed them thong tin.

7 BO Y T E CU C QUAN LY Dl/O'C DA FHE D l^ ^ y x T U B S ngay ^. 7 thang 7 ^ AT CAC THAY DOl TRONG TO HlTONG DAN SU DUNG UA THUOC DALACIN T (SDK: VN ) TO~HUONGTjAN SU DUNG CU (phan loai bo diroc gac-h-ngang) LPD Date : 18 Jul, 2013; Reference CDS Date : 16 Jul, 2013; Rx CANH BAO DAC BIET: Chi su dung thuoc nay theo do n. VAN PHONG DAI DIEN PHO TC> HUONG DAN SIT DUNG MOT \ CHI (Phan them vao/ thay doi dugc danh dau vang) LPD Date : 30 Dec, 2014; Reference CDS Date : 02 Jul, 2014 Rx CANH BAO DAC BIET: Thuoc nay chi dung theo don cua bac si. Ha^thong bao cho bac si biet neu xay ra bat ky tac dung ngoai y nao. Hay tham khao y kien bac si de ed them thong tin. Thong bao cho bac si nhung tac dung khong mong muon gap phai khi sir dung thuoc. Neu can them thong tin xin hoi y kien bac si. De thude-ngoai tarn voi cua tre em. De xa tarn tay tre em. 2. Thanh phan djnh tinh va djnh luong 2. Thanh phan djnh tinh va dinh Iirong Clindamycin phosphat la ester tan trong nude cua khang sinh ban tong hgp dugc tao ra bang each thay nhom 7(R) - hydroxyl cua nhom khang sinh lincomycin bang nhom the 7(S)-C1. Mot ml dung dich boi tai cho Dalacin T chua Clindamycin phosphate vdi nong do tuong ung 10 mg Clindamycin. Ta dirge: Xem muc 6.1 (D anh muc ta dugc2) Mot ml dung dich boi tai cho Dalacin T chua Clindamycin phosphat vdi nong do tuong ung 10 mg Clindamycin. Ta duoc: xem muc 6.1. Danh muc ta duoc 1

4. Cac dac tinh lam sang 4.1. Chi djnh dieu trj Dung djch boi tai cho Dalacin T (clindamycin) duoc chi djnh trong dieu trj mun trung ca. 4.2.

Chi djnh dieu trj Dung djch boi tai cho clindamycin duoc chi djnh trong dieu trj mun trung ca. 4.

8 4. Cac dac tinh lam sang 4.1. Chi djnh dieu trj Dung djch boi tai cho Dalacin T (clindamycin) duoc chi djnh trong dieu trj mun trung ca Lieu dung va each dung Boi mot lop mong Dalacin T (clindamycin) len vung da benh hai lan moi ngay. 4. Cac dac tinh lam sang 4.1. Chi djnh dieu trj Dung djch boi tai cho clindamycin duoc chi djnh trong dieu trj mun trung ca Lieu dung va each dimg Boi mot lop mong dung djch clindamycin len vung da benh hai lan moi ngay Canh bao va than trong dac biet khi su* dung Clindamycin dung duong uong hoac ngoai duong tieu hoa, cung nhu hau het cac khang sinh khac, duoc phat hien co lien quan tdi tieu chay va viem k& trang gia mac nghiem trong. Su dung clindamycin boi tai cho lam hap thu khang sinh tren be mat da (xem muc 5.2 Cac tinh emt duoc dong hoc). Da co nhung bao cao tieu chay va viem ruot ket khong thuong xuyen cung voi clindamycin boi tai cho. Do do, bac sy nen duoc canh bao co the xuat hien tieu chay va viem ruot ket lien quan den dung khang sinh. Tieu chay, viem ruot ket, va viem ket trang gia mac da duoc quan sat bit dau trong-vong vai tuan sau khi dung dieu tri bang clindamycin dung duong uong va dung ngoai duong tieu hoa. Dung djch clindamycin boi tai cho chua alcol bazo la chat co the gay rat, kich ung mat, mang nhay va lam tray da Tuong tac voi cac thuoc khac va cac dang tuong tac khac Clindamycin duoc thay co dac tinh chen than kinh co nen co the lam tang tac dung cua cac thuoc chen than kinh co khac Canh bao va than trong dac biet khi sir dung Clindamycin dung duong uong hoac ngoai duong tieu hoa, cung nhu hau het cac khang sinh khac, duoc phat hien co lien quan tdi tieu chay va viem dai trang gia mac nghiem trong. Su dung clindamycin boi tai cho lam hap thu khang sinh qua be mat da (xem muc 5.2. Cac dac tinh duoc dong hoc). Da co nhung bao cao khong thuong xuyen ve tieu chay va viem ruot ket lien quan den viec su dung clindamycin boi tai cho. Do do, bac sy nen duoc canh bao ve viec co the xuat hien tieu chay va viem ruot ket lien quan den dung khang sinh. Tieu chay, viem ruot ket va viem dai trang gia mac da duoc quan sat thay khi bat dau dieu trj cho den vai tuan sau khi dung dieu trj bang clindamycin duong uong va dung ngoai duong tieu hoa. Dung djch clindamycin boi tai cho chua alcol bazo la chat co the gay rat va kich ung mat, mang nhay va lam tray da Tuong tac voi cac thuoc khac va cac dang tiro ng tac khac Clindamycin dung toan than duoc thay co dac tinh chen than kinh co nen co the lam tang tac dung cua cac thuoc chen than kinh co khac. 2

4.6. Phu nu' co thai va cho con bu Su dung trong thai ki: Cac nghien cuu ve doc tmh hoc sinh san d chuot va tho theo duong uong va duong dudi da cua clindamycin khong cho thay bang chung nao lam suy

Anh huong den kha nang sinh san, phu nur co thai va cho con bu Su dung trong thai ki: Cac nghien cuu ve doc tinh hoc sinh san d chuot va tho theo duong uong va duong dudi da cua clindamycin khong cho

9 4.6. Phu nu' co thai va cho con bu Su dung trong thai ki: Cac nghien cuu ve doc tmh hoc sinh san d chuot va tho theo duong uong va duong dudi da cua clindamycin khong cho thay bang chung nao lam suy giam kha nang sinh san hay gay hai cho thai nhi do clindamycin, ngoai tru b cac lieu Iuong gay doc cho me Anh huong den kha nang sinh san, phu nur co thai va cho con bu Su dung trong thai ki: Cac nghien cuu ve doc tinh hoc sinh san d chuot va tho theo duong uong va duong dudi da cua clindamycin khong cho thay bang chung nao ve viec lam suy giam kha nang sinh san hay gay hai cho thai nhi do clindamycin, ngoai tru d cac lieu Iuong gay doc cho me. Trong cac thu nghiem lam sang vdi phu nu- dang mang thai, viec dung clindamycin theo duong mdu trong suot ba thang thu hai va ba thang cuoi cua thai ky khong lien quan den viec tang tan suat xuat hien dj tat bam sinh. Sir dung 0=phu nu1cho con bu: Chua biet lieu clindamycin co bai tiet vao sua hay khong sau khi dung clindamycin boi tai cho. Trong cac thu nghiem lam sang vdi phu nu- dang mang thai, viec dung clindamycin theo duong toan than trong suot ba thang thu hai va ba thang cuoi cua thai ky khong lien quan den viec tang tan suat xuat hien dj tat bam sinh. Su dung tren phu nu- cho con bu: Hien chua co du lieu chung minh clindamycin co bai tiet vao sua me hay khong sau khi dung clindamycin boi tai cho Tac dung khong mong muon Kho da la tac dung ngoai y-thudng gap nhat khi su dung thuoc. Cac tac dung ngoai y sau day duoc bao cao them khi su dung che pham dung tai cho co chua-clindamycin bao gom-r Roi loan m5t: nhuc-matr Roi loan tieu hoa: dau bungtcac bat-thudng tieu hoa, viem dai trang gia mac. Nhiem trung va nhiem ley sinh trung;-viem nang long gram arm Roi loan-da va mo dudi da: kich ung da, viem da tiep xuc, da nhom may day Tac dung khong mong muon B a n g ca c ta c du n g k h o n g m o n g m u on Phan loai theo he thong/ CO q uan R at th u o n g g a p > 1/10 T h u o n g g?p >1/100 den <1/10 It g?p > 1/1000 den < 1 /1 0 0 lliem g a p > 1/10,000 den <1/1000 R at hiem gap <1/10,000 K hong ro tan suat (khong the uoc tinh tir du lieu co san) y v> 41 H( \ 3

luu hanh. 4.9. Qua lieu Clindamycin boi tai cho co the hap thu voi Iuong du de gay ra tac dung toan than.

10 N h ie m tr u n g v a n h ie m ky sin h tru n g R oi lo a n v e m a t R oi lo a n tie u h o a R oi lo a n d a v a c a c m o d iro i d a K ic h u n g d a, d a k h o, m a y d a y R oi lo a n tie u h o a T a n g tie t b a n h d n V ie m n a n g long* D a u m at* V ie m d a i tra n g g ia m ac* D a u b ung* V ie m d a tie p xuc* *: Tac dung khong mong muon duoc xac djnh tir nghien cuu sau khi thuoc luu hanh Qua lieu Clindamycin boi tai cho co the hap thu voi Iuong du de gay ra tac dung toan than.trong trudng hop qua lieu, cac bien phap di u tri trieu chung va hd tro can duoc chi dinh khi can thiet. 5. Cac dac tinh duoc ly hoc 5.1. Cac dac tinh duoc lure hoc Vi sinh hoc: Du clindamycin phosphate bat hoat trong ong- nghiem, sir thuy phan nhanh trong moi trirdng in vivo ehuyen hop chat nay thanh ch&t-cd hoat tinh (ic che vi khuan clindamycin Qua lieu Clindamycin boi tai cho co the duoc hap thu voi Iuong du de gay ra tac dung toan than. Trong trudng hop qua lieu, cac bien phap dieu tri trieu chung va ho tro can dirge chi djnh khi can thiet. 5. Cac dac tinh duoc ly hoc 5.1. Cac dac tinh duoc luc hoc Vi sinh hoc: -Mac du clindamycin phosphat khong co hoat tinh tren in vitro, chat nay se duoc thuy phan nhanh chong trong moi trirdng in vivo thanh clindamycin co hoat tinh uc che vi khuan. 4

Clindamycin dirge thay la co tac dung chong cac chung phan lap cua cac vi sinh vat sau trong ong-ngh-iem: Cac cau khuan gram duong ai khi, gom: Tu cau vang {Staphylococcus aureus) (cac chung sinh men

Tu cau da (,Staphylococcus epidermidis) (cac chung sinh men penicillinase va khong sinh penicillinase).

11 Clindamycin dirge thay la co tac dung chong cac chung phan lap cua cac vi sinh vat sau trong ong-ngh-iem: Cac cau khuan gram duong ai khi, gom: Tu cau vang {Staphylococcus aureus) (cac chung sinh men penicillinase va khong sinh penicillinase). Khi thu nghiem trong ong nghiem, mot so chung tu cau khang vdi erythromycin ban dau da nhanh chong khang vdi clindamycin. Tu cau da (,Staphylococcus epidermidis) (cac chung sinh men penicillinase va khong sinh penicillinase). Khi thu- nghiem trong ong nghiem, mot so chung tu cau khang voi erythromycin ban dau da nhanh chong khang vdi clindamycin. Clindamycin dugc thay la co tac dung chong cac chung phan lap cua cac vi sinh vat sau tren in vitro: Cac cau khuan gram duong ai khi, gom: -Tu cau vang {Staphylococcus aureus) (cac chung sinh men penicillinase va khong sinh penicillinase). Khi thu nghiem tren in vitro, mot so chung tu cau khang vdi erythromycin ban dau da nhanh chong khang vdi clindamycin. -Tu cau da {Staphylococcus epidermidis) (cac chung sinh men penicillinase va khong sinh penicillinase). Khi thu nghiem tren in vitro, mot so chung tu cau khang vdi erythromycin ban dau da nhanh chong khang vdi clindamycin. Cac true khan gram am ky khi, gom: Loai Bacteroide (gom nhom Bacteroidesfragilis va nhom Bacteroides melaninogenicus) Cac true khan gram am ky khi, gom: -Loai Bacteroides ('gom nhom Bacteroides fragilis va nhom Bacteroides melaninogenicus) Khang cheo giua lincomycin va clindamycin da duoc chung minh. Doi khang nhau giua clindamycin va erythromycin duoc chung minh trong ong nghiem. Y nghta lam sang cua tuong tac nay chua duoc biet den Cac dac tinh duoc dong hoc Sau khi boi tai cho nhieu lan clindamycin phosphate vdi nong do tuong duong 10 mg/ml clindamycin trong dung djch nude va isopropyl alcohol, nong do clindamycin tim thay trong huyet thanh rat thap (0-3 ng/ml) va dudi 0 t2 % lieu dung xuat hien laitrong nude tieu dudi dang clindamycin. Khang cheo giua lincomycin va clindamycin da duoc chung minh. Doi khang nhau giua clindamycin va erythromycin duoc chung minh qua nghien cuu in vitro. Y nghta lam sang cua tuong tac nay chua dugc biet den Cac dac tinh duoc dong hoc Sau khi boi tai cho nhieu lan clindamycin phosphat vdi nong do tuong duong 10 mg/ml clindamycin trong dung djch nude va isopropyl alcohol, nong do clindamycin tim thay trong huyet thanh rat thap (0-3 ng/ml) va dudi 0,2 % lieu dung xuat hien trong nude tieu dudi dang clindamycin. 5

Trong moi truong in vitro, Clindamycin uc che tat ca mun trung ca do Propionibacterium trong 16 vi khuan thu nghiem (MIC 0,4 mcg/ml).

12 Hoat tinh clindamycin dugc chung minh tren mun trung ca a nhung benh nhan co mun trung ca. Nong do khang sinh co hoat tinh trung binh lay tu- mun trung ca sau khi su- dung clindamycin boi tai cho trong 4 tuan la 597 mcg/g (thay doi tu ). Trong moi truong in vitro, Clindamycin uc che tat ca mun trung ca do Propionibacterium trong 16 vi khuan thu nghiem (MIC 0,4 mcg/ml). Hoat tinh cua clindamycin dugc chung minh tren nhung benh nhan co mun trung ca. Nong do khang sinh co hgat tinh trung binh lay tir mun trung ca sau khi sir dung clindamycin boi tai cho trong 4 tuan la 597 mcg/g (thay doi tir ). Tren in vitro, Clindamycin uc che tat ca mun trung ca do Propionibacterium trong 16 vi khuan thu nghiem (MIC 0,4 mcg/ml). > 5.3. Dfl lieu an toan tien lam sang 5.3. Du* lieu an toan tien lam sang Suy giam kha nang sinh san: Cac nghien cuu ve kha nang san 6 chuot cong cho uong tai lieu 300mg/kg/ngay (khoang 1,1 lan lieu khuyen cao cao nhat 6 nguoi truong thanh tinh theo mg/m2) cho thay khong co anh huong len kha nang sinh san hoac giao phoi. Suy giam kha nang sinh san: Cac nghien cuu ve kha nang sinh san 6 chuot cong cho uong tdi lieu 300 mg/kg/ngay (khoang 1,1 lan lieu khuyen cao cao nhat 6 nguoi truong thanh tinh theo mg/m2) cho thay khong co anh huong len kha nang sinh san hoac giao phoi. 6. Cac dac tinh duoc hoc 6.1. Danh muc ta duoc Alcol isopropyl, propylene glycol, nuoc cat, acid hydrochloric va natri hydroxyd. 6. Cac dac tinh dugc hoc 6.1. Danh muc ta dugc Alcol isopropyl, propylen glycol, nuoc cat, acid hydrocloric va natri hydroxyd Huong dan sir dung/gach dung 6.6. Luu y dac biet khi loai bo va cac thao tac khac Duoc st co the co-ehai da dugc- lap rap cho ban, trong truong hgp do, dung cu boi da dugc lap san 6 dau chai. Dugc st co the da lap rap chai cho ban, trong truong hgp do, dung cu boi da dugc lap san 6 dau chai. 6

13 Tieu chuan thuoc thanh pham: Nha san xuat. Tieu chuan: Nha san xuat Nhan hieu da dang ky LPD Date: 30 Dec 2014 Reference CDS date: 02 Jul

NO CIIOONG THUONG NIEN NAM 2017 DAI H(.M DONG COn Vietcombank ran HANiOf-JMCP DAI THlTONG VIET NAM C0NG HOA XA HOl CHU NGHIA VIET NAM Doc lap - Tur do

NO CIIOONG THUONG NIEN NAM 2017 DAI H(.M DONG COn Vietcombank ran HANiOf-JMCP DAI THlTONG VIET NAM C0NG HOA XA HOl CHU NGHIA VIET NAM Doc lap - Tur do - Hanh phuc Dia< M3D1 16/12/201 ~.98 T*. Khai,HaN6i