UBNDTHANHPHOcANTHO CONG HOA XA HOI CHU NGHiA VI¢T NAM SOYTE DQc L~p - TV Do - H~nh Phuc

s6: gI.e /SYT-NVD Cdn Ther, ngay 14thang 4 ndm 2014 V/v C?P nhat thong tin lien quan oen thu6c chua epoetin alpha

Kinh giri: - Cac don vi t11JC thuoc So; - Cac dan vi san xuat, kinh doanh diroc pham; - Benh vien Da khoa Trung irong C~n ThO'; - Benh vien Dai hoc Y duoc Can ThO'; - B~nh vien 121 - Quan khu 9; - Benh vien Cong an ck ThO'; - Cac benh vien tu nhan; - Ban Bao v~ sire khoe Thanh uy; - Dai Phat thanh va Truyen hinh TP Can ThO'; - Bao Can ThO'; - HQi Diroc hoc C~n ThO'.

C\lC Quan ly duoc - BQ Y t~ co Cong van s6 4764/QLD-DK ngay 28/3/2014 v~ viec C?P nhat thong tin lien quan d~n thuoc chua epoetin alpha.

Ngay 29/8/2013, CO' quan Quan ly y t~ Singapore (HAS) dil canh bao vS SlJ gia tang cac tnrong hop co hoi clnrng bit san hong c~u don thuan (PRCA) lien quan d~n viec sir dung Eprex (heat chit chinh la epoetin alpha hoac co ten khac la erythropoietin) duong tiem duoi da tai Singapore. Ngay 02/10/2013, HAS da gui thu d~n can bo y tS thong bao chong chi dinh dirong tiem diroi da tren benh nhan mac benh than man tinh tai Singapore d6i voi san pham Eprex.

Tai Viet Nam, thea bao cao tir Trung tam DI & ADR Quoc gia nr nam 2010 d~n h~t thang 8/2013 trung tam dil ghi nhan 08 bao cao vS PRCA co lien quan dSn viec sir dung epoetin alpha duong tiem diroi da tren benh nhan mac benh than man tinh,

Can cir k~t luan cua HQi d6ng tir vin cip S6 dang ky - BQ Y tS d6i voi thuoc chua epoetin alpha; nham dam baa muc tieu sir dung thuoc hop ly, an toan va hieu qua, SO' Y tS thong bao:

1. Cac CO' so kham, chua benh, cac don vi kinh doanh dircc pham tren dia ban, cac can bQ y tS:

- C?P nhat thong tin lien quan dSn thuoc chua thanh phan epoetin alpha (co ten khac la erythropoietin) tai Cong van nay (chi tiSt trong phu luc dinh kern) .

- Tang cuong viec thea doi tac dung khong mong muon cua thuoc trong qua trinh sir dung va hru hanh; gui bao cao ADR (neu co) vS SO' Y t~ thanh ph6 C~n ThO' va Trung tam QU6c gia vS Thong tin thuoc va Theo doi phan irng co hai cua thuoc (13-15 Le Thanh Tong, quan Hoan Kiem, Ha N9i) hoac Trung tam khu VlJC vS Thong tin thuoc va Thea doi phan irng co hai cua thuoc TP. H6 Chi Minh (201B Nguyen Chi Thanh, quan 5, TP . H6 Chi Minh).

:2. Cac Cong ty dang ky san xuat: l) D6i voi thuoc chua thanh phan epoetin alpha da ducc cap phep Iuu hanh tren

thi tnrong: - Trang vong 03 thang kS ill ngay 28/3/2014, yeu c~u Cong ty dang ky,

nha san xuat thirc hien viec c~p nhat thong tin lien quan d~n duong dung, chong chi dinh, canh bao, than trong khi sir dung & bao quan thea cac noi dung quy dinh tai Phu luc kern thea Cong van nay vao nhan, to' huang d~n str dung, t6m t~t d~c tinh san pham.

- Hinh thirc b6 sung: Cac Cong ty ti~n hanh c~p nhat thong tin d6i voi thu6c chua thanh phk epoetin alpha nhu da neu tren thea hinh thirc nQP h6 sa thay d6i, b6 sung qui dinh tai Phu luc II - Thong nr 22/2009/TT-BYT ngay 24/11/2009 cua bQ Y t~ quy dinh viec dang ky thuoc va chiu trach nhiem vS cac noi dung b6 sung theo dung yeu c~u tai Cong van nay.

• D6i voi cac h6 sa dang ky thuoc chua heat ch~t epoetin alpha dang cho xet duyet tai C\lC Quan Iy duoc:

Cue Quan ly diroc chi xem xet c~p S6 dang ky sau khi Cong ty nop tai lieu sua d6i/b6 sung cac noi dung lien quan d~n dirong dung, each dung, chong chi dinh, canh bao va than trong khi sir dung va bao quan thea huang d~n tai Phu J\lC kern thea Cong van nay vao cac ph~n lien quan cua h6 sa va diroc tham dinh dat yeu e~u .

Sa Y t~ thong bao dS cac dan vi bi~t va thirc hien.'.

(Dinh kem Phu luc dinh kem thea Cong win s6 47641QLD-DI< ngay 28 thang 3 ndm 2014)

Noi nlt(in: -Nhu tren -Thanh tra Sa, NYY -Luu YP, NVD

Cac flQi dung thay d6i/b& sung dSi vOi tlm5c chua epoetin alpha

A ~ :.!f?hCj -, ngay r.,-.... j P/;~(L./(Dinh kem t ' heo cong van so /QLD DK ' ?C / / ..c.+-!'..7

1. Lien quan dSn duong dung:

1.1D6i voi chS pham epoetin alpha su dung albumin huyet thanh nguoi (HSA) lam ch~t bao quan:

Muc Dtrong dung va each dung:

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D6i voi benh nhan mac b~OO than man tinh, Uti tien dung duong tiem tinh mach cho benh nhan thftm tach mau va tham phan phuc mac. Truong hQ]J khong thS dung dirong tiem tinh mach, co thS dung Quang tiem duoi da sau khi Qff can nhac ley loi ich/ nguy ca.

1.2 D6i voi chS phftm epoetin alpha sir dung polysorbat 80 lam ch~t bao quan (HSA-free):

Muc Duirng dung va cdch dung:

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Chi nen dung duong tiem tinh mach cho benh nhan m~c benh than man tinh.

2. Muc Chdng chi djnh:

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Benh nhan off co tiSn trien clnrng b~t san hong c~u dan thuan (PRCA) sau khi diSu tri bang cac chS pham chua erythropoietin. (xem them IDl,lC Than trong va canh bao a~c biet khi sir dung thuoc va muc Tac dung khong mong muon)

3. M\lC Th~n trong va di!!h bao tliJc bi?-t khi sir dung t!;uac;

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Chirng b~t san hong c~u dan thu§n (PRCA) lien quan dSn viec sir dung cac erythropoietin aff duoc ghi nhan voi tY 1~ r~t hiem g~p. PRCA xay ra chu yeu tren benh nhan m~c benh than man tinh su dung erythropoietin dirong tiem diroi da. H9i clnrng nay diroc rna ta b61 hien tuong m~t/ giam d91 ngot hieu qua cua thuoc, tinh trang thieu mau trfun trong them, giam hemoglobin (1-2g/dI hoac 6,62-1,25 mmol/l m6i thang), s6 hrong hong e~u hroi thap « 10 000 tS bao/ml) va S\I co m~t khang thS trung hoa khang erythropoietin.

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C&n theo d5i ch~t che Gap trng cua benh nhan trong qua trinh diSu tri , NSu hieu qua bi giam hoac m~t Q(>t ngot, tinh trang thieu mau tram trong them, c~n danh gia nhiing nguyen nhan khac co thS gay hien nrong khong dap irng voi thuoc OOu: thiSu hut s~t, folat, vitamin B 12; nhiSm d(>c nhom, nhiem khuan hoac viern, m~t mau va tham tach mau. NSu nghi ngo b~t san hong c~u dan thufu1 (PRCA) va khong phat hien ra cac nguyen nhan khac, cftn ngirng dung epoetin alpha, lam xet nghiem khang thS khang erythropoietin va illy xirong d6. Khong nen chuyen sang cac erythropoietin khac do khang thS co kha nang pharr irng cheo gina cac erythropoietin. Cftn loai tnr cac nguyen nhan khac co thS gay PRCA va ap dung cac bien phap xu tri phu hop,

4. Muc Tdc dung khtmg mong mu8n:

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Chirng b~t san hong cftu don thuan (PRCA) sau nhiSu thang dSn nhieu nam diSu tri bfulg erythropoietin da diroc ghi nhan voi tY 1~ r~t hiern g~p «1/10 000). (xem them muc Than trong va canh bao d~c biet khi su dung thuoc).

5. Muc EJiJu ki?n biio quan:

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Tuan thu chat che cac diSu kien bao quan: bao quan a2-8°C trong bao bi dong goi ban d~u va khong dS dong da,

LU'u y: Truong hop benh nhan tv dung thuoc tai nha: can b(> y tS cftn thong tin cho benh nhan biet vS each bao quan chS pham epoetin alpha dS dam bao viec tuan thu dung diSu kien bao quan nhir khuyen cao neu tren,