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• ISSN: 0125-913X • CDK-279/ vol. 46 no. 8 • September 2019 • http://www.kalbemed.com/CDK 616

CDK-279/ vol. 46 no. 8 • September 2019

Bioekuivalen
Bioekuivalen terhadap
terhadapOriginator
1
Originator1

Profil
Profil Keamanan
Keamananpada
padaGinjal
GinjalRelatif
RelatifBaik
Baik
& Tingkat Viral Breakthrough Rendah2 2
& Tingkat Viral Breakthrough Rendah

Terbukti Menunjukkan Perbaikan

Terbukti Menunjukkan
Histologi Perbaikan
dan Fibrosis dengan
Histologi
Terapi dan Fibrosis
Jangka Panjang3dengan
Terapi Jangka Panjang3 571 592 605
Referensi
1. Bioequivalence study of 0.5 mg Entecavir film coated tablet (TKV® 0.5 mg) manufactured by PT. Kalbe Farma Tbk for PT. Dankos Farma in comparison with 0.5 mg Baraclude® film coated tablet manufactured by Bris
Referensi
tol-Myers Squibb Company, Indiana, USA, imported by PT. Taisho Pharmaceutical Indonesia Tbk, Depok, Indonesia. Jakarta, Indonesia: PT. Kalbe Farma Tbk; 2017.
2. Tsai MC, Chen
1. Bioequivalence studyCH,
ofTseng
0.5 mg PL,Entecavir
Hung CH,film
Chiu KW, Wang
coated tabletJH, et al.0.5
(TKV® Comparison of renal safety
mg) manufactured and
by PT. efficacy
Kalbe of telbivudine,
Farma entecavir
Tbk for PT. Dankos and tenofovir
Farma treatment
in comparison within0.5chronic hepatitis Bfilm
mg Baraclude® patients:
coatedreal world
tablet experience. Clin
manufactured by Bris
Microbiol
tol-Myers SquibbInfect. 2016;22(1):95.e1-95.e7.
Company, doi: 10.1016/j.cmi.2015.05.035.
Indiana, USA, imported by PT. Taisho Pharmaceutical Indonesia Tbk, Depok, Indonesia. Jakarta, Indonesia: PT. Kalbe Farma Tbk; 2017.
2. Tsai3.MC,
Chang
ChenTT, Liaw
CH, YF, Wu
Tseng PL, SS,
HungSchiff
CH,E,Chiu
Han KW,
KH, Lai
WangCL, JH,
et al.
etLong-term entecavir
al. Comparison therapy
of renal results
safety in the reversal
and efficacy of fibrosis/cirrhosis
of telbivudine, entecavir and
and continued histological
tenofovir treatment inimprovement in patients
chronic hepatitis with real
B patients: chronic hepatitis
world B. Hepatology
experience. Clin
2010;52:886-93.
Microbiol Infect. 2016;22(1):95.e1-95.e7. doi: 10.1016/j.cmi.2015.05.035.
3. Chang TT, Liaw YF, Wu SS, Schiff E, Han KH, Lai CL, et al. Long-term entecavir therapy results in the reversal of fibrosis/cirrhosis and continued histological improvement in patients with chronic hepatitis B. Hepatology
2010;52:886-93.
Untuk informasi lebih lanjut, hubungi:
PT KALBE FARMA Tbk.
Untuk informasi lebih lanjut, hubungi:
Gedung Kalbe
PT KALBE FARMA Tbk.
Jl. Let. Jend. Suprapto kav. 4, Jakarta 10510
Gedung Kalbe
PO BOX 3105 JAK, Jakarta – Indonesia
Jl. Let. Jend. Suprapto kav. 4, Jakarta 10510 HASIL PENELITIAN TINJAUAN PUSTAKA LAPORAN KASUS
Telp : (021) 428 738 88-89
POFaksBOX 3105 JAK,: Jakarta – Indonesia
(021) 426 4428 Hubungan antara Kecerdasan Ekstraksi Benda Asing di
Telp : (021) 428 738 88-89 Emosional dan Tingkat Gejala
Faks
Website : www.kalbemed.com
: (021) 426 4428 Kecemasan Mahasiswa Program
Tatalaksana Purpura Trombostipenik Laringofaring Anak Menggunakan
Website : www.kalbemed.com Studi Kedokteran tingkat I Fakultas Imun pada Anak Kateter Foley
Kedokteran Universitas Tanjungpura