Baraclude 0.5 mg

Country: Jórdanía

Tungumál: enska

Heimild: JFDA (Jordan Food & Drug Administration - المؤسسة العامة للغذاء والدواء)

Virkt innihaldsefni:

Entecavir 0.5 mg

Fáanlegur frá:

مستودع أدوية الشرق شخشير - ORIENT DRUG STORE CO

ATC númer:

J05AF10

INN (Alþjóðlegt nafn):

Entecavir 0.5 mg

Skammtar:

0.5 mg

Einingar í pakka:

30

Framleitt af:

ASTRAZENECA PHARMACEUTICALS LP/USA (امريكا)

Upplýsingar fylgiseðill

1
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE
HIGHLIGHTS
DO
NOT
INCLUDE
ALL
THE
INFORMATION
NEEDED
TO
USE
BARACLUDE SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
BARACLUDE.
BARACLUDE
 (ENTECAVIR) TABLETS, FOR ORAL USE
BARACLUDE
 (ENTECAVIR) ORAL SOLUTION
INITIAL U.S. APPROVAL: 2005
WARNING: SEVERE ACUTE EXACERBATIONS OF
HEPATITIS B, PATIENTS CO-INFECTED WITH HIV AND HBV,
AND LACTIC ACIDOSIS AND HEPATOMEGALY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING. _

SEVERE ACUTE EXACERBATIONS OF HEPATITIS B HAVE BEEN REPORTED IN
PATIENTS WHO HAVE DISCONTINUED ANTI-HEPATITIS B THERAPY, INCLUDING
ENTECAVIR. HEPATIC FUNCTION SHOULD BE MONITORED CLOSELY FOR AT LEAST
SEVERAL MONTHS AFTER DISCONTINUATION. INITIATION OF ANTI-HEPATITIS B
THERAPY MAY BE WARRANTED. (5.1)

BARACLUDE IS NOT RECOMMENDED FOR PATIENTS CO-INFECTED WITH
HUMAN IMMUNODEFICIENCY VIRUS (HIV) AND HEPATITIS B VIRUS (HBV)
WHO ARE NOT ALSO RECEIVING HIGHLY ACTIVE ANTIRETROVIRAL THERAPY
(HAART), BECAUSE OF THE POTENTIAL FOR THE DEVELOPMENT OF RESISTANCE
TO HIV NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS. (5.2)

LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS, INCLUDING
FATAL CASES, HAVE BEEN REPORTED WITH THE USE OF NUCLEOSIDE ANALOGUE
INHIBITORS. (5.3)
---------------------------INDICATIONS AND
USAGE----------------------------
BARACLUDE is a hepatitis B virus nucleoside analogue reverse
transcriptase
inhibitor indicated for the treatment of chronic hepatitis B virus
infection in
adults and children at least 2 years of age with evidence of active
viral
replication
and
either
evidence
of
persistent
elevations
in
serum
aminotransferases (ALT or AST) or histologically active disease. (1)
------------------------DOSAGE AND
ADMINISTRATION----------------------

Nucleoside-inhibitor-treatment-naïve
with
compensated
liver
disease
(greater than or equal to 16 years old): 0.5 mg once daily. (2.2)

Nucleoside-inhibitor-treatment-naïve and lamivudine-experienced
pediatric
patients at least 2 years of age and weighin