HEPSERA

Land: Indonesien

Sprog: indonesisk

Kilde: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Aktiv bestanddel:

ADEFOVIR DIPIVOXIL

Tilgængelig fra:

SMITH KLINE BEECHAM PHARMACEUTICAL IND. - Indonesia

INN (International Name):

ADEFOVIR DIPIVOXIL

Dosering:

10 MG

Lægemiddelform:

TABLET

Enheder i pakken:

DUS, BOTOL PLASTIK @ 30 TABLET

Fremstillet af:

GLAXO SMITHKLINE Co. Ltd - (Tianjin) China

Autorisation dato:

2017-12-06

Produktets egenskaber

Page 1 of 10
HEPSERA
ADEFOVIR DIPIVOXIL
1. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet for oral use contains 10 mg adefovir dipivoxil. For
excipients, see List of Excipients.
2. PHARMACEUTICAL FORM
_HEPSERA_ tablets, 10 mg, are white to off-white, round, flat-faced
tablets with a beveled edge and
debossed with “GSK KNU” on one side and blank on the other side.
3. CLINICAL PARTICULARS
3.1 INDICATIONS
_HEPSERA_ is indicated for the treatment of chronic hepatitis B in
adults with evidence of hepatitis
B viral replication.
Reductions in viral replication and improvements in liver function
have also been demonstrated in
supportive studies in a limited number of chronic hepatitis B patients
with genotypic evidence of
lamivudine-resistance.
3.2 DOSAGE AND ADMINISTRATION
ADULTS (18-65 YEARS)
The recommended dose of _HEPSERA _is 10 mg (one tablet) once daily
taken orally with or without
food.
The indication has been obtained primarily based on clinical trials of
48 weeks duration. The
optimum duration of treatment is unknown.
The relationship between treatment response and long-term outcomes
such as hepatocellular
carcinoma or decompensated cirrhosis is not known.
Higher dose must not be administered.
Patients should be monitored every six months for hepatitis B
biochemical, virological and
serological markers.
_ _
CHILDREN AND ADOLESCENTS (<18 YEARS)
The safety and efficacy of _ HEPSERA_ in patients under the age of 18
years have not been
established (_see Warnings and Precautions_).
ELDERLY (>65 YEARS)
The safety and efficacy of _HEPSERA_ in patients over the age of 65
years have not been established
(_see Warnings and Precautions_). Caution should be exercised when
prescribing _HEPSERA_ to the
elderly, keeping in mind the greater frequency of decreased renal or
cardiac function in these
patients,
and
the
increase
in
concomitant
diseases
or
use
of
other
medicinal
products
concomitantly in the elderly.
RENAL IMPAIRMENT
Adefovir is eliminated by renal excretion, therefore adjustments of
the dosing interval ar