VEMLIDY

Land: Indonesien

Sprog: indonesisk

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

Aktiv bestanddel:

TENOFOVIR ALAFENAMIDE FUMARATE

Tilgængelig fra:

SOHO INDUSTRI PHARMASI - Indonesia

INN (International Name):

TENOFOVIR ALAFENAMIDE FUMARATE

Dosering:

28.04 MG

Lægemiddelform:

TABLET SALUT SELAPUT

Enheder i pakken:

DUS, BOTOL @30 TABLET SALUT SELAPUT

Fremstillet af:

Patheon inc - Canada

Autorisation dato:

2019-01-24

Produktets egenskaber

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF MEDICINAL PRODUCT
_1.1 _
_PRODUCT NAME _
Vemlidy™ 25 mg film-coated tablets.
_1.2. _
_STRENGTH _
Tenofovir alafenamide fumarate equivalent to 25 mg of tenofovir
alafenamide.
_1.3 _
_PHARMACEUTICAL DOSAGE FORM _
Film-coated tablet.
2.
QUALITY AND QUANTITATIVE COMPOSITION
_2.1 _
_QUALITATIVE DECLARATION _
Tenofovir alafenamide fumarate
_2.2 _
_QUANTITATIVE DECLARATION_
Each film-coated tablet contains tenofovir alafenamide fumarate
equivalent to 25 mg of
tenofovir alafenamide.
3.
PHARMACEUTICAL FORM
Yellow, round, film-coated tablets,
8 mm in diameter, debossed with “GSI” on one side of the
tablet and “25” on the other side of the tablet.
4.
CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATION _
Vemlidy is indicated for the treatment of chronic hepatitis B in
adults.
_4.2. _
_POSOLOGY AND METHOD OF ADMINISTRATION _
Therapy should be initiated by a physician experienced in the
management of chronic
hepatitis B.
Posology
Adults: one tablet once daily.
_Treatment discontinuation _
Treatment discontinuation may be considered as follows:

In HBeAg-positive patients without cirrhosis, treatment should be
administered for at
least 6-12 months after HBe seroconversion (HBeAg loss and HBV DNA
loss with
anti-HBe detection) is confirmed or until HBs seroconversion or until
there is loss of
efficacy. Regular reassessment is recommended after treatment
discontinuation to
detect virological relapse.

In HBeAg-negative patients without cirrhosis, treatment should be
administered at least
until HBs seroconversion or until there is evidence of loss of
efficacy. With prolonged
treatment for more than 2 years, regular reassessment is recommended
to confirm that
continuing the selected therapy remains appropriate for the patient.
_Missed dose _
If a dose is missed and less than 18 hours have passed from the time
it is usually taken, the
patient should take Vemlidy as soon as possible and then resume their
normal dosing
schedule. If more than 18 hours have passed from the tim