Country: Индонезија
Језик: Индонежански
Извор: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
TENOFOVIR ALAFENAMIDE FUMARATE
SOHO INDUSTRI PHARMASI - Indonesia
TENOFOVIR ALAFENAMIDE FUMARATE
28.04 MG
TABLET SALUT SELAPUT
DUS, BOTOL @30 TABLET SALUT SELAPUT
Patheon inc - Canada
2019-01-24
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 Прочитајте комплетан документ