Country: Индонезија
Језик: Индонежански
Извор: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
MYCOPHENOLATE SODIUM
NOVARTIS INDONESIA - Indonesia
MYCOPHENOLATE SODIUM
192.40 MG
TABLET SALUT ENTERIK
DUS, 5 BLISTER @ 10 TABLET SALUT ENTERIK
NOVARTIS PHARMA PRODUKTIONS GMBH - Federal Republic of Germany
2021-03-28
1 MYFORTIC Immunosuppressant DESCRIPTION AND COMPOSITION PHARMACEUTICAL FORM Myfortic 180 mg enteric coated tablet: comes as a lime green, film coated round tablet, with bevelled edges and imprint (debossing) “C” on one side. Myfortic 360 mg enteric coated tablet comes as a pale orange red film-coated ovaloid tablet, with the imprint (debossing) “CT” on one side. ACTIVE SUBSTANCE Each enteric coated tablet contains 180 mg or 360 mg mycophenolic acid/MPA equivalent to 192.4 and 384.4 mycophenolate sodium . ACTIVE MOIETY Mycophenolate sodium is the sodium salt of the active moiety, mycophenolic acid. EXCIPIENTS Maize starch; povidone (K-30); crospovidone; lactose; colloidal silicon dioxide; magnesium stearate. The Myfortic 180 mg enteric coated tablet containing consist of hypromellose phthalate/ hydroxypropyl-methylcellulose phthalate; titanium dioxide; iron oxide yellow; indigotin. The Myfortic 360 mg enteric coated tablet containing consist of hypromellose phthalate/ hydroxypropyl-methylcellulose phthalate; titanium dioxide; iron oxide yellow; iron oxide red. INDICATIONS Myfortic is indicated in combination with ciclosporin for microemulsion and corticosteroids for the prophylaxis of acute transplant rejection in patients receiving allogenic renal transplants. Myfortic is indicated for induction and maintenance treatment of adult patients with WHO Class III, IV or V lupus nephritis. This indication is based on the evidence in literature reports of studies of treatment in patients with lupus nephritis, the majority of whom were ISN/RPS (2003) Class IV. The evidence for efficacy was based on surrogate endpoints. DOSAGE AND ADMINISTRATION DOSAGE The recommended dose is 720 mg (four 180 mg or two 360 mg Myfortic gastro-resistant tablets) administered twice daily (1,440 mg daily dose). In patients receiving mycophenolate mofetil (MMF) 2 g, treatment can be replaced by 720 mg administered twice daily (1,440 mg daily dose) of Myfortic. DISETUJUI OLEH BPOM : 02/03/2021 ID : EREG100005VR12000200 EREG100005VR12000 Прочитајте комплетан документ