Država: Indonezija
Jezik: indonezijščina
Source: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
MYCOPHENOLATE MOFETIL
BOEHRINGER INGELHEIM INDONESIA - Indonesia
MYCOPHENOLATE MOFETIL
500 MG
KAPLET SALUT SELAPUT
DUS, 5 BLISTER @ 10 KAPLET SALUT SELAPUT
F HOFFMANN LA ROCHE - Switzerland
2018-12-31
_Draft_CellCept_PI_MAT_CDS14.0_EN_v2_ _Page 1 of 21_ CELLCEPT ® Mycophenolate mofetil 1. DESCRIPTION 1.1 THERAPEUTIC/PHARMACOLOGIC CLASS OF DRUG Immunosuppressant; inosine monophosphate dehydrogenase (IMPDH) inhibitor. 1.2 TYPE OF DOSAGE FORM CellCept is supplied as film-coated caplets. 1.3 ROUTE OF ADMINISTRATION Oral administration. 1.4 STERILE/RADIOACTIVE STATEMENT No information. 1.5 QUALITATIVE AND QUANTITATIVE COMPOSITION _Active ingredient:_ mycophenolate mofetil. Each film-coated caplets contains 500 mg mycophenolate mofetil. 2. CLINICAL PARTICULARS 2.1 THERAPEUTIC INDICATION(S) CellCept is indicated for the prophylaxis of acute organ rejection and increased graft and patient survival in patients receiving allogeneic cardiac transplants. CellCept should be used concomitantly with ciclosporin and corticosteroids. CellCept is indicated for induction and maintenance therapy of adult patients with WHO Class III, IV, 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. 2.2 DOSAGE AND ADMINISTRATION TRANSPLANT PATIENTS _Standard dosage for prophylaxis of renal rejection_ The initial dose of CellCept should be given orally within 72 hours following transplantation. Although a dose of 1.5 g administered twice daily (daily dose of 3 g) was used in clinical trials and was shown to be safe and effective, no efficacy advantage could be established for renal transplant patients. Patients receiving 2 g per day of CellCept demonstrated an overall better safety profile compared to patients receiving 3 g per day of CellCept. _Standard dosage for prophylaxis of cardiac rejection_ The initial dose of CellCept should given orally within 5 days following transplantation. A dose of 1.5 g administered twice a day (daily dose of 3 g) is recommended for use in cardiac transplant patients. _Oral administration_ (see_ 3.2.1 Pharmacokine Preberite celoten dokument