Negara: Indonesia
Bahasa: Bahasa Indonesia
Sumber: 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
DELPHARM MILANO S.R.L - Italy
2020-04-16
_Draft_CellCept_PI_Safety update_CDS 17.0 and 18.0_EN_v4_ _Page 1 of 22_ CELLCEPT ® Mycophenolate mofetil 1. DESCRIPTION 1.1 THERAPEUTIC/PHARMACOLOGIC CLASS OF DRUG Selective immunosuppressive agent – mycophenolic acid. ATC code: L04AA06. 1.2 TYPE OF DOSAGE FORM CellCept is supplied as film-coated caplets. 1.3 ROUTE OF ADMINISTRATION Oral. 1.4 STERILE/RADIOACTIVE STATEMENT Not applicable. 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) TRANSPLANT PATIENTS CellCept is indicated for the prophylaxis of acute organ rejection in patients receiving allogeneic renal transplants. 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. LUPUS NEPHRITIS PATIENTS 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 CellCept oral dosage forms SHOULD NOT BE SWITCHED WITH MYCOPHENOLIC ACID DELAYED-RELEASE TABLETS WITHOUT SUPERVISION OF A PHYSICIAN WITH EXPERIENCE IN IMMUNOSUPPRESSIVE THERAPY because the rates of absorption following the administration of CellCept oral dosage forms and mycophenolic acid delayed-release tablets are not equivalent. 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 Baca dokumen lengkapnya