CELLCEPT

Negara: Indonesia

Bahasa: Bahasa Indonesia

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

Bahan aktif:

MYCOPHENOLATE MOFETIL

Tersedia dari:

BOEHRINGER INGELHEIM INDONESIA - Indonesia

INN (Nama Internasional):

MYCOPHENOLATE MOFETIL

Dosis:

500 MG

Bentuk farmasi:

KAPLET SALUT SELAPUT

Unit dalam paket:

DUS, 5 BLISTER @ 10 KAPLET SALUT SELAPUT

Diproduksi oleh:

F HOFFMANN LA ROCHE - Switzerland

Tanggal Otorisasi:

2018-12-31

Karakteristik produk

_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