CELLCEPT

Pays: Indonésie

Langue: indonésien

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

Ingrédients actifs:

MYCOPHENOLATE MOFETIL

Disponible depuis:

BOEHRINGER INGELHEIM INDONESIA - Indonesia

DCI (Dénomination commune internationale):

MYCOPHENOLATE MOFETIL

Dosage:

500 MG

forme pharmaceutique:

KAPLET SALUT SELAPUT

Unités en paquet:

DUS, 5 BLISTER @ 10 KAPLET SALUT SELAPUT

Fabriqué par:

F HOFFMANN LA ROCHE - Switzerland

Date de l'autorisation:

2018-12-31

Résumé des caractéristiques du produit

_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