CELLCEPT CAPSULE 250 mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

MYCOPHENOLATE MOFETIL

Available from:

ROCHE SINGAPORE PTE. LTD.

ATC code:

L04AA06

Dosage:

250 mg

Pharmaceutical form:

CAPSULE

Composition:

MYCOPHENOLATE MOFETIL 250 mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

Delpharm Milano S.r.l. (Primary and Secondary Packager)

Authorization status:

ACTIVE

Authorization date:

1997-03-26

Patient Information leaflet

 
1 
CELLCEPT®                         

Mycophenolate mofetil                            

1.   DESCRIPTION 
1.1 THERAPEUTIC / PHARMACOLOGIC CLASS OF DRUG 
IMMUNOSUPPRESSANT; INOSINE MONOPHOSPHATE DEHYDROGENASE (IMPDH) INHIBITOR 

1.2 TYPE OF DOSAGE FORM 
_Oral administration: _
CellCept is supplied as capsules and tablets. 

1.3 QUALITATIVE AND QUANTITATIVE COMPOSITION 
_Active ingredient:_ mycophenolate mofetil. 

_Oral administration:  _
Each  capsule  contains  250  mg  mycophenolate  mofetil;  each  tablet  contains  500  mg  mycophenolate 
mofetil. 

2.   CLINICAL PARTICULARS 
2.1 THERAPEUTIC INDICATION(S) 
CellCept  is  indicated  for  the  prophylaxis  of  acute  organ  rejection  and  for  the  treatment  of  refractory 
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  is  indicated  for  the  prophylaxis  of  acute  organ  rejection  in 
patients  receiving  allogeneic  hepatic  transplants.  CellCept  should  be  used  concomitantly  with 
cyclosporin and corticosteroids. 

2.2 DOSAGE AND ADMINISTRATION 
_Standard Dosage for prophylaxis of renal rejection_ 
A dose of 1 g administered twice a day (daily dose of 2 g)  is recommended  for use  in renal transplant 
patients.  Although a dose of 1.5g administered twice daily (daily dose of 3g) was used in clinical trials 
and was shown to  be safe and effective, no efficacy advantage could be established  for renal transplant 
patients. Pati

Summary of Product characteristics

1
PLEASE VISIT WWW.ROCHE.COM.SG/PHARMA/CELLCEPT FOR A PRINTABLE VERSION
OF THIS LEAFLET.
INF/ORAL-CEL-2022 12-0
CELLCEPT®
Mycophenolate mofetil
1.
DESCRIPTION
1.1.
THERAPEUTIC / PHARMACOLOGIC CLASS OF DRUG
IMMUNOSUPPRESSANT; INOSINE MONOPHOSPHATE DEHYDROGENASE (IMPDH)
INHIBITOR
1.2.
TYPE OF DOSAGE FORM
_Oral administration: _
CellCept is supplied as capsules and tablets.
_Intravenous administration: _
CellCept is supplied in single-use vials as powder for solution for
infusion.
1.3.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Active ingredient:_
mycophenolate mofetil.
_ _
_Oral administration: _
Each capsule contains 250 mg mycophenolate mofetil; each tablet
contains 500 mg mycophenolate
mofetil.
_Intravenous administration _
Each vial contain the equivalent to 500mg mycophenolate mofetil (as
the hydrochloride salt).
2.
CLINICAL PARTICULARS
2.1,
THERAPEUTIC INDICATION(S)
CellCept is indicated for:

prophylaxis of acute organ rejection and treatment of refractory organ
rejection in patients
receiving allogeneic renal transplants.

prophylaxis of acute organ rejection and increased graft and patient
survival in patients receiving
allogeneic cardiac transplants.

prophylaxis of acute organ rejection in patients receiving allogeneic
hepatic transplants.
CellCept should be used concomitantly with cyclosporin and
corticosteroids.
2.2.
DOSAGE AND ADMINISTRATION
Please refer to full prescribing information for corticosteroids and
either ciclosporin or tacrolimus, which
are used in combination with CellCept.
_Standard Dosage for prophylaxis of renal rejection_
A dose of 1 g administered orally or intravenously (over NO LESS THAN
2 HOURS) twice a day (daily
dose of 2 g) is recommended for use in renal transplant patients.
Although a dose of 1.5g administered
twice daily (daily dose of 3g) 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 2g per day of
CellCept demonstrated an overall better safety profile