CELLCEPT FOR I.V. INFUSION 500 mgvial

Country: Սինգապուր

language: անգլերեն

source: HSA (Health Sciences Authority)

active_ingredient:

MYCOPHENOLATE MOFETIL

MAH:

ROCHE SINGAPORE PTE. LTD.

ATC_code:

L04AA06

dosage:

500 mg/vial

pharmaceutical_form:

INJECTION, POWDER, FOR SOLUTION

composition:

MYCOPHENOLATE MOFETIL 500 mg/vial

administration_route:

INTRAVENOUS

prescription_type:

Prescription Only

manufactured_by:

Roche Diagnostics GmbH

authorization_status:

ACTIVE

authorization_date:

2000-05-22

PIL

 
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 
_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. 

_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 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 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�

SPC

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