CellCept

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Mycophenolate mofetil 500mg;  

Available from:

Roche Products (NZ) Ltd

INN (International Name):

Mycophenolate mofetil 500 mg

Dosage:

500 mg

Pharmaceutical form:

Tablet

Composition:

Active: Mycophenolate mofetil 500mg   Excipient: Croscarmellose sodium Magnesium stearate Microcrystalline cellulose Opadry lavender Y-5-10272-A Povidone

Units in package:

Blister pack, white opaque PVC, 50 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Roche Ireland Ltd

Therapeutic indications:

CellCept is indicated for the prophylaxis of solid organ rejection in adults receiving allogeneic organ transplants. CellCept is indicated for the prophylaxis of organ rejection in paediatric patients (2 to 18 years) receiving allogeneic renal transplants.

Product summary:

Package - Contents - Shelf Life: Blister pack, white opaque PVC - 50 tablets - 36 months from date of manufacture stored at or below 25°C

Authorization date:

1995-01-12

Patient Information leaflet

CellCept
®
20210329
1
_ _
CONSUMER MEDICINE INFORMATION
CELLCEPT
®
MYCOPHENOLATE MOFETIL
250 MG CAPSULES
500 MG TABLETS
500 MG POWDER FOR SOLUTION FOR INFUSION
200 MG/ML ORAL SUSPENSION (WHEN RECONSTITUTED)
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about CellCept capsules,
tablets, infusion and
oral suspension.
It does not contain all the available information.
It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the
risks of you taking
CellCept against the benefits expected for you.
IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR
OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT CELLCEPT IS USED FOR
CellCept contains the active ingredient mycophenolate mofetil.
CellCept belongs to a group of medicines called immunosuppressants.
Immunosuppressants
are used to prevent rejection of transplanted organs, and work by
stopping your immune
system from reacting to the transplanted organ.
CellCept may be used together with other medicines known as
cyclosporin and
corticosteroids.
Your doctor, however, may have prescribed CellCept for another
purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS WHY CELLCEPT HAS BEEN
PRESCRIBED FOR YOU.
This medicine is available only with a doctor’s prescription.
BEFORE YOU TAKE CELLCEPT
_WHEN YOU MUST NOT TAKE IT _
CellCept
®
20210329
2
_ _
DO NOT TAKE CELLCEPT IF:
1.
YOU HAVE HAD AN ALLERGIC REACTION TO CELLCEPT OR ANY INGREDIENTS
LISTED AT THE END OF
THIS LEAFLET
Symptoms of an allergic reaction include swelling, itching, rash,
breathing difficulties.
2.
YOU ARE PREGNANT
CellCept is harmful to an unborn baby when taken by a pregnant woman.
There have
been cases of miscarriage and severe birth defects reported in
patients exposed to
CellCept during pregnancy. You must tell your doctor if you are
pregnant or plan to
become pregnant.
3.
YOU ARE BREASTFEEDING
CellCept may pass into human breast milk and could cause serious side

Summary of Product characteristics

NEW ZEALAND DATA SHEET
Cellcept 210120
_ _
_ _
_ _
1
_ _
1.
PRODUCT NAME
CellCept 250 mg hard capsules
CellCept 500mg film-coated tablets
CellCept 500 mg powder for infusion.
CellCept 200 mg/mL powder for oral suspension
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
CellCept 250 mg hard capsules - each capsule contains 250mg of
mycophenolate mofetil
CellCept 500mg film-coated tablets - each tablet contains 500mg
mycophenolate mofetil
CellCept 500 mg powder for infusion - each vial contains 500 mg
mycophenolate mofetil (as
hydrochloride salt)
CellCept 200 mg/mL powder for oral suspension – each bottle contains
35 g mycophenolate
mofetil in 110 g powder for oral suspension. 5 mL of the reconstituted
suspension contains 1
g of mycophenolate mofetil.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
CellCept capsules are oblong, blue/brown, branded with black "CellCept
250" on the capsule
cap and "Roche" name on the capsule body.
CellCept tablets are lavender coloured capsule-shaped, engraved with
"CellCept 500" on one
side and "Roche" on the reverse.
CellCept powder for infusion is a sterile lyophilised white to
off-white powder.
CellCept 200 mg/mL powder for oral suspension
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
CellCept is indicated for the prophylaxis of solid organ rejection in
adults receiving allogeneic
organ transplants.
CellCept is indicated for the prophylaxis of organ rejection in
paediatric patients (2 to 18 years)
receiving allogeneic renal transplants.
Cellcept 210120
2
_ _
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSE
The
initial
dose
of
CellCept
should
be
given
as
soon
as
clinically
feasible
following
transplantation. Intravenous administration is recommended in those
patients unable to take oral
medication. However, oral administration should be initiated as soon
as possible.
ADULTS
RENAL TRANSPLANTATION
The recommended dose in renal transplant patients is 1 g administered
orally or intravenously
twice daily (2 g daily dose).
CARDIAC TRANSPLANTATION
The
recommended
do