CellCept

Land: Europeiska unionen

Språk: engelska

Källa: EMA (European Medicines Agency)

Aktiva substanser:

mycophenolate mofetil

Tillgänglig från:

Roche Registration GmbH

ATC-kod:

L04AA06

INN (International namn):

mycophenolate mofetil

Terapeutisk grupp:

Immunosuppressants

Terapiområde:

Graft Rejection

Terapeutiska indikationer:

CellCept is indicated in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in patients receiving allogeneic renal, cardiac or hepatic transplants.

Produktsammanfattning:

Revision: 38

Bemyndigande status:

Authorised

Tillstånd datum:

1996-02-14

Bipacksedel

111
B. PACKAGE LEAFLET
112
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CELLCEPT 250 MG HARD CAPSULES
mycophenolate mofetil
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even
if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What CellCept is and what it is used for
2.
What you need to know before you take CellCept
3.
How to take CellCept
4.
Possible side effects
5.
How to store CellCept
6.
Contents of the pack and other information
1.
WHAT CELLCEPT IS AND WHAT IT IS USED FOR
CellCept contains mycophenolate mofetil.
•
This belongs to a group of medicines called “immunosuppressants”.
CellCept is used to prevent your body rejecting a transplanted organ.
•
A kidney, heart or liver.
CellCept should be used together with other medicines:
•
Ciclosporin and corticosteroids.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CELLCEPT
WARNING
Mycophenolate causes birth defects and miscarriage. If you are a woman
who could become pregnant, you
must provide a negative pregnancy test before starting treatment and
must follow the contraception advice
given to you by your doctor.
Your doctor will speak to you and give you written information,
particularly on the effects of
mycophenolate on unborn babies. Read the information carefully and
follow the instructions.
If you do not fully understand these instructions, please ask your
doctor to explain them again before you
take mycophenolate. See also further information in this section under
“Warnings and precautions” and
“Pregnancy and breast-feeding”.
DO NOT TAKE CELLCEPT:
•
If you are allergic to mycophenola

Produktens egenskaper

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
CellCept 250 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 250 mg mycophenolate mofetil.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsules, hard (capsules)
Oblong, blue/brown, branded with black "CellCept 250" on the capsule
cap and "Roche" on the capsule
body.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
CellCept is indicated in combination with ciclosporin and
corticosteroids for the prophylaxis of acute
transplant rejection in patients receiving allogeneic renal, cardiac
or hepatic transplants.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be initiated and maintained by appropriately
qualified transplant specialists.
Posology
_Use in renal transplant _
_Adults _
Treatment should be initiated within 72 hours following
transplantation. The recommended dose in renal
transplant patients is 1 g administered twice daily (2 g daily dose).
_Paediatric population aged 2 to 18 years _
The recommended dose of mycophenolate mofetil is 600 mg/m
2
administered orally twice daily (up to a
maximum of 2 g daily). Capsules should only be prescribed to patients
with a body surface area of at least
1.25 m
2
. Patients with a body surface area of 1.25 to 1.5 m
2
may be prescribed mycophenolate mofetil
capsules at a dose of 750 mg twice daily (1.5 g daily dose). Patients
with a body surface area greater than
1.5 m
2
may be prescribed mycophenolate mofetil capsules at a dose of 1 g
twice daily (2 g daily dose). As
some adverse reactions occur with greater frequency in this age group
(see section 4.8) compared with
adults, temporary dose reduction or interruption may be required;
these will need to take into account
relevant clinical factors including severity of reaction.
_Paediatric population < 2 years _
There are limited safety and efficacy data in children below the age
of 2 years. These are insufficient to
make dosage recommendations and therefore use in this ag