Myclausen
Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Indlægsseddel
(PIL)
11-04-2024
Produktets egenskaber
(SPC)
11-04-2024
Offentlige vurderingsrapport
(PAR)
25-11-2011
Aktiv bestanddel:
mycophenolate mofetil
Tilgængelig fra:
Passauer Pharma GmbH
ATC-kode:
L04AA06
INN (International Name):
mycophenolate mofetil
Terapeutisk gruppe:
Immunosuppressants
Terapeutisk område:
Graft Rejection
Terapeutiske indikationer:
Myclausen is indicated in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in patients receiving allogeneic renal, cardiac or hepatic transplants.,
Produkt oversigt:
Revision: 15
Autorisation status:
Authorised
Autorisation dato:
2010-10-07
Indlægsseddel
51
B. PACKAGE LEAFLET
52
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MYCLAUSEN 500 MG FILM-COATED TABLETS
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 Myclausen is and what it is used for
2.
What you need to know before you take Myclausen
3.
How to take Myclausen
4.
Possible side effects
5.
How to store Myclausen
6.
Contents of the pack and other information
1.
WHAT MYCLAUSEN IS AND WHAT IT IS USED FOR
Myclausen contains mycophenolate mofetil.
•
This belongs to a group of medicines called “immunosuppressants”.
Myclausen is used to prevent your body rejecting a transplanted organ.
•
A kidney, heart or liver.
Myclausen should be used together with other medicines:
•
Ciclosporin and corticosteroids.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE MYCLAUSEN
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 MYCLAUSEN
•
If you are allergic
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Produktets egenskaber
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Myclausen 500 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 500 mg mycophenolate mofetil.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
White round film-coated tablets.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Myclausen 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). Tablets should only be prescribed to patients
with a body surface area
greater than 1.5 m
2
, 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 age group is
not recommended.
_Use in cardiac transplant _
_Adults_
Treatment should be initiated within 5 days following transplantation.
The recommended dose in
cardiac transplant patients is 1.5 g administered twice daily (3 g
daily dose).
_Paediatric population _
3
No data are available for paediatric cardiac transplan
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