Mykofenolatmofetil Actavis 250 mg Kapsel, hård

מדינה: שוודיה

שפה: שוודית

מקור: Läkemedelsverket (Medical Products Agency)

מרכיב פעיל:

mykofenolatmofetil

זמין מ:

Ebb Medical AB

קוד ATC:

L04AA06

INN (שם בינלאומי):

mycophenolate mofetil

כמות:

250 mg

טופס פרצבטיות:

Kapsel, hård

הרכב:

mykofenolatmofetil 250 mg Aktiv substans; propylenglykol Hjälpämne; natriumlaurilsulfat Hjälpämne

סוג מרשם:

Receptbelagt

leaflet_short:

Förpacknings: Blister, 100 kapslar

מצב אישור:

Avregistrerad

תאריך אישור:

2016-10-19

עלון מידע

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MYKOFENOLATMOFETIL ACTAVIS 250 MG CAPSULES, HARD
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 Mykofenolatmofetil Actavis is and what it is used for
2.
What you need to know before you take Mykofenolatmofetil Actavis
3.
How to take Mykofenolatmofetil Actavis
4.
Possible side effects
5.
How to store Mykofenolatmofetil Actavis
6.
Contents of the pack and other information
1.
WHAT MYKOFENOLATMOFETIL ACTAVIS IS AND WHAT IT IS USED FOR
Mykofenolatmofetil Actavis contains mycophenolate mofetil.
-
This belongs to a group of medicines called “immunosuppressants”.
Mykofenolatmofetil Actavis is used to prevent your body rejecting a
transplanted organ.
-
A kidney, heart or liver.
Mykofenolatmofetil Actavis should be used together with other
medicines:
-
Ciclosporin and corticosteroids.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE MYKOFENOLATMOFETIL ACTAVIS
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

מאפייני מוצר

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Mykofenolatmofetil Actavis 250 mg capsules, hard
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
Light blue/peach, size 1 hard capsule, 18.9 mm ± 0.5 mm in length,
imprinted with MMF on cap and 250 on
body, containing white to off-white powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Mykofenolatmofetil Actavis 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 mak