CELLCEPT 250 MG

Land: Israel

Sprog: engelsk

Kilde: Ministry of Health

Aktiv bestanddel:

MYCOPHENOLATE MOFETIL

Tilgængelig fra:

ROCHE PHARMACEUTICALS (ISRAEL) LTD

ATC-kode:

L04AA06

Lægemiddelform:

CAPSULES

Sammensætning:

MYCOPHENOLATE MOFETIL 250 MG

Indgivelsesvej:

PER OS

Recept type:

Required

Fremstillet af:

HOFFMANN LA ROCHE, SWITZERLAND

Terapeutisk gruppe:

MYCOPHENOLIC ACID

Terapeutisk område:

MYCOPHENOLIC ACID

Terapeutiske indikationer:

Prophylaxis of rejection in renal allograft recepients, and in patients reciving allogenic cardiac transplants. Cellcept should be used concomitantly with cyclosporin and corticosteroids.Allogenic hepatic transplant.

Autorisation dato:

2023-06-30

Indlægsseddel

CellCept PL version 9
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) – 198
This medicine is dispensed with a doctor’s prescription only
CELLCEPT
®
250 MG
Capsules
CELLCEPT
®
500 MG
Tablets
COMPOSITION:
Each capsule contains:
Each film-coated tablet contains:
Mycophenolate mofetil
250 mg
Mycophenolate mofetil
500 mg
*For information on the inactive
ingredients and allergens, see section 2
“Before using the medicine” and section 6
“Further Information”.
READ
THIS
LEAFLET
CAREFULLY
IN
ITS
ENTIRETY BEFORE USING THE MEDICINE.
This
leaflet
contains
concise
information about the medicine. If you
have further questions, refer to the
doctor or pharmacist. This medicine
has been prescribed to treat your illness only. Do not pass it
on to others. It may harm them even if it seems to you that
their medical condition is similar to yours.
IMPORTANT INFORMATION FOR YOUR REVIEW
Warning:
Mycophenolate causes miscarriages and birth defects. Do not
begin treatment with CELLCEPT in women of child-bearing age,
who do not have a negative pregnancy test before starting
treatment.
Follow the contraception instructions given to you by the
attending doctor. Before taking the preparation, consult the
doctor again if you did not fully understand the instructions.
For
further
information,
see
section
“Special
warnings
regarding use of this medicine” and “Pregnancy, contraception
and
breast-feeding”
section.
1.
WHAT IS THE MEDICINE INTENDED FOR?
CELLCEPT
is
used,
in
combination
with
cyclosporine
and
corticosteroids, to prevent rejection of a transplanted organ in
kidney, heart or liver transplant recipients.
THERAPEUTIC GROUP
Immunosuppressants.
2.
BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE IF:
You are allergic to mycophenolate mofetil, mycophenolic acid,
or to any of the other ingredients contained in the medicine
)for the list of inactive ingredients, see section 6 - “Further
Information”(.
You are a woman of child-bearing age and you have not
provided a negative preg

Produktets egenskaber

1
CellCept PI version 10
CELLCEPT
®
MYCOPHENOLATE MOFETIL
Capsules 250 mg and Tablets 500 mg
1.
NAME OF THE MEDICINAL PRODUCT
CellCept 250 mg capsules.
CellCept 500 mg film coated tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 250 mg mycophenolate mofetil.
Each tablet contains 500 mg mycophenolate mofetil.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
CellCept 250 mg capsules:
Capsules, hard oblong, blue/brown, branded with black "CellCept 250"
on the capsule cap and
"Roche" on the capsule body.
CellCept 500 mg film coated tablets:
Lavender coloured caplet-shaped tablet, engraved with "CellCept 500"
on one side and “ROCHE" on
the other.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prophylaxis of rejection in renal allograft recepients, and in
patients receiving allogenic cardiac
transplants.
Cellcept should be used concomitantly with cyclosporin and
corticosteroids.
Allogenic hepatic transplant.
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).
2
_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).
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 a