CELLCEPT Tablet 500 mg

Страна: Малайзия

Език: английски

Източник: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Активна съставка:

MYCOPHENOLATE MOFETIL

Предлага се от:

ROCHE (MALAYSIA) SDN. BHD.

INN (Международно Name):

MYCOPHENOLATE MOFETIL

Броя в опаковка:

50Tablet Tablets

Произведено от:

Delpharm Milano s.r.l

Листовка

_ _
_ _
_Consumer Medication Information Leaflet (RiMUP) _
CELLCEPT
®
_Contains active ingredient Mycophenolate Mofetil (250mg, 500mg) _
_ _
1
WHAT IS IN THIS LEAFLET
1.
What CellCept is used for
2.
How CellCept works
3.
Before you use CellCept
4.
How to use CellCept
5.
While you are using it
6.
Side effects
7.
Storage and disposal of CellCept
8.
Product Description
9.
Manufacturer
10.
Product Registration Holder
11.
Date of Revision
12.
Serial Number
WHAT CELLCEPT IS USED FOR
Cellcept is used to prevent your body
from rejecting a transplanted organ
(kidney, heart or liver) and it should
be used together with other
medicines known as ciclosporin and
corticorsteroids.
Cellcept is used for treatment of
kidney inflammation, lupus nephritis
and it should be used together with
other medicine known as
corticosteroids.
Ask your doctor if you have any
questions about why Cellcept has
been prescribed for you.
This medicine is available only with
a doctor's prescription.
HOW CELLCEPT WORKS
Cellcept contains mycophenolate
mofetil. This 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.
Immunosuppressants weaken the
body's immune system so it will not
produce auto-antibodies. The
immune system of lupus patients
produces auto-antibodies at a rapid
rate, which in turn attack the immune
system.
BEFORE YOU USE CELLCEPT
-
_WHEN YOU MUST NOT USE IT _
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 may include:
-
shortness of breath
-
wheezing or difficulty
breathing
-
swelling of the face, lips,
tongue or other parts of the
body
-
rash, itching, hives on the
skin.
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 when patients
took Cellcept dur

Данни за продукта

PACK INSERT FOR MALAYSIA
CellCept

Mycophenolate mofetil
1.
DESCRIPTION
1.1
THERAPEUTIC/ PHARMACOLOGIC CLASS OF DRUG
Selective Immunosuppressive agent – Mycophenolic acid (ATC Code:
L04AA06)
1.2
TYPE OF DOSAGE FORM
Oral administration:
CellCept is supplied as capsules and tablets.
1.3
ROUTE OF ADMINISTRATION
Oral administration.
1.4
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient: mycophenolate mofetil.
Oral administration:
Each capsule contains 250 mg mycophenolate mofetil; each tablet
contains 500 mg mycophenolate mofetil.
Excipients:
Capsule 250 mg: pregelatinised starch, croscarmellose sodium, povidone
K90, magnesium stearate.
Capsule shell: red iron oxide, yellow iron oxide, titanium dioxide,
FD&C blue2, bovine gelatin
Tablet 500 mg: microcrystalline cellulose, croscarmellose sodium,
povidone K90, magnesium stearate,
Opdaryl Lavender Y-5R-10272-A
2.
CLINICAL PARTICULARS
2.1
THERAPEUTIC INDICATION(S)
CellCept capsules and tablets are indicated for the prophylaxis of
acute organ rejection in patients receiving
allogeneic renal transplants.
CellCept capsules and tablets are indicated for the prophylaxis of
acute organ rejection in patients receiving
allogeneic cardiac transplants.
CellCept capsules and tablets are indicated for the prophylaxis of
acute organ rejection in patients receiving
allogeneic hepatic transplants.
CellCept should be used concomitantly with ciclosporin and
corticosteroids.
CellCept is indicated for induction and maintenance treatment of lupus
nephritis. CellCept should be used
concomitantly with corticosteroids.
2.2
DOSAGE AND ADMINISTRATION
Please refer to full prescribing information for corticosteroids and
either ciclosporin or tacrolimus, which are
used in combination with CellCept.
Transplant patients
Standard dosage for prophylaxis of renal rejection
A dose of 1 g administered orally twice a day (daily dose of 2 g) is
recommended for use in renal transplant
patients. Although a dose of 1.5 g administered twice daily (daily
dose of 3 g) was used in clinical trials and