Mofecon-GR 360 (Mycophenolic Acid Gastro-Resistant Tablets 360mg)

Šalis: Malaizija

kalba: anglų

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

Veiklioji medžiaga:

MYCOPHENOLIC ACID (AS SODIUM SALT)

Prieinama:

HOVID BERHAD

INN (Tarptautinis Pavadinimas):

MYCOPHENOLIC ACID (AS SODIUM SALT)

Vienetai pakuotėje:

60 Tablets

Pagaminta:

CONCORD BIOTECH LIMITED

Pakuotės lapelis

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
MOFECON-GR (MYCOPHENOLIC ACID
GASTRO-RESISTANT TABLETS)
MYCOPHENOLIC ACID (AS MYCOPHENOLATE SODIUM) (180, 360 MG)
1
WHAT IS IN THIS LEAFLET
1.
What Mofecon-GR is used for
2.
How Mofecon-GR works
3.
Before you use Mofecon-GR
4.
How to use Mofecon-GR
5.
While using Mofecon-GR
6.
Side effects
7.
Storage and Disposal of Mofecon-
GR
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
11.
Serial Number
WHAT MOFECON-GR IS USED FOR
Mofecon-GR
belong
to
the
class
of
drugs known as immunosuppressants.
Immunosuppressants
reduce
your
body’s response to anything that it sees
as
“foreign”
–
which
includes
transplant organs.
HOW MOFECON-GR WORKS
Mofecon-GR is used to prevent your
body
from
rejecting
a
transplanted
kidney. Mofecon-GR is used together
with
other
medicines
containing
ciclosporin and corticosteroids.
BEFORE YOU USE MOFECON-GR
Mofecon-GR will only be prescribed
for
you
by
a
doctor
experienced
in
transplantation medicine. Follow your
doctor’s
instructions
carefully.
They
might
differ
from
the
general
information contained in this leaflet.
_- When you must not use it _
Do not take Mofecon-GR:
•
If you are allergic (hypersensitive)
to
mycophenolate
mofetil,
mycophenolic acid or any of the
other ingredients in this medicine
•
If you are a woman who could be
pregnant
and
you
have
not
provided a negative pregnancy test
before
your
first
prescription
as
mycophenolate
causes
birth
defects and miscarriage.
•
If you are pregnant or planning to
become pregnant or think you may
be pregnant
•
If
you
are
not
using
effective
contraception
•
If you are breast-feeding.
If any of the above apply to you, talk to
your
doctor
or
pharmacist
before
taking Mofecon-GR.
_-Pregnancy and breast-feeding _
If you are pregnant or breast-feeding,
planning to have a baby or think you
may be pregnant, ask your doctor or
pharmacist
for
advice
before
taking
this medicine. Doctor will explain to
you
about
the
risks
in
case
of
pregnancy
and
alt

Prekės savybės

VIMOFxx-09 (MY)
MOFECON-GR 360
(MYCOPHENOLIC ACID GASTRO-RESISTANT TABLETS 360MG)
DESCRIPTION
MOFECON−GR
360
(MYCOPHENOLIC ACID GASTRO-RESISTANT TABLETS 360 MG):
Pink to light pink colored, enteric coated, ovaloid biconvex tablet,
debossed with “C 2” on one side and plain on other side.
COMPOSITION
MOFECON−GR
360
(MYCOPHENOLIC ACID GASTRO-RESISTANT TABLETS 360 MG):
Each enteric coated tablet contains: Mycophenolic acid 360 mg
_Excipients:_ Microcrystalline cellulose, croscarmellose sodium,
povidone,
colloidal silicon dioxide, talc, magnesium stearate, methacrylic acid
and
ethyl acrylate copolymer, titanium dioxide, triethyl citrate, sodium
bicarbonate, iron oxide yellow, iron oxide red, sodium lauryl sulfate.
PHARMACODYNAMICS
Mycophenolic acid (MPA) is a potent, selective, uncompetitive and
reversible inhibitor of inosine monophosphate dehydrogenase, and
therefore inhibits the _ de novo_ pathway of guanosine nucleotide
synthesis
without
incorporation
into
DNA.
Because
T-
and
B-lymphocytes are critically dependent for their proliferation on _de
_
_novo_ synthesis of purines whereas other cell types can utilize
salvage pathways, MPA has more potent cytostatic effects on
lymphocytes than on other cells.
PHARMACOKINETICS
ABSORPTION
Following oral administration, mycophenolate sodium is extensively
absorbed. Consistent with its enteric coated design, the time to
maximal concentration (T
max
) of MPA was approximately 1.5-2 hours.
DISTRIBUTION
The volume of distribution at steady state for MPA is 50 litres. Both
mycophenolic acid and mycophenolic acid glucuronide are highly
protein bound. The free MPA concentration may increase under
conditions of decreased protein binding sites (uraemia, hepatic
failure,
hypoalbuminaemia, concomitant use of drugs with high protein binding).
This may put patients at increased risk of MPA-related adverse
effects.
BIOTRANSFORMATION
MPA is metabolised principally by glucuronyl transferase to form
the phenolic glucuronide of MPA, mycophenolic acid glucuronide
(MPAG). MPAG is the pr