REFRAT Mycophenolate Mofetil Capsules USP 250mg

Šalis: Malaizija

kalba: anglų

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

Veiklioji medžiaga:

MYCOPHENOLATE MOFETIL

Prieinama:

UNIMED SDN BHD

INN (Tarptautinis Pavadinimas):

MYCOPHENOLATE MOFETIL

Vienetai pakuotėje:

100Capsule Capsules; 50Capsule Capsules

Pagaminta:

Strides Pharma Science Limited

Pakuotės lapelis

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
REFRAT
Mycophenolate Mofetil Capsules USP 250mg / Tablets USP 500mg
1
WHAT IS IN THIS LEAFLET
1.
What Refrat Capsule/ Tablet is
used for
2.
How Refrat Capsule/ Tablet
works
3.
Before you use Refrat Capsule/
Tablet
4.
How to take Refrat Capsule/
Tablet
5.
While you are using Refrat
Capsule/ Tablet
6.
Side Effects
7.
Storage and Disposal of Refrat
Capsule/ Tablet
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of Revision
WHAT REFRAT CAPSULE/ TABLET IS
USED FOR
Refrat is used to prevent your body
rejecting a transplanted organ; i.e.
kidney, heart or liver.
Refrat is indicated for induction and
maintenance treatment of lupus
nephritis (inflammation of the
kidney caused by systemic lupus
erythematosus (SLE)), a disease of
the immune system. Refrat is used
together with other medicines:
•
Cyclosporine
•
corticosteroids.
HOW REFRAT CAPSULE/ TABLET WORKS
Refrat contains mycophenolate
mofetil, This belongs to a group of
medicines called “immune -
suppressants”.
This medication works by lowering
your body's immune system activity.
BEFORE YOU USE REFRAT CAPSULE/
TABLET
_-When you must not take it _
DO NOT TAKE REFRAT IF:
•
you are allergic (hypersensitive) to
mycophenolate
mofetil,
mycophenolic acid or any of the
other ingredients of Refrat
If you are not sure, talk to your
doctor or pharmacist before taking
Refrat.
BEFORE YOU START TO TAKE IT
Take special care with Refrat
Talk to your doctor straight away
before taking Refrat if:
•
you have a sign of infection such
as a fever or sore throat
•
you have any unexpected bruising
or bleeding
•
you have ever had a problem with
your digestive system such as a
stomach ulcer
•
you have increased risk for cancer
especially skin cancer.
Taking Refrat with food and
drink
Taking food and drink has no
effect on your treatment with
Refrat.
Pregnancy, contraception and
breast- feeding
Pregnancy
If you are pregnant, do not take
Refrat. This is because Refrat may
harm your unborn baby.
•

Prekės savybės

D3 PROPOSED PACKAGE INSERT
REFRAT MYCOPHENOLATE MOFETIL CAPSULES USP 250MG
REFRAT MYCOPHENOLATE MOFETIL TABLETS USP 500MG
COMPOSITION:
Each capsule contains Mycophenolate Mofetil 250mg
Each film coated tablet contains Mycophenolate Mofetil 500mg
PRODUCT DESCRIPTION:
250mg: White to off white blend of Mycophenolate Mofetil filled in
size 1 hard gelatin capsules with
ivory Cap and ivory body printed “SAL” on cap & “726” on body
in black.
500mg: Pinkish brown coloured, capsule shaped, film coated tablets
with “SAL” engraved on one
side and engraved “725” on other side.
PHARMACOLOGY:
Mycophenolate mofetil, the 2-morpholinoethyl ester of mycophenolic
acid (MPA), is an
immunosuppressive agent. Mycophenolate mofetil is a prodrug that has
little pharmacologic activity
until hydrolyzed in vivo to mycophenolic acid (MPA), the
pharmacologically active metabolite. MPA
is a potent, selective, uncompetitive and reversible inhibitor of
inosine monophosphate
dehydrogenase (IMPDH), and therefore inhibits the de novo pathway of
guanosine nucleotide
synthesis without incorporation in to DNA. MPA has more potent
cytostatic effects on lymphocytes
than on other cells.
PHARMACOKINETICS:
ABSORPTION
Mycophenolate mofetil is well absorbed following oral administration,
having an absolute
bioavailability of approximately 94% (based on mycophenolic acid and.
undergoes complete
presystemic metabolism to the active metabolite, MPA. Mycophenolate
mofetil can be measured
systemically during intravenous infusion; however, after oral
administration it is below the limit of
quantitation (0.4
µ
g/mL).
Food had no effect on the extent of absorption (MPA AUC) of
mycophenolate mofetil administered
at doses of 1.5 g twice daily to renal transplant patients. However,
MPA C
max
was decreased by 40%
in the presence of food.
DISTRIBUTION
Secondary increases in plasma MPA concentration are usually observed
at approximately 6-12 hours
post-dose, consistent with enterohepatic recirculation. At clinically
relevant concentrations, MPA is
97% bo