MYCOKEM 500 mycophenolate mofetil 500mg tablet blister pack

Země: Austrálie

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktivní složka:

mycophenolate mofetil, Quantity: 500 mg

Dostupné s:

Pharmacor Pty Ltd

INN (Mezinárodní Name):

Mycophenolate mofetil

Léková forma:

Tablet, film coated

Složení:

Excipient Ingredients: povidone; magnesium stearate; microcrystalline cellulose; croscarmellose sodium; hyprolose; purified talc; titanium dioxide; hypromellose; iron oxide red; iron oxide black; macrogol 400; indigo carmine aluminium lake

Podání:

Oral

Jednotky v balení:

50 tablets, 150 tablets

Druh předpisu:

(S4) Prescription Only Medicine

Terapeutické indikace:

Prophylaxis of solid organ rejection in adults receiving allogeneic organ transplants. Prophylaxis of organ rejection in paediatric patients (with a body surface area > 1.5 m2) receiving allogeneic renal transplants.

Přehled produktů:

Visual Identification: Purple colored, capsule shaped, biconvex, film coated tablets debossed 'AHI' on one side and '500' on other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Stav Autorizace:

Licence status A

Datum autorizace:

2015-12-16

Informace pro uživatele

mycokem 500 (V 02) Page 1
of 5
MYCOKEM 500
_Mycophenolate mofetil _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Mycokem 500.
It does not contain all the
available information.
It does not take the place of
talking to your doctor,
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Mycokem
500 against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE
You may need to read it again.
WHAT MYCOKEM 500 IS USED
FOR
Mycokem 500 contains the active
ingredient
mycophenolate mofetil.
Mycokem 500 belongs to a group
of
medicines called
immunosuppressants.
Immunosuppressants are used to
prevent the rejection of a
transplanted organs and work by
stopping your immune system
from reacting to the transplanted
organ.
There are many different types of
medicines used to prevent
rejection of a transplanted organ
MycokemMycokem 500 may be
used together with other
medicines known as cyclosporin and
corticosteroids.
ASK
YOUR
DOCTOR
IF
YOU
HAVE
ANY
QUESTIONS ABOUT WHY MYCOKEM 500
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have
prescribed Mycokem 500 for
another reason.
Pharmacor
Mycophenolate
500
is
not addictive
This medicine is available only with a
doctor’s prescription.
Mycokem
BEFORE YOU TAKE MYCOKEM
500
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE MYCOKEM 500 IF:
1. YOU HAVE HAD AN ALLERGIC
TO:Mycokem 500 or any
ingredients listed at the end of
this leaflet.
Some of the symptoms of an
allergic reaction may include:

shortness of breath

wheezing
or
difficulty
breathing

swelling of face, lips,
tongue or other parts of
the body

rash, itching, hives on the
skin
2. YOU ARE PREGNANT

Mycokem 500 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 have taken
Mycokem 500 during
pregnancy.

You must tell y

Charakteristika produktu

MYCOKEM 500 (V-02)
1
AUSTRALIAN PRODUCT INFORMATION
MYCOKEM 500 (MYCOPHENOLATE MOFETIL) TABLETS
1
NAME OF THE MEDICINE
Mycophenolate mofetil
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Mycokem 500 contains mycophenolate mofetil 500 mg.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Mycokem 500 are purple coloured, capsule shaped, biconvex, film coated
tablets debossed
‘AHI’ on one side and ‘500’ on other side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS

Prophylaxis of solid organ rejection in adults receiving allogeneic
organ transplants.

Prophylaxis of organ rejection in paediatric patients (2-18 years)
receiving allogeneic
renal transplants.
4.2
D
OSE AND METHOD OF ADMINISTRATION
The initial dose of Mycokem 500 should be given as soon as clinically
feasible following
transplantation. Intravenous administration is recommended in those
patients unable to
take oral medication. However, oral administration should be initiated
as soon as possible.
ADULTS
_RENAL TRANSPLANTATION _
The
recommended
dose
in
renal
transplant
patients
is
1
g
administered
orally
or
intravenously twice daily (2 g daily dose).
_CARDIAC TRANSPLANTATION _
The recommended dose in cardiac transplant patients is 1.5 g
administrated orally or
intravenously twice daily (3 g daily dose).
_HEPATIC TRANSPLANTATION _
The recommended dose in hepatic transplant patients is 1 g
administrated intravenously
twice daily (2 g daily dose) followed by 1.5 g administered orally
twice daily (3 g daily dose).
MYCOKEM 500 (V-02)
2
_OTHER TRANSPLANTS _
The recommended dose in other transplants is 2 to 3 g per day
depending on the level of
immunosuppression required.
_PAEDIATRICS (2 TO 18 YEARS) _
The recommended dose of for renal transplant patients is 600mg/m
2
of mycophenolate
mofetil (MMF) administered orally twice daily (up to a maximum of 2 g
daily.)
Mycokem 500 may be administered in combination with ciclosporin and
corticosteroids.
COMPLETE
BLOOD
COUNTS
SHOULD
BE
PERFORMED
WEEKLY
DURING
THE
FIR