MYCOCEPT mycophenolate mofetil 500mg tablet blister pack

País: Australia

Idioma: inglés

Fuente: Department of Health (Therapeutic Goods Administration)

Ingredientes activos:

mycophenolate mofetil, Quantity: 500 mg

Disponible desde:

Arrotex Pharmaceuticals Pty Ltd

Designación común internacional (DCI):

Mycophenolate mofetil

formulario farmacéutico:

Tablet, film coated

Composición:

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

Vía de administración:

Oral

Unidades en paquete:

50 tablets

tipo de receta:

(S4) Prescription Only Medicine

indicaciones terapéuticas:

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.

Resumen del producto:

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

Estado de Autorización:

Licence status A

Fecha de autorización:

2015-11-17

Información para el usuario

MYCOCEPT – Consumer Medicine Information
1
MycoCept
Mycophenolate Mofetil 500 mg Tablets
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about MycoCept.
It does not contain all the available
information.
It does not take the place of talking
to your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking MycoCept
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 MYCOCEPT IS USED FOR
MycoCept contains the active
ingredient mycophenolate mofetil.
MycoCept 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.
There are many different types of
medicines used to prevent
transplant rejection.
MycoCept belongs to a new group
of these medicines.
MycoCept may be used together
with other medicines known as
cyclosporin and corticosteroids.
Your doctor, however, may have
prescribed MycoCept for another
purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY MYCOCEPT
HAS BEEN PRESCRIBED FOR YOU.
This medicine is available only with
a doctor’s prescription.
MycoCept is not addictive.
BEFORE YOU TAKE MYCOCEPT
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE MYCOCEPT IF:
1. YOU HAVE HAD AN ALLERGIC
REACTION TO MYCOCEPT 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 face, lips, tongue or
other parts of the body
•
rash, itching, hives on the skin
2. YOU ARE PREGNANT.
MycoCept 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 MycoCept during
pregnancy.
You must tell your doctor if

Ficha técnica

1
AUSTRALIAN PRODUCT INFORMATION MYCOCEPT (MYCOPHENOLATE MOFETIL) TABLET
1
NAME OF THE MEDICINE
Mycophenolate mofetil
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
MycoCept are available as purple-coloured film-coated tablets
containing 500 mg of mycophenolate
mofetil.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
MycoCept are purple colored, 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 (with a body
surface area ˃1.5 m
2
) receiving
allogeneic renal transplants.
4.2
D
OSE AND METHOD OF ADMINISTRATION
The initial dose of MycoCept 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.
_CARDIAC TRANSPLANTATION _
2
The recommended dose in cardiac transplant patients is 1.5 g
administrated orally.
_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).
_OTHER TRANSPLANTS _
The
recommended
dose in
other
transplants
is 2
to 3
g
per
day
depending
on the
level of
immunosuppression required.
_PAEDIATRICS (6 TO 18 YEARS) _
MycoCept is not suitable for paediatric patients whose body surface
area is <1.50 m
2
. Patients with a
body surface area ˃1.5 m
2
may be dosed with MycoCept at a dose of 1 g twice daily (2 g daily
dose).
MycoCept may be administered in combination with cyclosporin and
corticosteroids.
COMPLETE BLOOD COUNTS SHOULD BE PERFORMED WEEKLY DURING THE FIRST
MONTH, TWICE MONTHLY FOR