ARX-Mycophenolate mycophenolate mofetil 500mg tablet blister pack

Țară: Australia

Limbă: engleză

Sursă: Department of Health (Therapeutic Goods Administration)

Ingredient activ:

mycophenolate mofetil, Quantity: 500 mg

Disponibil de la:

Accord Healthcare Pty Ltd

INN (nume internaţional):

Mycophenolate mofetil

Forma farmaceutică:

Tablet, film coated

Compoziție:

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

Calea de administrare:

Oral

Unități în pachet:

50 tablets

Tip de prescriptie medicala:

(S4) Prescription Only Medicine

Indicații terapeutice:

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.

Rezumat produs:

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

Statutul autorizaţiei:

Licence status A

Data de autorizare:

2015-11-17

Prospect

MYCOPHENOLATE APOTEX
1
Mycophenolate
APOTEX
mycophenolate mofetil
Consumer Medicine Information
For a copy of a large print leaflet, Ph: 1800 195 055
What is in this leaflet
This leaflet answers some common
questions about this medicine. 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 this medicine
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 this medicine is
used for
This medicine contains the active
ingredient mycophenolate mofetil.
Mycophenolate 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.
Mycophenolate may be used together
with other medicines such as
cyclosporin and corticosteroids.
Ask your doctor if you have any
questions about why this medicine
has been prescribed for you.
Your doctor may have prescribed it
for another reason.
This medicine is not addictive.
This medicine is available only with
a doctor's prescription.
There is not enough information to
recommend the use of this medicine
for children under the age of 6 years.
Before you take this
medicine
When you must not take it
Do not take this medicine if you
have an allergy to:

any medicine containing
mycophenolate mofetil

any of the 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 the face, lips, tongue
or other parts of the body

rash, itching or hives on the skin
Do not take this medicine if you
are pregnant or plan to become
pregnant.
Mycophenolate is harmful to an
unborn baby when taken by a
pregnant woman.
There have bee

Caracteristicilor produsului

1
AUSTRALIAN PRODUCT INFORMATION –
MYCOPHENOLATE APOTEX (MYCOPHENOLATE MOFETIL)
1
NAME OF THE MEDICINE
Mycophenolate mofetil
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
500 mg mycophenolate mofetil
For the full list of excipients, see Section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
Purple colored, capsule shaped, biconvex, film coated tablets debossed
‘AHI’ on one side
and ‘500’ on other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC 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
DOSE AND METHOD OF ADMINISTRATION
The initial dose of mycophenolate 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
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)
Mycophenolate 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 mycophenolate at a dose of 1
g twice daily (2 g daily dose).
2
Mycophenolate may be administered in combination with cyclosporin and
corticosteroids.
COMPLETE BLOOD COUNTS SHOULD BE PERFORMED WEEKLY DURING THE FIRST
MONTH, TWICE
MONTHLY FOR THE SECOND AND THIRD MONTHS OF TREATMENT, THEN MONTHLY
THROUGH THE FIRST
YEAR.