MOFIT 500 mycophenolate mofetil 500 mg film coated tablet blister

Држава: Аустралија

Језик: Енглески

Извор: Department of Health (Therapeutic Goods Administration)

Активни састојак:

mycophenolate mofetil, Quantity: 500 mg

Доступно од:

Pharmacor Pty Ltd

Фармацеутски облик:

Tablet, film coated

Састав:

Excipient Ingredients: microcrystalline cellulose; magnesium stearate; croscarmellose sodium; povidone; titanium dioxide; hypromellose; iron oxide yellow; macrogol 6000; iron oxide red; iron oxide black; macrogol 400

Пут администрације:

Oral

Јединице у пакету:

10, 30, 50, 100, 300, 150

Тип рецептора:

(S4) Prescription Only Medicine

Терапеутске индикације:

Mycophenolate mofetil is indicated for the prophylaxis of solid organ rejection in adults receiving allogeneic organ transplants.,Mycophenolate mofetil is indicated for the prophylaxis of organ rejection in paediatric patients (2 to 18 years) receiving allogeneic renal transplants.

Резиме производа:

Visual Identification: Lavender coloured caplet shaped biconvex film coated tablets debossedwith 265 on one side and plain on other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Статус ауторизације:

Registered

Датум одобрења:

2022-04-22

Информативни летак

MOFIT 500
1
MOFIT 500
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING MOFIT 500?
MOFIT 500 contains the active ingredient mycophenolate mofetil. MOFIT
500 is indicated for the prophylaxis of solid organ
rejection in adults receiving allogeneic organ transplants and is
indicated for the prophylaxis of organ rejection in paediatric
patients (2 to 18 years) receiving allogeneic renal transplants.
For more information, see Section 1. Why am I using MOFIT 500 ? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE MOFIT 500?
Do not use if you have ever had an allergic reaction to MOFIT 500 or
any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
MOFIT 500? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with MOFIT 500 and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE MOFIT 500?
•
The dose of MOFIT 500 is related to body weight for all patients. Your
doctor will calculate the dose you need and tell you
how many tablets to take each day.
•
Take MOFIT 500 every day, at about the same time each day with full
glass of water.
More instructions can be found in Section 4. How do I use MOFIT 500?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING MOFIT 500?
THINGS YOU SHOULD
DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
MOFIT 500.
•
Keep all of your doctor's appointments so that your progress can be
checked. Your doctor will do
regular tests (blood, urine or Magnetic Resonance Imaging (MRI)) to
make sure the medicine is
working and to prevent unwanted side effects. Your doctor will also
use these tests to decid

Карактеристике производа

MOFIT 500 Ver: 00
Page 1
AUSTRALIAN PRODUCT INFORMATION
MOFIT 500 (MYCOPHENOLATE MOFETIL) TABLETS
1.
NAME OF THE MEDICINE
Mycophenolate mofetil
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film coated tablet contains
500 mg of mycophenolate mofetil.
For the full list of excipients,
SEE SECTION 6.1. LIST OF EXCIPIENTS
.
3.
PHARMACEUTICAL FORM
Lavender coloured caplet shaped biconvex film coated tablets debossed
with ‘265’ on one side and
plain on other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Mycophenolate mofetil is indicated for the prophylaxis of solid organ
rejection in adults receiving
allogeneic organ transplants.
Mycophenolate mofetil is indicated for the prophylaxis of organ
rejection in paediatric patients (2
to 18 years) receiving allogeneic renal transplants.
4.2
DOSE AND METHOD OF ADMINISTRATION
_Mycophenolate mofetil is available in other strengths and dosage
forms. Where correct _
_dosing requires these formulations, refer to the specific product
information for these _
_products for their complete dosage and administration instructions. _
DOSAGE
The initial dose of mycophenolate mofetil 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
administered orally or intravenously
twice daily (3 g daily dose).
_Hepatic Transplantation _
The recommended dose in hepatic transplant patients is 1 g
administered intravenously twice daily
(2 g daily dose) followed by 1.5 g administered orally twice daily (3
g daily dose)
_ _
_ _
MOFIT 500 Ver: 00
Page 2
_Other Transplants _
The recommended dose in other transplants is 2 to 3g per day depending
on the level of
immunosu