MYCOPHENOLATE ACCORD mycophenolate mofetil 500 mg powder for injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

mycophenolate mofetil, Quantity: 500 mg

Available from:

Accord Healthcare Pty Ltd

Pharmaceutical form:

Injection, powder for

Composition:

Excipient Ingredients: sodium hydroxide; sodium chloride; hydrochloric acid; citric acid; polysorbate 80

Administration route:

Intravenous

Units in package:

1, 4

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

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

Product summary:

Visual Identification: White to off-white powder; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2021-05-18

Patient Information leaflet

Mycophenolate Accord - version 2
1
MYCOPHENOLATE ACCORD
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 MYCOPHENOLATE ACCORD?
Mycophenolate Accord contains the active ingredient mycophenolate
mofetil. Mycophenolate Accord is used to prevent the
rejection of a transplanted organ 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. Mycophenolate Accord may be used
together with other medicines known as ciclosporin and
corticosteroids.
For more information, see Section 1. Why am I using Mycophenolate
Accord?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE MYCOPHENOLATE ACCORD?
Do not use if you have ever had an allergic reaction to mycophenolate
mofetil, polysorbate 80 or any of the other 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
Mycophenolate Accord?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Mycophenolate Accord 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 MYCOPHENOLATE ACCORD?
Mycophenolate Accord is an injection for infusion and will be given to
you by your doctor or nurse.
More instructions can be found in Section 4. How do I use
Mycophenolate Accord?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING MYCOPHENOLATE ACCORD?
THINGS YOU
SHOULD DO
•
If you are about to be started on any new medicine, remind your doctor
and pharmacist that you
are taking Mycophenolate Accord.
•
Remind any doctor, dentist or pharmacist you visit that you are using
Mycophenolate Accord.
•
If you are going t

Summary of Product characteristics

Page 1 of 28
AUSTRALIAN PRODUCT INFORMATION
MYCOPHENOLATE ACCORD (MYCOPHENOLATE MOFETIL) POWDER
FOR INJECTION
1
NAME OF THE MEDICINE
Mycophenolate mofetil
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 vial contains 500 mg of mycophenolate mofetil.
For the full list of excipients, see SECTION 6.1. LIST OF EXCIPIENTS
.
3
PHARMACEUTICAL FORM
Mycophenolate Accord is a white to off white powder for injection.
Mycophenolate Accord must be reconstituted and further diluted with
glucose intravenous infusion 5%
prior to administration to the patient. Reconstitution and dilution
with 5% glucose intravenous infusion
as recommended yields a clear colourless solution of mycophenolate
mofetil, 6 mg/mL.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Mycophenolate Accord is indicated for the prophylaxis of solid organ
rejection in adults receiving
allogeneic organ transplants.
Mycophenolate Accord is indicated for the prophylaxis of organ
rejection in paediatric patients (2 to 18
years) receiving allogeneic renal transplants.
4.2
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
_Mycophenolate mofetil oral formulations are unavailable in this brand
however, are available in other _
_brands. Where correct dosing requires mycophenolate mofetil tablet,
capsule or oral suspension, refer _
_to the specific product information for these formulations for their
complete dosage and administration _
_instructions. _
The initial dose of Mycophenolate Accord 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