PHARMACOR MYCOPHENOLATE mycophenolate mofetil 1g/5ml powder for oral suspension bottle pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

mycophenolate mofetil, Quantity: 200 mg/mL

Available from:

Pharmacor Pty Ltd

Pharmaceutical form:

Suspension

Composition:

Excipient Ingredients: sorbitol; sodium citrate dihydrate; citric acid; methyl hydroxybenzoate; xanthan gum; aspartame; lecithin; colloidal anhydrous silica; Flavour

Administration route:

Oral

Units in package:

225 ml

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Pharmacor Mycophenolate is indicated for the prophylaxis of solid organ rejection in adults receiving allogeneic organ transplants.,Pharmacor Mycophenolate 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 blend filled in 225ml white colored HDPE bottle with child resistant closure.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

2022-10-19

Patient Information leaflet

_Pharmacor Mycophenolate Ver: 00 _
_ 1 _
PHARMACOR MYCOPHENOLATE
_ _
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 PHARMACOR MYCOPHENOLATE?
Pharmacor
Mycophenolate
contains
the
active
ingredient
mycophenolate
mofetil.
It
belongs
to
a
group
of
immunosuppressants, which used to prevent the rejection of a
transplanted organ and work by stopping your immune
system from reacting to the transplanted organ.
For more information, see Section 1. Why am I using Pharmacor
Mycophenolate? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE PHARMACOR MYCOPHENOLATE?
Do not use if you have ever had an allergic reaction to Pharmacor
Mycophenolate 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
Pharmacor Mycophenolate? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Pharmacor Mycophenolate 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 PHARMACOR MYCOPHENOLATE?
TAKE PHARMACOR MYCOPHENOLATE EXACTLY AS YOUR DOCTOR HAS PRESCRIBED.
Your doctor will tell you how much Pharmacor
Mycophenolate suspension to take each day.
More instructions can be found in Section 4. How do I use Pharmacor
Mycophenolate? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING PHARMACOR MYCOPHENOLATE?
THINGS YOU SHOULD DO
•
Remind
any
doctor,
dentist
or
pharmacist
you
visit
that
you
are
using
Pharmacor
Mycophenolate
•
If you are about to be started on any new medicine, remind your doctor
and pharmacist that
you are taking Pharmacor Mycophenolate
•
Stop taking Pharmacor Mycophenolate and contact your doctor
immediately if you become
pregnant while you are ta

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
PHARMACOR MYCOPHENOLATE (MYCOPHENOLATE MOFETIL) POWDER FOR ORAL
SUSPENSION
1.
NAME OF THE MEDICINE
Mycophenolate mofetil
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Pharmacor Mycophenolate 1 g/5 ml powder for oral suspension contains 1
g mycophenolate mofetil
per 5 mL when reconstituted.
Excipients with known effect: aspartame
For the full list of excipients, see section 6.1. List of excipients.
3.
PHARMACEUTICAL FORM
Powder for oral suspension
White to off-white powder for oral suspension
4. CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Pharmacor Mycophenolate is indicated for the prophylaxis of solid
organ rejection in adults receiving
allogeneic organ transplants.
Pharmacor Mycophenolate 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 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 Pharmacor 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.
_* Mycophenolate mofetil powder for injection is available in other
brands._
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).
_Other Transplants_
Th