APO-MYCOPHENOLATE mycophenolate mofetil 500 mg tablet bottle
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Summary of Product characteristics
(SPC)
24-08-2020
Public Assessment Report
(PAR)
29-11-2017
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Active ingredient:
mycophenolate mofetil, Quantity: 500 mg
Available from:
Arrotex Pharmaceuticals Pty Ltd
INN (International Name):
Mycophenolate mofetil
Pharmaceutical form:
Tablet
Composition:
Excipient Ingredients: microcrystalline cellulose; croscarmellose sodium; colloidal anhydrous silica; magnesium stearate; titanium dioxide; hypromellose; hyprolose; iron oxide red; iron oxide black; macrogol 400
Administration route:
Oral
Units in package:
500 Tablets, 150 Tablets, 50 Tablets
Prescription type:
(S4) Prescription Only Medicine
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.
Product summary:
Visual Identification: Lavender, film-coated, capsule shaped tablets engraved "APO" on one side and "MYC500" on the other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Authorization status:
Registered
Authorization date:
2011-11-08
Summary of Product characteristics
1
AUSTRALIAN PRODUCT INFORMATION
APO-MYCOPHENOLATE (MYCOPHENOLATE MOFETIL)
TABLETS
1
NAME OF THE MEDICINE
Mycophenolate mofetil
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 500 mg mycophenolate mofetil as the active
ingredient.
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
500 MG TABLETS:
Lavender coloured, capsule shaped, film coated tablets, engraved with
‘APO’ and ‘MYC500’
on the other.
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
APO-Mycophenolate tablets are intended for oral administration.
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.
Note: Alternative preparations will be required for IV administration
and dosages requiring an
oral suspension.
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).
2
_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 _
The recommended dose in other transplants is 2 to 3g per day depending
on the level of
immunosuppression required.
_PAEDIATRICS (2 TO 18 YEARS) _
The recommended dose for renal transplant patients is 600 mg/
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