APO-MYCOPHENOLATE mycophenolate mofetil 250 mg capsule 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: 250 mg
Available from:
Arrotex Pharmaceuticals Pty Ltd
INN (International Name):
Mycophenolate mofetil
Pharmaceutical form:
Capsule
Composition:
Excipient Ingredients: Gelatin; titanium dioxide; indigo carmine; magnesium stearate; iron oxide red; purified water; croscarmellose sodium; sodium lauryl sulfate; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; Shellac; strong ammonia solution; iron oxide black; potassium hydroxide
Administration route:
Oral
Units in package:
100 Capsules, 500 Capsules, 300 Capsules
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: Opaque blue cap and opaque pink body in Size 1 capsule containing white to off white powder. "M250" and "APO" are imprinted on capsules in black ink.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Authorization status:
Licence status A
Authorization date:
2011-11-08
Summary of Product characteristics
1
AUSTRALIAN PRODUCT INFORMATION
APO-MYCOPHENOLATE (MYCOPHENOLATE MOFETIL)
CAPSULES
1
NAME OF THE MEDICINE
Mycophenolate mofetil
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 250 mg mycophenolate mofetil as the active
ingredient.
EXCIPIENTS WITH KNOWN EFFECT
Gelatin
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Capsules.
Opaque blue cap and opaque pink body in Size 1 capsules containing
white to off white
powder. "M250" and "APO" are imprinted on capsules in black ink.
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 capsules 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).
_ _
_ _
2
_ _
_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 _
The recommended dose in other transplants is 2 to 3g per day depending
on the level of
immunosuppression required.
PAEDIA
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