APO-MYCOPHENOLATE mycophenolate mofetil 250 mg capsule blister pack

País: Austrália

Língua: inglês

Origem: Department of Health (Therapeutic Goods Administration)

Ingredientes ativos:

mycophenolate mofetil, Quantity: 250 mg

Disponível em:

Arrotex Pharmaceuticals Pty Ltd

DCI (Denominação Comum Internacional):

Mycophenolate mofetil

Forma farmacêutica:

Capsule

Composição:

Excipient Ingredients: croscarmellose sodium; magnesium stearate; indigo carmine; purified water; titanium dioxide; Gelatin; iron oxide red; sodium lauryl sulfate; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; Shellac; strong ammonia solution; iron oxide black; potassium hydroxide

Via de administração:

Oral

Unidades em pacote:

100 capsules, 300 capsules

Tipo de prescrição:

(S4) Prescription Only Medicine

Indicações terapêuticas:

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.

Resumo do produto:

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: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Status de autorização:

Registered

Data de autorização:

2011-11-08

Folheto informativo - Bula

APO-MYCOPHENOLATE CAPSULES
1
APO-MYCOPHENOLATE
CAPSULES
_Contains the active ingredient mycophenolate mofetil _
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 _
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
TAKING YOUR MEDICINE.
This leaflet answers some common
questions about mycophenolate
mofetil.
It does not contain all the available
information.
It does not take the place of talking to
your doctor or pharmacist.
The information in this leaflet was
last updated on the date listed on the
last page. More recent information on
this medicine may be available.
ASK YOUR DOCTOR OR PHARMACIST:
•
if there is anything you do not
understand in this leaflet,
•
if you are worried about taking
your medicine, or
•
to obtain the most up-to-date
information.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using this medicine
against the benefits they expect it
will have for you.
Pharmaceutical companies cannot
give you medical advice or an
individual diagnosis.
Keep this leaflet with your medicine.
You may want to read it again.
WHAT THIS MEDICINE IS
USED FOR
The name of your medicine is APO-
Mycophenolate. It contains the active
ingredient mycophenolate mofetil.
It is used for:
•
the prophylaxis of solid organ
rejection in adults receiving
allogeneic organ transplants
•
the prophylaxis of organ rejection
in paediatric patients (2 to 18
years) receiving allogeneic renal
transplants.
Ask your doctor if you have any
questions about why this medicine
has been prescribed for you. Your
doctor may have prescribed this
medicine for another reason.
This medicine is available only with
a doctor's prescription.
_HOW IT WORKS _
Mycophenolate mofetil belongs to a
group of medicines called
immunosuppressants.
Immunosuppressants are used to
prevent rejection of transplanted
organs and work by stopping your
immune system from reacting to the
transplanted organ.
Mycophenolate mofetil may be used
together with other medicines such as
cyclosporin and co

Características técnicas

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
May contain traces of sulfites
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
250 MG 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).
_ _
_ _
_CARDIAC TRANSPLANTATION_
2
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
immunosup