PHARMACOR MYCOPHENOLATE 250 mycophenolate mofetil 250 mg capsule blister pack

Nchi: Australia

Lugha: Kiingereza

Chanzo: Department of Health (Therapeutic Goods Administration)

Viambatanisho vya kazi:

mycophenolate mofetil, Quantity: 250 mg

Inapatikana kutoka:

Pharmacor Pty Ltd

INN (Jina la Kimataifa):

Mycophenolate mofetil

Dawa fomu:

Capsule

Tungo:

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

Njia ya uendeshaji:

Oral

Vitengo katika mfuko:

One carton contains 100 capsules (10 strips of 10 capsules)

Dawa ya aina:

(S4) Prescription Only Medicine

Matibabu dalili:

Pharmacor Mycophenolate 250 is indicated for the prophylaxis of solid organ rejection in adults receiving allogeneic organ transplants. Pharmacor Mycophenolate 250 is indicated for the prophylaxis of organ rejection in paediatric patients (2 to 18 years) receiving allogeneic renal transplants.

Bidhaa muhtasari:

Visual Identification: Capsule with Blue cap, Brown body imprinted 266 on body in black; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 4 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Idhini hali ya:

Registered

Idhini ya tarehe:

2011-11-21

Taarifa za kipeperushi

Page 1 of 5
PHARMACOR MYCOPHENOLATE 250 CMI (V-06)
PHARMACOR MYCOPHENOLATE 250
(MYCOPHENOLATE MOFETIL CAPSULES 250 MG)
_contains the active ingredient mycophenolate mofetil _
_ _
CONSUMER MEDICINE
INFORMATION
WHAT IS IN THIS LEAFLET
This
leaflet
answers
some
common
questions
about
PHARMACOR
MYCOPHENOLATE
250.
It
does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All
medicines
have
risks
and
benefits.
Your
doctor
has
weighed the risks of you taking
PHARMACOR
MYCOPHENOLATE 250 against
the benefits expected for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP
THIS
LEAFLET
WITH
THE
MEDICINE.
You may need to read it again.
WHAT
PHARMACOR
MYCOPHENOLATE
250 IS USED FOR
PHARMACOR
MYCOPHENOLATE 250
contains the active ingredient
mycophenolate mofetil.
PHARMACOR
MYCOPHENOLATE 250
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.
There are many different types of
medicines
used
to
prevent
rejection of a transplanted organ.
PHARMACOR
MYCOPHENOLATE
250
may
be
used
together
with
other
medicines known as ciclosporin
and corticosteroids.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS
ABOUT
WHY
PHARMACOR
MYCOPHENOLATE
250
HAS
BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed
PHARMACOR
MYCOPHENOLATE
250
for
another reason.
PHARMACOR
MYCOPHENOLATE 250 is not
addictive
This medicine is only available
with a doctor’s prescription.
BEFORE YOU TAKE OR ARE
GIVEN
PHARMACOR
MYCOPHENOLATE
250
_WHEN YOU MUST NOT TAKE IT _
_ _
DO
NOT
TAKE
PHARMACOR
MYCOPHENOLATE 250 IF:
1.
YOU HAVE AN ALLERGY TO:

PHARMACOR
MYCOPHENOLATE 250 or
any of the ingredients listed
at the end of the leaflet.
Some
of
the
symptoms
of
an
allergic reaction may include:

shortness of breath

wheezing or difficulty
breathing

swelling
of
the
face,
lips,
tongue or other parts of the
body
�

Tabia za bidhaa

PHARMACOR MYCOPHENOLATE 250 PI (V-06)
Page
1
of
33
AUSTRALIAN PRODUCT INFORMATION
PHARMACOR MYCOPHENOLATE 250 (MYCOPHENOLATE MOFETIL) CAPSULES
1. NAME OF THE MEDICINE
Mycophenolate Mofetil
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
PHARMACOR MYCOPHENOLATE 250 MG CAPSULES:
Each capsules contains 250 mg mycophenolate mofetil
For the full list of excipients, see section 6.1 - list of excipients
.
3. PHARMACEUTICAL FORM
Capsules, hard.
PHARMACOR MYCOPHENOLATE 250 MG CAPSULES:
The capsules are oblong, size “1” blue colored cap, brown colored
body hard gelatin capsule
imprinted with “266” on body with black ink.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
PHARMACOR MYCOPHENOLATE 250 mg capsule is indicated for the
prophylaxis of solid organ
rejection in adults receiving allogeneic organ transplants.
PHARMACOR MYCOPHENOLATE 250 mg capsule 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
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.
ADULTS
_RENAL TRANSPLANTATION _
PHARMACOR MYCOPHENOLATE 250 PI (V-06)
Page
2
of
33
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 _
The
recommended
dose
in
other
transplants
is
2
to
3g
per
day
depending
on
the
level
of
immunosuppression required.
_PAEDIATRICS (2 TO 18 YEAR