CEPTOLATE mycophenolate mofetil 500 mg tablet blister pack.

Land: Australien

Sprog: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv bestanddel:

mycophenolate mofetil, Quantity: 500 mg

Tilgængelig fra:

Alphapharm Pty Ltd

INN (International Name):

Mycophenolate mofetil

Lægemiddelform:

Tablet, film coated

Sammensætning:

Excipient Ingredients: croscarmellose sodium; microcrystalline cellulose; pregelatinised maize starch; magnesium stearate; povidone; sodium lauryl sulfate; silicon dioxide; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350

Indgivelsesvej:

Oral

Enheder i pakken:

150, 50

Recept type:

(S4) Prescription Only Medicine

Terapeutiske indikationer:

Ceptolate (Mycophenolate mofetil) is indicated for the prophylaxis of solid organ rejection in adults receiving allogeneic organ transplants. Ceptolate (Mycophenolate mofetil) is indicated for the prophylaxis of organ rejection in paediatric patients with a body surface area of greater than or equal to 1.25 square metres, receiving allogeneic renal transplants.

Produkt oversigt:

Visual Identification: A light pink film coated, oval, biconvex, bevelled edge tablet debossed with "MYLAN" on one side of the tablet and "472" on the other side.; Container Type: Blister Pack; Container Material: Other composite material; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Autorisation status:

Licence status A

Autorisation dato:

2011-09-23

Indlægsseddel

CEPTOLATE
_mycophenolate mofetil_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about CEPTOLATE. 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 CEPTOLATE
against the benefits they expect it
will have 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 CEPTOLATE IS
USED FOR
CEPTOLATE contains the active
ingredient mycophenolate mofetil.
CEPTOLATE belongs to a group of
medicines called
immunosuppressants.
Immunosuppressants are used to
prevent the rejection of a
transplanted organ 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.
CEPTOLATE may be used together
with other medicines known as
ciclosporin and corticosteroids.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
CEPTOLATE is not addictive.
This medicine is available only with
a doctor's prescription.
BEFORE YOU TAKE
CEPTOLATE
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE CEPTOLATE IF:
1.
YOU HAVE AN ALLERGY TO:
•
any medicine containing
mycophenolate mofetil
•
any of the ingredients listed at the
end of this 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
•
rash, itching or hives on the skin
2.
YOU ARE PREGNANT
•
CEPTOLATE is harmful to an
unborn baby when taken by a
pregnant woman
•
there have been cases of
miscarriage and severe birth
defects reported when patients
have taken CEPTOLATE during
pregnancy
YOU MUST TELL YOUR DOCTOR IF YOU
ARE PREGNANT OR PLAN TO BECOME
PRE

Produktets egenskaber

AUSTRALIAN PRODUCT INFORMATION
CEPTOLATE
_Mycophenolate mofetil _
1
NAME OF THE MEDICINE
Mycophenolate mofetil
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
CEPTOLATE 250 mg capsules contain 250 mg of mycophenolate mofetil
(MMF).
CEPTOLATE 500 mg tablets contain 500 mg of mycophenolate mofetil.
For the full list of excipients, see section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
CEPTOLATE 250 mg capsules - caramel opaque cap/lavender opaque body,
hard shell gelatin capsule filled with
white to off-white powder. The capsule is axially printed with
“MYLAN” over “2250” in black ink on both the
cap and body.
CEPTOLATE 500 mg tablets - light pink film coated, oval, biconvex,
bevelled edge tablet debossed with
“MYLAN” on one side of the tablet and “472” on the other side
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
CEPTOLATE (mycophenolate mofetil) is indicated for the prophylaxis of
solid organ rejection in adults
receiving allogeneic organ transplants.
CEPTOLATE (mycophenolate mofetil) is indicated for the prophylaxis of
organ rejection in paediatric patients
with a body surface area of (≥ 1.25 m
2
) receiving allogeneic renal transplants (see section 4.2 Dose and
Method
of Administration).
4.2
DOSE AND METHOD OF ADMINISTRATION
The initial dose of MMF 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.
PLEASE NOTE THAT CEPTOLATE MYCOPHENOLATE MOFETIL IN NOT AVAILABLE IN
THE INTRAVENOUS DOSAGE FORM.
ADULTS
Renal Transplantation
The recommended dose in renal transplant patients is 1 g administered
orally twice daily (2 g daily dose).
Cardiac Transplantation
The recommended dose in cardiac transplant patients is 1.5 g
administrated orally twice daily (3 g daily dose).
Hepatic Transplantation
The recommended dose in hepatic transplant patients is 1.5 g
administered orally twice daily (3 g daily dose).
Other Transpl