CERTICAN everolimus 0.25mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

everolimus, Quantity: 0.25 mg

Available from:

Novartis Pharmaceuticals Australia Pty Ltd

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: butylated hydroxytoluene; lactose monohydrate; hypromellose; magnesium stearate; crospovidone; lactose

Administration route:

Oral

Units in package:

120 Tablets, 100 Tablets, 50 Tablets, 60 Tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Certican is indicated for the prophylaxis of organ rejection in adult patients at mild to moderate immunological risk receiving an allogeneic renal or cardiac transplant and in adult patients receiving an allogeneic hepatic transplant (see Precautions).

Product summary:

Visual Identification: White to yellowish, marbled, round, flat tablets with bevelled edge. Diameter 6mm. Engraved with "C" on one side and "NVR" on the other.; Container Type: Blister Pack; Container Material: Other plastic laminate/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

2005-03-17

Patient Information leaflet

CERTICAN
®
_everolimus_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Certican.
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
final page. More recent information
on the medicine may be available.
YOU SHOULD ENSURE THAT YOU SPEAK
TO YOUR PHARMACIST OR DOCTOR TO
OBTAIN THE MOST UP TO DATE
INFORMATION ON THE MEDICINE.
You can also download the most up
to date leaflet from
www.novartis.com.au. Those updates
may contain important information
about the medicine and its use of
which you should be aware.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Certican
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 CERTICAN IS USED
FOR
Certican is used to treat adult patients
who have had kidney, heart or liver
transplants. It helps to prevent your
body from rejecting the transplanted
organ.
Certican contains the active
ingredient everolimus. It belongs to a
group of medicines called
immunosuppressants. These
medicines help to control your body's
immune system.
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.
Certican is available only with a
doctor's prescription and is not
addictive.
There is not enough information to
recommend the use of this medicine
in children and adolescents.
BEFORE YOU TAKE
CERTICAN
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE CERTICAN IF YOU HAVE
AN ALLERGY TO:
•
everolimus, the active ingredient
in Certican
•
any of the ingredients listed at the
end of this leaflet.
•
a similar medicine called
Rapamune which contains the
active ingredient sirolimus.
Some of the symptoms of an allergic
reaction may inc

Summary of Product characteristics

Page 1 of 31
AUSTRALIAN PRODUCT INFORMATION - CERTICAN
®
(EVEROLIMUS)
1
NAME OF THE MEDICINE
Australian Approved Name: everolimus
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
CERTICAN TABLETS
0.25mg; 0.50 mg; 0.75 mg; 1.0 mg everolimus.
CERTICAN DISPERSIBLE TABLETS
0.10mg; 0.25mg everolimus.
Everolimus is a white to faintly yellow powder practically insoluble
in water but soluble in
organic solvents such as ethanol and methanol.
3
PHARMACEUTICAL FORM
CERTICAN TABLETS
(white to yellowish, marbled, round, flat with bevelled edge)
0.25mg (engraved with “C” on one side and “NVR” on the other):
60’s; 0.50 mg (engraved with
“CH” on one side and “NVR” on the other): 60’s; 0.75 mg
(engraved with “CL” on one side and
“NVR” on the other): 60’s; 1.0 mg (engraved with “CU” on one
side and “NVR” on the other):
50’s, 60’s, 100’s, 120’s.
CERTICAN DISPERSIBLE TABLETS
(white to yellowish, marbled, round, flat with bevelled edge) 0.10mg
(engraved with “I” on one side and “NVR” on the other): 0.25mg
(engraved with “JO” on one side
and “NVR” on the other): 50’s, 60’s, 100’s, 120’s
List of excipients with known effect: lactose, galactose, milk, sugars
For the full list of excipients, see Section 6.1 List of excipients
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Certican is indicated for the prophylaxis of organ rejection in adult
patients at mild to moderate
immunological risk receiving an allogeneic renal or cardiac transplant
and in adult patients
receiving an allogeneic hepatic transplant (see Precautions).
4.2 DOSE AND METHOD OF ADMINISTRATION
Treatment
with
Certican
should
only
be
initiated
and
maintained
by
physicians
who
are
experienced in immunosuppressive therapy following organ
transplantation. Everolimus should
be used in combination with cyclosporin microemulsion and
corticosteroids with cyclosporin
exposure reduced over time post-transplantation (see
_Therapeutic Drug Monitoring_
).
_ _
KIDNEY AND HEART TRANSPLANTATION
An initial dose regimen of