Certican

Ülke: Avustralya

Dil: İngilizce

Kaynak: Department of Health (Therapeutic Goods Administration)

Aktif bileşen:

Everolimus

Mevcut itibaren:

Novartis Pharmaceuticals Australia Pty Ltd

Sınıf:

Medicine Registered

Bilgilendirme broşürü

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

Ürün özellikleri

 
Page 1 of 31 

CERTICAN
®

(EVEROLIMUS) 

NAME OF THE MEDICINE 
The active ingredient of Certican is everolimus.   
The chemical name is 40-O-(2-hydroxyethyl)-rapamycin or
40-O-(2-hydroxyethyl)-sirolimus.  Its 
molecular formula is C
53
H
83
NO
14
 and its molecular weight is 958.2. 
CAS number: 159351-69-6 
The structural formula of everolimus is: 

N
O
O
O
O
O
O
O
OH
O
O
O
OH
OH
O

DESCRIPTION 
Everolimus is a white to faintly yellow powder
practically insoluble in water but soluble in 
organic solvents such as ethanol and methanol. 
EXCIPIENTS:  
Tablets: Butylated hydroxytoluene, magnesium stearate, lactose
monohydrate, hypromellose, 
crospovidone, lactose anhydrous. 

Page 2 of 31 

Dispersible tablets: Butylated hydroxytoluene, magnesium stearate,
lactose monohydrate, 
hypromellose, crospovidone, lactose anhydrous, colloidal
anhydrous silica. 
PHARMACOLOGY

PHARMACODYNAMICS 
Everolimus, a proliferation signal inhibitor, prevents allograft
rejection in rodent and non-human 
primate models of allotransplantation.  It exerts its
immunosuppressive effect by inhibiting the 
proliferation, and thus clonal expansion, of antigen-activated
T cells which is driven by T cell-
specific interleukins, e.g. interleukin-2 and interleukin-15.
 Everolimus inhibits an intracellular 
signalling pathway which is triggered upon binding of these T
cell growth factors to their 
respective receptors, and which normally leads to
cell proliferation. The blockage of this signal 
by everolimus leads to an arrest of the cells at the G
1
 stage of the cell cycle. 
At the molecular level, everolimus forms a complex with
the cytoplasmic protein FKBP-12.  In 
the presence of everolimus the growth factor-stimulated
phosphorylation of the p70 S6 kinase is 
inhibited.  Since p70 S6 kinase phosphorylation is under
the control of FRAP (also called m-
TOR), this finding suggests that the everolimus-FKBP-12
complex binds to