Clexane

País: Austràlia

Idioma: anglès

Font: Department of Health (Therapeutic Goods Administration)

ingredients actius:

Enoxaparin sodium

Disponible des:

Sanofi-Aventis Australia Pty Ltd

clase:

Medicine Registered

Informació per a l'usuari

CLEXANE
®
 AND CLEXANE
®
FORTE*

_enoxaparin sodium_
CONSUMER MEDICINE INFORMATION

WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Clexane.
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 using Clexane
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
Keep this leaflet with the medicine.
You may need to read it again.
WHAT CLEXANE IS USED
FOR
Clexane is used in a number of
medical conditions. It is used to:
•
treat blood clots
•
treat certain types of heart disease
(eg. angina and heart attacks),
when used with aspirin
•
prevent blood clots forming after
an operation, during
hospitalisation or extended bed
rest or during purification of the
blood by an artificial kidney
(haemodialysis).
Clexane is one of a group of
medicines called low molecular
weight heparins (LMWH). These
medicines work by reducing blood
clotting activity.
Your doctor may have prescribed
Clexane for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY CLEXANE HAS
BEEN PRESCRIBED FOR YOU.
There is no evidence that Clexane is
addictive.
This medicine is only available with
a doctor's prescription.
BEFORE YOU ARE GIVEN IT
_WHEN YOU MUST NOT USE IT_
DO NOT USE CLEXANE IF YOU HAVE AN
ALLERGY TO CLEXANE, HEPARIN OR ITS
DERIVATIVES INCLUDING OTHER
LMWHS. SOME SIGNS AND
SYMPTOMS OF AN ALLERGIC REACTION
CAN INCLUDE SWELLING OF THE FACE,
LIPS OR TONGUE, WHEEZING OR
TROUBLED BREATHING, SKIN RASH,
ITCHING HIVES, BLISTERS OR PEELING
SKIN.
DO NOT USE CLEXANE IF YOU HAVE, OR
HAVE EVER HAD ANY OF THE FOLLOWING
MEDICAL CONDITIONS:
•
major blood disorders
•
certain types of stroke
•
stomach or bowel problems such
as ulcers or ulcerative colitis
•
bacterial infections in your heart.
DO NOT GIVE CLEXANE TO A CHILD.
The safety and effectiveness of
Clexane has

Fitxa tècnica

Clexane
®
 PI 
PIv19 21 Jun 13

Page 1 

PRODUCT INFORMATION 
CLEXANE
®
 AND CLEXANE
®
 FORTE* 
NAME OF THE MEDICINE 
NON-PROPRIETARY NAME 
Enoxaparin sodium  
CHEMICAL STRUCTURE 

R 
X = 15 to 
25%

n= 0 to 20 

100 - X 
H 
n =1 to 21 
X = Percent of polysaccharide chain containing 1, 6
anhydro derivative on the reducing end 
DESCRIPTION 
Enoxaparin  sodium  is  a  low  molecular  weight  heparin  (MW  approx.  4500  D).  The  drug 
substance is the
sodium salt. The molecular weight distribution is: 
<2000 daltons 12 to 20%  
2000 to 8000 daltons 68 to 82%  
>8000 dalton
s ≤18%  
Enoxaparin sodium is obtained
by alkaline depolymerisation of heparin
benzyl ester derived from 
porcine intestinal mucosa. Its structure is characterised by a
4-enopyranose uronate group at the 
non-reducing  end.  About  20%  (ranging  between  15%  and  25%)  of  the  enoxaparin  structure 
contains a 1,6 anhydro derivative on the reducing end
of the polysaccharide chain. 
Enoxaparin  sodium  solution  for  injection  also  contains  water  for  injections  as  an  inactive 
ingredient. 
Clexane
®
 PI 
PIv19 21 Jun 13

Page 2 

PHARMACOLOGY 
In  comparison  with  natural  heparin  CLEXANE  is  characterised  by  a  clear  increase  in  the  ratio 
between anti-Xa and anti-IIa activities which is
always greater than 4. 
It has several actions on the coagulation pathway through binding to anti-thrombin III. The anti-
thrombotic  activity  is  related  to  inhibition  of  thrombin  generation  and  inhibition  of  two  main 
coagulation
factors: Factor Xa and Thrombin. CLEXANE also induces a sustained release of the 
Tissue Factor Pathway Inhibitor _in vivo_. 
In the experimental animal, CLEXANE was found to have potent anti-