LOVENOX enoxaparin sodium 20mg/0.2mL injection syringe with automatic safety lock system
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
24-08-2020
Summary of Product characteristics
(SPC)
15-10-2015
Public Assessment Report
(PAR)
26-11-2017
Active ingredient:
enoxaparin sodium
Available from:
Sanofi-Aventis Australia Pty Ltd
INN (International Name):
Enoxaparin sodium
Authorization status:
Registered
Patient Information leaflet
LOVENOX
®
AND LOVENOX
®
FORTE
1
LOVENOX
® AND
LOVENOX
® FORTE*
_enoxaparin sodium _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Lovenox.
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 Lovenox
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 LOVENOX IS USED
FOR
Lovenox 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).
Lovenox 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
Lovenox for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY LOVENOX HAS
BEEN PRESCRIBED FOR YOU.
There is no evidence that Lovenox 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 LOVENOX IF YOU HAVE AN
ALLERGY TO LOVENOX (ENOXAPARIN
SODIUM), 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 LOVENOX 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 LOVENOX TO A CHILD.
The s
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Summary of Product characteristics
lovenox-ccdsv12-piv15-12oct15
Page 1
PRODUCT INFORMATION
LOVENOX
® AND LOVENOX
® FORTE*
NAME OF THE MEDICINE
AUSTRALIAN APPROVED 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 daltons ≤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.
lovenox-ccdsv12-piv15-12oct15
Page 2
PHARMACOLOGY
In comparison with natural heparin LOVENOX 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. LOVENOX also induces a
sustained release of the
Tissue Factor Pathway Inhibitor _in vivo_.
In the experimental animal, LOVENOX was found to have potent
anti-thrombotic properties with
a minimum effect on bleeding.
PHARMACOKINETiCS
The pharmacokinetic parameters of LOVENOX were studied from the
changes in plasma anti-
Xa activity.
After injection of LOVENOX by the subcutaneous route (SC), the product
is rapidly and
completely absorbed. The absolute bioavailability is over 90%.
The maximum plasma activity is observed after 3 hours and is, on
average, 1.6 µg/mL after the
SC
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