Clexane 8,000IU (80mg)/0.8mL solution for injection in pre-filled syringes

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ENOXAPARIN SODIUM

Available from:

Sanofi S.R.L Viale L. Bodio, 37/b 20158, Milan, Italy

ATC code:

B01AB05

INN (International Name):

ENOXAPARIN SODIUM 100 mg/ml

Pharmaceutical form:

SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE

Composition:

ENOXAPARIN SODIUM 100 mg/ml

Prescription type:

POM

Therapeutic area:

ANTITHROMBOTIC AGENTS

Authorization status:

Authorised

Authorization date:

2006-02-24

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
CLEXANE 2,000 IU (20 MG)/0.2 ML SOLUTION FOR INJECTION IN PRE-FILLED
SYRINGES
CLEXANE 4,000 IU (40 MG)/0.4 ML SOLUTION FOR INJECTION IN PRE-FILLED
SYRINGES
CLEXANE 6,000 IU (60 MG)/0.6
ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGES
CLEXANE 8,000 IU (80 MG)/0.8 ML SOLUTION FOR INJECTION IN PRE-FILLED
SYRINGES
CLEXANE 10,000 IU (100 MG)/1 ML SOLUTION FOR INJECTION IN PRE-FILLED
SYRINGES
enoxaparin sodium
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist or
nurse.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Clexane is and what it is used for
2.
What you need to know before you use Clexane
3.
How to use Clexane
4.
Possible side effects
5.
How to store Clexane
6.
Contents of the pack and other information
1.
WHAT CLEXANE IS AND WHAT IT IS USED FOR
Clexane contains the active substance called enoxaparin sodium. This
belongs to a group of medicines
call ‘low molecular weight heparin’ or LMWH.
HOW CLEXANE WORKS
Clexane works in two ways:
1)
Stopping existing blood clots from getting any bigger. This helps your
body to break them
down and stops them from causing you harm.
2)
Stopping new blood clots from forming in your blood.
WHAT CLEXANE IS USED FOR
Clexane can be used to:
•
Treat blood clots that are in your blood
•
Stop blood clots from forming in your blood in the following
situations:
o
before and after an operation
o
when you have a short-term illness and will not be able to move around
for some time
o
if you have experienced a blood clot due to cancer to prevent further
clots from f

Summary of Product characteristics

1
1.
NAME OF THE MEDICINAL PRODUCT
Clexane 2,000 IU (20 mg)/0.2 mL solution for injection in pre-filled
syringes
Clexane 4,000 IU (40 mg)/0.4 mL solution for injection in pre-filled
syringes
Clexane 6,000 IU (60 mg)/0.6 mL solution for injection in pre-filled
syringes
Clexane 8,000 IU (80 mg)/0.8 mL solution for injection in pre-filled
syringes
Clexane 10,000 IU (100 mg)/1 mL solution for injection in pre-filled
syringes
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_2,000 IU (20 mg) /0.2 mL _
Each pre-filled syringe contains enoxaparin sodium 2,000 IU anti-Xa
activity (equivalent to 20 mg) in
0.2 mL water for injections.
_4,000 IU (40 mg) /0.4 mL _
Each pre-filled syringe contains enoxaparin sodium 4,000 IU anti-Xa
activity (equivalent to 40 mg) in
0.4 mL water for injections.
_6,000 IU (60 mg) /0.6 mL _
Each pre-filled syringe contains enoxaparin sodium 6,000 IU anti-Xa
activity (equivalent to 60 mg) in
0.6 mL water for injections.
_8,000 IU (80 mg) /0.8 mL _
Each pre-filled syringe contains enoxaparin sodium 8,000 IU anti-Xa
activity (equivalent to 80 mg) in
0.8 mL water for injections.
_10,000 IU (100 mg) /1.0 mL _
Each pre-filled syringe contains enoxaparin sodium 10,000 IU anti-Xa
activity (equivalent to 100 mg)
in 1.0 mL water for injections.
For the full list of excipients, see section 6.1.
Enoxaparin sodium is a biological substance obtained by alkaline
depolymerization of heparin benzyl
ester derived from porcine intestinal mucosa.
3.
PHARMACEUTICAL FORM
Solution for injection in pre-filled syringes.
Clear, colourless to yellowish solution, pH-value 5.5–7.5
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Clexane is indicated in adults for:
_ _
-
Prophylaxis of venous thromboembolic disease in moderate and high risk
surgical patients, in
particular those undergoing orthopaedic or general surgery including
cancer surgery.
-
Prophylaxis of venous thromboembolic disease in medical patients with
an acute illness (such as
acute heart failure, respiratory insufficiency, severe infections or
rheumatic disea