Clexane INJ. SOL.10.000 anti-Xa IU/1.0ml (100mg/1.0 ml)

Kraj: Malta

Język: angielski

Źródło: Medicines Authority

Składnik aktywny:

ENOXAPARIN SODIUM

Dostępny od:

Sanofi Malta Limited

Kod ATC:

B01AB05

INN (International Nazwa):

ENOXAPARIN SODIUM

Forma farmaceutyczna:

SOLUTION FOR INJECTION

Skład:

ENOXAPARIN SODIUM 10 mg/ml

Typ recepty:

POM

Dziedzina terapeutyczna:

ANTITHROMBOTIC AGENTS

Status autoryzacji:

Authorised

Data autoryzacji:

2006-02-24

Ulotka dla pacjenta

Page 1 of 10
PACKAGE LEAFLET: INFORMATION FOR THE USER
CLEXANE® SYRINGES 2,000 IU (20 MG)/0.2 ML SOLUTION FOR INJECTION
CLEXANE® SYRINGES 4,000 IU (40 MG)/0.4 ML SOLUTION FOR INJECTION
CLEXANE® SYRINGES 6,000 IU (60 MG)/0.6 ML SOLUTION FOR INJECTION
CLEXANE® SYRINGES 8,000 IU (80 MG)/0.8 ML SOLUTION FOR INJECTION
CLEXANE® SYRINGES 10,000 IU (100 MG)/1 ML SOLUTION FOR INJECTION
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 Syringes is and what it is used for
2.
What you need to know before you use Clexane Syringes
3.
How to use Clexane Syringes
4.
Possible side effects
5.
How to store Clexane Syringes
6.
Contents of the pack and other information
1.
WHAT CLEXANE SYRINGES IS AND WHAT IT IS USED FOR
Clexane Syringes contains the active substance called enoxaparin
sodium that is a low molecular
weight heparin (LMWH).
Clexane Syringes 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 blood clots from forming in your blood.
Clexane Syringes 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 an acute illness and face period of limited mobility
o
When you have unstable angina (a condition when not enough blood gets
to your
heart)
o
After a heart attack

Stop blood clots forming in the tubes of your dialysis machin

Charakterystyka produktu

Page 1 of 24
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Clexane
®
2,000 IU (20 mg)/0.2 mL solution for injection
Clexane
®
4,000 IU (40 mg)/0.4 mL solution for injection
Clexane
®
6,000 IU (60 mg)/0.6 mL solution for injection
Clexane
®
8,000 IU (80 mg)/0.8 mL solution for injection
Clexane
®
10,000 IU (100 mg)/1 mL solution for injection
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
_2,000 IU (20 mg) /0.2 mL _
Each prefilled 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 prefilled 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 prefilled 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 prefilled 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 prefilled syringe contains enoxaparin sodium 10,000 IU anti-Xa
activity (equivalent to
100 mg) in 1.0 mL water for injections.
For 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.
Clear, colourless to pale yellow solution.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Clexane is indicated in adults for:
Page 2 of 24

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 in medical patients with an acute
illness (such as acute
heart failure, respiratory insufficiency, severe infections or
rheumatic diseases) and reduced
mobility at increased risk of venous thromboembolism.

Treatment of deep venous thr