Clexane 10,000 IU (100 mg)/1 ml Solution for Injection in pre-filled syringes

Land: Ierland

Taal: Engels

Bron: HPRA (Health Products Regulatory Authority)

Werkstoffen:

Enoxaparin sodium

Beschikbaar vanaf:

PCO Manufacturing Ltd.

ATC-code:

B01AB05

INN (Algemene Internationale Benaming):

Enoxaparin sodium

Dosering:

10000 international unit(s)

farmaceutische vorm:

Solution for injection in pre-filled syringe

Therapeutisch gebied:

enoxaparin

Autorisatie datum:

2021-08-13

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE USER
CLEXANE
® 2,000 IU (20MG)/0.2ML 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
CLEXANE
® FORTE 12,000 IU (120 MG)/0.8 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 called ‘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

Productkenmerken

Health Products Regulatory Authority
01 July 2022
CRN00CYS8
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Clexane 10,000 IU (100 mg)/1 ml Solution for Injection in pre-filled
syringes
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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.
_Product imported from Belgium_
Clear, colourless to yellowish solution, pH value 5.5-7.5.
4 CLINICAL PARTICULARS
As per PA0540/097/001
5 PHARMACOLOGICAL PROPERTIES
As per PA0540/097/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Water for injections
6.2 INCOMPATIBILITIES
SC injection
Do not mix with other products.
IV (Bolus) Injection (for acute STEMI indication only):
This medicinal product must not be mixed with other medicinal products
except those mentioned in SmPC section 4.2 of
PA0540/097/001.
6.3 SHELF LIFE
The shelf life expiry date of this product shall be the date shown on
the container and outer package of the product on the
market in the country of origin.
Diluted solution
Diluted solution should be used immediately.
Health Products Regulatory Authority
01 July 2022
CRN00CYS8
Page 2 of 2
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25°C. Do not freeze.
6.5 NATURE AND CONTENTS OF CONTAINER
Solution for injection in glass pre-filled syringes fitted with an
injection needle (without an automatic safety system).
Supplied in packs of 10 pre-filled syringes.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR
WASTE MATERIALS DERIVED FROM SUCH MEDICINAL
PRODUCT AND OTHER HANDLING OF THE PRODUCT
Pre-filled syringes are ready for immediate use. For method of
administration see SmPC section 4.2 of PA0540/097/001.
Use only clear,