Clexane Forte 15,000 IU (150mg)/1ml Solution for Injection in pre-filled syringes

Land: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

Enoxaparin sodium

Fáanlegur frá:

Sanofi-Aventis Ireland Limited T/A SANOFI

ATC númer:

B01AB; B01AB05

INN (Alþjóðlegt nafn):

Enoxaparin sodium

Skammtar:

150 milligram(s)/millilitre

Lyfjaform:

Solution for injection in pre-filled syringe

Gerð lyfseðils:

Product subject to prescription which may not be renewed (A)

Lækningarsvæði:

Heparin group; enoxaparin

Leyfisstaða:

Marketed

Leyfisdagur:

2001-06-15

Upplýsingar fylgiseðill

PACKAGE LEAFLET: INFORMATION FOR THE USER
CLEXANE® 2,000 IU (20MG)/0.2ML SOLUTION FOR INJECTION IN PRE‐FILLED
SYRINGES
CLEXANE® 4,000 IU (40MG)/0.4ML SOLUTION FOR INJECTION IN PRE‐FILLED
SYRINGES
CLEXANE® 6,000 IU (60MG)/0.6ML SOLUTION FOR INJECTION IN PRE‐FILLED
SYRINGES
CLEXANE® 8,000 IU (80MG)/0.8ML SOLUTION FOR INJECTION IN PRE‐FILLED
SYRINGES
CLEXANE® 10,000 IU (100MG)/1ML SOLUTION FOR INJECTION IN PRE‐FILLED
SYRINGES
CLEXANE® FORTE 12,000 IU (120MG)/0.8ML SOLUTION FOR INJECTION IN
PRE‐FILLED
SYRINGES
CLEXANE® FORTE 15,000 IU (150MG)/1ML SOLUTION FOR INJECTION IN
PRE‐FILLED
SYRINGES
_enoxaparin sodium _
_ _
_ _
_ _
_ _
_ _
_ _
_ _ WITH ERIS NEEDLE GUARD SAFETY SYSTEM
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
. 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 fro

Vara einkenni

Health Products Regulatory Authority
18 February 2022
CRN00CT3T
Page 1 of 21
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Clexane Forte 15,000 IU (150mg)/1ml Solution for Injection in
pre-filled syringes
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pre-filled syringe contains enoxaparin sodium 15,000 IU anti-Xa
activity (equivalent to 150 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 Forte 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 diseases)
and reduced mobility at increased risk of venous
thromboembolism.

Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE),
excluding PE likely to require
thrombolytic therapy or surgery.

Extended treatment of deep vein thrombosis (DVT) and pulmonary
embolism (PE) and prevention of its recurrence
in patients with active cancer.

Prevention of thrombus formation in extracorporeal circulation during
haemodialysis.

Acute coronary syndrome:

Treatment of unstable angina and Non ST-segment elevation myocardial
infarction (NSTEMI), in combination with
oral acetylsalicylic acid.

Treatment of acute ST-segment elevation myocardial infarction (STEMI)
including patients to be managed
medically or with subsequent percutaneous coronary intervention (PCI).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Prophylaxis of venou