Enoxaparin sodium Ledraxen 4,000 IU (40 mg)/0.4 mL, solution for injection in pre-filled syringe

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv bestanddel:

Enoxaparin sodium

Tilgængelig fra:

Venipharm

ATC-kode:

B01AB05

INN (International Name):

Enoxaparin sodium

Lægemiddelform:

Solution for injection in pre-filled syringe

Terapeutisk område:

enoxaparin

Autorisation status:

Not marketed

Autorisation dato:

2022-09-16

Indlægsseddel

PACKAGE LEAFLET: INFORMATION FOR THE USER
Enoxaparin sodium Ledraxen 2,000 IU (20 mg)/0.2 mL solution for
injection in pre-
filled syringe
Enoxaparin sodium Ledraxen 4,000 IU (40 mg)/0.4 mL solution for
injection in pre-
filled syringe
Enoxaparin sodium Ledraxen 6,000 IU (60 mg)/0.6 mL solution for
injection in pre-
filled syringe
Enoxaparin sodium Ledraxen 8,000 IU (80 mg)/0.8 mL solution for
injection in pre-
filled syringe
Enoxaparin sodium Ledraxen 10,000 IU (100 mg)/1 mL solution for
injection in pre-
filled syringe
enoxaparin sodium
This medicine is subject to additional monitoring. This will allow
quick identification of
new safety information. You can help by reporting any side effects you
may get. See the
end of section 4 for how to report side effects.
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, pharmacist or nurse.
This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Enoxaparin sodium Ledraxen is and what it is used for
2.
What you need to know before you use Enoxaparin sodium Ledraxen
3.
How to use Enoxaparin sodium Ledraxen
4.
Possible side effects
5.
How to store Enoxaparin sodium Ledraxen
6.
Contents of the pack and other information
1.
WHAT ENOXAPARIN SODIUM LEDRAXEN IS AND WHAT IT IS USED FOR
Enoxaparin sodium Ledraxen contains the active substance called
enoxaparin sodium that is
a low molecular weight heparin (LMWH).
Enoxaparin sodium Ledraxen 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 for

Produktets egenskaber

Health Products Regulatory Authority
06 October 2023
CRN00DKFY
Page 1 of 22
SUMMARY OF PRODUCT CHARACTERISTICS
▼ This medicinal product is subject to additional monitoring. This
will allow quick identification of new safety information.
Healthcare professionals are asked to report any suspected adverse
reactions. See section 4.8 for how to report adverse
reactions.
1 NAME OF THE MEDICINAL PRODUCT
Enoxaparin sodium Ledraxen 4,000 IU (40 mg)/0.4 mL, solution for
injection in pre-filled syringe
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
10,000 IU/mL (100 mg/mL) solution for injection in pre-filled syringe
_Pre-Filled Syringes:_
_4,000 IU( 40 mg) /0.4mL_
Each prefilled syringe contains enoxaparin sodium 4,000 IU anti-Xa
activity (equivalent to 40 mg) in 0.4 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 syringe.
Colourless or light yellow transparent liquid, the pH of the solution
is between 5.5 and 7.5.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Enoxaparin sodium Ledraxen 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 extra corporeal circulation durin