Fondaparinux sodium Aspen 2.5 mg/0.5 ml solution for injection, pre-filled syringe.

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Fondaparinux sodium

Tilgjengelig fra:

Aspen Pharma Trading Limited

ATC-kode:

B01AX05

INN (International Name):

Fondaparinux sodium

Legemiddelform:

Solution for injection

Terapeutisk område:

fondaparinux

Autorisasjon status:

Not marketed

Autorisasjon dato:

2022-07-29

Informasjon til brukeren

1
June 2022
PACKAGE LEAFLET
2
June 2022
PACKAGE LEAFLET: INFORMATION FOR THE USER
FONDAPARINUX SODIUM ASPEN 2.5 MG/0.5 ML SOLUTION FOR INJECTION,
PRE-FILLED SYRINGE
_fondaparinux 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.

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 Fondaparinux Sodium Aspen is and what it is used for
2.
What you need to know before you use Fondaparinux Sodium Aspen
3.
How to use Fondaparinux Sodium Aspen
4.
Possible side effects
5
How to store Fondaparinux Sodium Aspen
6.
Contents of the pack and other information
1.
WHAT FONDAPARINUX SODIUM ASPEN IS AND WHAT IT IS USED FOR
FONDAPARINUX SODIUM ASPEN IS A MEDICINE THAT HELPS PREVENT BLOOD CLOTS
FROM FORMING IN THE
BLOOD VESSELS
(
_an antithrombotic agent_
).
Fondaparinux Sodium Aspen contains a synthetic substance called
fondaparinux sodium. This stops a
clotting factor Xa (“ten-A”) from working in the blood, and so
prevents unwanted blood clots
(
_thromboses_
) from forming in the blood vessels.
FONDAPARINUX SODIUM ASPEN IS USED TO:

prevent the formation of blood clots in the blood vessels of the legs
or lungs after orthopaedic
surgery (such as hip or knee surgery) or abdominal surgery

prevent the formation of blood clots during and shortly after a period
of restricted mobility
due to acute illness

treat some types of heart attack and severe angina (pain caused by
narrowing of the arteries in
the heart)

treat blood clots in blood vessels that are near the surface of the
skin of the legs (
_superficial-_
_vein thrombosis_
)
2.
WHAT

Preparatomtale

Health Products Regulatory Authority
29 July 2022
CRN00CKLN
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Fondaparinux sodium Aspen 2.5 mg/0.5 ml solution for injection,
pre-filled syringe.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pre-filled syringe (0.5 ml) contains 2.5 mg of fondaparinux
sodium.
Excipient(s) with known effect: Contains less than 1 mmol of sodium
(23 mg) per dose, and therefore is essentially sodium free.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
The solution is a clear and colourless liquid.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Prevention of Venous Thromboembolic Events (VTE) in adults undergoing
major orthopaedic surgery of the lower limbs such
as hip fracture, major knee surgery or hip replacement surgery.
Prevention of Venous Thromboembolic Events (VTE) in adults undergoing
abdominal surgery who are judged to be at high risk
of thromboembolic complications, such as patients undergoing abdominal
cancer surgery (see section 5.1).
Prevention of Venous Thromboembolic Events (VTE) in adult medical
patients who are judged to be at high risk for VTE and
who are immobilised due to acute illness such as cardiac insufficiency
and/or acute respiratory disorders, and/or acute
infectious or inflammatory disease.
Treatment of unstable angina or non-ST segment elevation myocardial
infarction (UA/NSTEMI) in adultsfor whom urgent (<
120 mins) invasive management (PCI) is not indicated (see sections 4.4
and 5.1).
Treatment of ST segment elevation myocardial infarction (STEMI) in
adults who are managed with thrombolytics or who initially
are to receive no other form of reperfusion therapy.
Treatment of adults with acute symptomatic spontaneous
superficial-vein thrombosis of the lower limbs without concomitant
deep-vein thrombosis (see sections 4.2 and 5.1).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Patients undergoing major orthopaedic or abdominal surgery_
The recommended dose of fondaparinux