Fondaparinux Sodium Aspen 1.5 mg/0.3 ml solution for injection, pre-filled syringe

Country: Ireland

Bahasa: Inggeris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Fondaparinux sodium

Boleh didapati daripada:

Aspen Pharma Trading Limited

Kod ATC:

B01AX05

INN (Nama Antarabangsa):

Fondaparinux sodium

Borang farmaseutikal:

Solution for injection

Kawasan terapeutik:

fondaparinux

Status kebenaran:

Not marketed

Tarikh kebenaran:

2022-07-29

Risalah maklumat

1
June 2022
PACKAGE LEAFLET
2
June 2022
PACKAGE LEAFLET: INFORMATION FOR THE USER
FONDAPARINUX SODIUM ASPEN 1.5 MG/0.3 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
(t
_hromboses_
) 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 blood clots in blood vessels that are near the surface of the
skin of the legs
_(superficial-_
_vein thrombosis_
)
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE FONDAPARINUX SODIUM ASPEN
DO NOT USE FONDAPARINUX SODIUM ASPEN:

IF YOU ARE

Ciri produk

Health Products Regulatory Authority
29 July 2022
CRN00CKLN
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Fondaparinux Sodium Aspen 1.5 mg/0.3 ml solution for injection,
pre-filled syringe
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pre-filled syringe (0.3 ml) contains 1.5 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 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 is 2.5 mg once daily administered
post-operatively by subcutaneous injection.
The initial dose should be given 6 hours following surgical closure
provided that haemostasis has been established.
Treatment should be continued until the risk of venous
thrombo-embolism has diminished, usually until the patient is
ambulant, at least 5 to 9 days after surgery. Experience shows that