Fondaparinux sodium Aspen 7.5 mg/0.6 ml solution for injection, pre-filled syringe.

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Fondaparinux sodium

Available from:

Aspen Pharma Trading Limited

ATC code:

B01AX05

INN (International Name):

Fondaparinux sodium

Pharmaceutical form:

Solution for injection

Therapeutic area:

fondaparinux

Authorization status:

Not marketed

Authorization date:

2022-07-29

Patient Information leaflet

1
June 2022
PACKAGE LEAFLET
2
June 2022
PACKAGE LEAFLET: INFORMATION FOR THE USER
FONDAPARINUX SODIUM ASPEN 5 MG/0.4 ML SOLUTION FOR INJECTION,
PRE-FILLED SYRINGE
FONDAPARINUX SODIUM ASPEN 7.5 MG/0.6 ML SOLUTION FOR INJECTION,
PRE-FILLED SYRINGE
FONDAPARINUX SODIUM ASPEN 10 MG/0.8 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 TREATS OR HELPS TO
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 TREAT ADULTS WITH A BLOOD CLOT IN
THE BLOOD VESSELS OF THEIR
LEGS
(
_deep vein thrombosis_
)
AND/OR LUNGS
(
_pulmonary embolism_
).
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE FONDAPARINUX SODIUM ASPEN
DO NOT USE FONDAPARINUX SODIUM ASPEN:

IF YOU ARE ALLERGIC
to fondaparinux sodium or to any of the other ingredients of this
medicine
(listed in s

Summary of Product characteristics

Health Products Regulatory Authority
29 July 2022
CRN00CKLN
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Fondaparinux sodium Aspen 7.5 mg/0.6 ml solution for injection,
pre-filled syringe.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pre-filled syringe contains 7.5 mg of fondaparinux sodium in 0.6
ml solution for injection.
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 to slightly yellow liquid.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of adults with acute Deep Vein Thrombosis (DVT) and
treatment of acute Pulmonary Embolism (PE), except in
haemodynamically unstable patients or patients who require
thrombolysis or pulmonary embolectomy_._
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose of fondaparinux is 7.5 mg (patients with body
weight
³
50,
£
100kg) once daily administered by
subcutaneous injection. For patients with body weight < 50 kg, the
recommended dose is 5 mg. For patients with body
weight > 100 kg, the recommended dose is 10 mg.
Treatment should be continued for at least 5 days and until adequate
oral anticoagulation is established (International
Normalised Ratio 2 to 3). Concomitant oral anticoagulation treatment
should be initiated as soon as possible and usually within
72 hours. The average duration of administration in clinical trials
was 7 days and the clinical experience from treatment beyond
10 days is limited.
_ _
_Special populations_
_Elderly patients_ - No dosing adjustment is necessary.In patients
³
75 years, fondaparinux should be used with care, as renal
function decreases with age (see section 4.4).
_Renal impairment - _Fondaparinux should be used with caution in
patients with moderate renal impairment (see section 4.4).
There is no experience in the subgroup of patients with _both_ high
body