Fondaparinux sodium Aspen 10 mg/0.8 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

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 10 mg/0.8 ml solution for injection,
pre-filled syringe.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pre-filled syringe contains 10 mg of fondaparinux sodium in 0.8
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 we