ARIXTRA fondaparinux sodium 5.0mg/0.4mL solution for injection syringe

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

fondaparinux sodium, Quantity: 5 mg

Available from:

Aspen Pharmacare Australia Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: water for injections; sodium chloride

Administration route:

Subcutaneous

Units in package:

15 syringes, 10 syringes, 7 syringes

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

ARIXTRA is indicated for the prevention of venous thromboembolic events (VTE) in patients undergoing major orthopaedic surgery of the lower limbs such as hip fracture, major knee or hip replacement surgery. ARIXTRA is indicated for the prevention of venous thromboembolic events (VTE) in patients undergoing abdominal surgery who are at risk of thromboembolic complications. ARIXTRA is indicated for the treatment of acute deep venous thrombosis (DVT) and acute pulmonary embolism (PE).

Product summary:

Visual Identification: Pre-filled glass syringe containing a clear to practically clear and colourless to slightly yellow liquid; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2004-11-29

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
ARIXTRA (FONDAPARINUX SODIUM)
SOLUTION FOR INJECTION
1
NAME OF THE MEDICINE
Fondaparinux sodium (INN)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pre-filled automatic safety syringe contains 2.5 mg of
fondaparinux sodium in 0.5 mL, 5.0 mg of
fondaparinux sodium in 0.4 mL, 7.5 mg of fondaparinux sodium in 0.6 mL
or 10.0 mg of fondaparinux sodium
in 0.8 mL of an isotonic solution of sodium chloride and water for
Injections.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Solution for injection
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
ARIXTRA is indicated for the prevention of venous thromboembolic
events (VTE) in patients undergoing major
orthopaedic surgery of the lower limbs such as hip fracture, major
knee or hip replacement surgery.
ARIXTRA is indicated for the prevention of venous thromboembolic
events (VTE) in patients undergoing
abdominal surgery who are at risk of thromboembolic complications.
ARIXTRA is indicated for the treatment of acute deep venous thrombosis
(DVT) and acute pulmonary
embolism (PE).
ARIXTRA is indicated for the treatment of unstable angina or non-ST
segment elevation myocardial infarction
(UA/NSTEMI) in patients for whom urgent (<120 min) invasive management
(PCI) is not indicated.
ARIXTRA is indicated for the treatment of ST segment elevation
myocardial infarction (STEMI) in patients who
are managed without any form of initial reperfusion therapy.
4.2
D
OSE AND METHOD OF ADMINISTRATION
ADULTS
-
_PROPHYLAXIS OF VTE_
_ _
The recommended dose of ARIXTRA 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. Administration before 6 hours has been associated with an
increased risk of major bleeding.
Treatment should be continued for at least 7 ± 2 days. For
orthopaedic surgery cases where the risk of VTE
persists, treatment can be extended for as long as indicated