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SPC: ARIXTRA Solution for injection (2018)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Arixtra 1.5 mg/0.3 ml solution for injection, pre-filled syringe.

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. ...

Pharmaceutical form

Solution for injection. The solution is a clear and colourless liquid.

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 ...

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 ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Active clinically significant bleeding. Acute bacterial endocarditis. Severe renal impairment defined by creatinine ...

Special warnings and precautions for use

Fondaparinux is intended for subcutaneous use only. Do not administer intramuscularly. Haemorrhage Fondaparinux should be used with caution in patients who have an increased risk of haemorrhage, such as ...

Interaction with other medicinal products and other forms of interaction

Bleeding risk is increased with concomitant administration of fondaparinux and agents that may enhance the risk of haemorrhage (see section 4.4). Oral anticoagulants (warfarin), platelet inhibitors (acetylsalicylic ...

Fertility, pregnancy and lactation

Pregnancy There are no adequate data from the use of fondaparinux in pregnant women. Animal studies are insufficient with respect to effects on pregnancy, embryo/foetal development, parturition and postnatal ...

Effects on ability to drive and use machines

No studies on the effect on the ability to drive and to use machines have been performed.

Undesirable effects

The most commonly reported serious adverse reactions reported with fondaparinux are bleeding complications (various sites including rare cases of intracranial/intracerebral and retroperitoneal bleedings) ...

Overdose

Fondaparinux doses above the recommended regimen may lead to an increased risk of bleeding. There is no known antidote to fondaparinux. Overdose associated with bleeding complications should lead to treatment ...

Pharmacodynamic properties

Pharmacotherapeutic group: antithrombotic agents ATC code: B01AX05 Pharmacodynamic effects Fondaparinux is a synthetic and selective inhibitor of activated Factor X (Xa). The antithrombotic activity of ...

Pharmacokinetic properties

Absorption After subcutaneous dosing, fondaparinux is completely and rapidly absorbed (absolute bioavailability 100%). Following a single subcutaneous injection of fondaparinux 2.5 mg to young healthy ...

Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, and genotoxicity. Animal studies are insufficient with respect to effects ...

List of excipients

Sodium chloride Water for injections Hydrochloric acid Sodium hydroxide

Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

Shelf life

Shelf life: 3 years.

Special precautions for storage

Store below 25°C. Do not freeze.

Nature and contents of container

Type I glass barrel (1 ml) affixed with a 27 gauge x 12.7 mm needle and stoppered with a bromobutyl or chlorobutyl elastomer plunger stopper. Arixtra is available in pack sizes of 2, 7, 10 and 20 pre-filled ...

Special precautions for disposal and other handling

The subcutaneous injection is administered in the same way as with a classical syringe. Parenteral solutions should be inspected visually for particulate matter and discoloration prior to administration. ...

Marketing authorization holder

Aspen Pharma Trading Limited, 3016 Lake Drive Citywest Business Campus, Dublin 24, Ireland

Marketing authorization number(s)

EU/1/02/206/005-008 EU/1/02/206/024 EU/1/02/206/025 EU/1/02/206/026

Date of first authorization / renewal of the authorization

Date of first authorisation: 21 March 2002 Date of latest renewal: 21 March 2007

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