Special Warning : אזהרת שימוש

4.4        Special warnings and precautions for use

Traceability
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.

Use of medicinal products that increase the risk of haemorrhage within 24 hours of Defitelio® administration (within 12 hours in the case of unfractionated heparin) is not recommended.

Concomitant systemic anticoagulant therapy (e.g. heparin, warfarin, direct thrombin inhibitors and direct factor Xa inhibitors) (see section 4.5), except for routine maintenance or reopening of central venous line, requires careful monitoring. Consideration should be given to discontinuation of Defitelio® during use of such therapy.

Medicinal products that affect platelet aggregation (e.g. non–steroidal anti-inflammatory agents) should be administered with care, under close medical supervision, during Defitelio® administration.

In patients who have or develop clinically significant acute bleeding requiring blood transfusion, Defitelio® is not recommended or should be discontinued. Temporary discontinuation of Defitelio® is recommended in patients who undergo surgery or invasive procedures at significant risk of major bleeding.
Administration of defibrotide to patients who have haemodynamic instability, defined as inability to maintain mean arterial pressure with single pressor support, is not recommended.

A bolus administration of Defitelio® may cause flushing or a sensation of “generalised heat”.

Excipients
This medicinal product contains 20.4 mg sodium per vial, equivalent to 1.02% of the WHO recommended maximum daily intake of 2 g sodium for an adult.

Effects on Driving

4.7     Effects on ability to drive and use machines

Defitelio® has no or negligible influence on the ability to drive and use machines. However, patients would not be expected to drive or operate machinery due to the nature of the underlying disease.