Praxbind

Restricted to hospital use only. 5 g/50 mL). 1). Administration of a second 5 g dose of idarucizumab may be considered in the following situations: • recurrence of clinically relevant bleeding together with prolonged clotting times, or • if potential re-bleeding would be life-threatening and prolonged clotting times are observed, or • patients require a second emergency surgery/urgent procedure and have prolonged clotting times.

1). 3 A maximum daily dose has not been investigated. Restarting antithrombotic therapy Dabigatran etexilate treatment can be re-initiated 24 hours after administration of idarucizumab, if the patient is clinically stable and adequate haemostasis has been achieved.

g. low-molecular weight heparin) can be started at any time, if the patient is clinically stable and adequate haemostasis has been achieved. Absence of antithrombotic therapy exposes patients to the thrombotic risk of their underlying disease or condition.

2). Patients with renal impairment No dose adjustment is required in renally impaired patients. 2). 2). Paediatric population The safety and efficacy of Praxbind in children below the age of 18 years have not been established. 1. Method of administration Intravenous use.

5 g/50 mL) is administered intravenously as two consecutive infusions over 5 to 10 minutes each or as a bolus injection. 6.

In a phase III study the safety of Praxbind has been evaluated in 503 patients, who had uncontrolled bleeding or required emergency surgery or procedures and were under treatment with Pradaxa (dabigatran etexilate), as well as in 224 volunteers in phase I studies.

Furthermore, 359 patients were enrolled in a global idarucizumab administration surveillance program to collect data on usage patterns in a real-world-setting. One paediatric patient was treated in the context of a paediatric safety trial.

No adverse reactions have been identified. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

Idarucizumab binds specifically to dabigatran and reverses its anticoagulant effect. 1). Praxbind treatment can be used in conjunction with standard supportive measures, which should be considered as medically appropriate. 4 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.

g. anaphylactoid reaction) to idarucizumab or to any of the excipients needs to be weighed cautiously against the potential benefit of such an emergency treatment. If an anaphylactic reaction or other serious allergic reaction occurs, administration of Praxbind should be discontinued immediately and appropriate therapy initiated.

Hereditary fructose intolerance The recommended dose of Praxbind contains 4 g sorbitol as an excipient. In patients with hereditary fructose intolerance, parenteral administration of sorbitol has been associated with reports of hypoglycemia, hypophosphatemia, metabolic acidosis, increase in uric acid, acute liver failure with breakdown of excretory and synthetic function, and death.

Therefore, in patients with hereditary fructose intolerance the risk of treatment with Praxbind must be weighed against the potential benefit of such an emergency treatment. If Praxbind is administered in these patients, intensified medical care during Praxbind exposure and within 24 hours of exposure is required.

Thromboembolic events Patients being treated with dabigatran have underlying disease states that predispose them to thromboembolic events. Reversing dabigatran therapy exposes patients to the thrombotic risk of their underlying disease.

2). 2). The transient proteinuria is not indicative of renal damage, which should be taken into account for urine testing. 5% of the WHO recommended maximum daily intake of 2 g sodium for an adult.