PRAXBIND Solution for injection (2018)
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Περιεχόμενα
Name of the medicinal product
Praxbind 2.5 g/50 mL solution for injection/infusion.
Qualitative and quantitative composition
Each mL of solution for injection/infusion contains 50 mg idarucizumab. Each vial contains 2.5 g idarucizumab in 50 mL. Idarucizumab is produced by recombinant DNA technology in Chinese Hamster Ovary cells. ...
Pharmaceutical form
Solution for injection/infusion. Clear to slightly opalescent, colourless to slightly yellow solution.
Therapeutic indications
Praxbind is a specific reversal agent for dabigatran and is indicated in adult patients treated with Pradaxa (dabigatran etexilate) when rapid reversal of its anticoagulant effects is required: For emergency ...
Posology and method of administration
Restricted to hospital use only. Posology The recommended dose of Praxbind is 5 g (2x2.5 g/50 mL). In a subset of patients, recurrence of plasma concentrations of unbound dabigatran and concomitant prolongation ...
Contraindications
None.
Special warnings and precautions for use
Idarucizumab binds specifically to dabigatran and reverses its anticoagulant effect. It will not reverse the effects of other anticoagulants (see section 5.1). Praxbind treatment can be used in conjunction ...
Interaction with other medicinal products and other forms of interaction
No formal interaction studies with Praxbind and other medicinal products have been performed. Based on the pharmacokinetic properties and the high specificity in binding to dabigatran, clinically relevant ...
Fertility, pregnancy and lactation
Pregnancy There are no data for the use of Praxbind in pregnant women. Reproductive and developmental toxicity studies have not been performed, given the nature and the intended clinical use of the medicinal ...
Effects on ability to drive and use machines
Not relevant.
Undesirable effects
In a phase III trial 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 ...
Overdose
There is no clinical experience with overdoses of Praxbind. The highest single dose of Praxbind studied in healthy subjects was 8 g. No safety signals have been identified in this group.
Pharmacodynamic properties
Pharmacotherapeutic group: all other therapeutic products, antidotes ATC code: V03AB37 Mechanism of action Idarucizumab is a specific reversal agent for dabigatran. It is a humanized monoclonal antibody ...
Pharmacokinetic properties
The pharmacokinetics of idarucizumab were investigated in 224 subjects in Phase I studies, of which data for a representative subgroup of 6 healthy subjects aged 45 to 64 years receiving a dose of 5 g ...
Preclinical safety data
Preclinical data reveal no special hazard for humans based on repeated dose toxicity studies of up to four weeks in rats and two weeks in monkeys. Safety pharmacology studies have demonstrated no effects ...
List of excipients
Sodium acetate trihydrate Acetic acid Sorbitol Polysorbate 20 Water for injection
Incompatibilities
This medicinal product must not be mixed with other medicinal products.
Shelf life
Shelf life: 3 years. After opening the vial, chemical and physical in-use stability of idarucizumab has been demonstrated for 6 hours at room temperature. From a microbiological point of view, unless the ...
Special precautions for storage
Store in a refrigerator (2°C-8°C). Do not freeze. Store in the original package in order to protect from light. Prior to use, the unopened vial may be kept at room temperature (up to 30°C) for up to 48 ...
Nature and contents of container
50 mL solution in a glass vial (type I glass), with a butyl rubber stopper, an aluminium cap and a label with integrated hanger. Pack size of 2 vials.
Special precautions for disposal and other handling
Parenteral medicinal products such as Praxbind should be inspected visually for particulate matter and discoloration prior to administration. Praxbind must not be mixed with other medicinal products. A ...
Marketing authorization holder
Boehringer Ingelheim International GmbH, Binger Str. 173, D-55216, Ingelheim am Rhein, Germany
Marketing authorization number(s)
EU/1/15/1056/001
Date of first authorization / renewal of the authorization
Date of first authorisation: 20 November 2015
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