PRAXBIND

Ülke: İsrail

Dil: İngilizce

Kaynak: Ministry of Health

Aktif bileşen:

IDARUCIZUMAB

Mevcut itibaren:

BOEHRINGER INGELHEIM ISRAEL LTD.

ATC kodu:

V03AB37

Farmasötik formu:

SOLUTION FOR INJECTION / INFUSION

Kompozisyon:

IDARUCIZUMAB 50 MG / 1 ML

Uygulama yolu:

I.V

Reçete türü:

Required

Tarafından üretildi:

BOEHRINGER INGELHEIM PHARMA GmbH &CO.KG

Terapötik alanı:

IDARUCIZUMAB

Terapötik endikasyonlar:

Idarucizumab is a specific reversal agent for dabigatran and is indicated in patients treated with dabigatran etexilate when rapid reversal of the anticoagulant effects of dabigatran is required:• for emergency surgery/urgent procedures• in life-threatening or uncontrolled bleeding

Yetkilendirme tarihi:

2021-06-30

Ürün özellikleri

Praxbind
Updated prescribing information
Solution for I.V. injection/infusion 50mg/ml
August 2020
1
PRAXBIND
Solution for I.V. injection/infusion 50mg/ml
PRESCRIBING INFORMATION
1.
NAME OF THE MEDICINAL PRODUCT
Praxbind
2.
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.
Excipients with known effect:
Each 50 mL vial contains 2 g sorbitol and 25 mg sodium (see section
4.4).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection/infusion
Clear to slightly opalescent, colourless to slightly yellow solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Praxbind is a specific reversal agent for dabigatran and is indicated
in adult patients treated with dabigatran
etexilate when rapid reversal of its anticoagulant effects is
required:
•
For emergency surgery/urgent procedures
•
In life-threatening or uncontrolled bleeding.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Restricted to hospital use only.
Posology
The recommended dose of Praxbind is 5 g (2x2.5 g/50 mL).
Praxbind
Updated prescribing information
Solution for I.V. injection/infusion 50mg/ml
August 2020
2
In a subset of patients, recurrence of plasma concentrations of
unbound dabigatran and concomitant
prolongation of clotting tests have occurred up to 24 hours after
administration of idarucizumab (see
section 5.1).
Administration of a second 5 g dose of Praxbind 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.
Relevant coagulation parameters are activated Partial Thromboplastin
Time (aPTT), diluted Thrombin Time
(dTT) or Ecarin Clotti