Praxbind

Krajina: Európska únia

Jazyk: angličtina

Zdroj: EMA (European Medicines Agency)

Aktívna zložka:

idarucizumab

Dostupné z:

Boehringer Ingelheim International GmbH

ATC kód:

V03AB

INN (Medzinárodný Name):

idarucizumab

Terapeutické skupiny:

All other therapeutic products

Terapeutické oblasti:

Hemorrhage

Terapeutické indikácie:

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 surgery/urgent procedures;in life-threatening or uncontrolled bleeding.

Prehľad produktov:

Revision: 12

Stav Autorizácia:

Authorised

Dátum Autorizácia:

2015-11-20

Príbalový leták

25 B. PACKAGE LEAFLET
26
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT AND USER
PRAXBIND 2.5 G/50 ML SOLUTION FOR INJECTION/INFUSION
idarucizumab
READ ALL OF THIS LEAFLET CAREFULLY, BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU. PLEASE NOTE
THIS MEDICINE IS MAINLY USED IN EMERGENCY SITUATIONS AND THE DOCTOR
WILL HAVE DECIDED THAT YOU
NEEDED IT.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or nurse.
-
If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Praxbind is and what it is used for
2.
What you need to know when you receive Praxbind
3.
How to use Praxbind
4.
Possible side effects
5.
How to store Praxbind
6.
Contents of the pack and other information
1. WHAT PRAXBIND IS AND WHAT IT IS USED FOR
WHAT PRAXBIND IS
Praxbind contains the active substance idarucizumab. Idarucizumab is a
reversal agent specific for
dabigatran (Pradaxa), a blood thinner medicine that blocks a substance
in the body, which is involved
in blood clot formation.
Praxbind is used to rapidly trap dabigatran in order to inactivate its
effect.
WHAT PRAXBIND IS USED FOR
Praxbind is used in adults in emergency situations where your doctor
decides that rapid inactivation of
the effect of Pradaxa is required:
-
For emergency surgery/urgent procedures;
-
In life-threatening or uncontrolled bleeding.
2. WHAT YOU NEED TO KNOW WHEN YOU RECEIVE PRAXBIND
WARNINGS AND PRECAUTIONS
Talk to your doctor or nurse before receiving Praxbind:
-
if you are allergic to idarucizumab or to any other of the substances
listed in section 6.
-
if you have a genetic disease called hereditary fructose intolerance.
In this case, the substance
sorbitol contained in this medicine may cause serious adverse
reactions.
They will take this into account before treating you with Praxbind.
This medicine will only remove dabigatran from your body. It will not
remove other medicines used to
prevent the

Súhrn charakteristických

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1. NAME OF THE MEDICINAL PRODUCT
Praxbind 2.5 g/50 mL solution for injection/infusion
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 vial contains 2 g sorbitol and 25 mg sodium in 50 mL (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
Pradaxa (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 is 5 g idarucizumab (2 vials of 2.5 g/50 mL).
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 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.
Relevant coagulation parameters are activated partial thromboplastin
time (aPTT), diluted thrombin
time (dTT) or ecarin clotting time (ECT) (see section 5.1).
3
A maximum daily dose has not been investigated.
_Restarting antithrombotic therapy_
Pradaxa (dabigatran etexilate) treatment