Praxbind 2.5g50ml solution for infusion vials

Țară: Regatul Unit

Limbă: engleză

Sursă: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredient activ:

Idarucizumab

Disponibil de la:

Boehringer Ingelheim Ltd

Codul ATC:

V03AB37

INN (nume internaţional):

Idarucizumab

Dozare:

50mg/1ml

Forma farmaceutică:

Solution for infusion

Calea de administrare:

Intravenous

Clasă:

No Controlled Drug Status

Tip de prescriptie medicala:

Valid as a prescribable product

Rezumat produs:

BNF: 02080400; GTIN: 5012816096189

Prospect

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 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.
Praxbind contains the active substance
idarucizumab.
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
Tell your doctor or nurse
• 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 formation of
blood clots.
After dabigatran has been removed from your
body, you are not protected from the
formation of blood clots. Your doctor will
continue treating you with medicines used to
prevent the formation of blood clots as soon
as your medical condition allows.
CHILDREN AND ADOLESCENTS
There is no information on the use of
Praxbind in children.
OTHER MEDICINES AND PRAXBIND
Tell your doctor if you are taking, have
recently taken or might take any other
medicines.
This medicine has been designed to only bind
to dabigatran. It is unlikely that Praxbind will
influence the effect of other medicines or that
other medicines

Caracteristicilor produsului

OBJECT 1
PRAXBIND 2.5 G/50 ML SOLUTION FOR
INJECTION/INFUSION
Summary of Product Characteristics Updated 15-Dec-2017 | Boehringer
Ingelheim Limited
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions. See
section 4.8 for how to report adverse reactions.
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 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 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 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 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