2.5 g / 50 ml solution for injection / infusion
idarucizumab

What Praxbind is and what it is used for

What Praxbind is

Praxbind contains the active substance idarucizumab. Idarucizumab is a drug that specifically removes the effect of dabigatran (Pradaxa), a blood-thinning drug that blocks a substance in the body that is involved in the formation of blood clots.

Praxbind is used to quickly catch dabigatran and thus deactivate its effect.

What Praxbind is used for

Praxbind is used in adults in emergencies when the doctor decides that rapid deactivation of Pradaxa’s effect is required:

  • Before emergency surgery / urgent treatment
  • In case of life-threatening or uncontrolled bleeding.

What you need to know when you receive Praxbind

Warnings and cautions

Talk to a doctor or nurse before receiving Praxbind

  • if you are allergic to idarucizumab or any of the other ingredients listed in section 6.
  • if you have the genetic disease hereditary fructose intolerance. In this case, the substance sorbitol, which is found in this medicine, can cause serious side effects.

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 drugs used to prevent the formation of blood clots.

After the dabigatran has disappeared from your body, you are no longer protected against the formation of blood clots. Your doctor will continue your drug treatment to prevent the formation of blood clots as soon as your medical condition allows.

Children and young people

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 is designed to bind only to dabigatran. Praxbind is unlikely to affect the effect of other medicines or that other medicines affect Praxbind.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.

There is no information on the effect of this medicine on pregnant or lactating women. Praxbind does not in itself affect body functions, so your doctor may decide to give you this medicine if the expected benefits outweigh the potential risks.

Praxbind contains sodium

This medicine contains 50 mg of sodium (the main ingredient in table salt/table salt) in each dose. This corresponds to 2.5% of the maximum recommended daily sodium intake for adults.

How to use Praxbind

This medicine should only be used in hospitals.

The recommended dose is 5 g (2 vials of 2.5 g / 50 ml).

In rare cases, you may still have too much dabigatran in your blood after the first dose of this medicine and in some situations, your doctor may decide to give you an additional dose of 5 g.

Your doctor or nurse will give you this medicine by injection or infusion into a vein.

After receiving this medicine, your doctor will decide if your treatment to prevent blood clots should continue. Dabigatran can be given again 24 hours after administration of this medicine.

Detailed instructions for your doctor or nurse on how to take this medicine can be found at the end of this leaflet (see ‘Handling instructions’).

If you have any further questions on the use of this product, ask your doctor.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

So far no side effects have been identified.

How to store Praxbind

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the vial and carton after EXP. The expiration date is the last day of the specified month. The expiration date is the last day of the specified month.

Store in a refrigerator (2 ° C ‑ 8 ° C).

Do not freeze.

Store in the original package. Sensitive to light.

This medicine should be used immediately after opening.

Contents of the pack and other information

Content declaration

  • The active substance is idarucizumab.
  • The other ingredients are sodium acetate trihydrate (E262), acetic acid (E260, for pH adjustment), sorbitol (E420), polysorbate (E432), and water for injections.

What the medicine looks like and the contents of the pack

Praxbind is a clear to slightly opalescent, colorless to the pale yellow solution, which is provided in a glass vial, closed with a butyl rubber stopper and an aluminum cap.

Each pack contains two vials.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Boehringer Ingelheim International GmbH

Binger Page 173

D 55216 Ingelheim am Rhein

Germany

Manufacturer

Boehringer Ingelheim Pharma GmbH & Co. KG

Birkendorfer Strasse 65

D ‑ 88397 Biberach an der Riss

Germany

Boehringer Ingelheim France

100-104 Avenue de France

75013 Paris

France

Contact the representative of the marketing authorization holder to find out more about this medicine:


Belgium / Belgique / BelgienSCS Boehringer Ingelheim Comm.V
Tel: +32 2 773 33 11

LithuaniaBoehringer Ingelheim RCV GmbH & Co KGLithuanian branchesTel: +370 5 2595942
BulgariaBoringer Inglehaim RIV Gemba and Co. KГ – clone of BulgariaTel: +359 2 958 79 98 Luxembourg / LuxemburgSCS Boehringer Ingelheim Comm.V
Tel: +32 2 773 33 11
Czech RepublicBoehringer Ingelheim spol. s roTel: +420 234 655 111 HungaryBoehringer Ingelheim RCV GmbH & Co KG Magyarországi FióktelepeTel: +36 1 299 8900
DenmarkBoehringer Ingelheim Danmark A / STel: +45 39 15 88 88 MaltaBoehringer Ingelheim Ireland Ltd.Tel: +353 1 295 9620
GermanyBoehringer Ingelheim Pharma GmbH & Co. KGTel: +49 (0) 800 77 90 900 The NetherlandsBoehringer Ingelheim bvTel: +31 (0) 800 22 55 889
EestiBoehringer Ingelheim RCV GmbH & Co KGEesti subsidiaryTel: +372 612 8000 NorwayBoehringer Ingelheim Norway KSTel: +47 66 76 13 00
GreeceBoehringer Ingelheim Ellas AETηλ: +30 2 10 89 06 300 AustriaBoehringer Ingelheim RCV GmbH & Co KGTel: +43 1 80 105‑7870
SpainBoehringer Ingelheim España, SATel: +34 93 404 51 00 PolandBoehringer Ingelheim Sp.zo.o.Tel: +48 22 699 0 699
FranceBoehringer Ingelheim France SASTel: +33 3 26 50 45 33 PortugalBoehringer Ingelheim Portugal, Lda.Tel: +351 21 313 53 00
CroatiaBoehringer Ingelheim Zagreb dooTel: +385 1 2444 600 RomaniaBoehringer Ingelheim RCV GmbH & Co KG Viena ‑ Sucursala BucurestiTel: +40 21 302 2800
IrelandBoehringer Ingelheim Ireland Ltd.Tel: +353 1 295 9620 SloveniaBoehringer Ingelheim RCV GmbH & Co KG Podružnica LjubljanaTel: +386 1 586 40 00
IcelandVistor hf.Phone: +354 535 7000 Slovak RepublicBoehringer Ingelheim RCV GmbH & Co. KG Organizing ServicesTel: +421 2 5810 1211
ItalyBoehringer Ingelheim Italia SpATel: +39 02 5355 1 Finland / FinlandBoehringer Ingelheim Finland KyPuh / Tel: +358 10 3102 800
.ΠροςBoehringer Ingelheim Ellas AETηλ: +30 2 10 89 06 300 SwedenBoehringer Ingelheim ABTel: +46 8 721 21 00
LatviaBoehringer Ingelheim RCV GmbH & Co KGLatvian branchTel: +371 67 240 011 United Kingdom (Northern Ireland)Boehringer Ingelheim Ireland Ltd.Tel: +353 1 295 9620

Muhammad Nadeem

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