Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - praxbind

Document Subject

Generated Narrative: MedicinalProductDefinition mpd22822bd27d19d92ff4537227a0ddc72

identifier: http://ema.europa.eu/identifier/EU/1/15/1056/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Praxbind 2.5 g/50 mL solution for injection/infusion

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-d22822bd27d19d92ff4537227a0ddc72

identifier: http://ema.europa.eu/identifier/EU/1/15/1056/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - praxbind

Attesters

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

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.

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 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 will influence Praxbind. Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before receiving this medicine. There is no information on the effects of this medicine in pregnant or breast-feeding women. Praxbind does not affect any functions in the body as such, so your doctor may decide to give you this medicine, if the expected benefits outweigh any potential risks. Praxbind contains sodium This medicine contains 50 mg sodium (main component of cooking/table salt) in each dose. This is equivalent to 2.5% of the recommended maximum daily dietary intake of sodium for an adult.

This medicine is for hospital use only. 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 a first dose of this medicine and your doctor may decide to give you a second 5 g dose in specific situations. Your doctor or nurse will give you this medicine by injection or infusion into a vein. After you have received this medicine, your doctor will decide on the continuation of your treatment to prevent blood clot formation. Dabigatran can be given again 24 hours after administration of this medicine. Detailed instructions for your doctor or nurse on how to administer this medicine can be found at the end of this package leaflet (see 'Handling instructions'). If you have any further questions on the use of this medicine, ask your doctor.

Like all medicines, this medicine may cause side effects, although not everybody gets them. Until now, no side effects have been identified. Reporting of side effects If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

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 the carton after EXP. The expiry date refers to the last day of that month. Store in a refrigerator (2 C-8 C). Do not freeze. Store in the original package in order to protect from light. Once opened, this medicine is intended for immediate use.

What Praxbind contains

The active substance is idarucizumab.

The other ingredients are: sodium acetate trihydrate (E262), acetic acid (E260, for pH adjustment), sorbitol (E420), polysorbate 20 (E432) and water for injections. What Praxbind looks like and contents of the pack Praxbind is a clear to slightly opalescent, colourless to slightly yellow solution supplied in a glass vial closed with a butyl rubber stopper and an aluminium cap. Each pack contains two vials. Marketing Authorisation Holder Boehringer Ingelheim International GmbH Binger Str. 55216 Ingelheim am Rhein Germany Manufacturer Boehringer Ingelheim Pharma GmbH & Co. KG Birkendorfer Strasse 88397 Biberach an der Riss Germany Boehringer Ingelheim France 100-104 Avenue de France 75013 Paris France For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: Belgi /Belgique/Belgien Boehringer Ingelheim SComm T l/Tel: +32 2 773 33 Lietuva Boehringer Ingelheim RCV GmbH & Co KG Lietuvos filialas Tel: +370 5 2595 .

: +359 2 958 79 Luxembourg/Luxemburg Boehringer Ingelheim SComm T l/Tel: +32 2 773 33 esk republika Boehringer Ingelheim spol. s r.o. Tel: +420 234 655 Magyarorsz g Boehringer Ingelheim RCV GmbH & Co KG Magyarorsz gi Fi ktelepe Tel: +36 1 299 89 Danmark Boehringer Ingelheim Danmark A/S Tlf: +45 39 15 88 Malta Boehringer Ingelheim Ireland Ltd. Tel: +353 1 295 9Deutschland Boehringer Ingelheim Pharma GmbH & Co. KG Tel: +49 (0) 800 77 90 Nederland Boehringer Ingelheim B.V. Tel: +31 (0) 800 22 55 Eesti Boehringer Ingelheim RCV GmbH & Co KG Eesti filiaal Tel: +372 612 8Norge Boehringer Ingelheim Norway KS Tlf: +47 66 76 13
Boehringer Ingelheim
A.E. T : +30 2 10 89 06 sterreich Boehringer Ingelheim RCV GmbH & Co KG Tel: +43 1 80 105-7Espa a Boehringer Ingelheim Espa a, S.A. Tel: +34 93 404 51 Polska Boehringer Ingelheim Sp. z o.o. Tel: +48 22 699 0 France Boehringer Ingelheim France S.A.S. T l: +33 3 26 50 45 Portugal Boehringer Ingelheim Portugal, Lda. Tel: +351 21 313 53 Hrvatska Boehringer Ingelheim Zagreb d.o.o. Tel: +385 1 2444 Rom nia Boehringer Ingelheim RCV GmbH & Co KG Viena Sucursala Bucure ti Tel: +40 21 302 28 Ireland Boehringer Ingelheim Ireland Ltd. Tel: +353 1 295 9Slovenija Boehringer Ingelheim RCV GmbH & Co KG Podru nica Ljubljana Tel: +386 1 586 40 sland Vistor hf. S mi: +354 535 7Slovensk republika Boehringer Ingelheim RCV GmbH & Co KG organiza n zlo ka Tel: +421 2 5810 1Italia Boehringer Ingelheim Italia S.p.A. Tel: +39 02 5355 1 Suomi/Finland Boehringer Ingelheim Finland Ky Puh/Tel: +358 10 3102
Boehringer Ingelheim
A.E. T : +30 2 10 89 06 Sverige Boehringer Ingelheim AB Tel: +46 8 721 21 Latvija Boehringer Ingelheim RCV GmbH & Co KG Latvijas fili le Tel: +371 67 240 United Kingdom (Northern Ireland) Boehringer Ingelheim Ireland Ltd. Tel: +353 1 295 9This leaflet was last revised in Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: