Patient leaflet - Praxbind
B. PACKAGE LEAFLET
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.
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– Keep this leaflet. You may need to read it again.
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– If you have any further questions, ask your doctor or nurse.
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– 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
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1. What Praxbind is and what it is used for
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2. What you need to know when you receive Praxbind
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3. How to use Praxbind
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4. Possible side effects
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5. How to store Praxbind
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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:
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– For emergency surgery/urgent procedures;
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– In life-threatening or uncontrolled bleeding.
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2. What you need to know when you receive Praxbind
Warnings and precautions
Talk to your doctor or nurse before receiving Praxbind:
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– if you are allergic to idarucizumab or to any other of the substances listed in section 6.
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– 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.
3. How to use Praxbind
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.
4. Possible side effects
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. By reporting side effects you can help provide more information on the safety of this medicine.
5. 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 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.
6. Contents of the pack and other information
What Praxbind contains
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– The active substance is idarucizumab.
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– 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. 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
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
| België/Belgique/Belgien SCS Boehringer Ingelheim Comm.V Tél/Tel: +32 2 773 33 11 | Lietuva Boehringer Ingelheim RCV GmbH & Co KG Lietuvos filialas Tel: +370 5 2595942 |
| Efc^rapufl EbopuHrep HHrenxaňM PUB R-ioX u Ko. Kr -K.TOH Ebnrapua | Luxembourg/Luxemburg SCS Boehringer Ingelheim Comm.V Tel/Tel: +32 2 773 33 11 |
Ten: +359 2 958 79 98
| Česká republika Boehringer Ingelheim spol. s r.o. Tel: +420 234 655 111 | Magyarorszag Boehringer Ingelheim RCV GmbH & Co KG Magyarorszagi Fioktelepe Tel: +36 1 299 8900 |
| Danmark Boehringer Ingelheim Danmark A/S Tlf: +45 39 15 88 88 | Malta Boehringer Ingelheim Ireland Ltd. Tel: +353 1 295 9620 |
| Deutschland Boehringer Ingelheim Pharma GmbH & Co. KG Tel: +49 (0) 800 77 90 900 | Nederland Boehringer Ingelheim b.v. Tel: +31 (0) 800 22 55 889 |
| Eesti Boehringer Ingelheim RCV GmbH & Co KG Eesti filiaal | Norge Boehringer Ingelheim Norway KS Tlf: +47 66 76 13 00 |
Tel: +372 612 8000
| EZZáSa Boehringer Ingelheim Ellas A.E. Tql: +30 2 10 89 06 300 | Österreich Boehringer Ingelheim RCV GmbH & Co KG Tel: +43 1 80 105–7870 |
| España Boehringer Ingelheim España, S.A. Tel: +34 93 404 51 00 | Polska Boehringer Ingelheim Sp.zo.o. Tel: +48 22 699 0 699 |
| France Boehringer Ingelheim France S.A.S. Tél: +33 3 26 50 45 33 | Portugal Boehringer Ingelheim Portugal, Lda. Tel: +351 21 313 53 00 |
| Hrvatska Boehringer Ingelheim Zagreb d.o.o. Tel: +385 1 2444 600 | România Boehringer Ingelheim RCV GmbH & Co KG Viena-Sucursala Bucuresti Tel: +40 21 302 2800 |
| Ireland Boehringer Ingelheim Ireland Ltd. Tel: +353 1 295 9620 | Slovenija Boehringer Ingelheim RCV GmbH & Co KG Podružnica Ljubljana Tel: +386 1 586 40 00 |
| Ísland Vistor hf. Sími: +354 535 7000 | Slovenská republika Boehringer Ingelheim RCV GmbH & Co KG organizačná zložka Tel: +421 2 5810 1211 |
Italia
Boehringer Ingelheim Italia S.p.A.
Tel: +39 02 5355 1
Suomi/Finland
Boehringer Ingelheim Finland Ky
Puh/Tel: +358 10 3102 800
Kûnpoç
Boehringer Ingelheim Ellas A.E.
Tql: +30 2 10 89 06 300
Latvija
Boehringer Ingelheim RCV GmbH & Co KG
Latvijas filiale
Tel: +371 67 240 011
Sverige
Boehringer Ingelheim AB
Tel: +46 8 721 21 00
United Kingdom (Northern Ireland)
Boehringer Ingelheim Ireland Ltd.
Tel: +353 1 295 9620
This leaflet was last revised in
Other sources of information
Detailed information on this medicine is available on the European Medicines Agency web site:
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The following information is intended for healthcare professionals only:
Praxbind binds specifically to dabigatran and reverses its anticoagulant effect. It will not reverse the effects of other anticoagulants.
Praxbind treatment can be used in conjunction with standard supportive measures, which should be considered as medically appropriate.
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
The recommended dose of Praxbind contains 4 g sorbitol as an excipient. In patients with hereditary fructose intolerance there is a risk for serious adverse reactions, which must be weighed against the benefit of an emergency treatment with Praxbind. If Praxbind is administered in these patients, intensified medical care during Praxbind exposure and within 24 hours of exposure is required.
Dosage and administration:
The recommended dose is 5 g idarucizumab (2 vials of 2.5 g/50 mL).
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).
A maximum daily dose has not been investigated.
Praxbind (2 vials of 2.5 g/50 mL) is administered intravenously, as two consecutive infusions over
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5 to 10 minutes each or as a bolus injection.