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Boehringer Ingelheim Limited

The Crescent Building, , Northwood, Santry, Dublin 9,
Telephone: +353 1 295 9620
Fax: : +353 1 816 3642
Medical Information e-mail: Medinfo@dbl.boehringer-ingelheim.com
Summary of Product Characteristics last updated on medicines.ie: 15/12/2017
SPC Praxbind 2.5 g/50 mL solution for injection/infusion

When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 15/12/2017 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   09-Nov-2017
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company



Sections 4.2, 4.8, 5.1 and 5.2 have been updated with information from a completed trial (RE-VERSE AD).

Section 4.2 updated as follows:

Patients with renal impairment

 

No dose adjustment is required in renally impaired patients. Renal impairment did not impact the reversal effect of idarucizumab. (see section 5.2).

 

Patients with hepatic impairment

 

No dose adjustment is required in hepatically impaired patients with hepatic injury (see section 5.2).

 

Section 4.8 updated as follows:

 

TheIn a phase III trial the safety of Praxbind has been evaluated in 224 healthy subjects as well as 123503 patients in an ongoing phase III trial, who had uncontrolled bleeding or required emergency surgery or procedures and were under treatment with Pradaxa (dabigatran etexilate).), as well as in 224 volunteers in phase I trials.

No adverse reactions have been identified.

 

Section 5.1

Updated to include results from completed trial

 

Section 5.2

Revised and additional information for 'Patients with renal impairment' and 'Patients with hepatic impairment'

 

Section 10

Date revised to 09 November 2017

Updated on 08/08/2017 and displayed until 15/12/2017
Reasons for adding or updating:
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   20-Jul-2017
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company

Sections 6.3 (Shelf life) and 6.4 (Special precautions for storage) of the SPC have been updated
Section 4.8 has been updated to include further contact information with regards to reporting adverse reactions in the UK (to the MHRA).
Section 10 of the SPC has also been revised to include the approval date of the variation – 20/7/17
Updated on 19/04/2017 and displayed until 08/08/2017
Reasons for adding or updating:
  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   03-Apr-2017
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company

Section 6.3: shelf life increased from 30 months to 3 years
Section 10: date updated to 03 April 2017
Updated on 22/08/2016 and displayed until 19/04/2017
Reasons for adding or updating:
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   27-Jul-2016
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company

The SPC includes the increased shelf life for the product (section 6.3 of the SPC).  Section 5.1 of the SPC has also been updated to include the Pharmacotherapeutic group and ATC code.  Section 10 of the SPC has also been revised.  Formatting changes e.g. to section headings/spacing have also been made. 
Updated on 01/12/2015 and displayed until 22/08/2016
Reasons for adding or updating:
  • New SPC for new product
Date of revision of text on the SPC:  
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company

None provided

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Active Ingredients

 
   Idarucizumab