Praxbind 2.5 g/50 mL solution for injection/infusion

  • Name:

    Praxbind 2.5 g/50 mL solution for injection/infusion

  • Company:
    info
  • Active Ingredients:

    Idarucizumab

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 05/09/18

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Summary of Product Characteristics last updated on medicines.ie: 30/8/2018
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.

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Boehringer Ingelheim Limited

Boehringer Ingelheim Limited

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When a pharmaceutical company changes any document, 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 5 September 2018 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision
  • Change to other sources of information section
  • Change to information for healthcare professionals

Updated on 30 August 2018 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

The SmPC has been updated in section 4.4 to add a statement regarding traceability of biological medicinal products and to revise the wording regarding sodium content.

Section 10 has been updated accordingly.

Updated on 15 December 2017 SmPC

Reasons for 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

Legal category: Product subject to medical prescription which may not be renewed (A)

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 15 December 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 8 August 2017 SmPC

Reasons for 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

Legal category: Product subject to medical prescription which may not be renewed (A)

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 April 2017 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

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 August 2016 SmPC

Reasons for 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

Legal category: Product subject to medical prescription which may not be renewed (A)

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 1 December 2015 SmPC

Reasons for updating

  • New SPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

None provided

Updated on 30 November 2015 PIL

Reasons for updating

  • New PIL for new product