Praxbind 2.5 g/50 mL solution for injection/infusion
*Company:
Boehringer Ingelheim LimitedStatus:
UpdatedLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 22 November 2024
File name
P9-EU-SPC-12 - medicines ie.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 10 - Date of revision of the text
- Improved presentation of SPC
- Document format updated
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
- Section 4.1 and 4.2: Removal of brand name "Pradaxa".
- Administrative and format changes throughout the SmPC e.g. addition/replacement of spaces/hard spaces.
- Section 10: Date of revision of the SmPC has been updated to 20 November 2024
Updated on 11 August 2023
File name
P9-EU-SPC-11 - medicine.ie .pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.1 - Pharmacodynamic 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
The following sections of the SmPC have been updated:
- Section 4.8: Editorial change, order change of a sentence. Also, editorial update to Malta AE reporting section.
- Section 5.1: Minor editorial changes (hyphen replaced with dot after each figure number).
- Section 10: Date of revision has been revised to 10 July 2023
Updated on 30 January 2023
File name
P9-EU-PI-0029.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 30 January 2023
File name
P9-EU-SPC-10.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.3 - Shelf life
- Change to section 7 - Marketing authorisation holder
- 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 following sections of the SmPC have been updated:
- Sections 4.8 and 5.1: Updated to include minor editorial changes.
- Section 6.3: Updated to extend the shelf life from 3 years to 4 years.
- Section 7: Updated to remove the “D-“ from the MAH address zip code.
- Section 10: Date of revision of the SmPC updated to 18 January 2023.
Updated on 01 July 2022
File name
P9-EU-SPC-9 - medicines.ie.pdf
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- 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
• SmPC Title Heading: Updated to include Northern Ireland (“United Kingdom (Northern Ireland)”)
• Section 4.8: AE details updated to include Northern Ireland (“United Kingdom (Northern Ireland)”)
• Section 10: Date of revision of the SmPC updated to 31 May 2021.
Updated on 10 December 2020
File name
Praxbind PIL annex text - Var-IAIN-21.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 19 October 2020
File name
Praxbind PIL annex text - Var-II-20.pdf
Reasons for updating
- Change to section 6 - date of revision
- Change to information for healthcare professionals
Updated on 19 October 2020
File name
P9-All-SPC-8-Approved.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic 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
Section 4.2 Update to the ‘Paediatric population’ section with cross-reference to section 5.1.
Section 4.8 Updated to include a statement regarding treating a paediatric patient in the context of paediatric safety trial.
Section 5.1 Editorial updates/clarification. Update to the ‘Paediatric population’ section with trial related information, including moving of this section before the ‘Immunogenicity’ section
Section 10 Date of revision has been updated to 17 September 2020
Updated on 06 August 2020
File name
Praxbind PIL annex text - R-0019.pdf
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 1 - what the product is used for
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 3 - how to take/use
- Change to section 4 - how to report a side effect
- Change to section 5 - how to store or dispose
- Change to section 6 - what the product contains
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
- Change to information for healthcare professionals
- Removal of Black Inverted Triangle
Updated on 06 August 2020
File name
P9-All-SPC-7 - Approved.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 6.1 - List of excipients
- Change to section 6.3 - Shelf life
- Change to section 6.4 - Special precautions for storage
- Change to section 6.5 - Nature and contents of container
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 9 - Date of first authorisation/renewal of the authorisation
- Change to section 10 - Date of revision of the text
- Removal of Black Inverted Triangle
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
|
Updated SmPC sections |
Description of changes |
|
Black triangle |
Removal of black triangle. |
|
2 |
Editorial updates/clarifications. |
|
4.1 |
Editorial updates/clarifications. |
|
4.2 |
Editorial updates/clarifications. Replacing ‘Praxbind’ with ‘idarucizumab’ where necessary. Addition of ‘Special populations’ as a new heading, including moving of Elderly section (no update to the text). |
|
4.4 |
Editorial updates/clarifications. |
|
4.5 |
Editorial updates/clarifications. |
|
4.6 |
Editorial updates/clarifications. Replacing ‘Praxbind’ with ‘idarucizumab’ where necessary. |
|
4.8 |
Editorial updates/clarifications. Addition of info related to global idarucizumab administration surveillance program to collect data on usage patterns in a real-world-setting. Update to the Irish AE reporting details. |
|
4.9 |
Replacing ‘Praxbind’ with ‘idarucizumab’ where necessary. |
|
5.1 |
Editorial updates/clarifications. Addition of ‘Paediatric population’ as a new heading, including moving of some sections. |
|
5.2 |
Editorial updates/clarifications. |
|
5.3 |
Editorial updates/clarifications. |
|
6.1 |
Editorial updates/clarifications. |
|
6.3 |
Editorial updates & clarification on room temperature of up to 30°C. |
|
6.4 |
Editorial updates/clarifications. |
|
6.5 |
Editorial updates/clarifications. |
|
6.6 |
Editorial updates & adding a statement to dispose unused medicinal product/waste material in line with the QRD template. |
|
9 |
Date of latest renewal added as 27 July 2020. |
|
10 |
Date of revision has been updated to 27 July 2020. |
Updated on 05 September 2018
File name
Praxbind PIL annex text - IB-12.pdf
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
File name
P9-All-SPC-6.pdf
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
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 15 December 2017
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 08 August 2017
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
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
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 10: date updated to 03 April 2017
Updated on 22 August 2016
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
Updated on 01 December 2015
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
Updated on 30 November 2015
File name
PIL_16529_119.pdf
Reasons for updating
- New PIL for new product