Striverdi Respimat 2.5 microgram, solution for inhalation

  • Name:

    Striverdi Respimat 2.5 microgram, solution for inhalation

  • Company:
    info
  • Active Ingredients:

    Olodaterol hydrochloride

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 02/12/19

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Summary of Product Characteristics last updated on medicines.ie: 2/12/2019
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 2 December 2019 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • 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 looks like and pack contents
  • Change to section 6 - date of revision
  • Change to other sources of information section
  • Change to improve clarity and readability

Updated on 2 December 2019 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 6.3 - Shelf life
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.2 – Posology and method of administration: to include the instructions for use for the re-usable device

Section 6.3 – Shelf life: to include an in-use shelf life for the inhaler and recommended use: 6 cartridges per inhaler

Section 6.5 – Nature and contents of container:  to include the new pack sizes

Section 10 – Date of revision

Updated on 16 November 2018 PIL

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 4 - how to report a side effect
  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision
  • Change to other sources of information section

Updated on 8 November 2018 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.5 - Nature and contents of container
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

The changes are:

  • addition of the term actuation in place of/alongside puff (sections 2, 4.2 and 6.5)
  • Inclusion of information on the excipient benzalkonium chloride (sections 2 and 4.4)
  • Revised dates (sections 9 and 10)
     
    Some minor editorial changes/corrections of typographical errors have also been made to section 4.5 heading, section 4.8 AE reporting, section 5.1, section 6.2 and section 8 heading. 
     

Updated on 21 June 2016 PIL

Reasons for updating

  • New PIL for new product

Updated on 21 June 2016 PIL

Reasons for updating

  • Change to improve clarity and readability

Updated on 23 March 2016 PIL

Reasons for updating

  • Change of trade or active ingredient name
  • Change to further information section
  • Change to date of revision
  • Change to improve clarity and readability

Updated on 22 March 2016 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 22 March 2016 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.2 updated in respect of the User Instructions.

In addition, the pharmaceutical form has been updated from ‘solution for inhalation’ to ‘inhalation solution’ (sections 1; 3).

 

Section 10: Revision date has been changed to March 2016

Updated on 14 October 2015 SmPC

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 be renewed (B)

Free text change information supplied by the pharmaceutical company

The change to the SPC was to update the details for reporting of suspected adverse reactions in section 4.8. (IMB details amended to HPRA details) as required by HPRA.  

Section 10 date of revision has been updated to reflect the date of approval.

Updated on 14 October 2015 PIL

Reasons for updating

  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 2 July 2014 PIL

Reasons for updating

  • New PIL for new product

Updated on 1 July 2014 SmPC

Reasons for updating

  • New SPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

None provided