Chirocaine 1.25mg/ml solution for infusion

Product Information *

  • Company:

    AbbVie Limited
  • Status:

    No Recent Update
  • Active Ingredients * :

    *Additional information is available upon request

  • Legal Category:

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

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 13 January 2021

Reasons for updating

  • 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)

Updated on 14 September 2020

Reasons for updating

  • Correction of spelling/typing errors

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

Updated on 12 August 2019

Reasons for updating

  • Correction of spelling/typing errors

Updated on 24 July 2019

Reasons for updating

  • Change to section 2 - excipient warnings

Updated on 24 July 2019

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition

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

Updated on 18 July 2018

Reasons for updating

  • File format updated to PDF

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

Updated on 11 July 2018

Reasons for updating

  • 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 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

Description of change

 

SmPC was updated to reflect approval of Type IB Label alignment for Chirocaine 1.25 mg/ml solution for infusion.

 

The following is summary of the changes:

 

The Summary of Product Characteristics title has been added in line with QRD

 

4.1     Therapeutic indications

Minor editorial update.

 

4.2     Posology and method of administration

Minor editorial updates.

 

4.4     Special warnings and precautions for use

Minor editorial updates.

 

4.5     Interaction with other medicinal products and other forms of interaction

Minor editorial updates.

 

4.6     Fertility, pregnancy and lactation

Minor editorial update.

 

4.8     Undesirable effects

Minor editorial updates.

 

10.       Date of Revision of Text

Update to July 2018.

Updated on 09 July 2018

Reasons for updating

  • 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 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

Description of change

 

SmPC was updated to reflect approval of Type IB Label alignment for Chirocaine 1.25 mg/ml solution for infusion.

 

The following is summary of the changes:

 

The Summary of Product Characteristics title has been added in line with QRD

 

4.1     Therapeutic indications

Minor editorial update.

 

4.2     Posology and method of administration

Minor editorial updates.

 

4.4     Special warnings and precautions for use

Minor editorial updates.

 

4.5     Interaction with other medicinal products and other forms of interaction

Minor editorial updates.

 

4.6     Fertility, pregnancy and lactation

Minor editorial update.

 

4.8     Undesirable effects

Minor editorial updates.

 

10.       Date of Revision of Text

Update to July 2018.

Updated on 16 November 2016

Reasons for updating

  • New PIL for new product

Updated on 16 November 2016

Reasons for updating

  • Correction of spelling/typing errors

Updated on 25 January 2016

Reasons for updating

  • New SPC for new product

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

Updated on 25 January 2016

Reasons for updating

  • Change to date of revision
  • Change to MA holder contact details

Updated on 25 January 2016

Reasons for updating

  • Change to section 10 - Date of revision of the text
  • Change to MA holder contact details

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

Free text change information supplied by the pharmaceutical company

Section 7: Marketing Holder Authorisation:

Update to MAH address

Updated on 18 November 2015

Reasons for updating

  • Correction of spelling/typing errors

Updated on 07 August 2015

Reasons for updating

  • Change to date of revision
  • Change to MA holder contact details

Updated on 22 June 2015

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

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

Free text change information supplied by the pharmaceutical company

 To update Section 4.4 of the SmPC to include adverse drug reaction of chondrolysis in patients receiving post-operative intra-articular continuous infusion of local anaesthetics.

Updated on 19 February 2015

Reasons for updating

  • New individual SPC (was previously included in combined SPC)

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 & Section 4.2

No data are available in paediatric population < 6 months of age.

 

 

Section 4.8

Information on how to report an AE in Ireland.



New individual SPC

Updated on 18 February 2015

Reasons for updating

  • Change to improve clarity and readability

Updated on 11 July 2013

Reasons for updating

  • Change to marketing authorisation holder

Updated on 29 April 2013

Reasons for updating

  • Change of manufacturer

Updated on 11 December 2012

Reasons for updating

  • Improved electronic presentation

Updated on 11 December 2012

Reasons for updating

  • Change to marketing authorisation holder

Updated on 16 November 2011

Reasons for updating

  • Change to side-effects

Updated on 04 November 2010

Reasons for updating

  • Change to side-effects

Updated on 05 July 2010

Reasons for updating

  • Change to MA holder contact details

Updated on 07 December 2009

Reasons for updating

  • Change of manufacturer
  • Change to date of revision

Updated on 07 October 2009

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 26 June 2009

Reasons for updating

  • Improved electronic presentation

Updated on 09 February 2009

Reasons for updating

  • Addition of separate PILs covering individual presentations
  • Change due to harmonisation of patient information leaflet
  • Change due to user-testing of patient information

Updated on 01 June 2005

Reasons for updating

  • New PIL for medicines.ie