Chirocaine 1.25mg/ml solution for infusion
*Company:
AbbVie LimitedStatus:
No Recent UpdateLegal 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 13 January 2021
File name
Chirocaine 1.25 mg-ml-SmPC_V66_Update 5.2 PK Data_Jan 2021.pdf
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
File name
Chirocaine 1.25 mg-ml-SmPC_V62_CRN00901F_Sodium Content_July 2019.pdf
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
File name
Chirocaine 1.25 mgml_PiL_V62_CRN00901F_Sodium Content_July 2019.pdf
Reasons for updating
- Correction of spelling/typing errors
Updated on 24 July 2019
File name
Chirocaine 1.25 mgml_PiL_V62_CRN00901F_Sodium Content_July 2019.pdf
Reasons for updating
- Change to section 2 - excipient warnings
Updated on 24 July 2019
File name
Chirocaine 1.25 mg-ml-SmPC_V62_CRN00901F_Sodium Content_July 2019.pdf
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
File name
Chirocaine 1.25 mg-ml-SmPC-IE V61 Label alignment_July 2018.pdf
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
File name
Chirocaine 1.25 mg-ml-SmPC-IE V61 Label alignment_July 2018.docx
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
File name
Chirocaine 1.25 mg-ml-SmPC-IE V61 Label alignment_July 2018.docx
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
File name
PIL_9919_505.pdf
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 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 25 January 2016
Reasons for updating
- Change to date of revision
- Change to MA holder contact details
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