Chirocaine 2.5 mg/ml solution for injection/concentrate for 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 2.5 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 25 September 2019
File name
Chirocaine 2.5_5.0 mg-ml_PiL_V62_CRN00901F_Sodium Content_July 2019.pdf
Reasons for updating
- Correction of spelling/typing errors
Updated on 25 September 2019
File name
Chirocaine 2.5_5.0 mg-ml_PiL_V62_CRN00901F_Sodium Content_July 2019.pdf
Reasons for updating
- Correction of spelling/typing errors
Updated on 25 September 2019
File name
Chirocaine 2.5_5.0 mg-ml_PiL_V62_CRN00901F_Sodium Content_July 2019.pdf
Reasons for updating
- Correction of spelling/typing errors
Updated on 24 September 2019
File name
Chirocaine 2.5_5.0 mg-ml_PiL_V62_CRN00901F_Sodium Content_July 2019.pdf
Reasons for updating
- Correction of spelling/typing errors
Updated on 24 July 2019
File name
Chirocaine 2.5_5.0 mg-ml_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 2.5 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 2.5 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 09 July 2018
File name
Chirocaine 2.5 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 4.8 - 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 2.5 mg/ml solution for injection/concentrate for 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 updates.
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.
4.8 Undesirable effects
Minor editorial updates.
10. Date of Revision of Text
Update to July 2018.
Updated on 16 November 2016
File name
PIL_14138_77.pdf
Reasons for updating
- New PIL for new product
Updated on 16 November 2016
Reasons for updating
- Correction of spelling/typing errors
Updated on 04 April 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 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 22 June 2015
Reasons for updating
- Correction of spelling/typing errors
Updated on 19 February 2015
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- 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 5.2 - Pharmacokinetic properties
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.
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 10 July 2013
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - MA number
- 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
Marketing Authorisation holder changed from
Abbott Laboratories Ireland Ltd
4051 Kingswood Drive
Citywest Business Campus
Dublin 24
to
AbbVie Limited
Block B
Liffey Valley Office Campus
Quarryvale
Co.Dublin
Section 8
PA number changed from PA 38/71/6 to PA 1824/3/1
Updated on 05 June 2013
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - 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
Section 4.2 (Posology and method of administration)
The following statement has been added:
There is limited safety experience with levobupivacaine therapy for periods exceeding 24 hours. In order to minimise the risk for severe neurological complications, the patient and the duration of administration of levbupivacaine should be closely monitored (see Section 4.4).
Section 4.4 (Special warnings and precautions for use)
The following sub section has been added:
Epidural Analgesia
There have been postmarketing reports of cauda equina syndrome and events indicative of neurotoxicity (see Section 4.8) temporally associated with the use of levobupivacaine for 24 hours or more for epidural analgesia. These events were more severe and in some cases led to permanent sequelae when levobupivacaine was administered for more than 24 hours. Therefore, infusion of levobupivacaine for a period exceeding 24 hours should be considered carefully and only be used when benefit to the patient outweighs the risk.
It is essential that aspiration for blood or cerebrospinal fluid (where applicable) be done prior to injecting any local anesthetic, both before the original dose and all subsequent doses, to avoid intravascular or intrathecal injection. However, a negative aspiration does not ensure against intravascular or intrathecal injection. Levobupivacaine should be used with caution in patients receiving other local anaesthetics or agents structurally related to amide-type local anaesthetics, since the toxic effects of these drugs are additive.
Section 4.8
The paragraph:
Rare reports have been received of cauda equina syndrome or signs and symptoms of potential injury to the base of the spinal cord or spinal nerve roots (including lower extremity weakness or paralysis, loss of bowel control and/or bladder control and priapism) associated with bupivacaine or levobupivacaine therapy.
has been changed to:
Reports have been received of cauda equina syndrome or signs and symptoms of potential injury to the base of the spinal cord or spinal nerve roots (including lower extremity paraesthesia, weakness or paralysis, loss of bowel control and/or bladder control and priapism) associated with levobupivacaine administration. These events were more severe and in some cases did not resolve when levobupivacaine was administered for more than 24 hours (see Section 4.4).
The sentence:
"There have been rare reports of transient Horner's syndrome---" has been changed to "There have been reports of transient Horner's syndrome---"
Updated on 06 February 2013
Reasons for updating
- Change to section 4.2 - Posology and method of administration
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
The following statement has been added under "Children".
The maximum dosage should be adjusted according to the size, body constitution and physical status of the patient/child.
Update has been made to the dosing table to better clarify the volume of the product for the 2.5 mg/ml concentration required to administer a dose of 1.25 mg/kg/side and the volume of the product for the 5.0 mg/ml concentration required to administer a dose of 1.25 mg/kg/side
Updated on 01 February 2013
Reasons for updating
- Correction of spelling/typing errors
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 17 November 2011
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
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 23 July 2010
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 22 June 2010
Reasons for updating
- Change to MA holder contact details
Updated on 07 October 2009
Reasons for updating
- Change to warnings or special precautions for use
Updated on 05 October 2009
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 6.3 - Shelf life
- Change to section 6.4 - Special precautions for storage
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 26 June 2009
Reasons for updating
- Improved electronic presentation
Updated on 17 February 2009
Reasons for updating
- New PIL for medicines.ie
Updated on 10 June 2008
Reasons for updating
- Change to section 8 - MA number
- 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
Correction of PA numbers and revsion date.
Updated on 21 May 2007
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 16 August 2005
Reasons for updating
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 27 June 2003
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may not be renewed (A)