Chirocaine 2.5 mg/ml solution for injection/concentrate for solution for infusion *

  • Company:

    AbbVie Limited
  • Status:

    No Recent Update
  • Legal 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

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

File name

Chirocaine 2.5 mg-ml-SmPC_V66_Update 5.2 PK Data_Jan 2021_1610538147.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_1569407369.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_1569405626.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_1563981511.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_1563981511.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_1563981511.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_1563981543.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

  • Correction of spelling/typing errors

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

  • 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

Section 7

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

Section 4.2 (Posology and method of administration)

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

  • Change to marketing authorisation holder

Updated on 11 December 2012

Reasons for updating

  • Improved electronic presentation

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

Updates to SPC section 4.4, 4.8 & 5.1.

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

  • In section 4.4 (special warnings and precautions for use), addition of the statement 'Levobupicacaine can cause acute allergic reactions, cardiovascular effects and neurological damage, see section 4.8'
  • In section 4.8 (undesirable effects), update to include certain preferred terms into the tablet which are currently located underneath the table
  • 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

    
  • In Section 2 - A statement regarding the level of Sodium in the product has been added.
  • In Section 4.4 - A warning for Sodium content has been placed in this section.
  • In section 4.8 -  The section has been reformatted to MedDRA system order class and frequency.
  • In Section 6.3 - This section has been updated to show a clearer definition of shelf life for reconstituted product and the product itself.
  • In Section 6.4 - A statement regarding the location of storage conditions information has been added.
  • 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

    Change to section 4.8 - Undesirable effects

    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)