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Abbott Laboratories Ireland Limited
4051 Kingswood Drive, Citywest Business Campus, Dublin 24,
Telephone: +353 1 469 1500
Fax: +353 1 469 1501
Summary of Product Characteristics last updated on medicines.ie: 23/07/2010
SPC Chirocaine 2.5, 5 and 7.5 mg/ml solution for injection/concentrate for solution for infusion

When a pharmaceutical company changes an SPC or PIL, 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 23/07/2010 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   15-Jul-2010
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 05/10/2009 and displayed until 23/07/2010
    Reasons for adding or 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
    Date of revision of text on the SPC:   18-Sep-2009
    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 10/06/2008 and displayed until 05/10/2009
    Reasons for adding or updating:
    • Change to section 8 - MA number
    • Change to section 10 - Date of revision of the text
    Date of revision of text on the SPC:   04/2008
    Legal Category:   prescription only

    Free-text change information supplied by the pharmaceutical company

    Correction of PA numbers and revsion date.
    Updated on 21/05/2007 and displayed until 10/06/2008
    Reasons for adding or updating:
    • Change to section 4.8 - Undesirable effects
    Date of revision of text on the SPC:   04/2007
    Legal Category:   prescription only

    Free-text change information supplied by the pharmaceutical company
    Change to section 4.8 - Undesirable effects
    Updated on 16/08/2005 and displayed until 21/05/2007
    Reasons for adding or updating:
    • Change to section 6.5 - Nature and contents of container
    Updated on 27/06/2003 and displayed until 16/08/2005
    Reasons for adding or updating:
    • New SPC for medicines.ie

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    Active Ingredients

     
      levobupivacaine hydrochloride