Summary of Product Characteristics
last updated on the eMC:
10/01/2012
When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.
Updated on 10/01/2012 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.1 - Therapeutic indications
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 04-Jan-2012 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section
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Summary of change
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4.1
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Addition of new paragraph:- Consideration should be given to official local guidance (e.g. national requirements) on the appropriate use of antibacterial agents. Susceptibility of the causative organism to the treatment should be tested (if possible), although the therapy may be initiated before the results are available.
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10.
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Updated with new date of revision of text
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Updated on 23/11/2010 and displayed until 10/01/2012
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Reasons for adding or updating:
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Change to section 4.2 - Posology and method of administration
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 5.2 - Pharmacokinetic Properties
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Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 17-Nov-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Sections changed:
4.2 Change from paediatric dosing by age to by weight instead
4.4 Addition of preaution for prenatal and neonatal children
5.2 Addition of information relating to dosing of pre-term infants
8 Correction to PL stem number
10 Date of revision of the text
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Updated on 04/03/2010 and displayed until 23/11/2010
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Reasons for adding or updating:
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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Change to section 4.8 - Undesirable Effects
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 01-Mar-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.4 - Addition of text with regards to prolongation of prothrombin time
Section 4.5 - Deletion and addition of text with regards to prolongation of prothrombin time
Section 4.8 - Changes made under Blood and lymphatic system disorders
Section 10 - Date of approval added
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Updated on 17/10/2008 and displayed until 04/03/2010
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Reasons for adding or updating:
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Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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Change to section 4.2 - Posology and method of administration
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Change to section 4.8 - Undesirable Effects
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 26-Sep-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.2 - lignocaine changed to lidocaine
Section 4.5 - Header changed + new paragraph on probenecid
Section 4.8 - Addition of infections and infestations + hairy black tongue
Section 10 - Date changed
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Updated on 02/08/2005 and displayed until 17/10/2008
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Reasons for adding or updating:
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Change to section 4.4 - Special Warnings and Precautions for Use
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Change to section 4.8 - Undesirable Effects
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Change to section 4.9 - Overdose
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Updated on 08/03/2005 and displayed until 02/08/2005
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Reasons for adding or updating:
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Change to section 4.4 - Special Warnings and Precautions for Use
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Change to section 4.8 - Undesirable Effects
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Change to section 4.9 - Overdose
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Updated on 07/03/2005 and displayed until 08/03/2005
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Reasons for adding or updating:
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Pending awaiting re-submission
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Change to section 4.4 - Special Warnings and Precautions for Use
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Change to section 4.8 - Undesirable Effects
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Change to section 4.9 - Overdose
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Updated on 02/10/2003 and displayed until 07/03/2005
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Reasons for adding or updating:
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Improved Electronic Presentation
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Updated on 23/07/2003 and displayed until 02/10/2003
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Reasons for adding or updating:
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New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
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