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 04/03/2010 and displayed until 10/01/2012
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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 26/10/2007 and displayed until 04/03/2010
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Reasons for adding or updating:
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Change to section 6. 3 - Shelf Life
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Change to section 6. 4 - Special Precautions for Storage
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Change to section 6. 5 - Nature and Contents of Container
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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: 01/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 6.3: 18 months shelf life changed to 24 month shelf life
Section 6.4: Wording changed from 'Amoxil vials should be stored in a cool dry place' to 'Amoxil Vials for Injection should be stored at or below 25°c.'
Section 6.5: Container and closure changed from 'butyl rubber closure and aluminium seal' to 'Clear Type I glass vials fitted with a chlorobutyl rubber bung and an aluminium overseal'.
Section 10: Revision of text date is now 29/01/07
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Updated on 17/01/2006 and displayed until 26/10/2007
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Reasons for adding or updating:
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Change to section 6. 5 - Nature and Contents of Container
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Updated on 04/08/2005 and displayed until 17/01/2006
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Reasons for adding or updating:
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Improved Electronic Presentation
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Updated on 02/08/2005 and displayed until 04/08/2005
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Reasons for adding or updating:
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Addition of separate SPCs covering individual presentations
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