Summary of Product Characteristics
last updated on the eMC:
04/09/2009
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 04/09/2009 and displayed until Current
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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 5.1 - Pharmacodynamic Properties
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Change to section 5.2 - Pharmacokinetic Properties
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| Date of revision of text on the SPC: 16-Jul-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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In Section 5.1 (pharmacodynamic properties) and 5.2 (pharmcokinetics properties) the SmPC has been updated to give more up to date information and bring them into line with current practice
Section 4.4 has been updated to remove the reference to the package insert of the IV use
Section 4.5 has been updated to give information regarding the potential for ototoxicity/nephrotoxicity with the use of other ototoxic/nephrotoxic drugs
Section 4.8. eosinophilia has been moved from the miscellaneous to haematological events.
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Updated on 19/07/2006 and displayed until 04/09/2009
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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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