Summary of Product Characteristics
last updated on the eMC:
21/04/2011
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 21/04/2011 and displayed until Current
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Reasons for adding or updating:
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Change to section 2 - Qualitative and quantitative composition
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Change to section 4.3 - Contraindications
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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 4.6 - Pregnancy and Lactation
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Change to section 4.7 - Effects on Ability to Drive and Use Machines
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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: 27-Mar-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 2 - addition of 'It also contains ethanol.
Section 4.3 - addition of 'Renal failure'
Section 4.4 - addition of information relating to gastro-intestinal bleeding.
Section 4.5 - addition of heading 'The following medicinal products are NOT to be co-administered with Ketorolac Injection:'
Addition of sections on NSAIDs/Aspirin and Anticoagulants.
Section 4.6 - revision to both Pregnancy and Lactation sections.
Section 4.7 - fatigue added
Section 4.8 - additional side-effects added
Section 10 - date of revision changed to 27/03/2011
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Updated on 12/06/2008 and displayed until 21/04/2011
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Reasons for adding or updating:
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| Date of revision of text on the SPC: |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| None provided |
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