Summary of Product Characteristics
last updated on the eMC:
29/03/2011
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 29/03/2011 and displayed until Current
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Reasons for adding or updating:
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Change to section 6. 3 - Shelf Life
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| Date of revision of text on the SPC: 25-Mar-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| In section 6.3, the shelf-life has been changed from 24 months to 36 months.
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Updated on 03/08/2009 and displayed until 29/03/2011
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Reasons for adding or updating:
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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 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 20-Jul-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.3: The use of neostigmine with depolarising muscle relaxants is contraindicated and cautionary statements about use in patients with various Conditions were relocated in section 4.4.
Also added in Section 4.4 is “Administration of anticholinesterase agents to patients with intestinal anastomoses may produce rupture of the anastomosis or leakage of intestinal contents.”
Section 4.8 was re-written to organise events into the appropriate System Organ Class and symptoms of cholinergic syndrome were included for greater clarity.
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Updated on 03/06/2008 and displayed until 03/08/2009
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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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| 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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