Summary of Product Characteristics
last updated on the eMC:
18/09/2007
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 18/09/2007 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 06/2007 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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section 4.8 (undesirable effects)
ADRs are very rare(<1/10,000),including isolated reports.
Symptoms of allergic-type reactions and anaphylaxis have been reported following topical ophthalmic administration of Fluorescein sodium and may manifest as:
Eye disorders: allergic conjunctivitis, peri-orbital oedema
Immune system disorders: anaphylactic reaction
Skin and subcutaneous tissue disorders: urticaria, rash
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Updated on 15/09/2003 and displayed until 18/09/2007
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Improved Electronic Presentation
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Updated on 15/09/2003 and displayed until 15/09/2003
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Improved Electronic Presentation
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Updated on 30/07/2001 and displayed until 15/09/2003
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Updated on 15/02/2000 and displayed until 30/07/2001
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Updated on 06/09/1999 and displayed until 15/02/2000
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