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 26/09/2006 and displayed until 18/09/2007
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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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| Date of revision of text on the SPC: 12/2002 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Change to the Qualitative and Quantitative Composition
From Paper strips each impregnated with approximately 1mg Fluorescein Sodium BP. changed to Paper strips each impregnated with approximately 1mg Fluorescein Sodium Ph. Eur.
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Updated on 27/06/2003 and displayed until 26/09/2006
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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Change to section 10 (date of (partial) revision of the text
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Updated on 24/08/2001 and displayed until 27/06/2003
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Reasons for adding or updating:
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Transferred from eMC version 1
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