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Bausch & Lomb U.K Limited
Bausch & Lomb House, 106 London Road, Kingston-upon-Thames, Surrey, KT2 6TN, UK
Telephone: +44 (0)208 781 2900
Fax: +44 (0)208 781 2901
Medical Information Direct Line: +44(0)1748 828849 or 08 1871 9318
Medical Information e-mail: medicalinformationuk@bausch.com
Customer Care direct line: +44 (0)208781 2991

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 18/09/2007
SPC Fluorets

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
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
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
 
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
Updated on 26/09/2006 and displayed until 18/09/2007
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
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
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.
Updated on 27/06/2003 and displayed until 26/09/2006
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 10 (date of (partial) revision of the text
Updated on 24/08/2001 and displayed until 27/06/2003
Reasons for adding or updating:
  • Transferred from eMC version 1

Active Ingredients/Generics

 
  fluorescein sodium