Minims Lidocaine & Fluorescein. *
Pharmacy Only: Prescription

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 01 June 2020

File name

leaflet clean_1591006842.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number
  • Change to section 6 - date of revision

Updated on 27 May 2020

File name

spc clean_1590569904.pdf

Reasons for updating

  • New SPC for medicines.ie

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 29 July 2015

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 9 - Date of renewal of authorisation

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

change in marketing authorisation  holder and date of revision of text

Updated on 29 July 2015

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 28 July 2015

File name

PIL_10276_940.pdf

Reasons for updating

  • New PIL for new product

Updated on 28 July 2015

Reasons for updating

  • Change to date of revision
  • Change to marketing authorisation holder

Updated on 30 August 2012

Reasons for updating

  • Correction of spelling/typing errors

Updated on 24 July 2008

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.8 - Undesirable effects
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Sections 1, 2 and 3 : Change in the wording following renewal of the product

 

Sections 9 and 10 : Change in the dates following renewal

 

Section 4.8 : addition of undesirable effects: symptoms of allergic-type reactions and anaphylaxis

Updated on 29 August 2007

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

section 4.3
replacement of the following sentence
Do not use in patients with a known hypersensitivity to fluorescein or lidocaine and other amide-tye local anaesthetics.
 by:
Do not use in patients with a known hypersensitivity to either of the active ingredients.
 
section 4.4
replacement of the following paragraph
The anaesthetised eye should be protected from foreign body contamination, particularly in elderly patients in whom the duration of anaesthesia may exceed 30 minutes.
by:
The cornea may be damaged by prolonged application of anaesthetic eye drops.
 
The anaesthetised eye should be protected from dust and contamination.

Updated on 15 August 2005

Reasons for updating

  • Change from the BAN of the active substance to the rINN

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 11 August 2005

Reasons for updating

  • New PIL for medicines.ie

Updated on 05 August 2005

Reasons for updating

  • Change from the BAN of the active substance to the rINN

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 16 May 2005

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.1 - List of excipients
  • Change to section 6.4 - Special precautions for storage
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 21 August 2003

Reasons for updating

  • Improved electronic presentation

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 16 July 2003

Reasons for updating

  • New SPC for medicines.ie

Legal category:Product subject to medical prescription which may not be renewed (A)