Flolan Injection 1.5mg (with pH 12 solvent)

Product Information *

  • Company:

    GlaxoSmithKline (Ireland) Ltd
  • Status:

    No Recent Update
  • Active Ingredients :

    *Additional information is available upon request

  • Legal Category:

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

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 09 June 2021

File name

ie-pl-flolan-ph12-shared-issue6draft2-clean medicines.ie no header_1623224867.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 4 - how to report a side effect
  • Change to section 5 - how to store or dispose
  • Change to section 6 - what the product contains
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision
  • Change to information for healthcare professionals

Updated on 09 June 2021

File name

ie-spc-flolan1-5-ph12-issue7draft1-clean medicines.ie no headers_1623224778.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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

Sec 4.4 - addition of Sodium excipients update

Section 6,5 - new pack contents includes a Vented Vial Adaptor

section 6.6 - addition of suitable pump and accessories to be used

section 6.6 - addtion of vial adaptor and update to instructions on reconstitution & dilution

Updated on 11 January 2019

File name

ie-pl-flolan-ph12-shared-issue5draft2-MED.IE_1547201916.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision
  • Change to drug interactions

Updated on 11 January 2019

File name

ie-spc-flolan1-5-ph12-issue6draft2-MED.IE_1547202008.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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

SPC sections 4.2, 6.2 and 6.6. Additional of how solution should not be prepared with materials containing PET
SPC section 4.8 - addition of unknown AE- High output cardiac failure

Updated on 30 April 2018

Reasons for updating

  • New SPC for new product

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

Updated on 13 October 2017

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text
  • Improved presentation of SPC

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

Free text change information supplied by the pharmaceutical company

SPC: Section 6.3 shelf life of the Sterile Diluent for Flolan has been updated from 24 months to 36 months

Updated on 13 October 2017

Reasons for updating

  • New SPC for new product

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

Updated on 20 March 2017

Reasons for updating

  • New SPC for medicines.ie

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

Free text change information supplied by the pharmaceutical company

None provided

Updated on 20 March 2017

File name

PIL_17125_999.pdf

Reasons for updating

  • New PIL for new product