Flolan Injection 0.5mg (with pH 12 solvent)
*Company:
GlaxoSmithKline (Ireland) LtdStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 22 June 2022
File name
ie-pl-flolan-ph12-shared-issue6draft2-clean medicines.ie no header.pdf
Reasons for updating
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Addition of a CE-marked medical device (swabable vented vial adaptor [SVVA]), to the current registered packs for Flolan (Epoprostenol)
Updated on 22 June 2022
File name
ie-spc-flolan0-5-pH12-issue8draft1-clean medcines.ie no header.pdf
Reasons for updating
- 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
Addition of a CE-marked medical device (swabable vented vial adaptor [SVVA]), to the current registered packs for Flolan (Epoprostenol)
Updated on 09 June 2021
File name
ie-spc-flolan0-5-pH12-issue8draft1-clean medcines.ie no header.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 PAH and Renal dialysis reconstitution & dilution
Updated on 09 June 2021
File name
ie-pl-flolan-ph12-shared-issue6draft2-clean medicines.ie no header.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 11 January 2019
File name
ie-pl-flolan-ph12-shared-issue5draft2-MED.IE.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-flolan0-5-pH12-issue7draft2-MED.IE.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 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
- 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
Updated on 20 March 2017
File name
PIL_17125_999.pdf
Reasons for updating
- New PIL for new product
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)