Minor administrative changes to the following sections:

- What is in this leaflet section

- Section 4 Possible side effects

- Section 5 How to store Flolan

- Section 6 Contents of the pack and other information

Section 4. Other side effects updated to: 

It is not known how many people are affected (frequency cannot be estimated from the available data):

Section 5. How to store Flolan updated to:

Freshly prepared Flolan solution (either as a concentrated solution or a further diluted solution) can be administered immediately or stored for a maximum of 8 days at refrigerated conditions (2 to 8 °CoC), in the medication cassette and used within a maximum time of:

• 48 hours at up to 25 °C or

• 36 hours at up to 30 ºC or

• 24 hours at up to 35 ºC or

• 12 hours at up to 40 ºC

Reconstituted solutions that have been stored at 2 to 8 °C for up to 7 days can be administered for up to 24 hours at 25 °C.

Freshly prepared reconstituted solutions, or solutions that have been stored at 2 to 8 °C for no longer than 5 days can be administered for up to:

• 48 hours at up to 25 °C or

• 24 hours at up to 35 °C

Section 6. Marketing Authorisation Holder and Manufacturer updated to:

This medicine product is authorised in the Member States of the European Economic Area under the following names: Austria, Belgium, Czech Republic, Estonia, Ireland, Italy, Luxembourg, Malta, The Netherlands, Norway, Spain: Flolan

Section 6 last revision date updated to:

June 2023

Type IB Submission to support the change to the maximum in-use period for the reconstituted solution.

Minor administrative changes to the following sections:

- Section 2 QUALITATIVE AND QUANTITATIVE COMPOSITION

- Section 4.2 Posology and method of administration

- Section 4.4 Special warnings and precautions for use

- Section 4.9 Overdose

- Section 5.1 Pharmacodynamic properties

- Section 6.3 Shelf life

- Section 6.4 Special precautions for storage

- Section 6.6 Special precautions for disposal and other handling 

Section 4.2 updated to:

Freshly prepared solutions for infusion (either as a concentrated solution or a further diluted solution) can be administered immediately or stored for up to 8 days at 2 °C to 8 °C prior to administration. Following this preparation or storage, the solution for infusion should be used within 48 hours at up to 25 °C, or 36 hours at up to 30 ºC, or 24 hours at up to 35 ºC, or 12 hours at up to 40 ºC (see section 6.3).

Section 6.3 Shelf life updated to:

Freshly prepared solutions for infusion (either as a concentrated solution or a further diluted solution) can be administered immediately or stored for up to 8 days at 2 °C to 8 °C prior to administration. Following this preparation or storage, the solution for infusion should be used within:

• 48 hours at up to 25 °C or

• 36 hours at up to 30 ºC or

• 24 hours at up to 35 ºC or

• 12 hours at up to 40 ºC

Discard any unused solution after this time.

For solutions >150 ,000 ng/mL and =300 ,000 ng/mL:

Reconstituted solutions that have been stored at 2 to 8°C for up to 7 days can be administered for up to 24 hours at 25 °C.

Freshly prepared reconstituted solutions, or solutions that have been stored at 2 to 8 °C for no longer than 5 days can be administered for up to:

• 48 hours at up to 25 ºC or

• 24 hours at up to 35 ºC

Section 10 revision date updated to: 29/01/2026.

Addition of a CE-marked medical device (swabable vented vial adaptor [SVVA]), to the current registered packs for Flolan (Epoprostenol) 

Addition of a CE-marked medical device (swabable vented vial adaptor [SVVA]), to the current registered packs for Flolan (Epoprostenol) 

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

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