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FLOLAN FOR INFUSION 0.5 MG/VIAL [SIN02241P]
Active ingredients: FLOLAN FOR INFUSION 0.5 MG/VIAL
Last updated 26 October 2025
Product Info
FLOLAN FOR INFUSION 0.5 MG/VIAL
[SIN02241P]
Product information
Active Ingredient and Strength | EPOPROSTENOL - 0.5 MG/VIAL |
Dosage Form | INJECTION, POWDER, FOR SOLUTION |
Manufacturer and Country | GLAXOSMITHKLINE MANUFACTURING S.P.A. (POWDER) - ITALY |
Registration Number | SIN02241P |
Licence Holder | GLAXOSMITHKLINE PTE LTD |
Forensic Classification | PRESCRIPTION ONLY MEDICINES |
Anatomical Therapeutic Chemical (ATC) code | B01AC09 |
Indications
Renal Dialysis
FLOLAN is indicated for use in renal dialysis when use of heparin carries a high risk of causing or exacerbating bleeding or when heparin is otherwise contraindicated.
Dosage and Administration
FLOLAN lyophilised powder must be reconstituted before use. Any further dilution must be performed using only the recommended solutions. The final infusion solution must be filtered with a sterile 0.22 micron or 0.20 micron filter prior to or during administration (see Instructions for Use/Handling – please refer to the Product Insert/Product Information Leaflet published on HSA for the full drug information).
FLOLAN prepared with sterile diluent (pH 12) must not be used with any preparation or administration materials containing polyethylene terephthalate (PET) or polyethylene terephthalate glycol (PETG; see Incompatibilities – please refer to the Product Insert/Product Information Leaflet published on HSA for the full drug information).
Populations
• Adults
Renal Dialysis
FLOLAN is suitable for continuous infusion only, either intravascularly or into the blood supplying the dialyser.
The following schedule of infusion has been found effective in adults:
prior to dialysis: 4 nanograms/kg/min intravenously for 15 minutes
during dialysis: 4 nanograms/kg/min into the arterial inlet of the dialyser
The infusion should be stopped at the end of dialysis.
The recommended dose for renal dialysis should be exceeded only with careful monitoring of patient blood pressure.
• Children
There is no specific information on the use of FLOLAN for renal dialysis or pulmonary hypertension in children.
• Elderly
There is no specific information on the use of FLOLAN in patients over 65 for renal dialysis or pulmonary hypertension. In general, dose selection for an elderly patient should be made carefully, reflecting the greater frequency of decreased hepatic, renal (in the case of pulmonary hypertension) or cardiac function and of concomitant disease or other drug therapy.
Contraindications
FLOLAN is contraindicated in patients with known hypersensitivity to the drug.
FLOLAN is contraindicated in patients with congestive heart failure arising from severe left ventricular dysfunction.
FLOLAN should not be used chronically in patients who develop pulmonary oedema during dose-ranging.