Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
INJECTION, POWDER, FOR SOLUTION
**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.
INTRAVASCULAR
Medical Information
**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.
**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.
B01AC09
epoprostenol
Manufacturer Information
GLAXOSMITHKLINE PTE LTD
GLAXOSMITHKLINE MANUFACTURING S.P.A. (Powder)
GLAXO OPERATIONS UK LTD.(TRADING AS GLAXO WELLCOME OPERATIONS)(Diluent-Manufacture,Primary Packager)
Active Ingredients
Documents
Package Inserts
Flolan for infusion PI.pdf
Approved: July 30, 2018