- Approval Id
- 214a69c778089873
- Drug Name
- FLOLAN FOR INFUSION 0.5 MG/VIAL
- Product Name
- FLOLAN FOR INFUSION 0.5 MG/VIAL
- Approval Number
- SIN02241P
- Approval Date
- 1988-07-04
- Registrant
- GLAXOSMITHKLINE PTE LTD
- Licence Holder
- GLAXOSMITHKLINE PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- INJECTION, POWDER, FOR SOLUTION
- Dosage
- <p><strong>Dosage and Administration</strong></p>
<p><em>FLOLAN</em> 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 <em>Instructions for Use/Handling</em> – <em>please refer to the Product Insert/Product Information Leaflet published on HSA for the full drug information</em>).</p>
<p><em>FLOLAN</em> 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 <em>Incompatibilities</em> – <em>please refer to the Product Insert/Product Information Leaflet published on HSA for the full drug information</em>).</p>
<p><strong>Populations</strong></p>
<p>• <strong>Adults</strong></p>
<p><u><strong>Renal Dialysis</strong></u></p>
<p><em>FLOLAN</em> is suitable for continuous infusion only, either intravascularly or into the blood supplying the dialyser.</p>
<p class="hanging-indent">The following schedule of infusion has been found effective in adults:<br>
prior to dialysis: 4 nanograms/kg/min intravenously for 15 minutes<br>
during dialysis: 4 nanograms/kg/min into the arterial inlet of the dialyser</p>
<p>The infusion should be stopped at the end of dialysis.</p>
<p>The recommended dose for renal dialysis should be exceeded only with careful monitoring of patient blood pressure.</p>
<p>• <strong>Children</strong></p>
<p>There is no specific information on the use of <em>FLOLAN</em> for renal dialysis or pulmonary hypertension in children.</p>
<p>• <strong>Elderly</strong></p>
<p>There is no specific information on the use of <em>FLOLAN</em> 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.</p>
- Route Of Administration
- INTRAVASCULAR
- Indication Info
- <p><strong>Indications</strong></p>
<p><u><strong>Renal Dialysis</strong></u></p>
<p><em>FLOLAN</em> 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.</p>
- Contraindications
- <p><strong>Contraindications</strong></p>
<ul class="dash">
<li> <em>FLOLAN </em>is contraindicated in patients with known hypersensitivity to the drug.</li>
<li> <em>FLOLAN </em>is contraindicated in patients with congestive heart failure arising from severe left ventricular dysfunction.</li>
<li> <em>FLOLAN </em>should not be used chronically in patients who develop pulmonary oedema during dose-ranging.</li>
</ul>
- Atc Code
- B01AC09
- Atc Item Name
- epoprostenol
- Pharma Manufacturer Name
- GLAXOSMITHKLINE PTE LTD
