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SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Epoprostenol Drehm 1.5mg Powder and Solvent for Solution for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 vial contains 1.593 mg Epoprostenol Sodium, corresponding to 1.5mg Epoprostenol.
Each vial of solvent contains 50 ml of a sterile glycine buffer solution containing approximately 55 mg sodium.
When 1 vial with 1.5 mg epoprostenol is reconstituted with 50 ml sterile diluent, the resultant concentration is 30,000
nanograms per ml.
Excipients: contains 0.05 mmol sodium (1.15 mg) per vial.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder and solvent for solution for infusion
White lyophilised powder cake in colourless glass-vials, and a clear, colourless solution in 50 ml glass vials.
When 1.5 mg epoprostenol powder is reconstituted with 50 ml of the Glycine Buffer Diluent, the final injection has a
pH of approximately 10.5 and a sodium ion content of approximately 56 mg.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
HAEMODIALYSIS
Epoprostenol Drehm 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.
PRIMARY AND SECONDARY PULMONARY HYPERTENSION
Epoprostenol Drehm is also indicated for the intravenous long-term treatment of primary pulmonary hypertension
(PPH) in New York Heart Association (NYHA) functional Class III and Class IV patients who do not respond
adequately to conventional therapy, and secondary pulmonary hypertension (SPH) in the scleroderma spectrum of
diseases (SSD) due to intrinsic precapillary pulmonary vascular disease in patients with NYHA functional class III and
IV.
There are limited data on long-term use.
4.2 POSOLOGY AND METHOD OF ADMINISTR
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