Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
EPOPROSTENOL
Drehm Pharma GmbH
500 Microgram
Pdr+Solv for soln for Inf
2011-06-17
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Epoprostenol Drehm 500 microgram Powder and Solvent for Solution for Infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 vial contains 531 microgram Epoprostenol Sodium, corresponding to 500 micrograms Epoprostenol. Each vial of solvent contains 50 ml of a sterile glycine buffer solution containing approximately 55 mg sodium. Where 1 vial with 500 microgram epoprostenol is reconstituted with 50 ml of sterile buffer, the resultant concentration is 10,000 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 500 microgram 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. Read the complete document