Ülke: Birleşik Krallık
Dil: İngilizce
Kaynak: MHRA (Medicines & Healthcare Products Regulatory Agency)
Epoprostenol sodium
pH10.5) for solution for infusion vials (Sandoz Ltd
B01AC09
Epoprostenol sodium
1.5mg
Powder and solvent for solution for infusion
Intravenous
No Controlled Drug Status
Valid as a prescribable product
BNF: 02080100
EPOPROSTENOL SODIUM 1.5 MG POWDER AND SOLVENT FOR SOLUTION FOR INFUSION Summary of Product Characteristics Updated 27-May-2015 | Sandoz Limited 1. Name of the medicinal product Epoprostenol Sodium 1.5 mg Powder and Solvent for Solution for Infusion 2. Qualitative and quantitative composition Epoprostenol Sodium 1.5 mg Powder and Solvent for Solution for Infusion: Each vial contains epoprostenol sodium equivalent to 1.5 mg epoprostenol. Excipient(s) with known effect: contains 0.054 mmol sodium (1.25 mg). Solvent for Epoprostenol Sodium 1.5 mg Powder and Solvent for Solution for Infusion: Each vial contains 50ml sterile glycine buffer solution. Excipient(s) with known effect: contains 1.25 mmol sodium (28,82 mg). For the full list of excipients, see section 6.1. One ml of reconstituted concentrate solution contains epoprostenol (as epoprostenol sodium) 30 000 nanogram. 3. Pharmaceutical form Powder and solvent for solution for infusion − White to almost white freeze dried powder − Clear solution (pH 10.3-10.8) 4. Clinical particulars 4.1 Therapeutic indications Epoprostenol is indicated for: Pulmonary Arterial Hypertension Epoprostenol is indicated for the treatment of pulmonary arterial hypertension (PAH) (idiopathic or heritable PAH and PAH associated with connective tissue diseases) in patients with WHO Functional Class III-IV symptoms to improve exercise capacity (see section 5.1). Renal Dialysis Epoprostenol is indicated for use in haemodialysis in emergency situations when use of heparin carries a high risk of causing or exacerbating bleeding or when heparin is otherwise contraindicated (see section 5.1). 4.2 Posology and method of administration Posology Epoprostenol is only indicated for continuous infusion by intravenous route. PULMONARY ARTERIAL HYPERTENSION Treatment should only be initiated and monitored by a physician experienced in the treatment of pulmonary arterial hypertension. Short-term (acute) dose ranging: This procedure should be conducted in a hospital with adequate resuscitation equipme Belgenin tamamını okuyun