国: アイルランド
言語: 英語
ソース: HPRA (Health Products Regulatory Authority)
ESMOLOL HYDROCHLORIDE
Orpha-Devel Handels und Vertriebs GmbH
2500 Milligram
Concentrate for Soln for Inf
2008-03-07
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Esmocard 2500 mg/10 ml concentrate for solution for infusion. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ampoule of 10 ml concentrate for solution for infusion contains 2500 mg esmolol hydrochloride. 1 ml aqueous solution contains 250 mg esmolol hydrochloride (250 mg/ml). Excipients: 2010 mg ethanol 96% and 2590 mg Propylene glycol in a 10 ml ampoule. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Concentrate for solution for infusion. The solution is clear and colourless. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Esmolol hydrochloride is indicated for supraventricular tachycardia (except for pre-excitation syndromes), and for the rapid control of ventricular rate in patients with atrial fibrillation or atrial flutter in perioperative, postoperative, or other circumstances where short-term control of the ventricular rate with a short acting agent is desirable. Esmolol hydrochloride is also indicated for tachycardia and hypertension occuring in the perioperative phase and non- compensatory sinus tachycardia where, in the physician’s judgement the rapid heart rate requires specific intervention. Esmolol hydrochloride is not intended for use in chronic settings. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION ESMOCARD 2500 mg/10 ml concentrate for solution for infusion must be diluted before administration , exact instructions for use are given in section 6.6. Esmocard 2500 mg/10 ml concentrate for solution for infusion must be diluted and used immediately after opening (see sections 4.4 and 6). Dilute the content of 2 ampoules to 500 ml with the appropriate solution to obtain a concentration of 10 mg/ml, see also section 6.6. The administration of Esmocard 2500 mg/10 ml concentrat 完全なドキュメントを読む