देश: इसराइल
भाषा: अंग्रेज़ी
स्रोत: Ministry of Health
ESMOLOL HYDROCHLORIDE
AOP ORPHAN PHARMACEUTICALS ISRAEL LTD, ISRAEL
C07AB09
SOLUTION FOR INJECTION
ESMOLOL HYDROCHLORIDE 10 MG/ML
I.V
Required
AOP ORPHAN PHARMACEUTICALS GMBH, AUSTRIA
ESMOLOL
Esmolol Amomed 100 mg/10 ml is indicated for supraventricular tachycardia (except for pre-excitation syndromes) and for the rapid control of the ventricular rate in adult 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 Amomed 100 mg/10 ml is also indicated for tachycardia and hypertension occurring in the perioperative phase and non-compensatory sinus tachycardia in adult patients where, in the physician’s judgement the rapid heart rate requires specific intervention.Esmolol Amomed 100 mg/10 ml is not intended for use in chronic settings.
2022-04-30
1 NAME OF THE MEDICINAL PRODUCT Esmolol Amomed 100 mg/10 ml solution for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial of 10 ml solution for injection contains 100 mg Esmolol hydrochloride. 1 ml aqueous solution contains 10 mg Esmolol hydrochloride (10 mg/ml). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection. The solution is clear and colourless. 4 CLINICAL PARTICULARS 4.1 Therapeutic indications Esmolol Amomed 100 mg/10 ml is indicated for supraventricular tachycardia (except for pre-excitation syndromes) and for the rapid control of the ventricular rate in adult 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 Amomed 100 mg/10 ml is also indicated for tachycardia and hypertension occuring in the perioperative phase and non- compensatory sinus tachycardia in adult patients where, in the physician’s judgement the rapid heart rate requires specific intervention. Esmolol Amomed 100 mg/10 ml is not intended for use in chronic settings. 4.2 Posology and method of administration Esmolol Amomed 100 mg/10 ml solution for injection is a clear solution ready for intravenous use. The concentration of this product is 10 mg/ml Esmolol hydrochloride. SUPRAVENTRICULAR TACHYARRHYTHMIA The dosage of Esmolol should be titrated individually. A starting dose is required, followed by a maintenance dosage. The effective dose of Esmolol hydrochloride is within the range of 50 to 200 micrograms/kg/min, although doses as high as 300 micrograms/kg/min have been used. In a few patients the average effective dosage of 25 micrograms/ kg/min has been adequate. As the desired heart rate or safety endpoint (e.g. lowered blood pressure) is approached, OMIT the loading infusion and reduce the incremental dose in the maintenance infusion from 50 micrograms/kg/min to 25 micrograms/kg/min or lower. If necessary, the interval betwee पूरा दस्तावेज़ पढ़ें