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parenteral formulation and esmolol and a ready-to-use solution containing the esmolol formulation, a kit containing said formulation and its production.
parenteral formulation and esmolol and a ready-to-use solution containing the esmolol formulation, a kit containing said formulation and its production.
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机译:肠胃外制剂和艾司洛尔以及包含艾司洛尔制剂的即用溶液,包含所述制剂的试剂盒及其生产。
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摘要
A parenteral formulation of esmolol hydrochloride for use in the treatment of a patient suffering from tachycardia comprising a lyophilized powder consisting of pure esmolol hydrochloride, wherein said powder is reconstituted to obtain a ready-to-use i.v. solution of esmolol hydrochloride at a concentration of 20-100 mg/mL, and said i.v. solution is directly administered to the patient, and further a method of producing a ready-to-use i.v. solution of esmolol hydrochloride by reconstituting a lyophilized powder consisting of pure esmolol hydrochloride with a solvent, characterized in that said solvent is an i.v. solvent devoid of alcohol or a buffer excipient, in an amount necessary to obtain a ready-to-use i.v. solution at a concentration of 20-100 mg/mL, and the ready-to-use i.v. solution containing a parenteral formulation of 20-100 mg/mL pure esmolol hydrochloride in an infusion device or consisting of a parenteral formulation of 20-100 mg/mL pure esmolol hydrochloride, WFI and/or saline solution, devoid of any alcohol or buffer excipients.
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