Страна: Нова Зеландія
мова: англійська
Джерело: Medsafe (Medicines Safety Authority)
Dexmedetomidine hydrochloride 0.118 mg/mL equivalent to Dexmedetomidine 0.100mg/mL;
Viatris Limited
Dexmedetomidine hydrochloride 0.118 mg/mL (equivalent to Dexmedetomidine 0.100mg/mL)
200 mcg/2mL
Concentrate for infusion
Active: Dexmedetomidine hydrochloride 0.118 mg/mL equivalent to Dexmedetomidine 0.100mg/mL Excipient: Sodium chloride Water for injection
Prescription
Alcami Wisconsin Corporation
ICU Sedation: For sedation of initially intubated patients during treatment in an intensive care setting. The use of Dexmedetomidine Viatris by continuous infusion in these patients should not exceed 24 hours. Procedural Sedation: For sedation of non-intubated patients prior to and/or during surgical and other procedures.
Package - Contents - Shelf Life: Vial, glass, 3 ml Type 1 vial, Closure: Rubber stopper, Al seal and plastic flip top cap - 5 dose units - 24 months from date of manufacture stored at or below 25°C 24 hours diluted stored between 20°C - 25°C
2016-03-24
Page 1 of 20 NEW ZEALAND DATA SHEET DEXMEDETOMIDINE VIATRIS 1. PRODUCT NAME Dexmedetomidine Viatris, 200 micrograms/2 mL, concentrated injection for intravenous solution. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1 mL of concentrate contains 118 micrograms of dexmedetomidine hydrochloride (equivalent to 100 micrograms dexmedetomidine base). Each 2 mL vial contains 200 micrograms of dexmedetomidine. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Dexmedetomidine hydrochloride is a sterile, nonpyrogenic solution suitable for intravenous infusion following dilution. Dexmedetomidine hydrochloride is a white or almost white powder, freely soluble in water and its pKa is 7.1. Dexmedetomidine is supplied as a clear, colourless, isotonic solution with a pH of 4.5 to 7.0. Its partition coefficient in octanol: water at pH 7.84 is 2.89. 4. CLINICAL PARTICULARS _4.1 _ _THERAPEUTIC INDICATIONS_ ICU SEDATION For sedation of initially adult intubated patients during treatment in an intensive care setting. The use of Dexmedetomidine Viatris by continuous infusion in these patients should not exceed 24 hours. PROCEDURAL SEDATION For sedation of non-intubated adult patients prior to and/or during surgical and other procedures. _4.2_ _DOSE AND METHOD OF ADMINISTRATION_ NOTE: Dexmedetomidine hydrochloride should be administered only by persons skilled in anaesthetics or in the management of patients in the intensive care setting. Due to the known pharmacological effects, patients should be continuously monitored. Clinically significant events of bradycardia and sinus arrest have been associated with dexmedetomidine administration in young, healthy volunteers with high vagal tone or with different routes of administration including rapid intravenous or bolus administration of dexmedetomidine. Page 2 of 20 DOSE Dexmedetomidine should be individualised and titrated to the desired clinical effect. _ICU SEDATION _ INITIATION For adult patients, Dexmedetomidine Viatris is generally initiated with a loading Прочитайте повний документ