Šalis: Naujoji Zelandija
kalba: anglų
Šaltinis: Medsafe (Medicines Safety Authority)
Dobutamine hydrochloride 12.5 mg/mL
Pfizer New Zealand Limited
Dobutamine hydrochloride 12.5 mg/mL
12.5 mg/mL
Solution for injection
Active: Dobutamine hydrochloride 12.5 mg/mL Excipient: Sodium metabisulfite Water for injection
Vial, 1x20ml, 20 mL
Prescription
Prescription
Abbott Laboratories Inc
Dobutamine hydrochloride is indicated when inotropic support is necessary for the treatment of patients with hypoperfusion states in whom cardiac output is insufficient to meet circulatory demands. Dobutamine hydrochloride is also indicated when inotropic support is required for the treatment of patients in whom abnormally increased ventricular filling pressures introduce the risk of pulmonary congestion and oedema. (Refer to the data sheet for conditions which may precipitate such situations).
Package - Contents - Shelf Life: Vial, 20ml - 1 dose units - 24 months from date of manufacture stored at or below 25°C
1991-06-26
Version 4.0 Page 1 of 14 NEW ZEALAND DATA SHEET _ _ 1. PRODUCT NAME _ _ DBL™ Dobutamine Hydrochloride Injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION DBL ™ Dobutamine Hydrochloride Injection is a sterile solution containing in each 20 mL vial, Dobutamine Hydrochloride USP 280.2 mg (250 mg Dobutamine equivalent) and Sodium Metabisulfite BP 4.4 mg. EXCIPIENT(S) WITH KNOWN EFFECT Sodium Metabisulfite For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection Dobutamine hydrochloride is a white to practically white, crystalline powder. It is sparingly soluble in water and methyl alcohol; soluble in alcohol. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Dobutamine hydrochloride is indicated when inotropic support is necessary for the treatment of patients with hypoperfusion states in whom cardiac output is insufficient to meet circulatory demands. Dobutamine hydrochloride is also indicated when inotropic support is required for the treatment of patients in whom abnormally increased ventricular filling pressures introduce the risk of pulmonary congestion and oedema. Conditions which may precipitate such situations include the following hypoperfusion states: INITIALLY CARDIAC IN ORIGIN _A. ACUTE HEART FAILURE _ 1. Acute myocardial infarction 2. Cardiogenic shock 3. Following cardiac surgery 4. Medicine-induced depression of cardiac contractility such as that which occurs in excessive β-adrenergic receptor blockade. Version 4.0 Page 2 of 14 _B. CHRONIC HEART FAILURE _ 1. Acute decompensation of chronic congestive heart failure 2. Temporary inotropic support in advanced chronic congestive heart failure, as an adjunct to therapy with conventional oral inotropic agents, systemic vasodilators, and diuretics. INITIALLY NONCARDIAC IN ORIGIN 1. Acute hypoperfusion states secondary to trauma, surgery, sepsis, or hypovolaemia when mean arterial pressure is above 70-mm Hg and pulmonary capillary wedge pressure is 18-mm Hg or greater, with inadequate response to volume reple Perskaitykite visą dokumentą