Australia - English - Department of Health (Therapeutic Goods Administration)

novo nordisk pharmaceuticals pty ltd - insulin aspart, quantity: 100 u/ml - injection, suspension - excipient ingredients: zinc; dibasic sodium phosphate dihydrate; protamine sulfate; metacresol; sodium chloride; sodium hydroxide; glycerol; phenol; hydrochloric acid; water for injections - treatment of diabetes mellitus.

New Zealand - English - Medsafe (Medicines Safety Authority)

baxter healthcare ltd - dobutamine hydrochloride 14.01 mg/ml equivalent to dobutamine 12.5 mg/ml - concentrate for injection - 12.5 mg/ml - active: dobutamine hydrochloride 14.01 mg/ml equivalent to dobutamine 12.5 mg/ml excipient: hydrochloric acid nitrogen sodium hydroxide sodium metabisulfite water for injection - 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 ?- adrenergic receptor blockade. 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 repletion and increased ventricular filling pressure 2. low cardiac output secondary to mechanical ventilation with positive end-expiratory pressure (peep). paediatric population dobutamine is indicated in all paediatric age groups (from neonates to 18 years of age) as inotropic support in low cardiac output hypoperfusion states resulting from decompensated heart failure, following cardiac surgery, cardiomyopathies and in cardiogenic or septic shock.

United States - English - NLM (National Library of Medicine)

hospira, inc. - dobutamine hydrochloride (unii: 0wr771djxv) (dobutamine - unii:3s12j47372) - dobutamine 12.5 mg in 1 ml - dobutamine injection, usp is indicated when parenteral therapy is necessary for inotropic support in the short-term treatment of adults with cardiac decompensation due to depressed contractility resulting either from organic heart disease or from cardiac surgical procedures. in patients who have atrial fibrillation with rapid ventricular response, a digitalis preparation should be used prior to institution of therapy with dobutamine hydrochloride. dobutamine hydrochloride is contraindicated in patients with idiopathic hypertrophic subaortic stenosis and in patients who have shown previous manifestations of hypersensitivity to dobutamine injection, usp solution.

Singapore - English - HSA (Health Sciences Authority)

novo nordisk pharma (singapore) pte ltd - protamine-crystallised insulin aspart; soluble insulin aspart - injection - 70.00% - protamine-crystallised insulin aspart 70%; soluble insulin aspart 30%

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

wockhardt uk ltd - protamine sulfate - solution for injection - 10mg/1ml

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

novo nordisk pharma (malaysia) sdn. bhd. - protamine crystallised insulin asparte; soluble insulin asparte -

Australia - English - Department of Health (Therapeutic Goods Administration)

novo nordisk pharmaceuticals pty ltd - insulin aspart, quantity: 100 u/ml - injection, suspension - excipient ingredients: glycerol; metacresol; sodium chloride; dibasic sodium phosphate dihydrate; hydrochloric acid; phenol; zinc; water for injections; sodium hydroxide; protamine sulfate - treatment of diabetes mellitus.

United States - English - NLM (National Library of Medicine)

hospira, inc. - dobutamine hydrochloride (unii: 0wr771djxv) (dobutamine - unii:3s12j47372) - dobutamine 12.5 mg in 1 ml - dobutamine injection is indicated when parenteral therapy is necessary for inotropic support in the short-term treatment of adults with cardiac decompensation due to depressed contractility resulting either from organic heart disease or from cardiac surgical procedures. in patients who have atrial fibrillation with rapid ventricular response, a digitalis preparation should be used prior to institution of therapy with dobutamine hydrochloride. dobutamine hydrochloride is contraindicated in patients with idiopathic hypertrophic subaortic stenosis and in patients who have shown previous manifestations of hypersensitivity to dobutamine injection.

United States - English - NLM (National Library of Medicine)

hospira, inc. - dobutamine hydrochloride (unii: 0wr771djxv) (dobutamine - unii:3s12j47372) - dobutamine injection, usp is indicated when parenteral therapy is necessary for inotropic support in the short-term treatment of adults with cardiac decompensation due to depressed contractility resulting either from organic heart disease or from cardiac surgical procedures. in patients who have atrial fibrillation with rapid ventricular response, a digitalis preparation should be used prior to institution of therapy with dobutamine hydrochloride. dobutamine hydrochloride is contraindicated in patients with idiopathic hypertrophic subaortic stenosis and in patients who have shown previous manifestations of hypersensitivity to dobutamine injection, usp solution.

United States - English - NLM (National Library of Medicine)

hf acquisition co llc, dba healthfirst - dobutamine hydrochloride (unii: 0wr771djxv) (dobutamine - unii:3s12j47372) - dobutamine injection, usp is indicated when parenteral therapy is necessary for inotropic support in the short-term treatment of adults with cardiac decompensation due to depressed contractility resulting either from organic heart disease or from cardiac surgical procedures. in patients who have atrial fibrillation with rapid ventricular response, a digitalis preparation should be used prior to institution of therapy with dobutamine hydrochloride. dobutamine hydrochloride is contraindicated in patients with idiopathic hypertrophic subaortic stenosis and in patients who have shown previous manifestations of hypersensitivity to dobutamine injection, usp solution.