Европейски съюз - английски - EMA (European Medicines Agency)

bial portela & companhia s.a. - opicapone - parkinson disease - anti-parkinson drugs - ontilyv is indicated as adjunctive therapy to preparations of levodopa/ dopa decarboxylase inhibitors (ddci) in adult patients with parkinson’s disease and end-of-dose motor fluctuations who cannot be stabilised on those combinations.

Великобритания - английски - MHRA (Medicines & Healthcare Products Regulatory Agency)

bial pharma uk ltd - opicapone - capsule - 50mg

Израел - английски - Ministry of Health

truemed ltd, israel - opicapone - hard capsule - opicapone 50 mg - opicapone - ongentys is indicated as adjunctive therapy to preparations of levodopa/ dopa decarboxylase inhibitors (ddci) in adult patients with parkinson’s disease and end-of-dose motor fluctuations who cannot be stabilised on those combinations.

Нова Зеландия - английски - 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.

САЩ - английски - NLM (National Library of Medicine)

general injectables and vaccines, inc. - dobutamine hydrochloride (unii: 0wr771djxv) (dobutamine - unii:3s12j47372) - 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 use 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.

Австралия - английски - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - dobutamine hydrochloride, quantity: 14 mg/ml (equivalent: dobutamine, qty 12.5 mg/ml) - injection, concentrated - excipient ingredients: sodium hydroxide; hydrochloric acid; water for injections; sodium metabisulfite - adults who require short-term treatment of cardiac failure secondary to acute myocardial infarction, or cardiac surgery.

Нова Зеландия - английски - Medsafe (Medicines Safety Authority)

hospira nz ltd - dobutamine hydrochloride 14.01 mg/ml equivalent to 12.5 mg/ml dobutamine - solution for injection - 12.5 mg/ml - active: dobutamine hydrochloride 14.01 mg/ml equivalent to 12.5 mg/ml dobutamine excipient: sodium metabisulfite water for injection