Dobutamine-hameln 12.5 mg/ml concentrate for solution for infusion

Země: Nový Zéland

Jazyk: angličtina

Zdroj: Medsafe (Medicines Safety Authority)

Aktivní složka:

Dobutamine hydrochloride 14 mg/mL equivalent to dobutamine 12.5 mg/mL, 250 mg dobutamine in 20 mL;  

Dostupné s:

Max Health Limited

INN (Mezinárodní Name):

Dobutamine hydrochloride 14 mg/mL (= dobutamine 12.5 mg/mL, 250 mg dobutamine in 20 mL)

Dávkování:

12.5 mg/mL

Léková forma:

Concentrate for infusion

Složení:

Active: Dobutamine hydrochloride 14 mg/mL equivalent to dobutamine 12.5 mg/mL, 250 mg dobutamine in 20 mL   Excipient: Hydrochloric acid Sodium metabisulfite Water for injection

Jednotky v balení:

Ampoule, glass, 20 mL x 1 vial, 1 dose unit

Třída:

Prescription

Druh předpisu:

Prescription

Výrobce:

BASF PharmaChemikalien GmbH & Co KG

Terapeutické indikace:

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 Acute myocardial infarction, Cardiogenic shock, Following cardiac surgery, Medicine-induced depression of cardiac contractility such as that which occurs in excessive ?-adrenergic receptor blockade. B. Chronic heart failure Acute decompensation of chronic congestive heart failure, 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: 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, 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. Dobutamine stress echocardiography: Dobutamine hydrochloride may be used as a substitute for physical exercise in stress testing in the diagnosis of coronary artery disease. Precautions apply (refer to data sheet).

Přehled produktů:

Package - Contents - Shelf Life: Ampoule, glass, 20 mL - 1 dose units - 36 months from date of manufacture stored at or below 25°C protect from light. do not refrigerate, do not freeze 24 hours diluted stored at or below 25°C - Ampoule, glass, 20 mL - 5 dose units - 36 months from date of manufacture stored at or below 25°C protect from light. do not refrigerate, do not freeze 24 hours diluted stored at or below 25°C

Datum autorizace:

2012-10-05

Charakteristika produktu

NEW ZEALAND DATA SHEET
1 PRODUCT NAME
Dobutamine-hameln 12.5 mg/ml concentrate for solution for infusion.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL contains dobutamine hydrochloride equivalent to dobutamine
12.5 mg.
Each ampoule contains 250 mg dobutamine in 20 mL.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Concentrate for infusion.
4 CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Dobutamine 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 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.
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).
_ _
_ _
Page 2 of 17
_PAEDIATRIC POPULATION _
Dobutamine is indicated in all paediatric age groups (from neonates to
18 years of age) as inotropic
support in low cardiac output hypoperfu