Dobutamine-Claris

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Dobutamine hydrochloride 14.01 mg/mL equivalent to dobutamine 12.5 mg/mL

Available from:

Baxter Healthcare Ltd

INN (International Name):

Dobutamine hydrochloride 14.01 mg/mL (equivalent to dobutamine 12.5 mg/mL)

Dosage:

12.5 mg/mL

Pharmaceutical form:

Concentrate for injection

Composition:

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

Prescription type:

Prescription

Manufactured by:

Recordati SpA

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 ?- 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 convention

Product summary:

Package - Contents - Shelf Life: Ampoule, glass, Type 1, 20 mL - 5 dose units - 24 months from date of manufacture stored at or below 25°C protect from light 24 hours diluted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light

Authorization date:

2013-07-11

Summary of Product characteristics

NEW ZEALAND DATA SHEET
V 1.0 March 2018
Page 1 of 15
1 DOBUTAMINE-CLARIS 250 MG/20 ML CONCENTRATED SOLUTION FOR
INJECTION
Dobutamine-Claris 250 mg/20 mL concentrated solution for injection.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Dobutamine-Claris, concentrated solution for injection is a
concentrated sterile aqueous solution
containing dobutamine hydrochloride equivalent to dobutamine 250 mg
per 20 mL ampoule. It must
be diluted before use.
Excipients with known effect:
Sodium metabisulfite
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Concentrated solution for injection.
A concentrated sterile aqueous solution.
4 CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Dobutamine -Claris 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-Claris 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 press