DBL™ Dobutamine Hydrochloride

Страна: Новая Зеландия

Язык: английский

Источник: Medsafe (Medicines Safety Authority)

Активный ингредиент:

Dobutamine hydrochloride 12.5 mg/mL

Доступна с:

Pfizer New Zealand Limited

ИНН (Международная Имя):

Dobutamine hydrochloride 12.5 mg/mL

дозировка:

12.5 mg/mL

Фармацевтическая форма:

Solution for injection

состав:

Active: Dobutamine hydrochloride 12.5 mg/mL Excipient: Sodium metabisulfite Water for injection

Штук в упаковке:

Vial, 1x20ml, 20 mL

класс:

Prescription

Тип рецепта:

Prescription

Производитель:

Abbott Laboratories Inc

Терапевтические показания :

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).

Обзор продуктов:

Package - Contents - Shelf Life: Vial, 20ml - 1 dose units - 24 months from date of manufacture stored at or below 25°C

Дата Авторизация:

1991-06-26

Характеристики продукта

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.
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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