Dobutamine 12.5mg/ml Sterile Concentrate

Страна: Мальта

Язык: английский

Источник: Malta Medicines Authority

Активный ингредиент:

DOBUTAMINE

Доступна с:

Mercury Pharmaceuticals (Ireland) Limited 4045 Kingswood Road, City West Business Park, Co, Dublin, Ireland

код АТС:

C01CA07

ИНН (Международная Имя):

DOBUTAMINE 12.5 mg/ml

Фармацевтическая форма:

CONCENTRATE FOR SOLUTION FOR INFUSION

состав:

DOBUTAMINE 12.5 mg/ml

Тип рецепта:

POM

Терапевтические области:

CARDIAC THERAPY

Статус Авторизация:

Withdrawn

Дата Авторизация:

2006-08-31

Характеристики продукта

Page 1 of 17
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Dobutamine 12.5mg/ml Concentrate for Solution for Infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml solution contains Dobutamine Hydrochloride Ph. Eur.
equivalent to 12.5
mg Dobutamine. Each 20 ml ampoule contains Dobutamine Hydrochloride
Ph. Eur.
equivalent to 250 mg Dobutamine.
EXCIPIENTS WITH KNOWN EFFECT:
4 mg sodium metabisulphite (E223) per 20 ml.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion (Sterile Concentrate).
Clear, colourless or almost colourless, sterile concentrate for
infusion following
dilution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Dobutamine is indicated for adults who require inotropic support in
the treatment of
low output cardiac failure associated with myocardial infarction, open
heart surgery,
cardiomyopathies, septic shock or cardiogenic shock.
Dobutamine can also be used for cardiac stress testing, in cases when
exercise stress
testing is not feasible.
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.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Method of administration
Dobutamine
Concentrate
should
be
diluted
before
use
and
administered
by
IV
infusion only.
The concentration of the dobutamine administered depends upon the
dosage and fluid
requirements of the individual patient. The final concentrations
generally used for
Page 2 of 17
perfusion are 250 micrograms/ml, 500 micrograms/ml or 1000
micrograms/ml. For
special precautions for storage of the prepared diluted infusion see
section 6.4. High
concentrations of dobutamine should only be given with an infusion
pump or other
suitable apparatus to ensure accurate dosage. Due to its short
half-life, dobutamine
should be administ