Dobutamine 250mg/50ml solution for infusion vials

País: Regne Unit

Idioma: anglès

Font: MHRA (Medicines & Healthcare Products Regulatory Agency)

ingredients actius:

Dobutamine hydrochloride

Disponible des:

hameln pharma Ltd

Codi ATC:

C01CA07

Designació comuna internacional (DCI):

Dobutamine hydrochloride

Dosis:

5mg/1ml

formulario farmacéutico:

Solution for infusion

Vía de administración:

Intravenous

clase:

No Controlled Drug Status

tipo de receta:

Valid as a prescribable product

Resumen del producto:

BNF: 02070100; GTIN: 4260016650637

Informació per a l'usuari

WHAT IS IN THIS LEAFLET
1. What Dobutamine is and what it is used for
2. What you need to know before you use Dobutamine
3. How to use Dobutamine
4. Possible side effects
5. How to store Dobutamine
6. Contents of the pack and other information
1.
WHAT DOBUTAMINE IS AND WHAT IT IS USED FOR
Dobutamine
belongs
to
a
group
of
medicines
called
catecholamines. It helps your heart to work more effectively. It
works by strengthening the pumping action of the heart, increasing
the amount of blood flow in the body and by expanding your veins
and arteries.
DOBUTAMINE IS USED:
-
to treat heart failure (cardiac decompensation) if the heart is not
beating strongly enough (depressed contractility),
-
in heart failure where there is severe low blood pressure
(hypotension),
-
to detect poor blood supply to the heart (cardiac stress testing).
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.
2.
WHAT
YOU
NEED
TO
KNOW
BEFORE
YOU
USE
DOBUTAMINE
DO NOT USE DOBUTAMINE IF:
-
you are ALLERGIC (hypersensitive) to DOBUTAMINE or ANY OF
THE OTHER INGREDIENTS (see list of ingredients in section 6). An
allergic reaction may include rash, itching, difficulty in breathing
or swelling of the face, lips, throat or tongue. You may know this
from earlier experience.
-
there is A NARROWING IN YOUR HEART OR BLOOD VESSELS THAT
PREVENTS THE HEART FROM FILLING OR EJECTING BLOOD PROPERLY
(your doctor will know this).
-
there is a LACK OF ADEQUATE CIRCULATORY FILLING (hypovolaemia).
If you have certain heart or blood vessel disorders, Dobutamine
should not be used to detect poor blood supply to your heart.
WARNINGS AND PRECAUTIONS
Tell your doctor if you have any of the following conditions:
-
asthma and you have been told that you are allergic to sulfites,
-
severe coronary heart disease,
-
acute (sudden) heart f

Fitxa tècnica

OBJECT 1
DOBUTAMINE 5 MG/ML, SOLUTION FOR INFUSION
Summary of Product Characteristics Updated 18-Jan-2016 | hameln
pharmaceuticals ltd
1. Name of the medicinal product
Dobutamine 5 mg/ml solution for infusion
2. Qualitative and quantitative composition
Each ampoule/vial Dobutamine contains dobutamine hydrochloride
corresponding to 250 mg
dobutamine.
50 ml ampoule/vial
1 ml contains 5 mg dobutamine.
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for infusion
The product is a clear, colourless or almost colourless solution.
4. Clinical particulars
4.1 Therapeutic indications
Dobutamine is indicated for patients who require a positive inotropic
support in the treatment of cardiac
decompensation due to depressed contractility.
In cardiogenic shock characterised by heart failure with severe
hypotension and in case of septic shock
Dobutamine may be useful if added to dopamine in case of disturbed
ventricular function, raised filling
pressure of the ventricles and raised systemic resistance.
Dobutamine may also be used for detection of myocardial ischaemia and
of viable myocardium within the
scope of an echocardiographic examination (dobutamine stress
echocardiography), if patients cannot
undergo a period of exercise or if the exercise yields no information
of value.
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
DOBUTAMINE DOSES MUST BE INDIVIDUALLY ADJUSTED.
The required rate of infusion depends on the patient's response to
therapy and the adverse reactions
experienced.
Dosage in adults:
According to experience, the majority of patients respond to doses of
2.5-10 µg dobutamine/kg/min. In
individual cases, doses up to 40 µg dobutamine/kg/min have been
administered.
Dosage in paediatric patients: