STERILE DOBUTAMINE HYDROCHLORIDE CONCENTRATE

Quốc gia: Ai-len

Ngôn ngữ: Tiếng Anh

Nguồn: HPRA (Health Products Regulatory Authority)

Thành phần hoạt chất:

DOBUTAMINE HYDROCHLORIDE

Sẵn có từ:

Hospira UK Limited

Mã ATC:

C01CA07

INN (Tên quốc tế):

DOBUTAMINE HYDROCHLORIDE

Liều dùng:

12.5 Mg/Ml

Dạng dược phẩm:

Concentrate for Soln for Inf

Loại thuốc theo toa:

Product subject to prescription which may not be renewed (A)

Khu trị liệu:

dobutamine

Tình trạng ủy quyền:

Not Marketed

Ngày ủy quyền:

1996-01-03

Tờ rơi thông tin

PATIENT INFORMATION LEAFLET
DOBUTAMINE 12.5 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor.
•
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them,
even if their symptoms are the same as yours.
•
If any of the side effects becomes serious, or if you notice any side
effects not listed in
this leaflet, please tell your doctor.
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.
Further information
1. WHAT DOBUTAMINE IS AND WHAT IT IS USED FOR
Dobutamine is a medicine which can help the pumping action of your
heart.
It is a concentrated solution which is diluted to make a solution
which can be given as a slow
injection via a drip.
Dobutamine is used to treat heart failure associated with:
•
Heart disease
•
Heart attack
•
Open heart surgery
•
Weakened or abnormal heart muscle
•
Low blood pressure after serious blood infections
•
Low blood pressure due to a failing heart
Dobutamine may also be used to help your heart work if you are on a
ventilator.
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 know you are hypersensitive (allergic) to dobutamine or
sulphites
•
if you have an obstruction which is preventing blood flow into, or out
of the heart
•
if you have a very low blood volume
•
if you suffer from chronic heart failure
TAKE SPECIAL CARE
You should speak to your doctor:
•
if you are pregnant
•
if you are bre

Đặc tính sản phẩm

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dobutamine 12.5 mg/ml Concentrate for Solution for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml contains 12.5 mg of dobutamine (as dobutamine
hydrochloride).
Each 20 ml presentation contains 250 mg of dobutamine (as dobutamine
hydrochloride).
For excipients see 6.1.
3 PHARMACEUTICAL FORM
Concentrate for solution for infusion
Clear, colourless or slightly yellow solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Dobutamine hydrochloride is a sympathomimetic agent, which acts by
stimulating the beta-1 adrenergic receptors of
the heart promoting a prominent inotropic action on the heart,
increasing cardiac contractility and stroke volume. It is a
direct acting agent.
Dobutamine is indicated for adults who require inotropic support in
the treatment of low output cardiac failure
associated with organic heart disease, myocardial infarction, open
heart surgery, cardiomyopathies, septic shock and
cardiogenic shock. Dobutamine can increase or maintain cardiac output
during positive end expiratory pressure (PEEP)
ventilation.
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 should be diluted before use and administered by IV
infusion only.
ADMINISTRATION
The concentration of dobutamine administered depends upon the dosage
and fluid requirements of the individual
patient.
Concentrations of 5000 micrograms/ml have been used in fluid
restricted patients but this concentration should
not be exceeded.
High concentrations of dobutamine should only be given with an
infusion pump to ensure accurate
dosage.
Due to its short half-life dobutamine should be administered as a
continuous intravenous infusion.
Dobutamine should be administered intravenously through an in