DOBUTAMINE 12.5 Mg/Ml Concentrate for Soln for Inf

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

DOBUTAMINE HYDROCHLORIDE

Available from:

Claris Lifesciences (UK) Limited

ATC code:

C01CA07

INN (International Name):

DOBUTAMINE HYDROCHLORIDE

Dosage:

12.5 Mg/Ml

Pharmaceutical form:

Concentrate for Soln for Inf

Prescription type:

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

Therapeutic area:

Adrenergic and dopaminergic agents

Authorization status:

Authorised

Authorization date:

2011-07-22

Patient Information leaflet

The name of your medicine is Dobutamine 12.5 mg/ml Concentrate for
solution for infusion, which will be referred to as Dobutamine
throughout this
leaflet.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if their sign of illness are the same
as yours.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. See
section 4.
WHAT IS IN THIS LEAFLET
1.
What Dobutamine is and what it is used for
4.
Possible side effects
2.
What you need to know before you use Dobutamine
5.
How to store Dobutamine
3.
How you will be given Dobutamine
6.
Contents of the pack and other information
1. WHAT DOBUTAMINE IS AND WHAT IT IS USED FOR
Dobutamine contains the active ingredient dobutamine, which belongs to
a group of medicines called beta receptor agonists (heart stimulants).
Dobutamine is used to stimulate the heart in adults who have heart
failure caused by a heart attack, open-heart surgery and heart
disease.
Dobutamine can also be used to for testing the heart when exercise
testing is not possible.
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
YOU SHOULD NOT BE GIVEN DOBUTAMINE IF:
•
You are allergic (hypersensitive) or might be allergic to dobutamine,
•
You have an obstruction that interferes with blood flow out of your
sodium metabisulphite, sulphites, or any of the other ingredients of
heart (your doctor will know this)
Dobutamine (see list of ingredi

Summary of Product characteristics

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 contains 12.5 mg of dobutamine (as 14.01 mg dobutamine
hydrochloride).
Each 20 ml ampoule contains 250 mg of dobutamine (as 280.2 mg
dobutamine hydrochloride).
Excipient(s) with known effect:
Each 1 ml contains 0.15 mg of Sodium metabisulphite.
Each 20 ml contains 3.0 mg of Sodium metabisulphite.
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Concentrate for solution for infusion
Clear, colourless or slightly yellow solution.
pH between 2.50 and 4.00
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Dobutamine is indicated for adults who require positive inotropic
support in the treatment of low output cardiac failure
normally associated with myocardial infarction, open-heart surgery,
cardiomyopathies, septic shock and 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 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
administered as a continuo