Dobutamine 12.5mg/ml Concentrate for Solution for Infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

DOBUTAMINE HYDROCHLORIDE

Available from:

Mercury Pharmaceuticals (Ireland) Ltd

ATC code:

C01CA07

INN (International Name):

DOBUTAMINE HYDROCHLORIDE

Dosage:

12.5 milligram(s)/millilitre

Pharmaceutical form:

Concentrate for solution for infusion

Prescription type:

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

Therapeutic area:

dobutamine

Authorization status:

Marketed

Authorization date:

1996-01-03

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DOBUTAMINE 12.5MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
Dobutamine Hydrochloride
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 nurse.
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor or nurse. This
includes any possible side
effects not listed in this leaflet. See section 4.
The name of your medicine is Dobutamine 12.5mg/ml Concentrate for
Solution for Infusion,
it will be referred to as Dobutamine Concentrate throughout the
leaflet for ease here after.
WHAT IS IN THIS LEAFLET:
1. What Dobutamine Concentrate is and what it is used for
2. What you need to know before you are given Dobutamine Concentrate
3. How you will be given Dobutamine Concentrate
4. Possible side effects
5. How to store Dobutamine Concentrate
6. Contents of the pack and other informationNCENTR1.
WHAT DOBUTAMINE CONCENTRATE IS AND WHAT IT IS USED FORATE IS A
1. WHAT DOBUTAMINE CONCENTRATE IS AND WHAT IT IS USED FOR
Dobutamine belongs to a group of medicines known as inotropic drugs,
which support your
heart to beat strongly in conditions where it is not able to pump
adequate blood.
It is used in the treatment of heart failure associated with
• a heart attack
• open heart surgery
• heart muscle disease of unknown cause (cardiomyopathies)
• shock due to heart disease (septic shock or cardiogenic shock)
• as an alternative to exercise for stress testing the heart.
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

Summary of Product characteristics

Health Products Regulatory Authority
15 March 2022
CRN00CTKW
Page 1 of 12
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
Posology
_Adults._
Inotropic support of the myocardium:
The usual dose is 2.5 to 10 micrograms/kg/min, which should be
adjusted according to the patient's heart rate, blood pressure,
cardiac output and urine output. The infusion must be started at a
rate of 2.5 micrograms/kg/min and the dose may be
increased in intervals of 10-30 minutes until desired hemodynamic
response is achieved or until side effects, such as excessive
tachycardia, arrhythmia, headache or tremor limit a further increase
in dosage. The dose should be adjusted individually
according to heart rate and rhythm, bl