Dobutamine 12.5mg/ml Concentrate for solution for infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Dobutamine

Available from:

Baxter Holding B.V.

ATC code:

C01CA; C01CA07

INN (International Name):

Dobutamine

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:

Adrenergic and dopaminergic agents; dobutamine

Authorization status:

Marketed

Authorization date:

2011-07-22

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
DOBUTAMINE 12.5 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
Dobutamine
(for high blood pressure or enlarged prostate gland)
•
Theophylline (a treatment for asthma)
It may still be all right for you to be given Dobutamine and your
doctor will be able to decide what is suitable for you.
Increments in heart rate and blood pressure appear to be more frequent
and intense in children than in adults. The new-born baby
cardiovascular system has been reported to be less sensitive to
dobutamine and hypotensive effect (low blood pressure) seems to be
more often observed in adult patients than in small children.
PREGNANCY AND BREAST-FEEDING
You will not be given Dobutamine if you are pregnant or breast-feeding
unless your doctor thinks it is necessary.
Dobutamine have no effect on your ability to drive or use machinery.
•
Beta-adrenergic blockers such as propranolol or metoprolol
•
Dipyridamole (a blood thinner)
OTHER MEDICINES AND DOBUTAMINE
•
Alpha-adrenergic blockers
•
General anaesthetics
•
Peripheral vasodilators (e.g. nitrates, sodium nitroprusside)
Children
Accordingly, the use of dobutamine in children should be monitored
closely.
DRIVING AND USING MACHINES
•
A tumour of the adrenal gland
•
Asthma
The medicinal product contains less than 1 mmol sodium (23 mg) per
dose, i.e. essentially ‘sodium- free’.
Dobutamine contains sodium metabisulphite, which may rarely cause
severe hypersensitivity reactions and bronchospasm.
3. HOW YOU WILL BE GIVEN DOBUTAMINE
You will be given Dobutamine in hospital by a doctor or nurse.
Dobutamine is diluted and infused into a vein.
•
Hyperthyroidism (over-active thyroid)
•
Severe hypotension (low blood pressure)
•
Oxytocin (used in labour)
•
Atropine sulphate (for inflammation of
(Reduction in serum potassium concentration and hypokalaemia)
•
Hypovolaemia (dehydration)
•
ACE-inhibitors, e.g. captopril (for high blood pressure or heart
failure)
•
Entacapone (a treatment for Parkinson's
disease)
•
A condition in w

Summary of Product characteristics

Health Products Regulatory Authority
23 November 2018
CRN008KGN
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 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 normallyassociated 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.
Health Products Regulatory Authority
23 November 2018
CRN008KGN
Page 2 of 17
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 give