Dopamine 40mg/ml Sterile Concentrate

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

DOPAMINE HYDROCHLORIDE

Available from:

Hospira UK Limited

ATC code:

C01CA04

INN (International Name):

DOPAMINE HYDROCHLORIDE

Pharmaceutical form:

CONCENTRATE FOR SOLUTION FOR INFUSION

Composition:

DOPAMINE HYDROCHLORIDE 40 mg/ml

Prescription type:

POM

Therapeutic area:

CARDIAC THERAPY

Authorization status:

Authorised

Authorization date:

2006-12-28

Patient Information leaflet

H03121
PACKAGE LEAFLET:
INFORMATION FOR THE USER
DOPAMINE 40 MG/ML
STERILE CONCENTRATE
READ ALL OF THIS LEAFLET CAREFULLY
BEFORE
YOU
START
USING
THIS
MEDICINE.
• Keep this leaflet. You may need to
read it again.
• If you have any further questions,
ask your doctor.
• If any of the side effects gets
serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor.
IN THIS LEAFLET:
1. What Dopamine Sterile Concentrate is
and what it is used for
2. Before Dopamine Sterile Concentrate
is used
3. How Dopamine Sterile Concentrate is
used
4. Possible side effects
5. How Dopamine Sterile Concentrate is
stored
6. Further information
1. WHAT DOPAMINE STERILE
CONCENTRATE IS AND WHAT IT IS
USED FOR
Dopamine is a medicine that stimulates
the heart and has effects on the blood
vessels.
DOPAMINE STERILE CONCENTRATE CAN
BE USED:
• to treat low blood pressure or shock
(reduction of blood flow through the
body tissues) after a heart attack,
blood poisoning, trauma (injury) or
kidney failure
• in combination with other treatments
where low blood pressure occurs after
open heart surgery
• in congestive heart failure (heart failure
due to a build up of fluid/blood)
2. BEFORE DOPAMINE STERILE
CONCENTRATE IS USED
DOPAMINE STERILE CONCENTRATE
SHOULD NOT BE USED
• if you have a tumour that causes an
increase in blood pressure
• if you have an overactive thyroid gland
• if you have irregular or rapid heartbeats
• i f
y o u
h a v e
s h o w n
s i g n s
o f
hypersensitivity (severe allergy) to
dopamine or sodium metabisulphite in
the past
If possible, tell your doctor if any of the
above applies to you before this medicine
is used.
SPECIAL CARE NEEDS TO BE TAKEN WITH
DOPAMINE STERILE CONCENTRATE
• if you have diabetes
• if you have kidney or liver problems
• if you have a history of blood circulation
problems (you will be monitored for
any changes in colour or temperature
of your fingers or toes)
If possible, tell your doctor if any of the
above applies to you before this medicine
is us

Summary of Product characteristics

Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Dopamine 40 mg/ml Sterile Concentrate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of concentrate contains 40 mg dopamine hydrochloride
Each 5 ml ampoule of concentrate contains 200 mg dopamine
hydrochloride
For excipients, see 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion
Ampoules containing a clear colourless or pale yellow solution
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Dopamine is indicated for the correction of haemodynamic imbalance
present in:
1)
Acute
hypotension
or
shock
associated
with
myocardial
infarction,
endotoxic
septicaemia, trauma and renal failure.
2)
As an adjunct after open heart surgery where there is persistent
hypotension after
correction of hypovolaemia.
3)
In chronic cardiac decompensation as in congestive failure.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
To be administered by intravenous infusion only after dilution with
the appropriate diluents.
A suitable metering device is required in the infusion system to
control the rate of flow, and this
should be adjusted to the optimum patient response and monitored
constantly in the light of the
individual patient’s response.
ADULTS
Where appropriate, the circulating blood volume must be restored with
a suitable plasma
expander or whole blood, prior to administration of dopamine
hydrochloride.
Begin infusion of dopamine hydrochloride solution at doses of 2.5
microgram/kg/min in
patients who are likely to respond to modest increments of heart force
and renal perfusion.
In more severe cases, administration may be initiated at a rate of 5
microgram/kg/min and
increased gradually in 5- to 10 microgram/kg/min increments up to 20
to 50 microgram/kg/min
as needed. If doses in excess of 50 microgram/kg/min are required, it
is advisable to check
urine output frequently.
Page 2 of 8
Should urinary flow begin to decrease in the absence of hypotension,
reduction of dopamine
dosage should be considered. It has been found that more tha