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DOPAMINE 40 MG/ML STERILE CONCENTRATE

Active substance(s): DOPAMINE HYDROCHLORIDE

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Transcript
If possible, tell your doctor if any of the
above applies to you before this medicine
is used.

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

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 used.

Taking/using other medicines
Special care is needed if you are taking/
using other medicines as some could
interact with dopamine, for example:
• anaesthetics (dopamine should
not be used with cyclopropane
and halogenated hydrocarbon
anaesthetics)
• alpha- and beta-blockers, e.g.
propranolol (medicines which are often
used for treating blood pressure and
heart disorders)
• monoamine oxidase inhibitors (antidepressant medicines)
• phenytoin (a medicine used to treat
epilepsy)
If possible, please tell your doctor if you
are taking or have recently taken any
other medicines, including medicines
obtained without a prescription.

Pregnancy and breast-feeding
Tell your doctor if you are pregnant, trying
to become pregnant or breast-feeding.
Your doctor will only use this medicine
if the expected benefits outweigh any
potential risk to your baby.
Ask your doctor or pharmacist for advice
before taking any medicine.

Driving and using machines
Do not drive or use machines if you
experience any side effect (e.g. dizziness
or difficulty seeing in bright light) which
may lessen your ability to do so.

Important information about some
of the ingredients of Dopamine
Sterile Concentrate
This medicinal product contains sodium
metabisulphite which, rarely, may cause
severe hypersensitivity (severe allergy)
reactions and bronchospasm (breathing
difficulties).
This medicinal product contains less than
1 mmol (23 mg) sodium per ampoule, i.e.
essentially ‘sodium free’.

3. HOW DOPAMINE STERILE
CONCENTRATE IS USED
This medicine will be diluted before it
is given to you. It will be given as an
infusion (drip) into a vein.

Dose
If your blood volume is low, you may be
given a transfusion of blood or a plasma
expander before dopamine is given.

Dopamine 40 mg/ml Sterile Concentrate
The following information is intended for medical or healthcare professionals only
Further to the information included in section 3, practical information on the preparation/
handling of the medicinal product is provided here.

Incompatibilities
Dopamine Sterile Concentrate should not be added to any alkaline intravenous solutions, i.e.
sodium bicarbonate. Any solution which exhibits physical or chemical incompatibility through
a colour change or precipitate should not be administered.
It is suggested that admixtures containing gentamicin sulphate, cephalothin sodium,
cephalothin sodium neutral or oxacillin sodium should be avoided unless all other viable
alternatives have been exhausted.
Admixtures of ampicillin and dopamine in 5% glucose solution are alkaline and incompatible
and result in decomposition of both drugs. They should not be admixed.
Admixtures of dopamine, amphotericin B in 5% glucose solution are incompatible as a
precipitate forms immediately on mixing.

Instructions for use and handling
For single use
Discard any unused contents
Do not use if the solution is discoloured

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Your doctor will work out the correct
dose of dopamine for you and how often
it must be given. The dose will depend
upon your medical condition and your
size.
The rate of administration will be carefully
controlled and adjusted according to
your response. During treatment your
heart rate, blood pressure and urine
output will be measured to check how
you are responding.

If you are given too much or too little
Dopamine Sterile Concentrate
This medicine will be given to you in
a hospital, under the supervision of a
doctor. It is unlikely that you will be given
too much or too little, however, tell your
doctor or nurse if you have any concerns.

4. POSSIBLE SIDE EFFECTS
Like all medicines, dopamine can cause
side effects, although not everybody gets
them.

If any of the following happen, tell
your doctor immediately:
• severe allergic reaction - you may
experience a sudden itchy rash (hives),
swelling of the hands, feet, ankles,
face, lips, mouth or throat (which
may cause difficulty in swallowing or
breathing), and you may feel you are
going to faint
• pain or poor circulation in your fingers
or toes (you may notice a change in
skin colour)
• pain or swelling at the injection site
during or immediately after the injection
• severe palpitations
These are serious side effects. You may
need urgent medical attention.

If any of the following happen, tell
your doctor as soon as possible:









irregular, rapid or slow heart beats
chest pain
shortness of breath
low blood pressure (you may feel dizzy
or faint, particularly when standing up
or getting out of bed)
feeling or being sick
headache
dilation of the pupil of the eye
(mydriasis) which may cause difficulty
seeing in bright light
goose pimples

Dopamine may lead to changes in your
blood chemistry. Your doctor may take
blood samples to monitor for these.

Reporting of side effects
If you get any side effects, talk to your
doctor or pharmacist or nurse. This
includes any possible side effects not
listed in this leaflet.

You can also report side effects directly
via
United Kingdom
Yellow Card Scheme
Website:
http://www.mhra.gov.uk/yellowcard
By reporting side effects you can help
provide more information on the safety
of this medicine.

5. HOW DOPAMINE STERILE
CONCENTRATE IS STORED
Keep out of the reach and sight of
children

Expiry
This medicine must not be used after
the expiry date which is stated on the
ampoule and carton after ‘EXP’. Where
only a month and year is stated, the
expiry date refers to the last day of that
month.

Storage
The ampoules should be kept in the
outer carton, in order to protect from
light, and stored at, or below, 30°C.
Prepared infusions should be used
immediately, however, if this is not
possible they can be stored for up to
48 hours provided they have been
prepared in a way to exclude microbial
contamination.

Visible signs of deterioration
Only clear, colourless or pale yellow
solutions should be used. Opaque,
cloudy or discoloured solutions should
be discarded.

6. FURTHER INFORMATION
What Dopamine Sterile Concentrate
contains
The active substance is dopamine
hydrochloride. Each millilitre (ml) of
concentrate contains 40 milligrams (mg)
of dopamine hydrochloride.
The other ingredients are sodium
metabisulphite and Water for Injections.
See section 2 for further information
about sodium metabisulphite.

What Dopamine Sterile Concentrate
looks like and contents of the pack
Dopamine Sterile Concentrate is a clear,
colourless or pale yellow concentrate
for solution for infusion which comes in
glass containers called ampoules.
It may be supplied in packs containing:
• 5 x 200 mg/5 ml ampoules
• 50 x 200 mg/5 ml ampoules
Not all packs may be marketed.

Marketing authorisation holder and
manufacturer
Hospira UK Limited, Horizon, Honey
Lane, Hurley, Maidenhead, SL6 6RJ, UK
This leaflet was last revised in 09/2015

Preparation of infusion solutions
Suggested dilution
Aseptically transfer Dopamine Sterile Concentrate into the IV solution as shown in the
following table:
Strength of
Concentrate

Volume of
concentrate
(ml)

IV Solution
Volume
(ml)

Final Concentration
(microgram/ml)

200 mg/5 ml

5

500

400

200 mg/5 ml

5

250

800

200 mg/5 ml

10

250

1600

200 mg/5 ml

20

500

1600

Dopamine hydrochloride can be diluted with:
• Sodium chloride (0.9%) solution
• Dextrose (5%), sodium chloride (0.45%) solution
• Sodium Lactate Intravenous Infusion, Compound (Hartmann’s Solution for Injection)

In use storage precautions
Following dilution in the recommended diluents chemical and physical in-use stability has
been demonstrated for 48 hours at a temperature not above 25°C.
However, from a microbiological point of view, the product should be used immediately. If not
used immediately, in-use storage times and conditions prior to use are the responsibility of
the user and would normally not be longer than 24 hours at 2-8°C unless dilution has taken
place in controlled and validated aseptic conditions.
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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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