Summary for ARTG Entry:
Dobutamine-Claris dobutamine (as hydrochloride) 250 mg/ 20 mL concentrated solution for injection
ARTG entry for
AFT Pharmaceuticals Pty Ltd
PO Box 748,North Ryde,Sydney, NSW, 1670
ARTG Start Date
Drug Safety Evaluation Branch
Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods
Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.
Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered
or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.
1. Dobutamine-Claris dobutamine (as hydrochloride) 250 mg/ 20 mL concentrated solution for injection
Single Medicine Product
See Product Information and Consumer Medicine Information for this product
Adults who require short-term treatment of cardiac failure secondary to acute myocardial infarction, or cardiac surgery.???
Additional Product information
Glass Type I Clear
Store below 25
Protect from Light
Pack Size/Poison information
20 mL per ampoule, 5 ampoules per pack
(S4) Prescription Only Medicine
1. Dobutamine-Claris dobutamine (as hydrochloride) 250 mg/ 20 mL concentrated solution for injection ampoule
Route of Administration
Colourless to pale yellow solution
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Dobutamine hydrochloride equivalent to dobutamine 250 mg/20 mL,
Concentrated Solution for Injection
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about Dobutamine-Claris. It does not contain all the
available information and does not take the place of talking with your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you being given
Dobutamine-Claris against the benefits they expect it will have for you.
If you have any concerns about being given this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine. You may need to read it again.
What Dobutamine-Claris is used for
This medicine contains dobutamine (as dobutamine hydrochloride) as the active ingredient. It
belongs to a group of medicines called catecholamines, which are a synthetic version of a naturally
occurring chemical, adrenaline.
Dobutamine-Claris is used to treat patients who need short-term treatment of heart failure following
a heart attack or heart surgery. It works by strengthening the pumping action of the heart,
increasing the amount of blood flowing to the body and by expanding both veins and arteries, so the
heart can more easily propel the blood. It helps your heart work more effectively.
Ask your doctor if you have any questions about why this medicine has been prescribed for you.
Your doctor may have prescribed it for another reason.
This medicine is only available with a doctor’s prescription. There is no evidence that it is addictive.
There is not enough safety and efficacy information available to recommend the use of Dobutamine-
Claris in children.
Before you are given it
When you must not be given it
You must not be given Dobutamine-Claris if you have ever had an allergic reaction to:
any medicine containing dobutamine hydrochloride
any of the ingredients listed at the end of this leaflet.
Some of the symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty
breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the
You must not be given this medicine if you have a condition called idiopathic hypertrophic sub
aortic stenosis (i.e. a narrowing of the artery coming from your heart).
Before you are given it
Tell your doctor if you are allergic to any other medicines, or any foods, preservative or dyes.
Tell your doctor if you have or have had any of the following conditions:
hypokalaemia (i.e. low potassium levels)
high blood pressure
fast or irregular heart beat
other heart problems.
Tell your doctor if you are pregnant or intend to become pregnant or are breast-feeding. Your
doctor can discuss with you the risks and benefits involved.
If you have not told your doctor about any of the above, tell them before you start being given
Taking other medicines
Tell your doctor if you are taking any other medicines, including any that you get from your
pharmacy, supermarket or health food shop.
Some medicines may interfere with Dobutamine-Claris. These include:
some general anaesthetics, such as halothane
nitroprusside and nitroglycerin
other adrenergic agents (adrenaline-like agents).
These medicines may be affected by Dobutamine-Claris or may affect how well it works. You may
need different amounts of your medicines or you may need to take different medicines. Your doctor
or pharmacist have more information on medicines to be careful with or avoid while having this
How it is given
Dobutamine-Claris is a sterile concentrated solution for injection which is diluted with suitable
sterile fluids prior to use. It is given as a slow injection into a vein, known as a continuous infusion or
a ‘drip’. Your doctor or nurse will prepare the infusion of Dobutamine-Claris for you.
How much to be given
Your doctor will decide the dose of Dobutamine-Claris you will be given and will adjust the flow rate
and duration accordingly.
If you are given too much (overdose)
As you will be given Dobutamine-Claris under the supervision of your doctor, it is unlikely that you
will receive too much.
However, if you experience any side effects after being given Dobutamine-Claris, immediately tell
your doctor or nurse or call the Poisons Information Centre (telephone 13 11 26 Australia, 0800 764
766 New Zealand) for advice. Do this even if there are no signs of discomfort or poisoning. You may
need urgent medical attention.
Symptoms of overdose may include loss of appetite, nausea, vomiting, tremor, anxiety, fast or
irregular heartbeats, headache, shortness of breath and chest pain.
While you are using it
Things you must do
Tell any other doctors, dentists and pharmacists who are treating you that you are having
Dobutamine-Claris, especially if you are being started on any new medicines.
Tell your surgeon or anaesthetist if you are having Dobutamine-Claris if you are about to undergo
surgery or an operation. It may affect other medications used during surgery.
If you are about to have any blood tests tell your doctor that you are having Dobutamine-Claris. It
may interfere with the results of some tests.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are having
Dobutamine-Claris. This medicine helps most people with heart failure but it may have unwanted
side effects in a few people.
All medicines can have side effects. Sometimes they are serious, most of the time they are not. You
may need medical attention if you get some of the side effects.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor or nurse if you notice any of the following side effects and they worry you:
These side effects are usually mild.
Tell your doctor or nurse as soon as possible if you notice any of the following:
pain where the needle went into your vein or pain along the vein following injection
fast or irregular heartbeat
non-specific chest pain
difficulty in breathing, wheezing or coughing
redness or itching of the skin
bleeding or bruising more easily than normal
The above list includes serious side effects which may require medical attention. These side effects
Do not be alarmed by this list of side effects. You may not experience any of them.
Other side effects not listed above may also occur in some people. Tell your doctor or pharmacist if
you notice anything that is making you feel unwell.
Dobutamine-Claris will be stored in the pharmacy or on the ward. The solution for injection should
be kept in a cool place, protected from light where the temperature stays below 25
What it looks like
Dobutamine-Claris is a clear, colourless or slightly yellow solution.
Active ingredient: dobutamine hydrochloride
Other ingredients: sodium metabisulphite, sodium hydroxide and/or hydrochloric acid for pH
adjustment, water for injections
does not contain lactose, sucrose, gluten, tartrazine or any other azo dyes.
AFT Pharmaceuticals Pty. Ltd
113 Wicks Road
AFT Pharmaceuticals Ltd
Australian Registration Number:
AUST R 212837
Date of Preparation
15 October 2015