PDFLARGE FONT PDF

Dobutamine-Claris

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 skin.

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 Dobutamine-Claris.

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 medicine.

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.

Side effects

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:

  • nausea
  • fever
  • headache.

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
  • feeling faint.

The above list includes serious side effects which may require medical attention. These side effects are rare.

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.

Storage

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 °C.

Product description

What it looks like

Dobutamine-Claris is a clear, colourless or slightly yellow solution.

Ingredients

Active ingredient: dobutamine hydrochloride

Other ingredients: sodium metabisulphite, sodium hydroxide and/or hydrochloric acid for pH adjustment, water for injections

Dobutamine-Claris does not contain lactose, sucrose, gluten, tartrazine or any other azo dyes.

Sponsor

Australia

AFT Pharmaceuticals Pty. Ltd
113 Wicks Road
North Ryde
NSW 2113

New Zealand

AFT Pharmaceuticals Ltd
Auckland

Australian Registration Number:

AUST R 212837

Date of Preparation

15 October 2015

Published by MIMS August 2017

Consumers should be aware that the information provided by the Consumer Medicines Information (CMI) search (CMI Search) is for information purposes only and consumers should continue to obtain professional advice from a qualified healthcare professional regarding any condition for which they have searched for CMI. CMIs are provided by MIMS Australia. CMI is supplied by the relevant pharmaceutical company for each consumer medical product. All copyright and responsibility for CMI is that of the relevant pharmaceutical company. MIMS Australia uses its best endeavours to ensure that at the time of publishing, as indicated on the publishing date for each resource (e.g. Published by MIMS/myDr January 2007), the CMI provided was complete to the best of MIMS Australia's knowledge. The CMI and the CMI Search are not intended to be used by consumers to diagnose, treat, cure or prevent any disease or for any therapeutic purpose. Dr Me Pty Limited, its servants and agents shall not be responsible for the continued currency of the CMI, or for any errors, omissions or inaccuracies in the CMI and/or the CMI Search whether arising from negligence or otherwise or from any other consequence arising there from.