Dobutamine-Claris dobutamine (as hydrochloride) 250 mg/ 20 mL concentrated solution for injection ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

dobutamine hydrochloride, Quantity: 14.01 mg/mL (Equivalent: dobutamine, Qty 12.5 mg/mL)

Available from:

Baxter Healthcare Pty Ltd

Pharmaceutical form:

Injection, concentrated

Composition:

Excipient Ingredients: sodium metabisulfite; hydrochloric acid; sodium hydroxide; water for injections

Administration route:

Intravenous

Units in package:

20 mL per ampoule, 5 ampoules per pack

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Adults who require short-term treatment of cardiac failure secondary to acute myocardial infarction, or cardiac surgery.???

Product summary:

Visual Identification: Colourless to pale yellow solution; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2014-07-11

Patient Information leaflet

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

Summary of Product characteristics

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