Posiject®

dobutamine hydrochloride

What you should know about
POSIJECT®
Sterile Concentrate

	

Please read this leaflet carefully before you start to take your medicine.  It contains a summary of the information available on your medicine.  The information in this leaflet applies to Posiject® only.  If after reading this you have any questions ask your doctor.

The name of your medicine is Posiject 50 mg/ml Sterile Concentrate.  Each ml contains 50 mg dobutamine hydrochloride as the active ingredient.  Posiject also contains the following inactive ingredients:

Ascorbic Acid BP

Water for Injections BP

Posiject Sterile Concentrate is available in packs of 5x5ml ampoules.

Posiject belongs to a group of medicines called cardiac stimulants which help strengthen the contraction of your heart muscles

The Product Licence and Product Authorisation for Posiject 50mg/ml Sterile Concentrate are held by:

Boehringer Ingelheim Limited
Ellesfield Avenue,
Bracknell,
Berkshire,
RG12 8YS.

and the product is manufactured by:

Leiras Oy,
Turku,
Finland

How Posiject helps you

Posiject helps to restore your heart’s  ability to pump blood around your body in heart failure associated with a heart attack, open heart surgery, disease of the heart muscle, septic shock and shock due to severe heart failure.  Posiject can also help your heart function if you require help in breathing from a machine

Posiject can also help test how your heart works under stress h you are unable to exercise.  Doctors will carry out this test in a unit where they normally perform exercise stress testing and taking the same level of care.

Before Receiving Your Medicine

Tell your doctor if:

•	You are pregnant or if you are likely to become pregnant.
	
•	You are sensitive to dobutamine hydrochloride, the active substance in Posiject.
	
•	You have any other problems with your heart.
	
•	You are taking any other medicines for your heart.

Your doctor will not use Posiject until any fall in the volume of blood in your circulation has been corrected.

Your doctor will closely monitor the response of your heart rate and rhythm and your blood pressure during administration of Posiject.

Depending on your response to treatment, the dose of Posiject may be increased, decreased or stopped, or you may be given other drugs in addition to Posiject.

How Your Medicine is Given

Adults and the elderly:

1.	Cardiac stimulant treatment

The doctor or nurse will dilute Posiject with a sterile sodium chloride or dextrose solution; they will then administer the diluted solution to you as an intravenous infusion through a needle or catheter inserted into one of your veins, carefully controlling the speed of the drip.

The usual dose is 2.5 to 10 micrograms/ kg/minute.  Your doctor may give you a lower or a higher dose than this

The doctor will decide how fast and for how long to give you Posiject depending on how your medical condition changes.  He will decrease the dose gradually at the end of treatment.

2.	Cardiac Stress Testing

When Posiject is used as an alternative to cardiac stress testing, the usual dose is an increase from 5 to 20 micrograms/ kg/min which is achieved by increasing the dose by 5 micrograms/kg/min every 8 minutes.  Your doctor will monitor your heart throughout the test; he may stop infusing Posiject if significant changes occur in the function of your heart or in your blood pressure, or if side effects occur.

Children:

The safety and effectiveness of Posiject for use in children has not been established .

After Receiving Your Medicine 

All medicines sometimes cause side effects

Posiject affects your heart and circulation: your doctor will monitor these effects.

Posiject can cause sickness, headache, anginal pain, chest pains, racing heart, shortness of breath and symptoms like an allergic reaction such as rash, fever, difficulty in breathing and an increase in the white cells in your blood.  Potassium levels in your blood can decrease.

The above side effects occur only rarely.

Inflammation which may include swelling, redness, itchiness or discomfort can occur at the site of injection.

If you experience any of these effects and they persist or become troublesome, tell your doctor.

If you experience any other effects not mentioned above, tell your doctor.

How Your Medicine is Stored

Posiject should be stored below 25ºC, protected from light.

Posiject must be diluted to at least 50ml with a sterile sodium chloride or dextrose intravenous infusion solution before administration.  Posiject should not be mixed with an alkaline solution or with any other intravenous preparation.  Posiject should not be used if any solid particles can be seen in the solution.  Any unused contents should be thrown away

The ampoules should not be used after the expiry date which will be found written on the packaging.

This leaflet was written in July 1994

	JAAKKO–TAARA OY