Wednesday 8 August 2012

Dobutamine Concentrate 250 mg / 20 ml.






Dobutamine Concentrate




Important information about your medicine


  • Your doctor or nurse will give you the injection

  • If this injection causes you any problems talk to your doctor, nurse or pharmacist

  • Please tell your doctor or pharmacist, if you have any other medical conditions or have an allergy to any of the ingredients of this medicine

  • Please tell your doctor or pharmacist, if you are taking any other medicines


  • Read all of this leaflet carefully before you start using this medicine. In some circumstances this may not be possible and this leaflet will be kept in a safe place should you wish to read it.


  • Keep this leaflet. You may need to read it again

  • If you have any further questions, please ask your doctor or your pharmacist.

  • This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.




Where to find information in this leaflet


  • 1. What Dobutamine Concentrate is and what it is used for

  • 2. Before you are given Dobutamine Concentrate

  • 3. How to use Dobutamine Concentrate

  • 4. Possible side effects

  • 5. Storing Dobutamine Concentrate

  • 6. Further information




What Dobutamine Concentrate is and what it is used for


Dobutamine Concentrate belongs to a group of medicines known as inotropes, which make your heart beat more strongly. It is used:


  • in open heart surgery

  • to treat heart disease

  • to treat heart failure

  • in shock

  • as an alternative to exercise for stress testing the heart.



Before you are given Dobutamine Concentrate



You should NOT be given Dobutamine Concentrate if you:


  • Are sensitive or allergic to Dobutamine Concentrate, sodium metabisulphite or any of the other ingredients in this injection.

  • suffer from high blood pressure due to a tumour near the kidney (Phaeocromocytoma).



Please tell your doctor or nurse before being given the injection if you:


  • have recently had a heart attack

  • are asthmatic

  • have unstable angina

  • have heart disease

  • have high blood pressure

  • have any condition that would make exercise dangerous for you.



Using other medicines:


Please tell your doctor or nurse if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This is especially important with the following medicines as they may interact with your Dobutamine Concentrate:



  • beta blockers (medicines used to relieve certain heart conditions, anxiety and migraine).


  • anaesthetics.


  • entacapone (a medicine to treat Parkinson’s Disease).



Pregnancy or breast feeding:


Please tell your doctor or nurse before being given this injection if you are pregnant or breast feeding. The doctor will then decide if the injection is suitable for you.




Driving and using machines:


You should not drive or use machinery if you are affected by the administration of Dobutamine Concentrate.





How to use Dobutamine Concentrate



Your nurse or doctor will give you the injection.


Your doctor will decide the correct dosage for you and how and when the injection will be given. Dobutamine Concentrate is not normally given to children.


Since the injection will be given to you by a doctor or nurse, it is unlikely that you will be given too much. If you think you have been given too much, feel sick, are sick, feel anxious, feel palpitations, have a headache, feel short of breath or have chest pain you must tell the person giving you the injection.




Possible side effects


Like all medicines, Dobutamine Concentrate can cause side effects, although not everybody gets them.


Intravenous infusions may cause inflammation of the vein and damage to the skin at the injection site. The surrounding skin may feel warm and tender and redness may be present.


Death due to rupture of the heart muscle has occurred very rarely after giving dobutamine to assess the response of the heart to stress in patients with a recent heart attack. Your doctor will examine your heart before giving you Dobutamine
Concentrate to decide if you are suitable to receive the drug.



The following side-effects have been reported:


  • Hypersensitivity reactions involving rash and difficulty breathing including life threatening asthmatic episodes

  • Changes in the levels of certain chemicals in the blood.

  • Increased heart rate, palpitations, chest pain and changes to the rhythm of your heart.

  • Changes to your blood pressure including both an increase and a decrease.

  • difficulty in breathing (your breathing may stop)


  • asthma


  • headache


  • nausea (feeling sick)

  • Sudden, involuntary twitching of a muscle or group of muscles.


If you think this injection is causing you any problems, or you are at all worried, talk to your doctor, nurse or pharmacist.




Storing Dobutamine Concentrate


Your injection will be stored at less than 21°C and protected from light. The nurse or doctor will check that the injection is not past its expiry date before giving you the injection.




Further information



What Dobutamine Concentrate contains:


This injection contains the active ingredient dobutamine hydrochloride. Each 1 ml contains dobutamine hydrochloride equivalent to 12.5 mg dobutamine in a sterile solution for injection.


This injection contains the following inactive ingredients: sodium metabisulphite, sodium hydroxide, hydrochloric acid, sterile water for injections and carbon dioxide.




What Dobutamine Concentrate looks like and contents of the pack:


Dobutamine Concentrate is supplied in 20 ml clear glass ampoules, in cartons containing one, five or ten ampoules. Not all sizes may be marketed.


The marketing authorisation number of this medicine is: PL 01502/0054




Marketing Authorisation Holder:



hameln pharmaceuticals ltd

Gloucester

United Kingdom




Manufacturer:



hameln pharmaceuticals gmbh

Langes Feld 13

31789 Hameln

Germany





For any information about this medicine, please contact the Marketing Authorisation Holder


This leaflet was last approved 12.08.2008


43821/20/09





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