Țară: Regatul Unit
Limbă: engleză
Sursă: MHRA (Medicines & Healthcare Products Regulatory Agency)
Dobutamine hydrochloride
hameln pharma Ltd
C01CA07
Dobutamine hydrochloride
5mg/1ml
Solution for infusion
Intravenous
No Controlled Drug Status
Valid as a prescribable product
BNF: 02070100; GTIN: 4260016650637
WHAT IS IN THIS LEAFLET 1. What Dobutamine is and what it is used for 2. What you need to know before you use Dobutamine 3. How to use Dobutamine 4. Possible side effects 5. How to store Dobutamine 6. Contents of the pack and other information 1. WHAT DOBUTAMINE IS AND WHAT IT IS USED FOR Dobutamine belongs to a group of medicines called catecholamines. It helps your heart to work more effectively. It works by strengthening the pumping action of the heart, increasing the amount of blood flow in the body and by expanding your veins and arteries. DOBUTAMINE IS USED: - to treat heart failure (cardiac decompensation) if the heart is not beating strongly enough (depressed contractility), - in heart failure where there is severe low blood pressure (hypotension), - to detect poor blood supply to the heart (cardiac stress testing). Paediatric population Dobutamine is indicated in all paediatric age groups (from neonates to 18 years of age) as inotropic support in low cardiac output hypoperfusion states resulting from decompensated heart failure, following cardiac surgery, cardiomyopathies and in cardiogenic or septic shock. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE DOBUTAMINE DO NOT USE DOBUTAMINE IF: - you are ALLERGIC (hypersensitive) to DOBUTAMINE or ANY OF THE OTHER INGREDIENTS (see list of ingredients in section 6). An allergic reaction may include rash, itching, difficulty in breathing or swelling of the face, lips, throat or tongue. You may know this from earlier experience. - there is A NARROWING IN YOUR HEART OR BLOOD VESSELS THAT PREVENTS THE HEART FROM FILLING OR EJECTING BLOOD PROPERLY (your doctor will know this). - there is a LACK OF ADEQUATE CIRCULATORY FILLING (hypovolaemia). If you have certain heart or blood vessel disorders, Dobutamine should not be used to detect poor blood supply to your heart. WARNINGS AND PRECAUTIONS Tell your doctor if you have any of the following conditions: - asthma and you have been told that you are allergic to sulfites, - severe coronary heart disease, - acute (sudden) heart f Citiți documentul complet
OBJECT 1 DOBUTAMINE 5 MG/ML, SOLUTION FOR INFUSION Summary of Product Characteristics Updated 18-Jan-2016 | hameln pharmaceuticals ltd 1. Name of the medicinal product Dobutamine 5 mg/ml solution for infusion 2. Qualitative and quantitative composition Each ampoule/vial Dobutamine contains dobutamine hydrochloride corresponding to 250 mg dobutamine. 50 ml ampoule/vial 1 ml contains 5 mg dobutamine. For a full list of excipients, see section 6.1. 3. Pharmaceutical form Solution for infusion The product is a clear, colourless or almost colourless solution. 4. Clinical particulars 4.1 Therapeutic indications Dobutamine is indicated for patients who require a positive inotropic support in the treatment of cardiac decompensation due to depressed contractility. In cardiogenic shock characterised by heart failure with severe hypotension and in case of septic shock Dobutamine may be useful if added to dopamine in case of disturbed ventricular function, raised filling pressure of the ventricles and raised systemic resistance. Dobutamine may also be used for detection of myocardial ischaemia and of viable myocardium within the scope of an echocardiographic examination (dobutamine stress echocardiography), if patients cannot undergo a period of exercise or if the exercise yields no information of value. Paediatric population Dobutamine is indicated in all paediatric age groups (from neonates to 18 years of age) as inotropic support in low cardiac output hypoperfusion states resulting from decompensated heart failure, following cardiac surgery, cardiomyopathies and in cardiogenic or septic shock. 4.2 Posology and method of administration DOBUTAMINE DOSES MUST BE INDIVIDUALLY ADJUSTED. The required rate of infusion depends on the patient's response to therapy and the adverse reactions experienced. Dosage in adults: According to experience, the majority of patients respond to doses of 2.5-10 µg dobutamine/kg/min. In individual cases, doses up to 40 µg dobutamine/kg/min have been administered. Dosage in paediatric patients: Citiți documentul complet