Ország: Málta
Nyelv: angol
Forrás: Malta Medicines Authority
DOBUTAMINE
Mercury Pharmaceuticals (Ireland) Limited 4045 Kingswood Road, City West Business Park, Co, Dublin, Ireland
C01CA07
DOBUTAMINE 12.5 mg/ml
CONCENTRATE FOR SOLUTION FOR INFUSION
DOBUTAMINE 12.5 mg/ml
POM
CARDIAC THERAPY
Withdrawn
2006-08-31
Page 1 of 17 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Dobutamine 12.5mg/ml Concentrate for Solution for Infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1 ml solution contains Dobutamine Hydrochloride Ph. Eur. equivalent to 12.5 mg Dobutamine. Each 20 ml ampoule contains Dobutamine Hydrochloride Ph. Eur. equivalent to 250 mg Dobutamine. EXCIPIENTS WITH KNOWN EFFECT: 4 mg sodium metabisulphite (E223) per 20 ml. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate for solution for infusion (Sterile Concentrate). Clear, colourless or almost colourless, sterile concentrate for infusion following dilution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Dobutamine is indicated for adults who require inotropic support in the treatment of low output cardiac failure associated with myocardial infarction, open heart surgery, cardiomyopathies, septic shock or cardiogenic shock. Dobutamine can also be used for cardiac stress testing, in cases when exercise stress testing is not feasible. 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 Method of administration Dobutamine Concentrate should be diluted before use and administered by IV infusion only. The concentration of the dobutamine administered depends upon the dosage and fluid requirements of the individual patient. The final concentrations generally used for Page 2 of 17 perfusion are 250 micrograms/ml, 500 micrograms/ml or 1000 micrograms/ml. For special precautions for storage of the prepared diluted infusion see section 6.4. High concentrations of dobutamine should only be given with an infusion pump or other suitable apparatus to ensure accurate dosage. Due to its short half-life, dobutamine should be administ Olvassa el a teljes dokumentumot