Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
DOBUTAMINE HYDROCHLORIDE
Pfizer Healthcare Ireland
12.5 Mg/Ml
Concentrate for Soln for Inf
2011-08-19
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Dobutamine Pfizer 12.5 mg/ml Concentrate for solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1 ml contains 12.5 mg of dobutamine (as 14.01 mg dobutamine hydrochloride). Each 20 ml ampoule contains 250 mg of dobutamine (as 280.2 mg dobutamine hydrochloride). Each 1 ml contains 0.15 mg of Sodium metabisulphite. Each 20 ml contains 3.0 mg of Sodium metabisulphite. For full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Concentrate for solution for infusion Clear, colourless or slightly yellow solution pH between 2.50 and 4.00 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Dobutamine is indicated for adults who require positive inotropic support in the treatment of low output cardiac failure normally associated with myocardial infarction, open-heart surgery, cardiomyopathies, septic shock and cardiogenic shock. Dobutamine can also be used for cardiac stress testing, in cases when exercise stress testing is not feasible. 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 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 administered as a continuous intravenous infusion. Dobutamine should be administered intravenously through an intrave Read the complete document