Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
DOBUTAMINE HYDROCHLORIDE
Hameln Pharmaceuticals GmbH
12.5 Mg/Ml
Concentrate for Soln for Inf
2003-11-04
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Dobutamine-hameln 250 mg/20 ml ampoule, concentrate for solution for infusion. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1ml of solution contains 12.5mg Dobutamine equivalent to 14mg Dobutamine HCl. Each 20 ml ampoule contains 250mg Dobutamine equivalent to 280mg Dobutamine Hydrochloride. For excipients, see 6.1 3 PHARMACEUTICAL FORM Concentrate for solution for infusion. A clear, colourless or almost colourless solution. 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 or cardiomyopathies. Dobutamine is also indicated for adults with cardiogenic or septic shock who are not severely hypotensive. Dobutamine can increase or maintain cardiac output during positive end expiratory pressure (PEEP) ventilation. Dobutamine may also be used for cardiac stress testing in case where exercise stress testing is not feasible or inadequate. 4.2 POSOLOGY AND METHOD OF ADMINSTRATION Due to its short half-life dobutamine has to be administered by continuous intravenous infusion. Dobutamine Hameln 12.5 mg/ml may be diluted if wanted. Diluents may be 5 % glucose solution, 0.9 % sodium chloride solution, Ringer-lactate or 0.45 % sodium chloride in 5 % glucose solution. Note: Dobutamine Hameln 12.5 mg/ml may not be mixed with 5 % sodium bicarbonate solution or any other strong alkaline solution. Due to the risk of incompatibility Dobutamine Hameln 12.5 mg/ml Amp. 20 ml is not recommended to be mixed in the same infusion as other medical substances. Dobutamine Hameln 12.5 mg/ml should not be used in solutions for intravenous infusion containing both sodium metabisulphite and ethanol. Sulphite is a very reactive subs Read the complete document