Maa: Israel
Kieli: englanti
Lähde: Ministry of Health
DOBUTAMINE AS HYDROCHLORIDE
RAZ PHARMACEUTICS LTD, ISRAEL
C01CA07
CONCENTRATE FOR SOLUTION FOR INFUSION
DOBUTAMINE AS HYDROCHLORIDE 12.5 MG/ML
I.V
Required
FISIOPHARMA S.R.L., ITALY
DOBUTAMINE
Dobutamine is indicated for patients who require a positive inotropic support in the short term treatment of adults with cardiac decompensation due to depressed contractility resulting either from organic heart disease or from cardiac surgical procedures, especially when a low cardiac output is associated with raised pulmonary pressure.
2023-08-10
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT MIOZAC 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial of 20 ml contains: Active ingredient: Dobutamine hydrochloride 280.28 mg (Equivalent to Dobutamine 250.0 mg) (each ml contains 12.5 mg of Dobutamine) Excipient with known effect: Sodium metabisulphite 4.4 mg For the full list of the excipients, see section 6.1 3. PHARMACEUTICAL FORM Sterile concentrated solution for intravenous infusion. Clear and colourless solution. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Dobutamine is indicated for patients who require a positive inotropic support in the short term treatment of adults with cardiac decompensation due to depressed contractility resulting either from organic heart disease or from cardiac surgical procedures, especially when a low cardiac output is associated with raised pulmonary pressure. NOTE In case of cardiogenic shock characterized by cardiac failure and severe hypotension and in case of septic shock dopamine is the drug of first-choice after correction of possible hypovolemia. In patients who have atrial fibrillation with rapid ventricular response, a digitalis preparation should be used prior to institution of therapy with Dobutamine 12.5 mg/ml. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Just before administration Dobutamine concentrate for solution for infusion MUST be further diluted to AT LEAST 50 ML prior to administration in a container for intravenous use and according to the table below with one of the intravenous solutions listed in section 6.6. The concentration used depends on the dosage and fluid requirements of the patient. The dilution should not be more concentrated than 5 mg/ml (5,000 µg/ml). Most patients will respond satisfactorily to doses from 2.5 to 10 µg/kg/min. Occasionally, however, a dose as low as 0.5 µg/kg/min will be effective. Rarely, a dose as high as 40 µg/kg/min has been required. The table below is a directive for the rate of infusion: DRUG DELIVERY RATE INFUSION DELIVERY RATE (ML Lue koko asiakirja