Страна: Израиль
Язык: английский
Источник: Ministry of Health
MILRINONE
SANOFI ISRAEL LTD
C01CE02
SOLUTION FOR INJECTION
MILRINONE 1 MG/ML
I.V
Required
DELPHARM DIJON, FRANCE
MILRINONE
MILRINONE
For the treatment of refractory heart failure immediately (up to 72 hours) following cardiac surgery. For the short term ( up to 48 hours) intravenous therapy of severe refractory congestive heart failure.In pediatric population Primacor is indicated for the short-term treatment (up to 35 hours) of severe congestive heart failure unresponsive to conventional maintenance therapy (glycosides, diuretics, vasodilators and/or angiotensin converting enzyme (ACE) inhibitors), and for the short-term treatment (up to 35 hours) of pediatric patients with acute heart failure, including low output states following cardiac surgery.
2022-11-30
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SUMMARY OF PRODUCT CHARACTERISTICS PRIMACOR INJECTION 1 NAME OF THE MEDICINAL PRODUCT Primacor Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ampoule contains 1 mg/ml of the active substance Milrinone. For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Solution for Injection. Clear, colourless to pale yellow liquid. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Primacor Injection is indicated for treatment of refractory heart failure immediately (up to 72 hours) following cardiac surgery. For the short-term (up to 48 hours) intravenous therapy of severe refractory congestive heart failure. In pediatric population Primacor is indicated for the short-term treatment (up to 35 hours) of severe congestive heart failure unresponsive to conventional maintenance therapy (glycosides, diuretics, vasodilators and/or angiotensin converting enzyme (ACE) inhibitors), and for the short-term treatment (up to 35 hours) of pediatric patients with acute heart failure, including low output states following cardiac surgery. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For intravenous administration. _Adults:_ Primacor Injection should be given as a loading dose of 50 µg/kg administered over a period of 10 minutes usually followed by a continuous infusion at a dosage titrated between 0.375 µg/kg/min and 0.75 µg/kg/ min according to haemodynamic and clinical response, but should not exceed 1.13 mg/kg/day total dose. The following provides a guide to maintenance infusion delivery rate based upon a solution containing milrinone 200 µg/ml prepared by adding 40 ml diluent per 10 ml ampoule (400 ml diluent per 100 ml Primacor Injection). 0.45% saline, 0.9% saline or 5% dextrose may be used as diluents. PRIMACOR INJECTION DOSE (ΜG/KG/MIN) INFUSION DELIVERY RATE (ML/KG/H) 0.375 0.400 0.500 0.600 0.700 0.750 0.11 0.12 0.15 0.18 0.21 0.22 Solutions of different concentrations may be used according to patient fluid requirements. The duration of therapy should depend upon the patient’s response. In congestive Прочитать полный документ