Land: Israel
Språk: engelska
Källa: Ministry of Health
LEVOSIMENDAN
BIO-MED - J.R LTD, ISRAEL
C01CX08
CONCENTRATE FOR SOLUTION FOR INFUSION
LEVOSIMENDAN 2.5 MG/ML
I.V
Required
ORION CORPORATION ORION PHARMA,FINLAND
LEVOSIMENDAN
LEVOSIMENDAN
Therapeutic indications: Short-term treatment of acutely decompensated severe chronic heart failure.Simdax should only be used as add-on therapy in situations where conventional therapy with e.g. diuretics, ACE-inhibitors and digitalis is not sufficient and where there is a need for inotropic support.
2013-12-31
SUMMARY OF THE PRODUCT CHARACTERISTICS 1 N AME OF THE M EDICINAL P RODUCT Simdax 2.5 mg/ml. 2 Q UALITATIVE AND Q UANTITATIVE C OMPOSITION Each ml of concentrate _ _ for solution for infusion contains 2.5 mg of levosimendan. One 5 ml vial contains 12.5 mg of levosimendan. Excipient with known effect: Ethanol. This medicinal product contains 785 mg/ml ethanol (alcohol). For a full list of excipients, see section 6.1. 3 P HARMACEUTICAL F ORM Concentrate for solution for infusion. The concentrate is a clear yellow or orange solution for dilution prior to administration. 4 C LINICAL P ARTICULARS 4.1 THERAPEUTIC INDICATIONS Simdax is indicated for the short-term _ _ treatment of acutely decompensated severe chronic heart failure (ADHF). Simdax should only be used as add-on therapy in situations where conventional therapy with e.g. diuretics, ACE-inhibitors and digitalis _ _ is not sufficient, where there is a need for inotropic support (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Simdax is for in-hospital use only. It should be administered in a hospital setting where adequate monitoring facilities and expertise with the use of inotropic agents are available. _Posology _ The dose and duration of treatment should be individualised according to the patient's clinical condition and response. The treatment _ _ should be initiated with a loading dose of 6-12 microgram/kg infused over 10 minutes followed by a continuous infusion of 0.1 microgram/kg/min (see section 5.1). The lower loading dose of 6 microgram/kg is recommended for patients on concomitant intravenous vasodilators or inotropes or both at the start of the infusion. Higher loading doses within this range will produce a stronger haemodynamic response but may be associated with a transient increased incidence of adverse reactions. _ _ The response of the patient should be assessed with the loading dose or within 30 to 60 minutes of dose adjustment and as clinically indicated. If the response is deemed excessive (hypotension, tachycardia), the rate o Läs hela dokumentet