1. Name of the Medicinal Product
Levosimendan 2.5 mg/ml concentrate for solution forinfusion.
2. Qualitative and Quantitative Composition
Each ml of concentrate contains 2.5 mg of levosimendan.
One 5 ml vial contains 12.5 mg of levosimendan.
One 10 ml vial contains 25 mg of levosimendan.
For a full list of excipients, see section 6.1.
3. Pharmaceutical Form
Concentrate for solution for infusion.
The concentrate is a clear yellow or orange solution for dilutionprior to administration.
4. Clinical Particulars
4.1 Therapeutic indications
Simdax is indicated for the short-term treatment of acutelydecompensated
severe chronic heart failure (ADHF) in situations whereconventional therapy is
not sufficient, and in cases where inotropic support is consideredappropriate.