Precautions: renal and liver failure mild to moderate in severity, tachycardia, hypotension, atrial fibrillation with high ventricular rate, potentially life-threatening arrhythmias, concomitant myocardial ischemia, anemia, hypokalemia, prolonged interval, regardless of the etiology, the simultaneous application of drugs prolong the interval of the , ischemic heart disease.
There is enough experience reapplying masteron 100, as well as experience with heart failure after surgery, with severe chronic heart failure in patients awaiting heart transplantation, in combination with vasoactive drugs, including drugs with inotropic effect (except digoxin). No data on the use of Simdaksa in cardiogenic shock, restrictive cardiomyopathy, hypertrophic cardiomyopathy, severe mitral valve insufficiency, myocardial rupture, cardiac tamponade, acute myocardial infarction of the right ventricle.
Pregnancy and lactation
Experience of using levosimendan in pregnant women do not have. In this regard, levosimendan in pregnant women can be used only if the benefit to the mother outweighs the potential risk to the fetus and / or the child. Data on excretion of levosimendan in breast milk does not. Women should not breast-feed during application and for 14 days after infusion of levosimendan.
Concentrate Simdaksa 2.5 mg / ml is intended for single use only!
Before infusion of diluted solution, as well as other products for parenteral use, test for the presence of foreign particles and discoloration. When storing the concentrate color may change to orange, which is not accompanied by a decrease in the activity of the drug.
The infusion may be carried out through a peripheral or central vein.
The dose and duration of treatment picked individually, taking into account the clinical condition of the patient and the therapeutic effect.
The treatment starts with a loading dose of 6-12 micrograms / kg, which is administered over 10 minutes (see. table 1 and 2). Then, continuous infusion is carried out at a rate of 0.1 g / kg / min. A lower dose of 6 mg / kg is recommended in patients receiving concomitant intravenous vasodilator therapy, and / or inotropic agents. Assigning higher loading dose of 12 mg / kg will be accompanied by a stronger hemodynamic effect, but it is not excluded that the frequency of transient side effects will also increase.
The reaction of the patient to therapy masteron 100 evaluated when administered a loading dose or within 3060 minutes following adjustment of the dose or according to on the clinical picture.
When expressed changes of hemodynamic parameters (arterial hypotension, tachycardia), the rate of infusion should be reduced to 0.05 mcg / kg / min infusion or stop. If the initial dose tolerability and the need for a more pronounced effect hemodynamic infusion rate can be increased to 0.2 ug / kg / min. The recommended infusion duration is 24 hours. After stopping the infusion masteron 100 signs of development of tolerance or the syndrome of “cancellation” has been identified.
Hemodynamic effects are observed for at least 24 hours and can be called to persist for 9 days after the 24-hour infusion.Elderly patients No dose adjustment in elderly patients is not required. Renal impairment Simdaks should be used with caution in patients with mild to moderate renal insufficiency. It should not be administered to patients with severe renal impairment (creatinine clearance less than 30 ml / min) (see. Forums Pharmacokinetics, Contraindications, Special instructions). Abnormal liver function Simdaks should be used with caution in patients with mild (5-6 points classification Child-Pyuga) or moderate (7-9 points on the Child-Pyuga classification) hepatic impairment, however, does not require dose adjustment. It should not be administered to patients with severe hepatic impairment (> 9 points for the classification of Child-Pyuga) (see. Forums Pharmacokinetics, Contraindications, Special instructions).Children Simdaks should not be used in children and adolescents under the age of 18 years (see. Forums Pharmacokinetics, Contraindications, Special instructions) Experience of repeated infusions Simdaksa and its use in combination with other inotropic agents (except digoxin) is limited. Compatibility at the same time you can enter masteron 100.