Special Warning : אזהרת שימוש

 4.4 Special warnings and precautions for use
An initial haemodynamic effect of levosimendan may be a decrease in systolic and diastolic blood pressure, therefore, levosimendan should be used with caution in patients with low baseline systolic or diastolic blood pressure or those at risk for a hypotensive episode. More conservative dosing regimens are recommended for these patients. Physicians should tailor the dose and duration of therapy to the condition and response of the patient (see sections 4.2, 4.5 and 5.1).

Severe hypovolaemia should be corrected prior to levosimendan infusion.

If excessive changes in blood pressure or heart rate are observed, the rate of infusion should be reduced or the infusion discontinued.

The exact duration of all haemodynamic effects has not been determined, however, the haemodynamic effects, generally last for 7-10 days. This is partly due to the presence of active metabolites, which reach their maximum plasma concentrations about 48 hours after the infusion has been stopped. Non-invasive monitoring for at least 4-5 days after the end of infusion is recommended. Monitoring is recommended to continue until the blood pressure reduction has reached its maximum and the blood pressure starts to increase again, and may need to be longer than 5 days if there are any signs of continuing blood pressure decrease, but can be shorter than 5 days if the patient is clinically stable. In patients with mild to moderate renal or mild to moderate hepatic impairment an extended period of monitoring may be needed.

Levosimendan should be used cautiously in patients with mild to moderate renal impairment.
Limited data on the elimination of the active metabolites are available in patients with impaired renal function. Impaired renal function may lead to increased concentrations of the active metabolites, which may result in a more pronounced and prolonged haemodynamic effect (see section 5.2).

Levosimendan should be used cautiously in patients with mild to moderate hepatic impairment. Impaired hepatic function may lead to prolonged exposure to the active metabolites, which may result in a more pronounced and prolonged haemodynamic effect (see section 5.2).
Levosimendan infusion may cause a decrease in serum potassium concentration. Thus, low serum potassium concentrations should be corrected prior to the administration of levosimendan and serum potassium should be monitored during treatment.
As with other medicinal products for heart failure, infusions of Levosimendan may be accompanied by decreases in haemoglobin and haematocrit and caution should be exercised in patients with ischaemic cardiovascular disease and concurrent anaemia.

Levosimendan infusion should be used cautiously in patients with tachycardia atrial fibrillation with rapid ventricular response or potentially life-threatening arrhythmias.

Experience with repeated administration of levosimendan is limited. Experience with concomitant use of vasoactive agents, including inotropic agents (except digoxin), is limited.
Benefit and risk should be assessed for the individual patient.

Levosimendan should be used cautiously and under close ECG monitoring in patients with ongoing coronary ischaemia, long QTc interval regardless of aetiology, or when given concomitantly with medicinal products that prolong the QTc interval (see section 4.9).
The use of levosimendan in cardiogenic shock has not been studied. No information is available on the use of levosimendan in the following disorders: restrictive cardiomyopathy, hypertrophic cardiomyopathy, severe mitral valve insufficiency, myocardial rupture, cardiac tamponade, and right ventricular infarction.

Levosimendan should not be administered to children as there is very limited experience of use in children and adolescent under 18 years of age (see section 5.2).

Limited experience is available on the use of levosimendan in severe heart failure in patients awaiting heart transplantation.

Excipients
This medicine contains 3925 mg of alcohol (anhydrous ethanol) in each 5 ml vial, which is equivalent to appr 98 vol%. The amount in one 5 ml vial of this medicine is equivalent to 99.2 ml beer or 41.3 ml wine.
Harmful for those suffering from alcoholism.
To be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease or epilepsy. The amount of alcohol in this medicinal product may alter the effects of other medicines.
Because this medicine is usually given slowly over 24 hours, the effects of alcohol may be reduced.

Effects on Driving

4.7 Effects on ability to drive and use machines
Not applicable