Quest for the right Drug
סימדקס 2.5 מ"ג/מ"ל SIMDAX 2.5 MG/ML (LEVOSIMENDAN)
תרופה במרשם
תרופה בסל
נרקוטיקה
ציטוטוקסיקה
צורת מתן:
תוך-ורידי : I.V
צורת מינון:
תרכיז להכנת תמיסה לאינפוזיה : CONCENTRATE FOR SOLUTION FOR INFUSION
עלון לרופא
מינוניםPosology התוויות
Indications תופעות לוואי
Adverse reactions התוויות נגד
Contraindications אינטראקציות
Interactions מינון יתר
Overdose הריון/הנקה
Pregnancy & Lactation אוכלוסיות מיוחדות
Special populations תכונות פרמקולוגיות
Pharmacological properties מידע רוקחי
Pharmaceutical particulars אזהרת שימוש
Special Warning עלון לרופא
Physicians Leaflet
Adverse reactions : תופעות לוואי
4.8 Undesirable effects In placebo-controlled clinical trials for ADHF (REVIVE programme), 53% of patients experienced adverse reactions, the most frequent of which were ventricular tachycardia, hypotension, and headache. In a dobutamine-controlled clinical trial for ADHF (SURVIVE), 18% of patients experienced adverse reactions, the most frequent of which were ventricular tachycardia, atrial fibrillation, hypotension, ventricular extrasystoles, tachycardia, and headache. The following table describes the adverse reactions observed in 1% or greater of patients during REVIVE I, REVIVE II, SURVIVE, LIDO, RUSSLAN, 300105, and 3001024 clinical trials. If the incidence of any particular event in an individual trial was greater than that seen across the other trials, then the higher incidence is reported in the table. The events considered at least possibly related to levosimendan are displayed by system organ class and frequency, using the following convention: very common (≥ 1/10), common (≥ 1/100 < 1/10). Table 3 Summary of Adverse Reactions SURVIVE Clinical Study, REVIVE Programme, and LIDO/RUSSLAN/300105/3001024 Clinical Studies combined Body System Frequency Preferred Term Metabolism and nutrition Common Hypokalaemia disorders Psychiatric disorders Common Insomnia Nervous system disorders Very Common Headache Common Dizziness Cardiac disorders Very Common Ventricular Tachycardia Common Atrial Fibrillation Tachycardia Ventricular Extrasystoles Cardiac Failure Myocardial Ischaemia Extrasystoles Vascular disorders Very Common Hypotension Gastrointestinal disorders Common Nausea Constipation Diarrhoea Vomiting Investigations Common Haemoglobin Decreased Post-marketing adverse reactions: In post-marketing experience, ventricular fibrillation has been reported in patients being administered Simdax. Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form: https://sideeffects.health.gov.il
שימוש לפי פנקס קופ''ח כללית 1994
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תאריך הכללה מקורי בסל
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הגבלות
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מידע נוסף