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Fintepla · 4.6 Fertility, pregnancy, and lactation · 1
Eintrag öffnenFintepla · 4.8 Undesirable effects · 1
Eintrag öffnenFintepla · 4.8 · 10 Skin and subcutaneous tissue Rash disorders General disorders and Fatigue administration site conditions In
Eintrag öffnenFintepla · 4.8 · Adverse reactions reported with fenfluramine in placebo-controlled clinical studies and from post- marketing s
Eintrag öffnenFintepla · 4.8 · All events reported for diarrhoea and constipation were mild or moderate in severity.
Eintrag öffnenFintepla · 4.8 · Decreased appetite and weight loss Fenfluramine can cause decreased appetite and weight loss. In the controlle
Eintrag öffnenFintepla · 4.8 · Description of selected adverse reactions
Eintrag öffnenFintepla · 4.8 · Echocardiographic safety assessments Valvular heart disease and pulmonary arterial hypertension were evaluated
Eintrag öffnenFintepla · 4.8 · Gastrointestinal disorders In the Phase 3 LGS controlled trial in children and young adults, diarrhoea (13.1%)
Eintrag öffnenFintepla · 4.8 · In the LGS controlled trial through the open-label trial, diarrhoea and constipation were observed more freque
Eintrag öffnenFintepla · 4.8 · In the controlled trials in patients with Dravet syndrome seizures were reported less frequently in the fenflu
Eintrag öffnenFintepla · 4.8 · Lethargy, somnolence, and fatigue (grouping of fatigue/asthenia/malaise/decreased activity) In the controlled
Eintrag öffnenFintepla · 4.8 · Metabolism and nutrition Decreased appetite disorders Psychiatric disorders Abnormal behaviour Irritability Ag
Eintrag öffnenFintepla · 4.8 · Reporting of suspected adverse reactions
Eintrag öffnenFintepla · 4.8 · Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows con
Eintrag öffnenFintepla · 4.8 · Status epilepticus and seizures (Epilepsy, Seizure cluster, Change in seizure) In the Dravet syndrome phase 3
Eintrag öffnenFintepla · 4.8 · Summary of the safety profile
Eintrag öffnenFintepla · 4.8 · Table 3: Adverse reactions MedDRA System Organ Class Very common Common Not known Infections and infestations
Eintrag öffnenFintepla · 4.8 · Tabulated list of adverse reactions
Eintrag öffnenFintepla · 4.8 · The mean days to onset of seizure events in the LGS phase 3 trial after starting treatment was 44.4 days in th
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