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Abiraterone Mylan · 4.8 · A higher incidence of hypertension and hypokalaemia was observed in the hormone sensitive population (study 30
Eintrag öffnenAbiraterone Mylan · 4.8 · Abiraterone may cause hypertension, hypokalaemia and fluid retention as a pharmacodynamic consequence of its m
Eintrag öffnenAbiraterone Mylan · 4.8 · Adverse reactions observed during clinical studies and post-marketing experience are listed below by frequency
Eintrag öffnenAbiraterone Mylan · 4.8 · Description of selected adverse reactions Cardiovascular reactions The three Phase 3 studies excluded patients
Eintrag öffnenAbiraterone Mylan · 4.8 · Hepatotoxicity Hepatotoxicity with elevated ALT, AST and total bilirubin has been reported in patients treated
Eintrag öffnenAbiraterone Mylan · 4.8 · In clinical studies, the risk for hepatotoxicity was mitigated by exclusion of patients with baseline hepatiti
Eintrag öffnenAbiraterone Mylan · 4.8 · Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medi
Eintrag öffnenAbiraterone Mylan · 4.8 · Summary of the safety profile In an analysis of adverse reactions of composite Phase 3 studies with abirateron
Eintrag öffnenAbiraterone Mylan · 4.8 · Table 1: Adverse reactions identified in clinical studies and post-marketing System Organ Class Adverse reacti
Eintrag öffnenAbiraterone Mylan · 4.8 · Tabulated list of adverse reactions In studies of patients with metastatic advanced prostate cancer who were u
Eintrag öffnenAbiraterone Mylan · 4.8 · The following CTCAE (version 4.0) Grade 3 adverse reactions occurred in patients treated with abiraterone acet
Eintrag öffnenAbiraterone Mylan · 4.8 · The incidence and severity of adverse events was higher in the subgroup of patients with baseline ECOG2 perfor
Eintrag öffnenAbiraterone Mylan · 4.8 · Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Eintrag öffnenAmbrisentan Viatris (previously Ambrisentan Mylan)
Eintrag öffnenAmbrisentan Viatris (previously Ambrisentan Mylan) · 4.1 Therapeutic indications · 1
Eintrag öffnenAmbrisentan Viatris (previously Ambrisentan Mylan) · 4.3 Contraindications · 1
Eintrag öffnenAmbrisentan Viatris (previously Ambrisentan Mylan) · 4.3 · 3 Pregnancy (see section 4.6).
Eintrag öffnenAmbrisentan Viatris (previously Ambrisentan Mylan) · 4.3 · Baseline values of hepatic aminotransferases (aspartate aminotransferases (AST) and/or alanine aminotransferas
Eintrag öffnenAmbrisentan Viatris (previously Ambrisentan Mylan) · 4.3 · Breast-feeding (see section 4.6).
Eintrag öffnenAmbrisentan Viatris (previously Ambrisentan Mylan) · 4.3 · Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
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