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Rukobia · 4.6 Fertility, pregnancy and lactation · 1
Eintrag öffnenRukobia · 4.8 Undesirable effects · 1
Eintrag öffnenRukobia · 4.8 · 1 Calculated based on safety data from 570 subjects (n=370 from phase III [BRIGHTE] study at 144 weeks, and n=
Eintrag öffnenRukobia · 4.8 · 10 Table 2: Tabulated list of adverse reactions System Organ Class Frequency1 Adverse Reactions
Eintrag öffnenRukobia · 4.8 · 11 Asymptomatic elevations in creatinine, creatine phosphokinase and liver enzymes were mainly grade 1 or 2 an
Eintrag öffnenRukobia · 4.8 · Cardiac disorders Common Electrocardiogram QT prolonged (see section 4.4) Gastrointestinal Very Diarrhoea, nau
Eintrag öffnenRukobia · 4.8 · Changes in laboratory chemistries Increases in creatine phosphokinase (CPK) were observed following treatment
Eintrag öffnenRukobia · 4.8 · Clinically relevant increases in serum creatinine have primarily occurred in patients with identifiable risk f
Eintrag öffnenRukobia · 4.8 · Description of selected adverse reactions
Eintrag öffnenRukobia · 4.8 · Hepatobiliary Common Transaminases increased4 disorders Skin and Very Rash5 subcutaneous tissue common disorde
Eintrag öffnenRukobia · 4.8 · Immune system Common Immune reconstitution inflammatory syndrome2 (see disorders section 4.4)
Eintrag öffnenRukobia · 4.8 · Increases in direct (conjugated) bilirubin have been observed following treatment with fostemsavir. Cases of c
Eintrag öffnenRukobia · 4.8 · Musculoskeletal and Common Myalgia connective tissue disorders General disorders Common Fatigue and administra
Eintrag öffnenRukobia · 4.8 · Psychiatric disorders Common Insomnia Nervous system Very Headache disorders common Common Dizziness, somnolen
Eintrag öffnenRukobia · 4.8 · Reporting of suspected adverse reactions
Eintrag öffnenRukobia · 4.8 · Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows con
Eintrag öffnenRukobia · 4.8 · Summary of the safety profile
Eintrag öffnenRukobia · 4.8 · Tabulated list of adverse reactions
Eintrag öffnenRukobia · 4.8 · The adverse reactions identified in clinical trials are listed in Table 2 by body system, organ class and freq
Eintrag öffnenRukobia · 4.8 · The most serious adverse reaction was immune reconstitution inflammatory syndrome (see section 4.4). The most
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