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Givlaari
Eintrag öffnenGivlaari · 4.1 Therapeutic indications · 1
Eintrag öffnenGivlaari · 4.3 Contraindications · 1
Eintrag öffnenGivlaari · 4.3 · Severe hypersensitivity (e.g. anaphylaxis) to the active substance or to any excipients listed in section 6.1.
Eintrag öffnenGivlaari · 4.4 Special warnings and precautions for use · 1
Eintrag öffnenGivlaari · 4.5 Interaction with other medicinal products and other forms of interaction · 1
Eintrag öffnenGivlaari · 4.5 · 4 • CYP3A4: 1.2-fold increase in Cmax and 1.5-fold increase in AUC0–∞ of midazolam • CYP2C9: no effect on the
Eintrag öffnenGivlaari · 4.5 · Caution is recommended during the use of medicinal products that are substrates of CYP1A2 or CYP2D6 while on t
Eintrag öffnenGivlaari · 4.5 · In a clinical drug-drug interaction study, givosiran resulted in a weak to moderate reduction in activity of c
Eintrag öffnenGivlaari · 4.6 Fertility, pregnancy and lactation · 1
Eintrag öffnenGivlaari · 4.8 Undesirable effects · 1
Eintrag öffnenGivlaari · 4.8 · 5 Table 1: Adverse reactions System organ class Adverse reaction Frequency Hypersensitivity Common Immune syst
Eintrag öffnenGivlaari · 4.8 · Description of selected adverse reactions
Eintrag öffnenGivlaari · 4.8 · Injection site reactions In placebo-controlled and open-label clinical studies, injection site reactions have
Eintrag öffnenGivlaari · 4.8 · Liver function tests In the placebo-controlled study, 7 (14.6%) patients treated with givosiran and one (2.2%)
Eintrag öffnenGivlaari · 4.8 · Reporting of suspected adverse reactions
Eintrag öffnenGivlaari · 4.8 · Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows con
Eintrag öffnenGivlaari · 4.8 · Summary of the safety profile
Eintrag öffnenGivlaari · 4.8 · Tabulated list of adverse reactions
Eintrag öffnenGivlaari · 4.8 · The adverse reactions are presented as MedDRA preferred terms under the MedDRA system organ class (SOC) by fre
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