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Leqvio
Eintrag öffnenLeqvio · 4.1 Therapeutic indications · 1
Eintrag öffnenLeqvio · 4.3 Contraindications · 1
Eintrag öffnenLeqvio · 4.3 · Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Eintrag öffnenLeqvio · 4.4 Special warnings and precautions for use · 1
Eintrag öffnenLeqvio · 4.5 Interaction with other medicinal products and other forms of interaction · 1
Eintrag öffnenLeqvio · 4.5 · Inclisiran is not a substrate for common drug transporters and, although in vitro studies were not conducted,
Eintrag öffnenLeqvio · 4.6 Fertility, pregnancy and lactation · 1
Eintrag öffnenLeqvio · 4.8 Undesirable effects · 1
Eintrag öffnenLeqvio · 4.8 · 4 Table 1 Adverse reactions reported in patients treated with inclisiran
Eintrag öffnenLeqvio · 4.8 · 5 Reporting of suspected adverse reactions
Eintrag öffnenLeqvio · 4.8 · Adverse reactions are presented by system organ class (Table 1). Frequency categories are defined as: very com
Eintrag öffnenLeqvio · 4.8 · Adverse reactions at the injection site Adverse reactions at the injection site occurred in 8.2% and 1.8% of i
Eintrag öffnenLeqvio · 4.8 · Description of selected adverse reactions
Eintrag öffnenLeqvio · 4.8 · Elderly Of the 1 833 patients treated with inclisiran in the pivotal studies, 981 (54%) were 65 years of age o
Eintrag öffnenLeqvio · 4.8 · Immunogenicity
Eintrag öffnenLeqvio · 4.8 · In the phase III clinical studies, there were more frequent elevations of serum hepatic transaminases between
Eintrag öffnenLeqvio · 4.8 · In the pivotal studies 1 830 patients were tested for anti-drug antibodies. Confirmed positivity was detected
Eintrag öffnenLeqvio · 4.8 · Laboratory values
Eintrag öffnenLeqvio · 4.8 · Paediatric population The safety and efficacy of inclisiran were assessed in two phase III studies in paediatr
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