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Elfabrio
Eintrag öffnenElfabrio · 4.1 Therapeutic indications · 1
Eintrag öffnenElfabrio · 4.3 Contraindications · 1
Eintrag öffnenElfabrio · 4.3 · Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Eintrag öffnenElfabrio · 4.4 Special warnings and precautions for use · 1
Eintrag öffnenElfabrio · 4.5 Interaction with other medicinal products and other forms of interaction · 1
Eintrag öffnenElfabrio · 4.5 · No interaction studies and no in vitro metabolism studies have been performed. Based on its metabolism, peguni
Eintrag öffnenElfabrio · 4.5 · Pegunigalsidase alfa is a protein and is expected to be metabolically degraded through peptide hydrolysis.
Eintrag öffnenElfabrio · 4.6 Fertility, pregnancy and lactation · 1
Eintrag öffnenElfabrio · 4.8 Undesirable effects · 1
Eintrag öffnenElfabrio · 4.8 · * Preferred terms considered as IRR as described in the section below.
Eintrag öffnenElfabrio · 4.8 · 7 Frequency System organ class Common Uncommon Respiratory, thoracic and bronchospasm* mediastinal disorders s
Eintrag öffnenElfabrio · 4.8 · 8 serious. Four of these events were confirmed type I hypersensitivity reactions and 3 led to the discontinuat
Eintrag öffnenElfabrio · 4.8 · Adverse reactions are listed in Table 3. Information is presented by system organ class. Frequencies are defin
Eintrag öffnenElfabrio · 4.8 · Description of selected adverse reactions
Eintrag öffnenElfabrio · 4.8 · Frequency System organ class Common Uncommon Immune system disorders hypersensitivity* type I hypersensitivity
Eintrag öffnenElfabrio · 4.8 · Immunogenicity In clinical studies, 17 out of 111 of patients (16%) treated with 1 mg/kg pegunigalsidase alfa
Eintrag öffnenElfabrio · 4.8 · In clinical studies, 5 patients (3.5%) experienced a serious reaction that was considered related to pegunigal
Eintrag öffnenElfabrio · 4.8 · Infusion related reactions (adverse reactions within 2 hours of infusion) IRRs were reported in a total of 36
Eintrag öffnenElfabrio · 4.8 · Membranoproliferative glomerulonephritis During the clinical development of pegunigalsidase alfa, one patient
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