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Elaprase
Eintrag öffnenElaprase · 4.1 Therapeutic indications · 1
Eintrag öffnenElaprase · 4.3 Contraindications · 1
Eintrag öffnenElaprase · 4.3 · Severe or life-threatening hypersensitivity to the active substance or to any of the excipients listed in sect
Eintrag öffnenElaprase · 4.4 Special warnings and precautions for use · 1
Eintrag öffnenElaprase · 4.5 Interaction with other medicinal products and other forms of interaction · 1
Eintrag öffnenElaprase · 4.5 · Based on its metabolism in cellular lysosomes, idursulfase would not be a candidate for cytochrome P450 mediat
Eintrag öffnenElaprase · 4.5 · No formal medicinal product interaction studies have been conducted with idursulfase.
Eintrag öffnenElaprase · 4.6 Fertility, pregnancy and lactation · 1
Eintrag öffnenElaprase · 4.8 Undesirable effects · 1
Eintrag öffnenElaprase · 4.8 · 5 System organ Adverse reaction (preferred term) class Very common Common Uncommon Not known Urticaria, rash,
Eintrag öffnenElaprase · 4.8 · 6 also tested positive for neutralizing antibodies on at least 3 consecutive study visits. Antibody-negative p
Eintrag öffnenElaprase · 4.8 · Across 4 clinical studies (TKT008, TKT018, TKT024 and TKT024EXT), 53/107 patients (50%) developed anti-idursul
Eintrag öffnenElaprase · 4.8 · Across clinical studies, serious adverse reactions were reported in a total of 5 patients who received 0.5 mg/
Eintrag öffnenElaprase · 4.8 · Adverse reactions are listed in table 1 with information presented by system organ class and frequency. Freque
Eintrag öffnenElaprase · 4.8 · Adverse reactions reported in the paediatric population were, in general, similar to those reported in adults.
Eintrag öffnenElaprase · 4.8 · Adverse reactions that were reported for the 32 patients treated with 0.5 mg/kg idursulfase weekly in the TKT0
Eintrag öffnenElaprase · 4.8 · All patients with the complete deletion/large rearrangement genotype developed antibodies, and the majority of
Eintrag öffnenElaprase · 4.8 · Clinical study HGT-ELA-038 evaluated immunogenicity in children 16 months to 7.5 years of age. During the 53-w
Eintrag öffnenElaprase · 4.8 · Description of selected adverse reactions
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