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Crysvita
Eintrag öffnenCrysvita · 4.1 Therapeutic indications · 1
Eintrag öffnenCrysvita · 4.3 Contraindications · 1
Eintrag öffnenCrysvita · 4.3 · Concurrent administration with oral phosphate, active vitamin D analogues (see section 4.5).
Eintrag öffnenCrysvita · 4.3 · Fasting serum phosphate above the normal range for age due to the risk of hyperphosphatemia (see section 4.4).
Eintrag öffnenCrysvita · 4.3 · Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Eintrag öffnenCrysvita · 4.3 · Patients with severe renal impairment or end stage renal disease.
Eintrag öffnenCrysvita · 4.4 Special warnings and precautions for use · 1
Eintrag öffnenCrysvita · 4.5 Interaction with other medicinal products and other forms of interaction · 1
Eintrag öffnenCrysvita · 4.5 · Caution should be exercised when combining burosumab with calcimimetic medicinal products (i.e. agents that mi
Eintrag öffnenCrysvita · 4.5 · Concurrent administration of burosumab with oral phosphate and active vitamin D analogues is contraindicated a
Eintrag öffnenCrysvita · 4.6 Fertility, pregnancy and lactation · 1
Eintrag öffnenCrysvita · 4.8 Undesirable effects · 1
Eintrag öffnenCrysvita · 4.8 · 11 Table 1: Adverse reactions reported in paediatric patients 4 months to 17 years of age with XLH, observed f
Eintrag öffnenCrysvita · 4.8 · 12 Table 2: Adverse reactions observed from clinical trials in adults (N=203) with XLH (N=176) and TIO (N=27)
Eintrag öffnenCrysvita · 4.8 · 13 Description of selected adverse reactions
Eintrag öffnenCrysvita · 4.8 · 14 In patients with TIO, based on data from completed long term clinical studies, 11% of patients experienced
Eintrag öffnenCrysvita · 4.8 · Adult patients with XLH and TIO: The incidence of patients that tested positive for ADAs to burosumab in adult
Eintrag öffnenCrysvita · 4.8 · Adult patients with XLH or TIO: Hypersensitivity reactions were mild or moderate in severity. In XLH patients,
Eintrag öffnenCrysvita · 4.8 · Adult patients with XLH or TIO: Injection site reactions were generally mild in severity, required no treatmen
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