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Naglazyme
Eintrag öffnenNaglazyme · 4.1 Therapeutic indications · 1
Eintrag öffnenNaglazyme · 4.3 Contraindications · 1
Eintrag öffnenNaglazyme · 4.3 · Severe or life-threatening hypersensitivity to the active substance or to any of the excipients, if hypersensi
Eintrag öffnenNaglazyme · 4.4 Special warnings and precautions for use · 1
Eintrag öffnenNaglazyme · 4.5 Interaction with other medicinal products and other forms of interaction · 1
Eintrag öffnenNaglazyme · 4.5 · No interaction studies have been performed.
Eintrag öffnenNaglazyme · 4.6 Fertility, pregnancy and lactation · 1
Eintrag öffnenNaglazyme · 4.8 Undesirable effects · 1
Eintrag öffnenNaglazyme · 4.8 · 1 Reactions reported more frequently in the active arm of the placebo-controlled study than the placebo arm; f
Eintrag öffnenNaglazyme · 4.8 · 5 Table 1: Frequency of adverse drug reactions with Naglazyme
Eintrag öffnenNaglazyme · 4.8 · 6 Although a larger proportion of subjects with high total antibody titres experienced recurrent infusion reac
Eintrag öffnenNaglazyme · 4.8 · A comprehensive antibody analysis based on data from three clinical studies has been carried out in 48 patient
Eintrag öffnenNaglazyme · 4.8 · Adverse reactions are listed in Table 1 by System Organ Class.
Eintrag öffnenNaglazyme · 4.8 · Adverse reactions reported during the Post Marketing period are included at a frequency category of “unknown”.
Eintrag öffnenNaglazyme · 4.8 · All patients treated with NAGLAZYME (59/59) reported at least one AE. The majority (42/59; 71%) of patients ex
Eintrag öffnenNaglazyme · 4.8 · Due to the low number of patients in clinical trials, adverse event (AE) data from all Naglazyme studies have
Eintrag öffnenNaglazyme · 4.8 · Immunogenicity
Eintrag öffnenNaglazyme · 4.8 · In four patients <1 year of age, the overall safety profile of a higher dose (2 mg/kg/week) did not differ in
Eintrag öffnenNaglazyme · 4.8 · Infections and infestations Pharyngitis1, gastroenteritis1 Very common
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