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Advate · 4.8 · 20 Table 2. Frequency of adverse reactions in clinical trials and from spontaneous reports MedDRA Standard Sys
Eintrag öffnenAdvate · 4.8 · 6 Tabulated summary of adverse reactions
Eintrag öffnenAdvate · 4.8 · 7 a) Calculated based on total number of patients who received ADVATE (418) in clinical trials, except for adv
Eintrag öffnenAdvate · 4.8 · ADRs specific to residues from the manufacturing process
Eintrag öffnenAdvate · 4.8 · ADRs specific to residues from the manufacturing process
Eintrag öffnenAdvate · 4.8 · Allergic type reactions include anaphylaxis and have been manifested by dizziness, paraesthesia, rash, flushin
Eintrag öffnenAdvate · 4.8 · Allergic type reactions include anaphylaxis and have been manifested by dizziness, paraesthesia, rash, flushin
Eintrag öffnenAdvate · 4.8 · Clinical studies with ADVATE included 418 subjects with at least one exposure to ADVATE reporting in total 93
Eintrag öffnenAdvate · 4.8 · Clinical studies with ADVATE included 418 subjects with at least one exposure to ADVATE reporting in total 93
Eintrag öffnenAdvate · 4.8 · Description of selected adverse reactions
Eintrag öffnenAdvate · 4.8 · Description of selected adverse reactions
Eintrag öffnenAdvate · 4.8 · Development of antibodies to mouse and/or hamster protein with related hypersensitivity reactions may be obser
Eintrag öffnenAdvate · 4.8 · Development of antibodies to mouse and/or hamster protein with related hypersensitivity reactions may be obser
Eintrag öffnenAdvate · 4.8 · Development of neutralising antibodies (inhibitors) may occur in patients with haemophilia A treated with fact
Eintrag öffnenAdvate · 4.8 · Development of neutralising antibodies (inhibitors) may occur in patients with haemophilia A treated with fact
Eintrag öffnenAdvate · 4.8 · Frequency has been evaluated according to the following convention: very common (≥ 1/10), common (≥ 1/100 to <
Eintrag öffnenAdvate · 4.8 · Frequency has been evaluated according to the following convention: very common (≥ 1/10), common (≥ 1/100 to <
Eintrag öffnenAdvate · 4.8 · Frequency, type and severity of adverse reactions in children are expected to be the same as in adults. Other
Eintrag öffnenAdvate · 4.8 · Frequency, type and severity of adverse reactions in children are expected to be the same as in adults. Other
Eintrag öffnenAdvate · 4.8 · Hypersensitivity
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