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Remicade · 4.8 · 16 * including bovine tuberculosis (disseminated BCG infection), see section 4.4 1 At month 12 of the controll
Eintrag öffnenRemicade · 4.8 · 17 Delayed hypersensitivity In clinical studies delayed hypersensitivity reactions have been uncommon and have
Eintrag öffnenRemicade · 4.8 · 18 In long-term safety follow-up of clinical studies with infliximab of up to 5 years, representing 6,234 pati
Eintrag öffnenRemicade · 4.8 · 19 Table 2 Proportion of patients with increased ALT activity in clinical studies Indication Number of patient
Eintrag öffnenRemicade · 4.8 · 20 Infections Infections occurred in 68% (41/60) of children receiving 3 mg/kg over 52 weeks, 65% (37/57) of c
Eintrag öffnenRemicade · 4.8 · 21 make any definitive conclusions about the effect of age on safety events, there were higher proportions of
Eintrag öffnenRemicade · 4.8 · A population-based retrospective cohort study found an increased incidence of cervical cancer in women with rh
Eintrag öffnenRemicade · 4.8 · Additional information on special populations Elderly In rheumatoid arthritis clinical studies, the incidence
Eintrag öffnenRemicade · 4.8 · Antinuclear antibodies (ANA)/Anti-double-stranded DNA (dsDNA) antibodies Approximately half of infliximab-trea
Eintrag öffnenRemicade · 4.8 · Cases of malignancies, including lymphoma, have also been reported in the post-marketing setting (see section
Eintrag öffnenRemicade · 4.8 · Description of selected adverse drug reactions
Eintrag öffnenRemicade · 4.8 · Heart failure In a Phase II study aimed at evaluating Remicade in CHF, higher incidence of mortality due to wo
Eintrag öffnenRemicade · 4.8 · Hepatobiliary events In clinical studies, mild or moderate elevations of ALT and AST have been observed in pat
Eintrag öffnenRemicade · 4.8 · Immunogenicity Antibodies to infliximab developed in 38% of patients receiving 3 mg/kg compared with 12% of pa
Eintrag öffnenRemicade · 4.8 · Immunogenicity Antibodies to infliximab were detected in 3 (2.9%) paediatric patients.
Eintrag öffnenRemicade · 4.8 · Immunogenicity Antibodies to infliximab were detected in 4 (7.7%) patients through week 54.
Eintrag öffnenRemicade · 4.8 · Immunogenicity Patients who developed antibodies to infliximab were more likely (approximately 2-3 fold) to de
Eintrag öffnenRemicade · 4.8 · In a 1-year clinical study with repeated infusions in patients with Crohn’s disease (ACCENT I study), the inci
Eintrag öffnenRemicade · 4.8 · In a clinical study of patients with Crohn’s disease (SONIC), infusion-related reactions occurred in 16.6% (27
Eintrag öffnenRemicade · 4.8 · In a clinical study of patients with rheumatoid arthritis (ASPIRE), infusions were to be administered over 2 h
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