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Kyntheum
Eintrag öffnenKyntheum · 4.1 Therapeutic indications · 1
Eintrag öffnenKyntheum · 4.3 Contraindications · 1
Eintrag öffnenKyntheum · 4.3 · Active Crohn’s disease.
Eintrag öffnenKyntheum · 4.3 · Clinically important active infections (e.g. active tuberculosis, see section 4.4).
Eintrag öffnenKyntheum · 4.3 · Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Eintrag öffnenKyntheum · 4.4 Special warnings and precautions for use · 1
Eintrag öffnenKyntheum · 4.5 Interaction with other medicinal products and other forms of interaction · 1
Eintrag öffnenKyntheum · 4.5 · In patients with moderate to severe plaque psoriasis, a single subcutaneous dose of 210 mg brodalumab increase
Eintrag öffnenKyntheum · 4.5 · Live vaccines should not be given concurrently with brodalumab (see section 4.4).
Eintrag öffnenKyntheum · 4.5 · The formation of CYP450 enzymes can be altered by increased levels of certain cytokines (e.g. IL-1, IL-6, IL-1
Eintrag öffnenKyntheum · 4.6 Fertility, pregnancy and lactation · 1
Eintrag öffnenKyntheum · 4.8 Undesirable effects · 1
Eintrag öffnenKyntheum · 4.8 · 5 Table 1: List of adverse reactions in clinical trials and post-marketing experience
Eintrag öffnenKyntheum · 4.8 · Adverse reactions from clinical trials and post-marketing experience (Table 1) are listed by MedDRA system org
Eintrag öffnenKyntheum · 4.8 · Description of selected adverse reactions
Eintrag öffnenKyntheum · 4.8 · Infections During the 12-week placebo-controlled trial period in plaque psoriasis, infections were reported in
Eintrag öffnenKyntheum · 4.8 · Inflammatory bowel disease Cases of new or exacerbations of inflammatory bowel disease (including Crohn's dise
Eintrag öffnenKyntheum · 4.8 · Neutropenia During the 12-week placebo-controlled period of clinical trials, neutropenia was reported in 0.9%
Eintrag öffnenKyntheum · 4.8 · Neutropenia Grade 3 (<1.0 × 109/L to 0.5 × 109/L) was reported in 0.5% of patients receiving brodalumab compar
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