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Eintrag öffnenPoteligeo · 4.1 Therapeutic indications · 1
Eintrag öffnenPoteligeo · 4.3 Contraindications · 1
Eintrag öffnenPoteligeo · 4.3 · Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Eintrag öffnenPoteligeo · 4.4 Special warnings and precautions for use · 1
Eintrag öffnenPoteligeo · 4.5 Interaction with other medicinal products and other forms of interaction · 1
Eintrag öffnenPoteligeo · 4.5 · No interaction studies have been performed.
Eintrag öffnenPoteligeo · 4.6 Fertility, pregnancy and lactation · 1
Eintrag öffnenPoteligeo · 4.8 Undesirable effects · 1
Eintrag öffnenPoteligeo · 4.8 · 5 the available data). Within each frequency grouping, undesirable effects are presented in order of decreasin
Eintrag öffnenPoteligeo · 4.8 · 6 of patients recovered from infection. In the clinical trial (0761-010), there were 2 reports of respiratory
Eintrag öffnenPoteligeo · 4.8 · Dermatologic reactions Patients receiving POTELIGEO have experienced drug rash (drug eruption), some of which
Eintrag öffnenPoteligeo · 4.8 · Description of selected adverse reactions
Eintrag öffnenPoteligeo · 4.8 · Elderly The safety profile in elderly patients (≥ 65 years) was generally consistent with that of adult patien
Eintrag öffnenPoteligeo · 4.8 · Gastrointestinal disorders Colitis was mainly characterized by watery diarrhoea, in some cases excessive.
Eintrag öffnenPoteligeo · 4.8 · Immunogenicity Following infusion of POTELIGEO during clinical trials of the use of POTELIGEO in patients with
Eintrag öffnenPoteligeo · 4.8 · Infusion interruptions occurred in approximately 6% of patients, most of which (approximately 90%) occurred wi
Eintrag öffnenPoteligeo · 4.8 · Infusion-related reactions Infusion-related reactions have been observed in 33% of patients treated with POTEL
Eintrag öffnenPoteligeo · 4.8 · Less than 1% of patients treated in Clinical Trial 0761-010 discontinued treatment due to infusion- related re
Eintrag öffnenPoteligeo · 4.8 · Of these, SADRs that were reported in more than one patient were coded under the SOCs Infections and infestati
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