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Aucatzyl
Eintrag öffnenAucatzyl · 4.1 Therapeutic indications · 1
Eintrag öffnenAucatzyl · 4.3 Contraindications · 1
Eintrag öffnenAucatzyl · 4.3 · Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Contraindications
Eintrag öffnenAucatzyl · 4.4 Special warnings and precautions for use · 1
Eintrag öffnenAucatzyl · 4.5 Interaction with other medicinal products and other forms of interaction · 1
Eintrag öffnenAucatzyl · 4.5 · Administration of tocilizumab or corticosteroids for the treatment of CRS and ICANS did not affect the rate or
Eintrag öffnenAucatzyl · 4.5 · Live vaccines
Eintrag öffnenAucatzyl · 4.5 · No interaction studies have been performed.
Eintrag öffnenAucatzyl · 4.5 · Prophylactic use of systemic corticosteroids may interfere with the activity of Aucatzyl. Prophylactic use of
Eintrag öffnenAucatzyl · 4.5 · The safety of immunisation with live viral vaccines during or following treatment with Aucatzyl has not been s
Eintrag öffnenAucatzyl · 4.6 Fertility, pregnancy and lactation · 1
Eintrag öffnenAucatzyl · 4.8 Undesirable effects · 1
Eintrag öffnenAucatzyl · 4.8 · 15 Table 4: Adverse drug reactions identified with Aucatzyl System organ Frequency Adverse reaction class (SOC
Eintrag öffnenAucatzyl · 4.8 · 16 System organ Frequency Adverse reaction class (SOC) Pain Fatigue Oedema Common Chills Investigations Very c
Eintrag öffnenAucatzyl · 4.8 · 17 The median time to onset for ICANS events was 12 days (range: 1-31 days) with a median duration of 8 days (
Eintrag öffnenAucatzyl · 4.8 · 18 Reporting of suspected adverse reactions
Eintrag öffnenAucatzyl · 4.8 · Among the safety set (N=127), median time from day of Aucatzyl infusion to neutrophil recovery to ≥ 0.5 × 109/
Eintrag öffnenAucatzyl · 4.8 · CRS was reported in 68.5% of patients, including grade 3 CRS in 2.4% of patients. The median time to onset of
Eintrag öffnenAucatzyl · 4.8 · Cytokine release syndrome
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