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Lynozyfic
Eintrag öffnenLynozyfic · 4.1 Therapeutic indications · 1
Eintrag öffnenLynozyfic · 4.3 Contraindications · 1
Eintrag öffnenLynozyfic · 4.3 · Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Eintrag öffnenLynozyfic · 4.4 Special warnings and precautions for use · 1
Eintrag öffnenLynozyfic · 4.5 Interaction with other medicinal products and other forms of interaction · 1
Eintrag öffnenLynozyfic · 4.5 · 14 products that are CYP substrates where minimal changes in concentration may lead to serious adverse reactio
Eintrag öffnenLynozyfic · 4.5 · No drug interaction studies have been conducted with LYNOZYFIC.
Eintrag öffnenLynozyfic · 4.5 · Transient elevation of cytokines may suppress CYP450 enzyme activities. The highest risk of drug interaction i
Eintrag öffnenLynozyfic · 4.6 Fertility, pregnancy and lactation · 1
Eintrag öffnenLynozyfic · 4.8 Undesirable effects · 1
Eintrag öffnenLynozyfic · 4.8 · 15 Permanent discontinuation of LYNOZYFIC due to adverse reactions occurred in 19% of patients. The most frequ
Eintrag öffnenLynozyfic · 4.8 · 16 MedDRA System Adverse reaction Frequency Any grade Grade 3 or 4 Organ Class categories (All (%) (%) grades)
Eintrag öffnenLynozyfic · 4.8 · 17 MedDRA System Adverse reaction Frequency Any grade Grade 3 or 4 Organ Class categories (All (%) (%) grades)
Eintrag öffnenLynozyfic · 4.8 · 18 in all patients except one who withdrew consent to follow-up. The median time to onset of ICANS was 1 (rang
Eintrag öffnenLynozyfic · 4.8 · Adverse reactions observed during the clinical study are listed below by MedDRA system organ class classificat
Eintrag öffnenLynozyfic · 4.8 · Clinical signs and symptoms of CRS included, but were not limited to, pyrexia, chills, hypoxia, tachycardia, a
Eintrag öffnenLynozyfic · 4.8 · Cytokine release syndrome CRS occurred in 46% of patients who received LYNOZYFIC at the recommended dose, with
Eintrag öffnenLynozyfic · 4.8 · Description of selected adverse reactions
Eintrag öffnenLynozyfic · 4.8 · Hyperuricaemia Very common 10 1.7
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