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Blincyto
Eintrag öffnenBlincyto · 4.1 Therapeutic indications · 1
Eintrag öffnenBlincyto · 4.3 Contraindications · 1
Eintrag öffnenBlincyto · 4.3 · - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. - Breast-feeding
Eintrag öffnenBlincyto · 4.4 Special warnings and precautions for use · 1
Eintrag öffnenBlincyto · 4.5 Interaction with other medicinal products and other forms of interaction · 1
Eintrag öffnenBlincyto · 4.5 · Initiation of BLINCYTO treatment causes transient release of cytokines during the first days of treatment that
Eintrag öffnenBlincyto · 4.5 · No formal drug interaction studies have been performed. Results from an in vitro test in human hepatocytes sug
Eintrag öffnenBlincyto · 4.6 Fertility, pregnancy and lactation · 1
Eintrag öffnenBlincyto · 4.8 Undesirable effects · 1
Eintrag öffnenBlincyto · 4.8 · 16 leukopenia (13.8%), constipation (13.5%), decreased immunoglobulins (13.4%), viral infectious disorders (13
Eintrag öffnenBlincyto · 4.8 · 17 MedDRA system Very common Common Uncommon organ class (≥ 1/10) (≥ 1/100 to < 1/10) (≥ 1/1 000 to < 1/100) S
Eintrag öffnenBlincyto · 4.8 · 18 reactions (including psychiatric disorders), primarily involving the CNS. Serious and grade ≥ 3 neurologic
Eintrag öffnenBlincyto · 4.8 · 19 Cytokine release syndrome was reported in 8.9% of adult patients with Philadelphia chromosome- positive rel
Eintrag öffnenBlincyto · 4.8 · 20 Leukoencephalopathy including progressive multifocal leukoencephalopathy
Eintrag öffnenBlincyto · 4.8 · 21 Immunogenicity
Eintrag öffnenBlincyto · 4.8 · Adverse reactions are presented below by system organ class and frequency category. Frequency categories were
Eintrag öffnenBlincyto · 4.8 · Anti-blinatumomab antibody formation may affect the pharmacokinetics of BLINCYTO.
Eintrag öffnenBlincyto · 4.8 · At a dose higher than the recommended dose in study MT103-205, a case of fatal cardiac failure occurred in the
Eintrag öffnenBlincyto · 4.8 · BLINCYTO has also been evaluated in paediatric patients with high-risk first relapsed B-cell precursor ALL in
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