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Atriance
Eintrag öffnenAtriance · 4.1 Therapeutic indications · 1
Eintrag öffnenAtriance · 4.3 Contraindications · 1
Eintrag öffnenAtriance · 4.3 · Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Eintrag öffnenAtriance · 4.4 Special warnings and precautions for use · 1
Eintrag öffnenAtriance · 4.5 Interaction with other medicinal products and other forms of interaction · 1
Eintrag öffnenAtriance · 4.5 · Concomitant administration of nelarabine in combination with adenosine deaminase inhibitors such as pentostati
Eintrag öffnenAtriance · 4.5 · Nelarabine and ara-G did not significantly inhibit the activities of the major hepatic cytochrome P450 (CYP) i
Eintrag öffnenAtriance · 4.6 Fertility, pregnancy and lactation · 1
Eintrag öffnenAtriance · 4.8 Undesirable effects · 1
Eintrag öffnenAtriance · 4.8 · 5 Blood and lymphatic system disorders Febrile neutropenia Very common: 12 (12%) Common: 1 (1%) Neutropenia Ve
Eintrag öffnenAtriance · 4.8 · 6 Gastrointestinal disorders Diarrhoea Very common: 23 (22%) Common: 2 (2%) Stomatitis Common: 8 (8%) Common:
Eintrag öffnenAtriance · 4.8 · 7 studies of nelarabine. The following additional adverse reactions were seen:
Eintrag öffnenAtriance · 4.8 · Adverse reactions Adults (1,500 mg/m2) Children (650 mg/m2) N=103 N=84 Infections and infestations Infection (
Eintrag öffnenAtriance · 4.8 · Data from NCI studies/compassionate use programme and phase I studies
Eintrag öffnenAtriance · 4.8 · Description of selected adverse reactions
Eintrag öffnenAtriance · 4.8 · In addition to the adverse reactions seen in the pivotal clinical studies, there are also data from 875 patien
Eintrag öffnenAtriance · 4.8 · Infection and infestations There was a single additional report of biopsy confirmed progressive multifocal leu
Eintrag öffnenAtriance · 4.8 · Neoplasms benign and malignant (including cysts and polyps) Tumour lysis syndrome – 7 cases (see sections 4.2
Eintrag öffnenAtriance · 4.8 · Nervous system disorders There have been reports of events associated with demyelination and ascending periphe
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