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Tecfidera，Inn fumarate Inn -Fumarate-欧洲药品局
在暗示PML的第一个症状或症状下，应扣留tecfidera并进行适当的诊断评估，包括通过定量聚合酶链反应（PCR）方法学在脑脊液（CSF）中确定JCV DNA，需要进行。PML的症状可能类似于MS复发。与PML相关的典型症状是多种多样的，几天到几周的进展，包括身体一侧的渐进弱点或四肢的笨拙，视力障碍以及思维，记忆和方向的变化，导致混乱和人格变化。医生应特别警惕表明患者可能不会注意到的PML的症状。还应建议患者通知其伴侣或看护者的治疗，因为他们可能会注意到患者不知道的症状。
欧盟（EU）风险管理计划（RMP）tecfidera ...
Abbreviation Definition ADR adverse drug reaction ADME absorption, distribution, metabolism, and excretion AE adverse event ALC absolute lymphocyte counts ALP alkaline phosphatase ALT alanine transaminase AST aspartate transaminase ATC Anatomical Therapeutic Chemical Classification System AUC area under the concentration-time curve BID twice daily CBC complete blood count CD4 cluster of differentiation 4 CD8 cluster of differentiation 8 CI confidence interval CIS clinically isolated syndrome CLL chronic lymphocytic leukaemia CPN chronic progressive nephropathy CSF cerebrospinal fluid CSR clinical study report CV Cardiovascular CYP cytochrome P450 DHPC Direct Healthcare Professional Communication DILI drug-induced liver injury DMF dimethyl fumarate DMT disease-modifying therapy DNA deoxyribonucleic acid EDSS Expanded Disability Status Scale EEA European Economic Area EMA European Medical Agency EU European Union EUROCAT European Surveillance of Congenital Anomalies and Twins FAS full analysis set GA glatiramer acetate GCP Good Clinical Practice GFR glomerular filtration rate GI Gastrointestinal HCP health care professional hERG human ether-a-go-go-related基因HIV人类免疫缺陷病毒
