منابع مشابه
Off-label use of vaccines.
This article reviews the off-label recommendations and use of vaccines, and focuses on the differences between the labelled instructions on how to use the vaccine as approved by the regulatory authorities (or "label"1), and the recommendations for use issued by public health advisory bodies at national and international levels. Differences between public health recommendations and the product l...
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Clinical use of drugs is approved for specified clinical indication, route of administration, dose and population group. Off-label prescribing of a registered medicine occurs outside of these parameters and may be justified by pharmacology and physiology, as well as sufficient evidence from published clinical trials and reviews. Misoprostol and mifepristone in combination have recently been reg...
متن کاملAutomated Detection of Off-Label Drug Use
Off-label drug use, defined as use of a drug in a manner that deviates from its approved use defined by the drug's FDA label, is problematic because such uses have not been evaluated for safety and efficacy. Studies estimate that 21% of prescriptions are off-label, and only 27% of those have evidence of safety and efficacy. We describe a data-mining approach for systematically identifying off-l...
متن کاملThe Off - label Use of Mitomycin C
By Steven D. Vold, MD Isolated from the fungus Streptomyces caespitosus, mitomycin C (MMC) inhibits DNA synthesis, which prevents cells from dividing and growing.1,2 It is this quality that led the FDA to approve MMC for the treatment of advanced stomach and pancreatic cancer in combination with other chemotherapeutic agents. MMC is also currently widely used in ophthalmology, including glaucom...
متن کاملOff-label use of drug-eluting stents.
ince Food and Drug Administration (FDA) approval of he first drug-eluting stent (DES) in April 2003, their use ncreased to 90% of all coronary stent procedures in the U.S. y 2006 (1). With restenosis virtually eliminated, DES were pplied to increasingly more complex coronary lesions. owever, over the past few years, reports of late stent hrombosis began to emerge. Additional reports of late ste...
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ژورنال
عنوان ژورنال: Vaccine
سال: 2017
ISSN: 0264-410X
DOI: 10.1016/j.vaccine.2017.02.056