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...
متن کامل[Challenges on off label medicine use].
p After the Second World War, the so-called pharmacological explosion took place, leading to major advances in the treatment of diseases that were once inevitably fatal or disabling. This pharmacological expansion contributed to the occurrence of catastrophic incidents, such as the phocomelia epidemic attributed to thalidomide. Since then, concerns about drug safety have contributed to the deve...
متن کاملHypoglycemia associated with off-label sitagliptin use
PURPOSE To describe a case of hypoglycemia induced by off-label use of sitagliptin in an adult patient with type 2 diabetes. CASE SUMMARY Addition of sitagliptin to metformin, glimepiride, and NovoLog(®) 70/30 Mix induced hypoglycemia in a 55-year-old Caucasian female. Hypoglycemia improved, although still occurred periodically, following sulfonylurea discontinuation and a 28% insulin dose re...
متن کاملOff-label drug use: author's reply.
The authors have stated that the accuracy of dose was checked from standard neonatal formularies, viz. British National Formulary 2005 and Neofax 2008, and stated that 75% of medications were not approved by FDA for neonatal use. They have not mentioned the document or the source that they relied upon to classify the drug as off-label or otherwise. It may not be advisable to decide if use of a ...
متن کاملOff-label use of misoprostol in gynaecology
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...
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ژورنال
عنوان ژورنال: Annals of Oncology
سال: 2016
ISSN: 0923-7534
DOI: 10.1093/annonc/mdw489