TREATMENT OF URTICARIA OFF-LABEL



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Abstract

The application of the drug, as indicated in the dosage form, dosage regimen, in population or other application parameters that are not mentioned in the approved instructions, called the use of off-label treatment. The prevalence of this phenomenon is as high as 90% in some areas. The vast majority of drugs used for the treatment of chronic urticaria, have no indication for its treatment. To reduce the risk of drug administration off-lable it is necessary to evaluate the clinical situation, the quality of evidence for the efficacy and safety of the drug. There are three categories of situations to make a decision to use off-lable treatment: to use justifiable proof of the quality, to use in the context of scientific research, to use in exceptional cases justified by special clinical situations. Legal support can help the doctor to decide responsibly to treat a patient offlabel.

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About the authors

I V Danilycheva

Institute of Immunology

Email: ivdanilycheva@mail.ru

I O Pecherey

Moscow State University of Medicine and Dentistry

Department of Forensic Medicine and Medical Law

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