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I have contacted CM REC about confidentiality and it is OK to pose this question:-
In one clinical trial Midazolam 0.1mg/ml for oral administration was prepared by diluting Midazolam solution for injection 2mg/ml with 5% glucose. Presumably this will not be covered by Hameln's (the injection manufacturer) marketing authorisation. The BNF 72 quotes a non proprietary Midazolam 2mg/ml and Buccolam 5mg/ml oromucosal solution.
1) Should the trial participants be informed that the Midazolam 0.1mg/ml is used off license when other licensed forms are available or is this irrelevant in CTs.
2) What is the significance of "non-proprietary". I believe this form is imported from Paddock labs USA so would this be "off label"use too?
3) Should the Shire licensed Buccolam oromucosal solution be used instead?
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