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The specific announcement is as follows: The State Drug Administration's announcement on the revision of the instructions for the injection of mentamate birdine (No. 121 of 2020) In order to further ensure the safety of public drug use, the State Drug Administration has decided to inject mentamate birdine (including The instructions "Adverse reactions", "precautions", "taboos", "pregnant and lactating women's medication", "children's medicine" and "old age medication" are revised.
The relevant matters will now be announced as follows: First, all production enterprises of methionine birdine injections shall, in accordance with the Measures for the Administration of Drug Registration and other relevant provisions, in accordance with the revised requirements of the instructions for the injection of methionine (see annex), put forward a supplementary application for revision of the instructions, to be reported to the provincial drug regulatory authorities before January 28, 2021 for the record.
the contents of the drug shall be revised together, and the instructions and other contents of the label shall be consistent with the original approval contents.
to replace all factory-issued drug instructions and labels within 9 months of filing the supplementary application.
The above-mentioned production enterprises for the occurrence of new adverse reactions should carry out in-depth research on the mechanism of new adverse reactions, take effective measures to do a good job in the use and safety of publicity and training, related to drug safety content changes should immediately and appropriately notify the drug management and use units, guide physicians, pharmacists reasonable drug use.
. Clinicians and pharmacists shall carefully read the revised contents of the instruction manual for the injection of methionine and, when selecting the drug, conduct a full benefit/risk analysis in accordance with the newly revised instruction manual.
, patients should strictly follow the doctor's instructions for medication, before taking the drug should carefully read the instructions.
this announcement.