The State Food and Drug Administration issued a revised instruction manual for cimetidine injection preparations

On January 12, according to the evaluation results of adverse drug reactions, in order to further ensure the safety of public medication, the State Food and Drug Administration issued the "About Amendment of the Instructions for Cimetidine Injection Preparations", and decided to impose restrictions on cimetidine injection preparations (including cimetidine injection preparations).
The contents of the instructions for injection, cimetidine for injection, and cimetidine sodium chloride injection) were revised uniformly
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The relevant matters are hereby announced as follows: 1.
The marketing authorization holders of the above-mentioned drugs shall, in accordance with the relevant regulations such as the "Administrative Measures for Drug Registration", and in accordance with the requirements for the revision of the instruction manual of cimetidine injection preparations (see attachment), on April 10, 2022 A few days ago, it was reported to the Drug Evaluation Center of the State Drug Administration or the provincial drug supervision and administration department for the record
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If the revised content involves the drug label, it shall be revised together; the instructions and other contents of the label shall be consistent with the original approved content
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Drugs produced from the date of filing shall not continue to use the original drug inserts
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The drug marketing authorization holder shall replace the package insert and label of the drug that has already left the factory within 9 months after filing
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2.
The drug marketing license holder shall conduct in-depth research on the occurrence mechanism of newly added adverse reactions, take effective measures to do a good job in publicity and training on drug use and safety issues, and guide physicians and pharmacists to use drugs rationally
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3.
Clinicians and pharmacists should carefully read the revised contents of the above-mentioned drug insert sheets, and should conduct adequate benefit/risk analysis according to the newly revised insert sheets when choosing medication
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4.
Patients should read the instructions carefully before taking medication, and those who use prescription drugs should strictly follow the doctor's instructions
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5.
Provincial drug regulatory authorities shall urge the drug marketing authorization holders of the above-mentioned drugs within the administrative region to do a good job in revising the corresponding instructions and replacing the labels and instructions as required, and strictly investigate and punish violations of laws and regulations in accordance with the law
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