Two enterprises were affected by the revised specification of Bufonis injection

On March 18, the State Food and Drug Administration announced that it had decided to revise the instructions for bufoni injection drugs [warning words], [adverse reactions], [taboos] and [precautions] According to the pharmaceutical intelligence data, only Jiangsu Pujin Pharmaceutical Co., Ltd and Anhui Fengyang Keyuan Pharmaceutical Co., Ltd have been approved for the production of Chansu injection, with 2 specifications and 4 production approvals respectively The details are as follows: according to the evaluation results of adverse drug reactions, in order to further ensure the safety of drug use by the public, the State Drug Administration decided to revise the "warning words", "adverse reactions", "Taboos" and "precautions" and other items in the drug Manual of Bufonis injection The relevant matters are hereby announced as follows: 1 All the above-mentioned pharmaceutical manufacturers shall, in accordance with the measures for the administration of drug registration and other relevant provisions, put forward the supplementary application for the revision of the instructions in accordance with the revision requirements of the corresponding instructions (see Annex 1-2), and report to the provincial drug regulatory authorities for the record before May 25, 2019 If the revised contents involve drug labels, they shall be revised together; the instructions and other contents of the labels shall be consistent with the original approved contents Within 6 months after the supplementary application is filed, the ex factory drug instructions and labels shall be replaced The above-mentioned drug manufacturing enterprises shall conduct in-depth research on the mechanism of new adverse reactions, take effective measures to do a good job in the publicity and training of relevant drug use and safety issues, and guide doctors to use drugs reasonably 2、 Clinicians should carefully read the revised contents of the above drug instructions, and make full benefit / risk analysis according to the newly revised instructions when selecting drugs 3、 The above-mentioned drugs are prescription drugs, and patients should strictly follow the doctor's instructions, and carefully read the above-mentioned drug instructions before use 4、 Each provincial drug regulatory department shall urge the above-mentioned drug manufacturing enterprises in the administrative region to do a good job in the revision of the corresponding instructions and the replacement of labels and instructions according to the requirements; and strictly investigate and punish the illegal behaviors according to law It is hereby announced Appendix: requirements for the revision of the specification of Bufo Su injection issued by the State Food and Drug Administration on March 12, 2019 This product has serious allergic reaction case report and should be used in the medical institutions with rescue conditions The user should have received the rescue training of anaphylactic shock If there is anaphylactic reaction or other serious adverse reactions after using, the drug should be stopped immediately and treated in time 2、 [adverse reactions] add the following content: the monitoring data after marketing shows that the product has the following adverse reactions: 1 Allergic reactions: skin flushing, rash, pruritus, dyspnea, palpitation, blood pressure drop, anaphylactic shock, etc 2 Application site: pain and rash 3 Cardiovascular system: palpitation, arrhythmia, etc 4 Others: nausea, vomiting, chills, fever, etc 3、 Increase under contraindications: forbidden for newborns and infants 4、 [precautions] add the following contents: 1 This product has serious allergic reaction case report, should be used in the medical institutions with rescue conditions, the user should have received the rescue training of anaphylactic shock, and if there is anaphylactic reaction or other serious adverse reactions after use, the drug should be stopped immediately and treated in time 2 Use in strict accordance with the functions specified in the drug manual 3 Strictly control the usage, dosage and treatment course According to the recommended dosage and dispensing requirements of the drug manual, the drug shall not be over dosage, over rapid infusion or long-term continuous use 4 It is strictly prohibited to mix and use drugs carefully This product should be used alone and should not be mixed with other drugs If it is necessary to use other drugs in combination, the interval time and drug interaction with the product should be carefully considered The infusion pipeline should be flushed with a proper amount of diluent to avoid the risk of mixing the toad venom injection and other drugs in the pipeline 5 Before medication, the patient's condition, medication history and allergy history should be inquired carefully For the elderly and other special groups and patients who use this product for the first time, we should use it carefully and strengthen the clinical medication monitoring 6 This product has no evidence of children's safety and effectiveness, so it is not recommended for children 7 Strengthen medication monitoring During the course of medication, the reaction of medication should be closely observed, especially at the beginning of 30 minutes If any abnormality is found, the drug should be stopped immediately, and active treatment measures should be taken to treat the patient 8 Improper storage of the product may affect the quality of the drug Before, after and during the use of the drug, the product and the infusion solution should be checked carefully It is forbidden to use the drug solution when it is found that the properties of the drug such as turbidity, precipitation, discoloration, crystallization and the bottle body has air leakage, cracks and other phenomena.