[hot spot] State Food and Drug Administration: 3. Revision of drug instructions, attention paid to infants and pregnant women!

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 add warning words to Zhongjiefeng injection and revise the [adverse drug reactions], [contraindications] and [precautions] in the drug Manual of Xiaojin preparation (pills, capsules, tablets) The relevant matters are hereby announced as follows: 1 All the manufacturers of Zhongjiefeng injection and Xiaojin preparation shall, in accordance with the measures for the administration of drug registration and other relevant regulations, put forward the supplementary application for the revision of the instructions in accordance with the revision requirements of the corresponding instructions (see Annex 1-3), and report to the provincial drug regulatory authorities for the record before March 10, 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 drug manufacturers 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 corresponding instructions and the replacement of labels and instructions as required It is hereby announced Appendix of State Food and Drug Administration on December 25, 2018: 1 Requirements for revision of the instruction manual of Zhongjiefeng injection 2 Requirements for revision of the instruction manual of Xiaojin pill (capsule) 3 Requirements for revision of the instruction manual of Xiaojin tablet 1 Requirements for revision of the instruction manual of Zhongjiefeng injection 1 Warning words shall be added: 1 The adverse reactions of this product include anaphylactic shock, which should be used in the medical institutions with rescue conditions In case of anaphylactic reaction or other serious adverse reactions, the drug should be stopped immediately and treated in time 2 Intravenous administration is prohibited! 2、 [adverse reactions] items should be added: the following clinical manifestations can be seen in the case report of adverse reactions after the product is put on the market: Allergy and anaphylactic reactions: flush or pale skin, rash, pruritus, dyspnea, palpitation, cyanosis, anaphylactic shock, etc Whole body: shiver, fever, etc Skin: rash, pruritus, hyperhidrosis, flushing, paleness, etc Respiratory system: chest tightness, shortness of breath, dyspnea, etc Cardiovascular system: palpitation, cyanosis, etc Nervous system: dizziness, numbness of limbs, etc Digestive system: nausea, vomiting, etc Application site: pain, swelling, induration, etc 3、 [contraindications] should be added: 1 It is forbidden to use this product or the adjuvants listed in the preparations and ingredients of Sarcandra or those with a history of serious adverse reactions 2 It is forbidden for newborns and infants 4、 [precautions] items should be added: 1 The adverse reactions of this product include anaphylactic shock, which should be used in the medical institutions with rescue conditions The user should have received the training of anaphylactic shock rescue In case of anaphylactic reaction or other serious adverse reactions, the drug should be stopped immediately and be rescued in time 2 It is strictly used according to the functional indications specified in the drug manual, and it is forbidden to use the super functional indications 3 Strictly follow the usage and dosage recommended in the drug manual, do not exceed the dosage, do not use continuously for a long time, and do not use intravenous drugs 4 Those who have a history of drug allergy or allergic constitution should use it with caution 5 Improper storage of the product may affect the quality of the drug It is not allowed to use the product when it is found that the drug liquid has turbidity, precipitation, discoloration, crystallization and other changes in drug properties, as well as air leakage, cracks and other phenomena on the bottle body 6 This product should be used alone and should not be mixed with other drugs 7 Patients with abnormal liver and kidney function and the first use of traditional Chinese medicine injection should be carefully used and monitored 8 Children over 4 years old, the elderly, pregnant women and lactating women should use it with caution 9 Strengthen the monitoring of drug use and closely observe the drug response of patients, especially within 30 minutes after the drug use, if any abnormality is found, immediately and actively treat Annex 2 amendment requirements of Xiaojin pill (capsule) instruction 1 [adverse reactions] shall include: the monitoring data of adverse reactions after marketing shows that the following adverse reactions can be seen in the product: skin: rash, erythema multiforme, urticaria like rash, skin flushing, swelling, pruritus, etc., and case report of serious skin anaphylaxis Digestive system: nausea, vomiting, abdominal pain, diarrhea, dry mouth, abdominal distention, constipation, etc Others: dizziness, headache, palpitation, chest distress, fatigue, etc 2、 [contraindications] should be added: forbidden for pregnant women 3、 [precautions] items should be added: 1 This product contains Radix Aconiti, which should be taken under the guidance of doctors 2 Use with caution if you are allergic 3 Use with caution if the spleen and stomach are weak 4 Athletes should be careful 5 Use with caution in patients with liver and kidney dysfunction Annex 3 amendment requirements of Xiaojin tablet instructions 1 [adverse reactions] shall include: the monitoring data of adverse reactions after marketing shows that the following adverse reactions can be seen in the product: skin: rash, erythema multiforme, urticaria, skin flushing, swelling, pruritus, etc Digestive system: nausea, vomiting, abdominal pain, diarrhea, dry mouth, abdominal distention, constipation, etc Others: dizziness, headache, palpitation, chest distress, fatigue, etc 2、 [contraindications] should include: forbidden for pregnant women 3、 [precautions] should include: 1 This product contains Radix Aconiti, and should be taken under the guidance of a doctor 2 Use with caution if you are allergic 3 Use with caution if the spleen and stomach are weak 4 Athletes should be careful 5 Use with caution in patients with liver and kidney dysfunction.