National Medical Products Administration： Qingkailing injection is prohibited for newborns, infants and pregnant women.

　　CCTV News:Recently, official website, National Medical Products Administration released a message to revise the instructions for Qingkailing injection and Yiqifumai (freeze-drying) for injection. It is worth noting that Qingkailing injection, a large variety of Chinese patent medicine with an annual sales income of over 100 million yuan, clearly stipulates in the contraindications in the instructions that newborns, infants and pregnant women are prohibited.

　　The two drugs involved in the revision of the instructions belong to the category of traditional Chinese medicine injections, together with Shenmai injection, Bupleurum injection, Shuanghuanglian injection and Danshen injection previously announced, which is the announcement of the revision of the instructions for The 5th Wave traditional Chinese medicine injections issued by official website, National Medical Products Administration in 2018. What they have in common is that these traditional Chinese medicine injections are included in the "children’s forbidden list" to varying degrees, which should attract the attention of doctors and parents.

　　According to industry insiders, the revision of drug instructions is based on data such as adverse drug reaction monitoring, which is an inevitable trend of strengthening drug supervision and constantly standardizing clinical drug use, and should be more detailed and perfect. Take the adverse reactions in the modified instructions of Yiqi Fumai (freeze-drying) for injection as an example: the third item before the modification is "rare rash, chills and fever after using this product." If the above situation occurs, please stop taking the medicine immediately and deal with the symptoms. " After revision, the related contents of "3." under "Adverse Reactions" in the original manual were deleted, and nine items "Allergic reactions: skin flushing, rash, itching, dyspnea, palpitation, cyanosis, blood pressure drop, anaphylactoid reaction, anaphylactic shock, etc." were added. Systemic reactions: chills, fever, chills, chills, tremors, etc. Respiratory system: shortness of breath, breath holding, etc. Cardiovascular system: palpitation, chest tightness, elevated blood pressure, tachycardia, etc. Digestive system: nausea, vomiting and dry mouth. Neuropsychiatric system: dizziness, headache, tremor, irritability, local numbness, etc. Skin reactions: rash, itching, hyperhidrosis, local reactions, etc. Medication site: pain, injection site reaction, phlebitis, etc. Others: pain, fatigue, abnormal vision, menstrual disorder, etc. " Experts say that hospital pharmacists will report the adverse reactions in the process of clinical medication in time. The revised instructions list the adverse reactions in detail, which has played an important role in guiding clinical standardized drug use to some extent. (Reporter Zhang Ke)

　　(Professional Pharmaceutical Guidance: Director Lin Yang, Pharmacist Peng Wenxing, Department of Pharmacy, anzhen hospital, Beijing)

　　Attachment 1: Requirements for Revision of Instructions for Qingkailing Injection

　　First, warnings should be added, which should include:

　　Adverse reactions of this product include anaphylactic shock, which should be used in medical institutions with rescue conditions. Users should be trained in anaphylactic shock rescue, and allergic reactions or other serious adverse reactions after taking the drug should be stopped immediately and treated in time.

　　Two, [adverse reactions] shall include:

　　Allergic reaction: skin flushing or pallor, rash, itching, dyspnea, palpitation, cyanosis, blood pressure drop, laryngeal edema, anaphylactic shock, etc.

　　Systemic reactions: chills, chills, fever, high fever, pain, fatigue, hyperhidrosis, edema, trembling, etc.

　　Respiratory system: nasal congestion, sneezing, runny nose, throat discomfort, cough, wheezing, shortness of breath, dyspnea, etc.

　　Cardiovascular system: palpitation, chest tightness, chest pain, cyanosis, decreased or increased blood pressure, arrhythmia, etc.

　　Digestive system: nausea, vomiting, abdominal distension, abdominal pain, diarrhea, etc.

　　Neuropsychiatric system: dizziness, headache, irritability, convulsion, convulsion, syncope, tremor, confusion, coma, numbness of mouth and tongue or (and) limbs, drowsiness, insomnia, etc.

　　Skin and its accessories: redness, itching, rash, maculopapule, erythema, urticaria, local swelling, etc.

　　Vascular damage and coagulation disorders: mucosal congestion, purpura, phlebitis, etc.

　　Application site: pain, redness, rash, itching, etc.

　　Others: facial discomfort, tinnitus, abnormal tears, abnormal vision, eye congestion, myalgia, limb pain, herpes, hypokalemia, hematuria, etc.

　　Three, [taboo] should include:

　　1. Those who are allergic to this product or accessories listed in cholic acid, mother-of-pearl (powder), hyodeoxycholic acid, Gardenia, buffalo horn (powder), Radix Isatidis, baicalin and honeysuckle preparations and ingredients or have a history of serious adverse reactions are prohibited.

　　2. Newborns, infants and pregnant women are prohibited.

　　3. People with allergies are prohibited.

　　4. Persons with family allergy history are prohibited.

　　5. Those with hypokalemia including a history of periodic paralysis related to hypokalemia are prohibited.

　　Four, [matters needing attention] should include:

　　1. The adverse reactions of this product include anaphylactic shock, which should be used in medical institutions with rescue conditions. Users should be trained in anaphylactic shock rescue. If allergic reactions or other serious adverse reactions occur after taking the drug, the drug should be stopped immediately and treated in time.

　　2. Strictly follow the functional indications specified in the drug instructions, and prohibit the use of superfunctional indications.

　　3. Use in strict accordance with the recommended usage and dosage of the drug instructions, especially pay attention to not exceeding the dosage, too fast drip and long-term continuous medication.

　　4. Improper storage of this product may affect the quality of the drug. Before taking the drug, after preparation and during use, the product and the drip solution should be carefully checked. When the drug solution is found to have changes in drug properties such as turbidity, precipitation, discoloration and crystallization, as well as air leakage and cracks in the bottle body, it should not be used.

　　5. It is strictly forbidden to mix compatibility, and careful combination of drugs. This product should be used alone, and it is forbidden to mix with other drugs. If it is really necessary to use other drugs in combination, we should carefully consider the time interval and drug interaction with this product, and flush the infusion pipeline with appropriate diluent between the two drugs.

　　6. Patients should be carefully asked about their medication history and allergy history before medication. People with deficiency-cold constitution, those who use digitalis, patients with severe heart disease, patients with abnormal liver and kidney function, the elderly, lactating women and other special groups, as well as patients who use traditional Chinese medicine injections for the first time, should use them carefully and strengthen monitoring.

　　7. Strengthen medication monitoring. In the process of medication, the drug reaction should be closely observed, especially in the first 30 minutes. If any abnormality is found, stop taking medicine immediately and adopt active treatment measures to treat patients.

　　Attachment 2: Requirements for Revision of Instructions for Yiqi Fumai Injection (Freeze-dried)

　　First, warnings should be added, which should include:

　　II. Item [Adverse Reaction] shall:

　　Delete the related contents of "3." under "Adverse Reactions" in the original manual and add the following contents:

　　3. Post-marketing monitoring data show that the following adverse reactions can be seen in this product:

　　Allergic reaction: skin flushing, rash, itching, dyspnea, palpitation, cyanosis, blood pressure drop, anaphylactoid reaction, anaphylactic shock, etc.

　　Systemic reactions: chills, fever, chills, chills, tremors, etc.

　　Respiratory system: shortness of breath, breath holding, etc.

　　Cardiovascular system: palpitation, chest tightness, elevated blood pressure, tachycardia, etc.

　　Digestive system: nausea, vomiting and dry mouth.

　　Neuropsychiatric system: dizziness, headache, tremor, irritability, local numbness, etc.

　　Skin reactions: rash, itching, hyperhidrosis, local reactions, etc.

　　Medication site: pain, injection site reaction, phlebitis, etc.

　　Others: pain, fatigue, abnormal vision, menstrual disorder, etc.

　　Three, [taboo] should add the following contents:

　　Those who are allergic to this product or accessories listed in preparations and ingredients containing Ginseng Radix Rubri, Radix Ophiopogonis and Fructus Schisandrae Chinensis or have a history of serious adverse reactions are prohibited.

　　Four, [notes] should be:

　　Delete the related contents of "3." under [Precautions] in the original manual and add the following contents:

　　2. Strictly follow the functional indications specified in the drug instructions, and prohibit the use of superfunctional indications.

　　3. Use in strict accordance with the drug instructions, especially pay attention to not exceeding the dosage, too fast drip and long-term continuous medication.

　　4. It is strictly forbidden to mix compatibility, and careful combination of drugs. This product should be used alone, and it is forbidden to mix with other drugs. If it is really necessary to use other drugs in combination, we should carefully consider the time interval and drug interaction with this product, and flush the infusion pipeline with appropriate diluent between the two drugs.

　　5. Before taking the medicine, you should carefully ask about the allergic history, and it is forbidden for those with allergic constitution.

　　6. The elderly and patients who use traditional Chinese medicine injections for the first time should use them carefully and strengthen monitoring.

　　8. This product has a blood pressure increase reaction, so you should pay attention to the change of blood pressure when using this product.

　　9. This product should not be used with Veratrum nigrum, Oletum Trogopterori and their preparations.