In 2017, the new medical insurance catalog restricted 26 Chinese medicine injections used in medical institutions above Grade II, while Xuesaitong injection and Xueshuantong injection were not listed. In this revision of the drug label, in addition to restricting the use of the institution, it is also clear that the child is banned. It can be said that the restriction is on the new medical insurance catalogue in 2017.
â–血塞通 injection, thrombus injection, a large number of medical institutions disabled
1. According to the results of adverse drug reaction assessment, in order to further protect the safety of public medication, the State Drug Administration decided to inject Xuesaitong injection (Beisaitong injection, Xuesaitong for injection (freeze-dried)] and Xueshuantong injection [thrombotic Tong injection and thrombus injection (freeze-dried) are added to the warning, and the [taboo] and [precautions] items are revised.
It is also required to apply for a supplementary application for revision of the instructions of all Xuesaitong injection and thrombus injection preparation enterprises, and report to the provincial drug regulatory authority for filing before September 20, 2018.
As early as 2016, the former State Food and Drug Administration also revised the instructions for the two drugs. This revision can be said to be a limited use plus code, which clarifies that children are banned and should be used in medical institutions with rescue conditions.
On January 12, 2016, the former State Food and Drug Administration issued (No. 2, 2016) announcement, based on the results of adverse drug reaction assessment, announced the revision of adverse reactions, contraindications, and precautions in the instructions for Xuesaitong injection and Xueshuantong injection. Three items.
â– affects 10 billion markets and affects a batch of pharmaceutical companies
According to the latest data from the intranet, in 2017, the list of top 20 Chinese patent medicine products in Chinese public medical institutions, thrombus (freeze-dried) for injection and Xuesaitong (freeze-dried) for injection was 7.34 billion yuan, 5.66 billion yuan. Sales are ranked first and third.
According to the official website of the State Food and Drug Administration, there are currently 47 approvals for Xuesaitong injection, and the production units mainly involve 15 pharmaceutical companies.
There are a total of 10 approvals for Xueshuantong injection, and the production units mainly involve 5 pharmaceutical companies.
In other words, the limited use and ban of the two drugs will affect the 13 billion pharmaceutical market and affect 22 pharmaceutical companies.
In addition, according to the data of the intranet, in the Chinese patent medicine market, cardiovascular and cerebrovascular diseases accounted for more than 60% of the total, and sales exceeded 70 billion yuan. In 2016, 9 of the Chinese public medical institutions terminal Chinese medicine injection TOP10 products belonged to cardiovascular and cerebrovascular diseases.
It can be said that Xueshuantong and Xuesaitong not only occupy a huge share of traditional Chinese medicine injections and cardiovascular and cerebrovascular diseases, but also are the masters of many pharmaceutical enterprises. This revision of the drug specifications and restrictions on the scope of use can be seen.
Attachment: Revision requirements for Xuesaitong injection and Xueshuantong injection instructions
First, the warning should be added, the content is as follows:
Warning words: The adverse reactions of this product include anaphylactic shock. It should be used in medical institutions with rescue conditions. Users should receive anaphylactic shock training. Allergic reactions or other serious adverse reactions should be stopped immediately and treated promptly. .
Second, the [taboo] item should be increased:
Children are disabled.
Third, [Notes] items should be increased:
1. The adverse reactions of this product include anaphylactic shock. It should be used in medical institutions with rescue conditions. Users should receive anaphylactic shock training. Allergic reactions or other serious adverse reactions should be stopped immediately and treated promptly.
Replace the original instructions: "This product may cause anaphylactic shock. Once an allergic reaction or other serious adverse reactions occur after administration, the drug should be discontinued immediately and appropriate treatment should be given."
2. Strictly follow the functions prescribed by the drug label, and prohibit the use of super-function indications.
3. According to the original manual [Usage and Dosage] description is different, respectively revised:
(1) Original instructions [Usage and Dosage] No treatment description:
Strictly control the usage and dosage. Do not overdose, overdose, or long-term continuous use according to the recommended dosage and dosage requirements of the drug label.
(2) The original instructions [Usage and Dosage] have a description of the course of treatment:
Strictly control the dosage and treatment. Do not overdose, overdose, or long-term continuous use according to the recommended dosage and dosage requirements of the drug label.
4. Strengthen medication monitoring. During the course of medication, the drug response should be closely observed. In particular, within 30 minutes of starting the drug, abnormal abnormal drug withdrawal was found, and active treatment was used to treat the patient.
5. Improper storage of this product may affect the quality of the drug. The product and the instillation solution should be carefully inspected before, during and after the preparation, and it is found that the medicinal properties such as turbidity, sedimentation, discoloration, crystallization, etc., and leakage or cracking of the bottle body are not allowed.
â–血塞通 injection, thrombus injection, a large number of medical institutions disabled
1. According to the results of adverse drug reaction assessment, in order to further protect the safety of public medication, the State Drug Administration decided to inject Xuesaitong injection (Beisaitong injection, Xuesaitong for injection (freeze-dried)] and Xueshuantong injection [thrombotic Tong injection and thrombus injection (freeze-dried) are added to the warning, and the [taboo] and [precautions] items are revised.
It is also required to apply for a supplementary application for revision of the instructions of all Xuesaitong injection and thrombus injection preparation enterprises, and report to the provincial drug regulatory authority for filing before September 20, 2018.
As early as 2016, the former State Food and Drug Administration also revised the instructions for the two drugs. This revision can be said to be a limited use plus code, which clarifies that children are banned and should be used in medical institutions with rescue conditions.
On January 12, 2016, the former State Food and Drug Administration issued (No. 2, 2016) announcement, based on the results of adverse drug reaction assessment, announced the revision of adverse reactions, contraindications, and precautions in the instructions for Xuesaitong injection and Xueshuantong injection. Three items.
â– affects 10 billion markets and affects a batch of pharmaceutical companies
According to the latest data from the intranet, in 2017, the list of top 20 Chinese patent medicine products in Chinese public medical institutions, thrombus (freeze-dried) for injection and Xuesaitong (freeze-dried) for injection was 7.34 billion yuan, 5.66 billion yuan. Sales are ranked first and third.
According to the official website of the State Food and Drug Administration, there are currently 47 approvals for Xuesaitong injection, and the production units mainly involve 15 pharmaceutical companies.
There are a total of 10 approvals for Xueshuantong injection, and the production units mainly involve 5 pharmaceutical companies.
In other words, the limited use and ban of the two drugs will affect the 13 billion pharmaceutical market and affect 22 pharmaceutical companies.
In addition, according to the data of the intranet, in the Chinese patent medicine market, cardiovascular and cerebrovascular diseases accounted for more than 60% of the total, and sales exceeded 70 billion yuan. In 2016, 9 of the Chinese public medical institutions terminal Chinese medicine injection TOP10 products belonged to cardiovascular and cerebrovascular diseases.
It can be said that Xueshuantong and Xuesaitong not only occupy a huge share of traditional Chinese medicine injections and cardiovascular and cerebrovascular diseases, but also are the masters of many pharmaceutical enterprises. This revision of the drug specifications and restrictions on the scope of use can be seen.
Attachment: Revision requirements for Xuesaitong injection and Xueshuantong injection instructions
First, the warning should be added, the content is as follows:
Warning words: The adverse reactions of this product include anaphylactic shock. It should be used in medical institutions with rescue conditions. Users should receive anaphylactic shock training. Allergic reactions or other serious adverse reactions should be stopped immediately and treated promptly. .
Second, the [taboo] item should be increased:
Children are disabled.
Third, [Notes] items should be increased:
1. The adverse reactions of this product include anaphylactic shock. It should be used in medical institutions with rescue conditions. Users should receive anaphylactic shock training. Allergic reactions or other serious adverse reactions should be stopped immediately and treated promptly.
Replace the original instructions: "This product may cause anaphylactic shock. Once an allergic reaction or other serious adverse reactions occur after administration, the drug should be discontinued immediately and appropriate treatment should be given."
2. Strictly follow the functions prescribed by the drug label, and prohibit the use of super-function indications.
3. According to the original manual [Usage and Dosage] description is different, respectively revised:
(1) Original instructions [Usage and Dosage] No treatment description:
Strictly control the usage and dosage. Do not overdose, overdose, or long-term continuous use according to the recommended dosage and dosage requirements of the drug label.
(2) The original instructions [Usage and Dosage] have a description of the course of treatment:
Strictly control the dosage and treatment. Do not overdose, overdose, or long-term continuous use according to the recommended dosage and dosage requirements of the drug label.
4. Strengthen medication monitoring. During the course of medication, the drug response should be closely observed. In particular, within 30 minutes of starting the drug, abnormal abnormal drug withdrawal was found, and active treatment was used to treat the patient.
5. Improper storage of this product may affect the quality of the drug. The product and the instillation solution should be carefully inspected before, during and after the preparation, and it is found that the medicinal properties such as turbidity, sedimentation, discoloration, crystallization, etc., and leakage or cracking of the bottle body are not allowed.
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