Food and Drug Administration (Drugs and Drugs Supervision Bureaus) of provinces, autonomous regions, and municipalities directly under the Central Government:
According to the results of adverse reaction assessment, it was decided to revise the specifications of safflower injection in order to control the risk of drug use. The relevant matters are hereby notified as follows:
First, the safflower injection specification is revised in accordance with the attached specification amendment requirements. The other contents of the manual should be consistent with the original approval.
Second, please inform the pharmaceutical production enterprises in the administrative area to do the relevant work:
(1) Pharmaceutical manufacturers should revise their manuals as soon as possible and file them according to relevant regulations. Pharmaceuticals that have been manufactured since the date of approval of the supplementary application may not continue to use the original drug instructions. Pharmaceutical production companies should actively track the safety of clinical use of such drugs, collect adverse reactions and report them in a timely manner.
(2) Pharmaceutical production enterprises shall promptly notify the relevant medical institutions, drug management companies and other entities of the contents of the revision, and promptly replace the exempted pharmaceutical instructions. The adverse consequences caused by the failure to replace the manual in a timely manner shall be the responsibility of the drug manufacturer.
(3) If the label of a drug involves related content, it should be revised together.
State Food and Drug Administration Aug. 27, 2012 Attachment of the safflower injection instructions. Amendments 1. Increase the warning words as follows:
Warning words: This product adverse reactions include anaphylactic shock, should be used in medical institutions with rescue conditions, allergic reactions or other serious adverse reactions after medication should be immediately discontinued and timely treatment.
Second, the "adverse reactions" item should include:
Systemic damage: allergic reactions, anaphylactic shock, chills, fever, pale, etc.
Respiratory damage: difficulty breathing, coughing, wheezing, laryngeal edema, etc.
Cardiovascular system damage: palpitations, arrhythmia, cyanosis, etc.
Central and peripheral nervous system damage: dizziness, headache, convulsions, etc.
Gastrointestinal system damage: Nausea and vomiting.
Damage to the skin and its accessories: rashes, itching.
Third, taboo items should include:
1. Allergic or severe adverse reactions to this product or preparations containing safflower are prohibited.
2. Diabetic patients with abnormal blood coagulation and retinal hemorrhage were banned.
3. Pregnant women, lactating women and children are banned.
Fourth, [Note] items should include:
1. The adverse reactions of this product include anaphylactic shock, which should be used in medical institutions with rescue conditions. Any allergic reactions or other serious adverse reactions after drug use should be stopped immediately and promptly treated.
2. In strict accordance with the functional indications specified in the drug instruction manual, it is forbidden to use hyperactive drugs.
3. Strictly control usage and dosage and treatment. According to the drug manual recommended dose, medication use during treatment. Do not overdose and long-term continuous medication.
4. Patients should be carefully asked about medication history and history of allergies before treatment, and allergic persons should be used with caution.
5. Before using the drug, the drug and the instillation liquid after configuration should be carefully checked, and any change in drug properties, such as turbidity, sedimentation, discoloration, and crystallization, and slight breakdown of the bottle body, should not be used.
6. The drug dilution should be prepared strictly in accordance with the requirements of the instructions. The type of dilution, dilution concentration, and amount of diluted solution should not be arbitrarily changed. After dispensing, it should be adhered to and used immediately. It should not be placed for a long time.
7. It is forbidden to mix and combine drugs carefully. Chinese medicine injections should be used alone, and taboos should be mixed and used with other drugs. Careful combination of drugs, such as the need to jointly use other drugs, should carefully consider the time interval and the drug interactions with traditional Chinese medicine injections and other issues.
8. Patients with special diseases such as the elderly, patients with abnormal liver and kidney function, and those who use traditional Chinese medicine injections for the first time should be cautiously used to strengthen monitoring. For long-term use, there should be a certain interval between each treatment.
9. The monitoring data suggest that there are cases of liver and kidney dysfunction cases related to this product, and it is recommended to strengthen liver and kidney function monitoring during clinical use.
10. Strengthen medication monitoring. The medication should be instilled slowly while observing the medication response, especially starting 30 minutes. If abnormalities are found, medication should be discontinued immediately and positive measures should be taken to treat the patient.
According to the results of adverse reaction assessment, it was decided to revise the specifications of safflower injection in order to control the risk of drug use. The relevant matters are hereby notified as follows:
First, the safflower injection specification is revised in accordance with the attached specification amendment requirements. The other contents of the manual should be consistent with the original approval.
Second, please inform the pharmaceutical production enterprises in the administrative area to do the relevant work:
(1) Pharmaceutical manufacturers should revise their manuals as soon as possible and file them according to relevant regulations. Pharmaceuticals that have been manufactured since the date of approval of the supplementary application may not continue to use the original drug instructions. Pharmaceutical production companies should actively track the safety of clinical use of such drugs, collect adverse reactions and report them in a timely manner.
(2) Pharmaceutical production enterprises shall promptly notify the relevant medical institutions, drug management companies and other entities of the contents of the revision, and promptly replace the exempted pharmaceutical instructions. The adverse consequences caused by the failure to replace the manual in a timely manner shall be the responsibility of the drug manufacturer.
(3) If the label of a drug involves related content, it should be revised together.
State Food and Drug Administration Aug. 27, 2012 Attachment of the safflower injection instructions. Amendments 1. Increase the warning words as follows:
Warning words: This product adverse reactions include anaphylactic shock, should be used in medical institutions with rescue conditions, allergic reactions or other serious adverse reactions after medication should be immediately discontinued and timely treatment.
Second, the "adverse reactions" item should include:
Systemic damage: allergic reactions, anaphylactic shock, chills, fever, pale, etc.
Respiratory damage: difficulty breathing, coughing, wheezing, laryngeal edema, etc.
Cardiovascular system damage: palpitations, arrhythmia, cyanosis, etc.
Central and peripheral nervous system damage: dizziness, headache, convulsions, etc.
Gastrointestinal system damage: Nausea and vomiting.
Damage to the skin and its accessories: rashes, itching.
Third, taboo items should include:
1. Allergic or severe adverse reactions to this product or preparations containing safflower are prohibited.
2. Diabetic patients with abnormal blood coagulation and retinal hemorrhage were banned.
3. Pregnant women, lactating women and children are banned.
Fourth, [Note] items should include:
1. The adverse reactions of this product include anaphylactic shock, which should be used in medical institutions with rescue conditions. Any allergic reactions or other serious adverse reactions after drug use should be stopped immediately and promptly treated.
2. In strict accordance with the functional indications specified in the drug instruction manual, it is forbidden to use hyperactive drugs.
3. Strictly control usage and dosage and treatment. According to the drug manual recommended dose, medication use during treatment. Do not overdose and long-term continuous medication.
4. Patients should be carefully asked about medication history and history of allergies before treatment, and allergic persons should be used with caution.
5. Before using the drug, the drug and the instillation liquid after configuration should be carefully checked, and any change in drug properties, such as turbidity, sedimentation, discoloration, and crystallization, and slight breakdown of the bottle body, should not be used.
6. The drug dilution should be prepared strictly in accordance with the requirements of the instructions. The type of dilution, dilution concentration, and amount of diluted solution should not be arbitrarily changed. After dispensing, it should be adhered to and used immediately. It should not be placed for a long time.
7. It is forbidden to mix and combine drugs carefully. Chinese medicine injections should be used alone, and taboos should be mixed and used with other drugs. Careful combination of drugs, such as the need to jointly use other drugs, should carefully consider the time interval and the drug interactions with traditional Chinese medicine injections and other issues.
8. Patients with special diseases such as the elderly, patients with abnormal liver and kidney function, and those who use traditional Chinese medicine injections for the first time should be cautiously used to strengthen monitoring. For long-term use, there should be a certain interval between each treatment.
9. The monitoring data suggest that there are cases of liver and kidney dysfunction cases related to this product, and it is recommended to strengthen liver and kidney function monitoring during clinical use.
10. Strengthen medication monitoring. The medication should be instilled slowly while observing the medication response, especially starting 30 minutes. If abnormalities are found, medication should be discontinued immediately and positive measures should be taken to treat the patient.
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