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    Home > Medical News > Latest Medical News > Two more prescription directions have been revised!

    Two more prescription directions have been revised!

    • Last Update: 2019-12-13
    • Source: Internet
    • Author: User
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    According to the results of adverse drug reaction monitoring and safety evaluation, in order to further ensure the public drug safety, the State Drug Administration decided to add warning words to the instructions of danxiangguanxin injection, and revise the instructions of danxiangguanxin injection and compound cantharid capsule [adverse reactions], [taboos] and [precautions] The relevant matters are hereby announced as follows: 1 All the above-mentioned drug manufacturers shall, in accordance with the measures for the administration of drug registration and other relevant provisions, put forward the supplementary application for amending the instructions in accordance with the revision requirements of the corresponding instructions (see Annex 1 and 2), and report to the provincial drug regulatory authorities for the record before January 10, 2020 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; organize strict investigation and punishment of the illegal behaviors according to law It is hereby announced Annex: 1 Requirements for the revision of the instructions of compound cantharis capsule 2 Requirements for the revision of the instructions of danxiangguanxin injection on October 9, 2019 of the State Food and Drug Administration 1 The following content should be added to the [adverse reactions] item: the monitoring data after the listing shows that the product can see the following adverse reactions: Digestive system: nausea, vomiting, abdominal pain, diarrhea, abdominal discomfort, etc., with a case report of liver dysfunction Skin: rash, pruritus, etc Nervous system: dizziness, convulsion, numbness of mouth and tongue Urinary system: case report of hematuria, dysuria and renal dysfunction Others: a case report of palpitation and elevated blood sugar 2、 The following contents should be added to the [contraindications]: 1 Forbidden for pregnant women and lactating women 2 It is forbidden to use this product or its ingredients if they are allergic 3、 [precautions] the following contents should be added: 1 Those with disorder of glucose metabolism should be used with caution 2 The allergic history should be inquired, and the allergic constitution should be used with caution 3 Those with abnormal liver and kidney function should be used with caution 4 Strictly control the dosage and do not overdose it Requirements for revision of danxiangguanxin injection Manual 1 The following contents should be added to the warning words: This product has case reports of anaphylactic shock, and should be used in medical institutions with rescue conditions The user should have received the training of anaphylactic shock rescue In case of anaphylactic shock or other serious adverse reactions, the drug should be stopped immediately and treated in time 2、 [adverse reaction] item is modified as: the monitoring data after marketing shows that the following adverse reactions can be seen in this product: 1 Allergic or anaphylactic reactions: skin flushing or pallor, skin rash, pruritus, dyspnea, palpitation, cyanosis, blood pressure drop, laryngeal edema, anaphylactic shock, etc 2 Skin and its accessories: rash, pruritus, redness, hyperhidrosis, etc 3 Systemic response: chest tightness, chills, fever, pain, fatigue, etc 4 Digestive system: nausea, vomiting, abdominal pain, diarrhea, abdominal distention, dry mouth, etc 5 Neuropsychiatric system: dizziness, headache, local numbness, convulsion, restlessness, etc 6 Respiratory system: dyspnea, shortness of breath, cough, etc 7 Cardiovascular system: palpitation, cyanosis, tachycardia, etc 8 Vascular damage: flushing, phlebitis, etc 9 Application site: pain, pruritus, redness, etc 3、 [contraindications] added: forbidden for children 4、 [precautions] add the following contents: 1 This product has the case report of anaphylactic shock and should be used in the medical institutions with rescue conditions The user should have received the training of anaphylactic shock rescue If anaphylactic shock or other serious adverse reactions occur after the application, the drug should be stopped immediately and the treatment should be carried out in time 2 Use in strict accordance with the functions specified in the drug manual 3 Strictly control the usage and dosage 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 appropriate diluent to avoid the risk of mixing danxiangguanxin injection and other drugs in the pipeline (delete Article 1 of the original precautions) 5 Carefully inquire about the patient's condition, medication history and allergy history before medication 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 (delete Article 5 of the original precautions) 6 Strengthen the monitoring of drug use 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 7 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 (Article 2 of the original precautions is deleted) 37
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