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| The general administration's announcement on the revision of Yin zhi huang oral preparation instructions |
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| Author：中國銘鉉 企劃部 Release Time：2017-8-22 11:27:32 Number Browse：693 |
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Medical network - August 22, according to the results of the adverse drug reactions assessment in order to further ensure public security, the state food and drug supervision and administration bureau decided to wormwood Zhi yellow oral preparation instructions 【 side effect 】 and 【 notes 】 to revise. The relevant matters are hereby announced as follows:
A, all yellow wormwood Zhi oral preparation production enterprises shall be in accordance with the relevant provisions of the "drug registration management measures" and so on, in accordance with the requirements for yellow wormwood Zhi oral preparation manual revision (see attachment), put forward to revise the description of the supplement, on September 29, 2017 provincial food and drug regulatory authorities for the record.
Amendments to the contents relating to drug labels shall be revised together. The description and other contents of the label shall be consistent with the original approval. The manufacturer's instructions and labels shall be replaced within 6 months after the application is filed.
Different enterprises producing mold Zhi yellow oral preparations should be new adverse reaction mechanism to carry out in-depth study, take effective measures to do mold Zhi yellow oral agents use and safety propaganda and training, to guide physicians rational drug use.
2. The clinical physician should carefully read the revised contents of Yin zhi huang oral preparation instructions, and make full benefit/risk analysis according to the new revision instructions when choosing the medicine.
3. The oral preparation of Yin zhi huang is a prescription drug. Patients should strictly follow the prescribed medicine, and carefully read the revised content of Yin zhi huang oral preparation instructions before taking the medicine.
Hereby notice.
Annex: revision requirements of Yin zhi huang oral preparation instructions
Food and drug administration
August 17, 2017
The attachment
Revision requirements of Yin zhi huang oral preparation instructions
1. The following contents are added:
This product has diarrhea, vomiting and rash.
2. The following contents are added:
1. Given the wormwood Zhi yellow oral preparations have glucose - 6 - phosphate dehydrogenase (G6PD) in patients with lack of hemolysis, relevance is still uncertain, needs further study, suggested that glucose - 6 - phosphate dehydrogenase (G6PD) lack of careful use.
2. The spleen defecator should be used with caution.
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