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In accordance with the revised requirements of the blood-for-blood preparation instructions, its "adverse reactions" item should include "adverse reaction monitoring data show that the following adverse reactions can be seen in this product: nausea, vomiting, bloating, abdominal pain, diarrhea, rash, itching, redness, etc., there are reports of allergic reactions."
"Taboos" should increase the ban on pregnant women, allergies to this product and the ingredients contained in it.
"Precautions" item should be added 5 items, respectively, avoid eating cold food, this product is recommended to take after meals, spleen and stomach weakness, allergic physique careful use, should not be used with quinoa, seaweed, beijing daelin, red geese, gansui,flowers.
In accordance with the revised requirements of the wet poison preparation instructions, its "adverse reactions" item should be added" monitoring data show that this product has nausea, vomiting, diarrhea, abdominal pain, rash, itching, stomach discomfort, dry mouth, dizziness, headache, allergic reactions and other adverse reactions reported, there are cases of liver injury reported."
"Taboos" shall include a ban on persons allergic to this product and the ingredients contained therein, a ban on pregnant women, and a ban on patients with a known personal history of liver damage from this product or group drug.
"Precautions" item should include 14 items, such as, this product should not be used for eczema, dermatitis acute period; Yellow, skin yellow dye and other clinical manifestations related to liver injury, should immediately stop medicine and timely medical treatment, hypertension, heart disease, diabetes, kidney disease, tumors and other patients should be taken under the guidance of a physician;
reporter combed found that since this year, the State Drug Administration has issued seven drug instructions revision announcement, five of which are Chinese medicine preparations, the revision content is related to the "adverse reactions" (taboos) and "precautions" items.
revision of the manual is a routine work of the State Drug Administration.
, with the accumulation of safety and ability data on some of the earlier Chinese medicines on the market, the revision of their manuals has been accelerated.
The Implementation Opinion of the State Drug Administration on Promoting the Innovation and Development of Chinese Medicine, issued in December 2020, emphasizes in "Strengthening the Quality and Safety Supervision of Traditional Chinese Medicine" that the chinese medicine instructions and label management should be strengthened, and the relevant contents such as "taboos" and "adverse reactions" and "precautions" in the listed Chinese medicine instructions should be improved.