All four varieties are limited! The big storm of Chinese medicine injections is coming?!
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Last Update: 2018-06-13
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Source: Internet
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Author: User
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After the pharmaceutical network on June 13th, the State Drug Administration ordered more than 100 million Chinese medicine injections to modify the drug specificationDansan injections, newborns, infants, pregnant women banned, affecting 48 well-known pharmaceutical companiesless than half a month three large varieties of Chinese medicine injections have been revised, some industry insiders have speculated that the 26 restrictions on the use of traditional Chinese medicine in the new 2017 medical insurance catalogue are required to revise the specificationEven, Chinese medicine injections could face a general revision crisisyesterday (June 12), the State Drug Administration issued the State administration ofsupervision on the revision of the densininjection specification (No34 of 2018)announcement requires that the specification of dansin injections (Dansan injection, injection dansin (frozen drying), dansan drop infusion) be added warning words, and the items of "adverse reactions", "taboos" and "precautions" should be revised, should add warning words, content should include:adverse reactions of this product can be seen severe allergic reactions (including anaphylactic shock), should be used in medical institutions with rescue conditions, users should receive relevant rescue training, after the use of the drug allergic reactions or other serious adverse reactions should be immediately discontinued and timely treatment2The items of "Taboo" should include:1Disabled for those who are allergic to this type of medicine or have a history of serious adverse reactions2Banned for newborns, infants, and pregnant women3Those with a tendency to bleed are disabledDecember 13, 2013, the State Administration of Food and Drug Administration issued a notice that since August 2013, Sichuan Shenghe Pharmaceutical Co., Ltdproduced some batches of dansin injections in a number of provinces in adverse events, many patients after the use of drugs cold, feverin order to control safety hazards in a timely manner and prevent the recurrence of incidents, the Sichuan Provincial Bureau requiresrecall the corresponding batch of drugs and find the causeSichuan Shenghe Pharmaceutical Co., Ltdalso released information, said that due to dansin injection (10ml) 1712103 batches, 1801111 batch, 1801114 batches in individual areas of agglomeration adverse reactions, the company took the initiative to the batch of products involved in the implementation of secondary recall(Note: Screenshot sprung on the official website of the enterprise)According to Sichuan Shenghe Pharmaceutical's official website, as of May 10, 2018, the company has recalled and sold products to 13 provinces in Sichuan, Shandong, Jiangxi, Anhui, Fujian, Liaoning, Guangxi, Hunan, Yunnan, Hubei, Shanxi, Inner Mongolia and Guangdongin addition, in 2012, Jiangsu Province Food and Drug Administration announced the 3rd issue of the 2012 drug quality bulletin, there have been 3 batches of dansin injections, the State Drug Administration issued a 2017 drug inspection report, reported that last year, danson injections found 486 defects (including 38 major defects, 448 general defects)on the injection of Dansan, Seiber Blue to FengtaiPharmacy Director learned that, because Dansan is mainly used for cerebral hemorrhage of live blood, the general neurology of Chinese and Western medicine combined with moreAccording to Cypress Blue inquiry, Dansan injections a total of 73 drug approvals, involving 48 pharmaceutical companiesAmong them, Dansan injection involves 45 pharmaceutical enterprises, Dansan drip injection involves 2 pharmaceutical enterprises, injection dansan (freeze-dried) involves 1 pharmaceutical enterprise(chart production: Seiber Blue) according to the Economic News, long before the State Drug Administration issued a letter, sales of Dansan injections went down track from the sample hospital data, the two chinese medicine plant of the Pharmaceutical Group and Zhengda Youth Bao Pharmaceuticals together accounted for more than 90% of the share According to the 2017 annual report, the injection dansin (freeze-dried) of the pharmaceutical plant of the Chinese medicine group last year sales exceeded 100 million yuan, but showed a downward trend overall, from 2012 to 2017, the annual COMPOUND growth rate of dansin injections showed a downward trend, with an average decline of 20% Sales in 2016 and 2017 fell by 16.5% and 41.82%, respectively and the State Drug Administration this time, and further limited the use of Dansan injection, it can be seen that the market situation of Dansan injection is not optimistic According to Cypress Blue, since the new website of the State Drug Administration officially launched, from April 25 to June 12, a total of 9 drug modification instructions Among them, there are 4 Chinese medicine injections, respectively, ginseng injection, Chaihu injection, double yellow injection, dansin injection, accounting for nearly half (Chart Production: Seiber Blue) , in addition to Chaihu injections, the remaining three Chinese medicine injections in the 2017 new version of the health insurance catalog are only eligible for use in hospitals above the second level , while ginseng injection, double yellow injection, dansan injection three Chinese medicine injection specification revision requirements are concentrated in late April to date, more frequent signs of change in recent days industry insiders have speculated that the 26 restrictions on the use of traditional Chinese medicines in the new 2017 medical insurance catalogue are likely to be ordered to revise the drug's specifications (Chart Production: Seiber Blue) According to the National Drug Monitoring Annual Report (2015), the top five chinese medicine injections reported in 2015 were: Clear-up injections, ginseng injections, blood plug-to-inject synta injections, double-yellow injections, and scourin injections among them, ginseng injection, double yellow injection has been ordered in recent times to modify the drug specification, the specification requires this product to be used in medical institutions with rescue conditions and banned infants and young children it is understood that China's existing Chinese medicine injection varieties more than 130, involving nearly a thousand product approvals Some analysts believe that the action of the Fda administration in recent times is a signal that the regulation of Chinese medicine injections is tightening And the next step of Chinese medicine injections is more likely to face a complete overhaul , should add warning words, content should include: adverse reactions of this product can be seen severe allergic reactions (including anaphylactic shock), should be used in medical institutions with rescue conditions, users should receive relevant rescue training, after the use of the drug allergic reactions or other serious adverse reactions should be immediately discontinued and timely treatment II, "Adverse Reactions" items should include: allergic reactions: red or pale skin, rash, itching, chills, larynx edema, breathing difficulties, palpitations, cyanosis, blood pressure drop and even shock skin and its accessories: rashes (including erythema, papules, rubella, etc.), itching, sweating, local skin reactions, etc systemic reactions: chills, chills, fever and even high fever, fatigue, body pain, pale, edema, anaphylactic shock, etc respiratory system: cough, sore throat, chest tightness, breathing gas, breathing difficulties, etc cardiovascular system: palpitations, chest tightness, afirmness, cyanosis, arrhythmia, elevated or decreased blood pressure, etc digestive system: nausea, vomiting, abdominal pain, bloating, dry mouth, etc mental and nervous system: dizziness, headache, convulsions, tremors, local or peripheral numbness, etc dosage sites: red, pain, cyanosis, etc other: visual abnormalities, facial discomfort, etc third, "taboo" items should include: 1 Disabled for those who are allergic to this type of medicine or have a history of serious adverse reactions 2 Banned for newborns, infants, and pregnant women 3 Those with a tendency to bleed are disabled fourth, "Precautions" items should include: 1 Adverse reactions of this product can be seen severe allergic reactions (including anaphylactic shock), should be used in medical institutions with rescue conditions, users should have received relevant rescue training, after the use of allergic reactions or other serious adverse reactions should be immediately discontinued and timely treatment 2 Strictly grasp the functional treatment, dialectical drug use In strict accordance with the provisions of the drug specification of the main use of functional treatment, the use of super-functional main treatment is prohibited 3 Strictly master usage usage In accordance with the drug specification recommended dose and requirements of medication, strictly control the drip speed and dosage Pay particular attention to not overdosing, excessive drips and long-term continuous medication 4 It is strictly prohibited to mix and combine medicine sparingly This product should be used alone, taboo mixed with other drugs If it is necessary to use other drugs in combination, careful consideration should be given to the time between the product and the interaction of the drug, the infusion between the two drugs must be flushed with a moderate amount of dilution 5 Patients should be carefully asked before taking medication, medication history and allergy history Allergy, allergy to other drug allergies, patients with abnormal liver and kidney function, the elderly and other special groups, as well as the first use of Chinese medicine injectionpatient patients should be used carefully, if the need to use, should strengthen monitoring 6 Strengthen drug monitoring In the course of medication, should closely observe the drug reaction, especially the beginning of 30 minutes, found abnormal, immediately stop the drug, active treatment 7 This product should not be used in conjunction with chinese herbal quinoa and its preparations 8 This product is pure Chinese medicine preparation, improper preservation may affect the quality, if found that the solution appears cloudy, precipitation, discoloration, gas leakage or the slight rupture of the bottle body, can not be used.
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