Confirm it is related that six patients inject the immunoglobulin (Ig) death in Jiangxi

Confirm it is related that six patients inject the immunoglobulin (Ig) death in Jiangxi
Confirm it is related that six patients inject the immunoglobulin (Ig) death in Jiangxi
The appearance is breathed and stopped with the heartbeat suddenly after six patients use this medicines, symptom is developed very fast, the time of death is in the daytime from May 22 to the 28th of May On June 1, Jiangxi Province food medicines supervise the administration bureau (call Bureau of Drugs Supervision of Jiangxi Province in the following text) Press Office notifies six patients to the outside the incident dies after intravenous injection person immunoglobulin (Ig). " the finance and economics " reporter learn the intersection of Jiangxi Province and already on relevant medicines samples May 29 Bureau of Drugs Supervision, deliver to Nat'l Pharmaceutical Biological Products Control Inst, the test result will be obtained recently. These six patients go to a doctor in the second affiliated hospital of Nanchang university, it is 20070514 to use and label the lot number produced for the learned bio-pharmaceuticals Limited Company of Jiangxi, specification whether 5% intravenous injection of 2.5g choose the right person immunoglobulin (Ig) ( PH4) (liquid) And then die. The time of death is from May 22 to May 28. The second affiliated hospital in Nanchang university was established in 1924, it was a large-scale comprehensive tertiary first rate hospitals incorporated medical treatment, teaching, scientific research, recovering, first aid into an organic whole. The reporter knows from the second related departments of affiliated hospital of Nanchang university, this hospital is after a hematology patient's death on May 28, notice its death and inject the concerned withing of the above-mentioned medicine. According to relevant person of the hospital, according to the condition, the doctors of this institute judge, declare on May 28 this patient that does not manage originally should not die. Subsequently, when the hospital makes analysis to patient's cause of the death, think this patient's death has something to do with with injecting the above-mentioned medicines. The patient is after using this medicines, the appearance is breathed and stopped with the heartbeat suddenly, and symptom is developed very fast, " have no enough time to rescue " . The hospital traces back the case that used this medicines recently from this, has found it since May 22, there are six patients in all to die in different departments, and present common symptom and characteristic. The first five have not caused and pay special attention to, mainly in that the top five patient conditions are very critical, as soon as some have already been in a coma, some have had certain life dangers itself. The relevant persons of this hospital say, last year, very in short supply that blood products were supplied on the market. It is that the condition need that the above-mentioned case uses intravenous injection people immunoglobulin (Ig). The in that patient just dies several days after using medicines of this batch. After the incident happens, the second affiliated hospital in Nanchang university has reported the above-mentioned situation to Bureau of Drugs Supervision of Jiangxi Province at 45 past 17 on May 28. After receiving the report, Bureau of Drugs Supervision of Jiangxi Province sends personnel to Nanchang university in the second affiliated hospital, relevant medicines and deals in enterprises, learned biological drugmaker scene of Jiangxi right away, take the urgent control measure, collect samples to hand over Nat'l Pharmaceutical Biological Products Control Inst and examine, seal relevant medicines and materials up for safekeeping. Meanwhile, supervise the urgent report of administration bureau to people's government and national food medicines of Jiangxi Province. Will it be that night May 28, Jiangxi provincial government establish by the intersection of Vice Governor and big gift and take the post as group leader, the intersection of Vice Governor and Xie Ru, take the post as the vice group leader, office of provincial government, the department of public health of the province, province food medicines supervision bureau, province public security bureau, Provincial Party committee propaganda department, chief leading cadre of medical college of Nanchang university are members' investigation work group. On May 29, national food medicines supervise the administration bureau and Ministry of Public Health jointly sending the documents, demand to adopt and delay selling and using immediately, label all lot number intravenous injection immunoglobulin (Ig) emergency measures of people produced for the learned bio-pharmaceuticals Limited Company of Jiangxi. And urge enterprises to recall 20070514 lot number products rapidly. National food medicines supervise the administration bureau sending the investigation group composed of experts in many aspects, go to Jiangxi to investigate. On June 2, the learned bio-pharmaceuticals Limited Company of Jiangxi publishes declaring in its website of company, claim medicines of this batch sell No. 9575 Branch together, has already used No. 3192 Branch, remaining No. 6383 Branch has already been sealed up for safekeeping and recall. In No. 3192 Branch that has already used, besides second affiliated hospital in Nanchang university, the other regional hospitals of the whole country use medicines of this lot number at present, have not received report of any bad reaction. Declare, point out the intersection of lot number and according to " biologicals criticize issue the certificate of quality " that procedure sign and issue by Nat'l Pharmaceutical Biological Products Control Inst already medicines this especially also. At present, the investigation group has already entered this company to carry on the all-round investigation. The relevant personnel of general manager office says, before appearing on the stage in investigation result, it is inconvenient to comment. The learned predecessor of bio-pharmaceuticals Limited Company in Jiangxi is the learned bio-pharmaceuticals Co., Ltd. of Jiangxi, set up in 1994, confirmed through Chinese Health Ministry in March of 1994, put into production formally. Approved by Jiangxi Government, this enterprise was Co., Ltd. by the whole alteration of limited company in January of 2001, it is only a blood product production unit, national new high-tech enterprises, the first new high-tech enterprises of Jiangxi Province asserted by the country in Jiangxi Province. This company took the lead in authorizing in national blood product trades through Chinese medicines GMP in 1998, the intersection of Chinese and the intersection of blood product and the intersection of association and ten the intersection of member and enterprise one of, leading product for the intersection of human blood and albumin, immunoglobulin (Ig), people of intravenous injection, inject the intersection of people and immunoglobulin (Ig),etc. intramuscularly, it is relatively high in more than 20 pieces of province market share such as Beijing, Shanghai. The reporter knows, the second affiliated hospital in Nanchang university uses the blood products that the learned biological drugmaker of Jiangxi produced, had a history of several years already, has not also found the bad reaction before this. Blood products, medicines bade and purchased in unison for the local Ministry of Health that this company produces, the local hospital must follow the result bade and purchased, confirm medicines varieties selected for use.


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