Cefmenoxime Hydrochloride for Injection Instructions
Release time:
2020-07-31
Approval Date: March 29, 2007
First Amendment Date: September 16, 2009
Second Amendment Date: December 01, 2013
Third Amendment Date: October 31, 2014
Fourth Amendment Date: December 01, 2015
Fifth Amendment Date: december 03, 2015
Cefmenoxime Hydrochloride for Injection Instructions
Please read the instructions carefully and use
[Drug Name]
General Name: Cefmenoxime Hydrochloride for Injection
English Name: Cofmenoxime Hydrochloride for Injection
Chinese Pinyin: Zhusheyong Yansuan Toubaojiawo
[Ingredients] The main ingredient of this product is Cefmenoxime Hydrochloride, whose chemical name is:(6R,7R) -7-[(Z)-2-(2-amino-4-thiazolyl)-2-methoxyiminoacetamido]-3-[[(1-methyl-1H-tetrazol-5-yl)-thio] methyl]-8-oxo-5-thia-1-azabicyclo [4.2.0] oct-2-ene-2-Formic acid hydrochloride (2:1).
chemical structural formula:
molecular formula:(C16H17N9O5S3)2 · HCl molecular weight: 1059.58 auxiliary material: anhydrous sodium carbonate
[properties] this product is white to light yellow crystal or crystalline powder.
[Indications] This product is applicable to cefmenoxime-sensitive Streptococcus (except Enterococcus), Streptococcus pneumoniae, Digestococcus, Digestococcus, Escherichia coli, Citrobacter, Klebsiella, Enterobacter, Serratia, Proteus, Haemophilus influenzae, Bacteroides, etc. caused by the following infections:
1, pneumonia, bronchitis, bronchiectasis complicated with infection, secondary infection of chronic respiratory diseases; Lung abscess, empyema;
2, pyelonephritis, cystitis; Bartholin's adenitis, endometritis, uterine adnexitis, pelvic inflammation, parauterine tissue inflammation;
3, cholangitis, cholecystitis, liver abscess; Peritonitis;
4, secondary infection of burns and surgical trauma;
5;
6. Cerebrospinal meningitis.
[Specifications] 0.25g, 0.5g, 1.0g, 2.0g (by C16H17N9O5S3)
[Usage and Dosage] Usage: This product is dissolved in 0.9 sodium chloride injection or glucose injection for intravenous drip.
In addition, for adults, 0.5g-2g of this product can also be added to the rehydration of sugar solution, electrolyte solution or amino acid preparation for intravenous drip within 30 minutes to 2 hours. For children, one dose can also be considered to be added to the fluid infusion, and intravenous drip is carried out within 30 minutes to 1 hour. For static injection, inject about 5ml of dissolved solution into the bottle for dissolution when using 1g, and inject not less than 100ml of dissolved solution into the bottle for drip.
Dosage: 1. Adults: mild infection: 1-2g a day, divided into 2 intravenous drips; Moderate and severe infection: it can be increased to 4g a day, divided into 2-4 intravenous drips. The dose can also be adjusted according to the clinical situation. 2. Children: mild infection: 40-80mg per kilogram of body weight per day, divided into 3-4 times of intravenous drip; Moderate and severe infection: it can be increased to 160mg per kilogram of body weight per day, divided into 3-4 times of intravenous drip; Cerebrospinal meningitis: it can be increased to 200mg per kilogram of body weight per day, divided into 3-4 times of intravenous drip.
[Adverse Reactions] 1. Serious Adverse Reactions:
⑴ Sometimes Shock (less than 0.1%) is caused. Therefore, careful observation should be made. In case of abnormal symptoms such as discomfort, abnormal feeling in mouth, wheezing, vertigo, defecation, tinnitus, sweating, etc., administration should be stopped and appropriate treatment should be carried out.
(2) Occasionally, severe renal dysfunction such as acute renal insufficiency (less than 0.1%), so renal function should be checked regularly and carefully observed. If abnormal, drug administration should be stopped and appropriate treatment should be carried out.
(3) Sometimes granulocytopenia (less than 0.1-5%) or no granulocytosis (less than 0.1). In addition, other cephalosporin antibiotics have been reported to cause hemolytic anemia. In case of abnormality, administration should be stopped and appropriate management should be carried out. Severe colitis with bloody stool, such as pseudomembranous colitis, sometimes occurs (less than 0.1 percent), such as abdominal pain and repeated diarrhea, should be stopped immediately and managed appropriately.
(5) Interstitial pneumonia and PIE syndrome (less than 0.1 percent) with fever, cough, dyspnea, chest X-ray abnormalities, eosinophilia, etc., should be discontinued and managed appropriately.
(6) In patients with renal insufficiency, spasticity and the like are sometimes caused when a large amount of drugs are administered.
2, Other Adverse Reactions
⑴ Allergy: Rash, Urticaria, Erythema, Pruritus, Fever, Lymphadenopathy, Arthralgia;
⑵ Blood: Anemia, Eosinophilia, Thrombocytopenia;
(3) Liver: ALT, AST, ALP, LDH Elevation, Jaundice, γ-GTP Elevation;
(4) Digestive Tract);
(5) Flora disorder: stomatitis, candidiasis;
(6) Vitamin deficiency: vitamin K deficiency symptoms (hypocoagulinemia, bleeding tendency, etc.), vitamin B deficiency symptoms (glossitis, stomatitis, loss of appetite, neuritis, etc.);
(7) Others: burnout, staggering, headache.
[Taboo] The product and cephalosporins have a history of allergic reactions are prohibited.
[Precautions] 1. The following patients take drugs carefully
(1) Patients with a history of allergy to penicillin antibiotics;
(2) I or my parents and brothers have patients who are prone to allergic symptoms such as bronchial asthma, rash, urticaria, etc.
(3) Patients with severe renal dysfunction (continuous increase of blood drug concentration may occur);
(4) Elderly Patients (Decline in Physiological Function, side effects are easy to occur; Sometimes vitamin K deficiency and bleeding tendency);
(5) people with poor oral feeding or intravenous nutrition, and people with poor general state (sometimes vitamin K deficiency can be caused, so careful observation should be made);
2, because shock reaction may occur, so detailed consultation is required. It is recommended to do skin allergy test before injection. First aid should be done in advance in the event of shock.
3, the use of this product, the best regular liver function, kidney function, blood and other tests.
4. Interference to diagnostic reagents: In addition to the reaction of urine sugar test strip (TES-tape), false positive reaction may occur when urine sugar test is carried out with Banns reagent, Flynn reagent and Clinitest (sheet reagent containing copper sulfate), and direct antiglobulin (Coombs) test is positive, please pay attention.
[Medication for pregnant and lactating women] The safety of medication for pregnancy has not been established, and the use of this product by pregnant and lactating women should be weighed.
[Use in children] The safety of use in preterm infants and newborns is uncertain.
[Elderly medication] Most elderly patients have decreased physiological functions and are prone to side effects. Sometimes vitamin K deficiency and bleeding tendency.
[Drug Interactions]
1. Furananilic Acid Diuretics: It has been reported that renal dysfunction can be aggravated when combined with other cephalosporins. Therefore, renal function should be paid attention to when combined.
2. Ethanol (drinking): alcohol intake due to drinking, sometimes flushing, nausea, tachycardia, hyperhidrosis, headache, etc., so alcohol intake should be avoided during and at least one week after medication.
[Drug Overdose] Unclear
[Pharmacology and Toxicology] Pharmacological Effects
Cefmenoxime is a semi-synthetic cephalosporin broad-spectrum antibiotic that achieves bactericidal effects by inhibiting the biosynthesis of bacterial cell walls. This product has a strong antibacterial effect on gram-negative bacteria due to its good extracellular membrane permeability, stability to β-lactamase, and strong affinity to penicillin binding proteins (PBPs)1A, 1B and 3, which has a strong barrier to the formation of cell wall mucin cross-linking.
In vitro tests show that this product has an effect on both gram-positive and gram-negative bacteria. The antibacterial activity of Gram-positive bacteria was stronger than that of cefotiam (CTM) and cefazolin (CEZ) in terms of Streptococcus pyogenes and Streptococcus pneumoniae. It has strong antibacterial power against digestive cocci and digestive streptococcus. The antibacterial power to Gram-negative bacteria was slightly stronger than CTM and much stronger than CEZ in terms of E. coli and pneumoniae. The antibacterial force against influenza bacilli, Proteus, Serratia marcescens, Citrobacter, and intestinal bacteria was stronger than CTM, and much stronger than CEZ. In addition, it also shows strong antibacterial power to Bacteroides.
Toxicology study Reproductive toxicity: Animal experiments showed that in rats, rabbits and monkeys during the organ formation period of administration, each administration group of rabbits had female rabbit death or abortion, but all kinds of animals had no teratogenic effect. There was no obvious abnormality in general reproductive toxicity test and perinatal reproductive toxicity test in rats. [Pharmacokinetics] According to literature data, the peak blood drug concentration can reach 50.9mg/L and 135.7mg/L respectively after a single intravenous infusion of 0.5g and 1g of this drug in adults with normal renal function, and 75mg/L and 125mg/L respectively after a single intravenous infusion of 0.5g and 1g of cefmenoxime. The serum elimination half-life of this product is about 1 hour. It is well distributed in various tissues and body fluids after administration. It can also cross the blood-brain barrier. The drug is mainly excreted through the kidney. After an intravenous injection or intravenous drip of 0.5g, 1g and 2g of the drug in adults (with normal renal function), the excretion rate in urine within 6 hours is 60-82%. In addition, the urine drug concentration after 1g of intravenous drip was about 4400 μg/L for 0-2 hours, about 750 μg/L for 2-4 hours, and about 120 μg/L for 4-6 hours. Children (with normal renal function) had the same urinary excretion rate at 6 hours after a single intravenous injection or intravenous drip of 10, 20, and 40 mg/kg as adults.
[Storage] Shaded, airtight, and stored in a cool and dry place (not more than 20 ℃).
[Package] Antibiotic Glass Bottle, 0.25g × 2 Bottle/Box, 0.25g × 1 Bottle/Box; 0.5g × 1 bottle/box, 0.5g × 2 bottle/box; 1.0g × 1 bottle/box; 2.0g × 2 bottles/box, 2.0g × 1 bottle/box; 0.25g × 5 bottles/box, 0.5g × 5 bottles/box, 1.0g × 5 bottles/box.
[Validity Period] 24 Months
[Implementation Standard] "Chinese Pharmacopoeia" 2015 Edition II
[Approval Document No.] Chinese Medicine Standard H20041145( 0.25g), Chinese Medicine Standard H20041146( 0.5g), Chinese Medicine Standard H20041147(1.0g), Chinese Medicine Standard H20093940( 2.0g)
[Production Enterprise] Enterprise Name: Zhejiang Jianfeng Pharmaceutical Co., Ltd. Address: no. 58, Gaofan Section, Baitang Downline, Wucheng District, Jinhua City, Zhejiang Province Tel: 0579-82661998 (Consultation) 0579-82131973 (Sales)
Fax: 0579-82661998 Postal Code: 321075
Website:
www.zjjfyy.com.cn
More information
On December 30, the group company held a special study meeting. Members of the group's party committee and management team concentrated on learning the spirit of the central economic work conference and the Zhejiang provincial party committee economic work conference. From December 16 to 18, the annual Central Economic Work Conference was held in Beijing, which made it clear that in 2021, "we should continue to implement a proactive fiscal policy and a prudent monetary policy, maintain the necessary support for economic recovery, be more accurate and effective in policy operation, do not make sharp turns, and grasp the effectiveness of the policy. It is necessary to make good use of the precious time window, concentrate on promoting reform and innovation, and take high-quality development as the general tone of the 14th five-year Plan. It is proposed to strengthen the national strategic scientific and technological strength, enhance the independent and controllable ability of the industrial chain supply chain, adhere to the strategic basis of expanding domestic demand, and comprehensively promote reform and opening up. On the 25th, the Zhejiang Provincial Party Committee Economic Work Conference was held in Hangzhou to make specific arrangements for the economic development of Zhejiang Province in 2021. At the study meeting, Jiang Xiaomeng, secretary of the party committee and chairman of the group company, together with the leaders attending the meeting, analyzed and studied the key issues raised at the economic work conference of the central and Zhejiang provincial party committees one by one. In his study and discussion, Jiang Xiaomeng stressed that the current neo-coronary pneumonia epidemic is still spreading around the world, the world economy is in a deep recession, the risk of strong stimulus policies in developed countries has spilled over, the global industrial chain supply chain cycle has been blocked, and international trade and investment have shrunk; major strategic achievements have been made in the prevention and control of the domestic epidemic, and the economy has recovered steadily, but there is still greater uncertainty of instability. China has turned to the stage of high-quality development, the economy has been improving for a long time, the development resilience is strong, and the overall social situation is stable. At the same time, the problem of unbalanced and inadequate development in China is still prominent, the reform task of key links in key areas is still arduous, and the innovation ability is not suitable; at present and in the future, China's development is still in an important period of strategic opportunities, but there are new development and changes in opportunities and challenges, we are accelerating the construction of a new development pattern with the domestic cycle as the main body and the domestic and international double cycle promoting each other. The economic work conference of the Central Committee and the Zhejiang provincial Party committee has set the tone and pointed the way for the future development of enterprises. Party organizations at all levels and enterprise management teams should seriously organize and study, deeply understand the spirit of the conference, correctly understand and judge the future policy direction and industry trend, scientifically plan the work of the new year in combination with the actual work of the enterprise, and promote the better development of the enterprise. (this newspaper reporter)
2021
01-04
A few days ago, Tianjin Jianfeng Flanders Company successfully passed the national high-tech enterprise re-identification review work, and once again joined the ranks of high-tech enterprises after the transformation of the enterprise. The original development orientation of Flanders is pharmaceutical excipients, which belongs to the biomedical industry supported by the state. Its products are mainly aimed at major pharmaceutical factories, with clear product standards and strong technical pertinence, so it has been recognized as a national high-tech enterprise for a long time. Starting from 2019, Flanders has embarked on an industrial transformation in the direction of healthy functional foods. The food industry has a variety of products and serves a wide range of people. Enterprises need to come up with products with unique value in order to be accepted and recognized by the market. The difficulty of identifying high-tech enterprises has also increased accordingly. In order to do a good job in the application evaluation of high-tech enterprises, Flanders, in addition to further combing the achievements of previous technological innovation, has also adjusted and established a high-level R & D team on the basis of establishing postdoctoral workstations in cooperation with Shenyang Pharmaceutical University and Tianjin University of traditional Chinese Medicine, and strengthened technological innovation and intellectual property protection in the direction of new industries. For more than a year, Flanders has successfully transformed, produced and put on the market a number of small molecule functional foods and special dietary products such as Huizhi Gold Drink. In order to further accelerate the pace of development in the health food industry, Flanders has successively joined the Tianjin Health Association, Tianjin Food Safety Association and other food industry organizations; and with the strong support of the Tianjin Association for Science and Technology, it began to prepare for the establishment of the Tianjin Medical and Health Society Health Industry Professional Committee. National high-tech enterprises identified once every three years. The person in charge of Flanders said that the company is currently in a critical period of development and transformation. The identification of high-tech enterprises is not only the recognition of the work of Flanders in the past two years by the competent authorities and the industry, but also will provide assistance to the future development of the company. In the future, Flanders will further increase its scientific research efforts, continue to develop and create new products with high-tech content, and make more contributions to public health. (Liu Hairong)
2020
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On the afternoon of December 2, Sang Weiliang, secretary of the Qiandongnan Prefecture Party Committee of Guizhou Province, Wu Ming, deputy director of the Standing Committee of the State People's Congress, Long Zaichong, deputy secretary-general of the State Party Committee, and the main party and government leaders of Huangping County visited Huangping Jianfeng Cement Co., Ltd. to investigate and investigate, and preach the spirit of the Fifth Plenary Session of the 19th Central Committee of the Party. After visiting and understanding the company's production process, Sang Weiliang said happily: "I am very satisfied with the construction of a modern, clean and standardized cement production line in such a short period of time!" At the peak of Huang Ping, Sang Weiliang conveyed and preached the main contents of the spirit of the Fifth Plenary session of the 19th CPC Central Committee. He pointed out that governments at all levels in Qiandongnan Prefecture should thoroughly study and implement the spirit of the Fifth Plenary session of the 19th CPC Central Committee, earnestly implement the decisions and arrangements of the plenary session, focus on the main line of high-quality development, firmly grasp industrial projects, pay close attention to industrial economy, fully promote high-quality economic and social development, and strive to start a new journey of socialist modernization. We should persist in promoting the "four wheels" of new industrialization, we should pay close attention to the industrial economy, accelerate the transformation and upgrading of industrial industries, improve quality and efficiency, and strive to promote high-quality development and achieve stability and long-term development. During the investigation, Hu Hongwei, general manager of Huang Ping Jianfeng, introduced the basic situation of Jianfeng Group and Huang Ping Jianfeng to the state and county leaders, and focused on the equipment and process advantages of the production line, production process, production process, product quality control indicators, as well as various consumption indicators and emission indicators at the leading level in China. He also reported some problems and difficulties encountered after the formal operation of the enterprise. In view of the deficiencies in road traffic construction in Huangping County, Sang Weiliang asked the transportation department to strengthen communication, report and docking, strive for relevant support, do a solid job in the "14th Five-Year Plan" transportation development plan, further improve the road network connection and improve the transportation system, and provide strong support for the development of advantageous enterprises in Huangping Jianfeng and other regions. Sang Weiliang and his party also conducted in-depth research in the production workshop, checked the operation of the production line, and talked with the line staff. At the end of the investigation, he highly affirmed the construction and production work of Huang Ping Jianfeng for more than a year. The development of enterprises must take the road of sustainable development. It is necessary to ensure product quality and take into account the local ecology in order to develop in a long-term and sustainable manner. Sang Weiliang hopes that the Huangping County Government will do its best to ensure service, firmly establish a sense of service, and actively serve the enterprise. Serve, sincerely solve practical difficulties for the enterprise, create a good business environment, and help the enterprise achieve better development; also hope that Huang Ping Jianfeng will continue to play a pioneering role, jointly promote the high-quality economic and social development of Huangping County. (Pan Yi)
2020
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Beirunning won the "13th Five-Year Chinese Medical Science and Technology Iconic Achievement" Award
From December 8 to 11, under the guidance of China Pharmacists Association, China over the counter drug Association and China Medical Education Association, the "2020 national pharmaceutical economic information conference and rice room annual meeting" sponsored by punctuation information (Group) was held in Guangzhou. During the event, the authoritative professional media of Chinese medicine, "Pharmaceutical Economics", released the list of "13th Five-Year China Pharmaceutical Science and Technology Iconic Achievements" and awarded the honorary certificate. The peak pharmaceutical product Berunning (Olopatadine Hydrochloride Eye Drops) is among them. Great changes have taken place in China's pharmaceutical industry during the 13th Five-Year Plan period. Drug review reform, consistency evaluation, volume procurement and other heavy policies in-depth promotion, driving the pharmaceutical industry innovation and upgrading. Chinese pharmaceutical leading enterprises take advantage of the trend, devote themselves to the development of new drugs, actively promote international registration, expand the international market, carry out international mergers and acquisitions, in the world life science stage blooming Chinese style. Lin Jianning, director of the Southern Institute of Pharmaceutical Economics of the State Drug Administration, combed the current operation of the pharmaceutical economy in detail and led the delegates to think deeply about the new changes in the pharmaceutical market in 2021. The industry authoritative media "Pharmaceutical Economic News" sponsored by the Southern Institute of Pharmaceutical Economics released the "13th Five-Year China Pharmaceutical Science and Technology Iconic Achievements" list during the event. The selection of this award aims to explore the scientific and technological achievements of China's pharmaceutical industry during the 13th five-year Plan period from the dimensions of scientific and technological innovation, clinical efficacy, market share and industry influence, so as to help transform pharmaceutical scientific and technological achievements. to help China move from a big pharmaceutical country to a pharmaceutical power. Pinnacle Pharmaceuticals' product, Berunning, is on the list. Berunning is the first eye drops to pass the consistency evaluation in China, and by virtue of its antagonistic histamine H1-receptor, stable mast cell two-way anti-allergy unique efficacy has been widely concerned. Beirunning in the treatment of children with allergic conjunctivitis has good effect, fast curative effect, will not cause significant mast cell degranulation, so the use of more safe, and almost no adverse reactions to the eye tissue, is the current treatment of allergic conjunctivitis an ideal drug. Since its launch in 2019, Berunning has received unanimous recognition and praise from domestic ophthalmologists. (Xu Yuting)
2020
12-22
On December 15, Xing Zhihong, deputy secretary of the Jinhua Municipal CPC Committee and acting mayor, accompanied by Cai Yan, secretary of the Wucheng District CPC Committee, Huang Guojun, and other leaders, visited the company for research, discussed and exchanged views with the company's management team, and put forward hope for the future development of Jianfeng as a leading enterprise in Jinhua City. Jiang Xiaomeng, chairman of the group company, introduced to Xing Zhihong and his party the development strategy, industrial layout, business performance in recent years, scientific and technological innovation, management innovation, as well as the work in charity, poverty alleviation and so on, which was fully affirmed by Xing Zhihong. Xing Zhihong said in the exchange that the peak is Jinhua's landmark enterprise and Jinhua's pride. It is not easy to stick to the industry for many years. Peak has a clear strategic direction and policy, and its good business performance in recent years has fully proved the courage and foresight of the management team. In view of the current situation that the pattern of economic competition at home and abroad is undergoing tremendous changes and the country's increasing requirements for environmental and ecological development, Xing Zhihong hopes that in the future work, Jianfeng will unswervingly follow the path of innovation and development, further increase investment in innovation and research and development, and further promote Green environmental protection production sets an example for Jinhua enterprises. He also hopes that the peak can "lay out the golden industry in the golden area", not only the enterprise itself through technological innovation to achieve high-quality development, but also further lead the upstream and downstream industries, attract potential and competitive enterprises to invest in Jinhua, forming a cluster effect. The municipal party committee and municipal government will also actively study and introduce better support policies to further optimize the business environment, so that enterprises can do a good job in production and operation without distractions, so that Jinhua can form a better industrial ecology. (this newspaper reporter)
2020
12-22
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