Instructions for Penciclovir for Injection
Release time:
2020-07-31
核准日期:2007年8月31日
第1次修改日期:2008年 05月28日
第2次修改日期:2014年 10月31日
恒奥普康
注射用喷昔洛韦说明书
请仔细阅读说明书并在医师指导下使用
【药品名称】
通用名称:注射用喷昔洛韦
商品名称:恒奥普康
英文名称:Penciclovir for Injection
汉语拼音:Zhusheyong Penxiluowei
【成份】
本品主要成份为喷昔洛韦,辅料为低分子右旋糖酐和氢氧化钠。
化学名称:9-[4-羟基-3-(羟甲基)-丁基]鸟嘌呤。
化学结构式:

分子式:C10H15N5O3
分子量:253.26
【性状】
本品为白色疏松块状物或粉末。
【适应症】
适用于严重带状疱疹患者,如出血性带状疱疹,坏疽性带状疱疹,播散性带状疱疹,三叉神经支带状疱疹,带状疱疹脑膜炎,严重疼痛的早期带状疱疹等和免疫机能障碍并发的带状疱疹。
【规格】0.25g。
【用法用量】
一次每公斤体重5mg,一日2次,隔12小时滴注一次,每次滴注时间应持续1小时以上,5-7日为一疗程。
临用前,取本品1瓶(含喷昔洛韦0.25g),用适量灭菌注射用水或氯化钠注射液使之溶解,再用氯化钠注射液至少100ml稀释,供静脉滴注用。
有肾脏疾病、脱水或同时使用其它对肾脏有毒性药物的病人,应调整剂量,缓慢静脉滴注(1小时以上)。
【不良反应】
1、静脉用药在注射部位可发生静脉炎和局部刺激,这是注射液pH值高(大于9.0)的缘故,而非喷昔洛韦的直接效应。
2、喷昔洛韦浓度过高可导致肾小管和集合管损害,并引起血肌酐值升高和肾功能损害,可引起肾区疼痛,这常发生于快速静脉滴注。
3、临床试验中曾见胃肠道反应、尿中红细胞高于正常值、头痛、头晕、双下肢及内踝水肿、手足发热、鼻塞、腹泻和寒战等。
【禁忌】
对本品有过敏反应史者禁用,肾功能异常者、儿童及孕妇慎用。
【注意事项】
1、对更昔洛韦过敏者也可能对本品过敏。
2、本品为静脉滴注用药,忌用作其它途径给药。
3、静脉滴注时应缓慢(1小时以上),防止局部浓度过高,引起疼痛及炎症。
4、溶液配制后应立即使用,不能冷藏,因冷藏时会析出结晶,用剩溶液应废弃,稀释药液时出现白色浑浊或结晶则不能使用。
5、本品呈碱性,与其它药物混合时易引起溶液pH值改变,应尽量避免配伍使用。
6、有肾脏疾病、脱水或同时使用其它对肾脏有毒性药物的病人,应调整剂量,缓慢静脉滴注(1小时以上)。
【孕妇及哺乳期妇女用药】
药物能通过胎盘,虽动物实验证实对胚胎无影响,但孕妇用药仍需权衡利弊。
药物在乳汁中的浓度为血药浓度的0.6~4.1倍,虽未发现婴儿异常,但哺乳期妇女应慎用。
【儿童用药】
儿童中虽未发现特殊不良反应,但应慎用。新生儿不宜以含苯甲醇的稀释液配制滴注液,否则易引起致命性的综合征,包括酸中毒、中枢抑制、呼吸困难、肾功能衰竭、低血压、癫痫和颅内出血等。
【老年用药】
由于生理性肾功能的衰退,应用本品需注意调整剂量。
【药物相互作用】
1.与干扰素或甲氨蝶呤(鞘内)合用,可能引起精神异常,应慎用。
2.与肾毒性药物合用可加重肾毒性,特别是肾功能不全者更易发生。
3.与齐多夫定(Zidovudine)合用可引起肾毒性,表现为深度昏睡和疲劳。
4.与丙磺舒竞争性抑制有机酸分泌,合并用丙磺舒可使本品的排泄减慢,半衰期延长,体内药物蓄积。
【药物过量】尚不明确。
【临床试验】
本项临床试验采用多中心、随机双盲、阳性药对照的方法评价注射用喷昔洛韦治疗严重带状疱疹的疗效和安全性。对于带状疱疹患者,给予注射用喷昔洛韦粉针剂每次0.25g(1瓶),临用前将药物加适量注射用水或氯化钠注射液使之溶解,再加入到250ml氯化钠注射液中,供静脉滴注。每日两次,每8~12小时静脉滴注1次。用药疗程:7天。总观察时间为21天(必要时需随访至第28天)。患者于用药后第1~7,8,14,21天,(必要时增加第28天)接受观察,对时间指标:开始结痂时间、全部结痂时间、开始脱痂时间、全部脱痂时间,以及疼痛开始减轻时间、疼痛完全消失时间、新水疱停止出现时间、水疱完全消退时间;主观指标:有无后遗神经痛及后遗神经痛的持续时间;客观指标:包括丘疱疹/水疱、血疱、坏死、糜烂、红斑/水肿、皮损分布范围三方面进行疗效评价。
Ⅱ期109例带状疱疹临床试验结果表明:注射用喷昔洛韦治疗带状疱疹,水疱停止出现时间1.44±1.21天,水疱消退时间4.53±3.29天,开始结痂时间2.85±1.74天,全部结痂时间6.07±3.35,开始脱痂时间7.24±3.51天,全部脱痂时间13.72±5.14,疼痛减轻时间3.22±3.32天,疼痛消失时间11.82±8.63天。
对于后遗神经痛的发生率,注射用喷昔洛韦组为2.75%。对于客观指标治疗7天、14天、28天的总有效率分别为80.74%、、97.25%、100%。对于疼痛指标,
治疗7天、14天、28天的总有效率分别为66.35%、85.04%、98.13%。
Ⅲ期345例带状疱疹临床试验结果表明:
注射用喷昔洛韦治疗带状疱疹,水疱停止出现时间为1.08±1.13天,水疱消退时间为2.52±1.31天,开始结痂时间为2.92±1.56天,全部结痂时间为5.98±2.87天,开始脱痂时间为6.42±2.72天,全部脱痂时间为12.65±4.42天,疼痛减轻时间为3.34±2.63天,疼痛消失时间为11.56±6.26天。
对于后遗神经痛的发生率,注射用喷昔洛韦组为8.3%。
在有效率方面,第4、8、14、21天时,注射用喷昔洛韦组的有效率分别为18.2%、69.6%、96.4%和99.1%。
25例严重带状疱疹患者,如出血性带状疱疹,坏疽性带状疱疹,播散性带状疱疹,三叉神经支带状疱疹,带状疱疹脑膜炎、严重疼痛的早期带状疱疹等和免疫机能障碍并发的带状疱疹补充临床试验结果表明:
注射用喷昔洛韦治疗带状疱疹,水疱停止出现时间为1.42±0.83天,水疱消退时间为5.88±3.53天,开始结痂时间为2.33±1.13天,全部结痂时间为5.65±2.21天,开始脱痂时间为7.17±4.32天,全部脱痂时间为14.83±5.73天,疼痛开始减轻时间为2.33±1.37天,疼痛消失时间为12.90±5.86天。
对于后遗神经痛的发生率,注射用喷昔洛韦组为33.3%。
在有效率方面,第4、8、14、21天时,注射用喷昔洛韦组的有效率分别为32.0%、84.0%、88.0%和96.0%。
在安全性方面,通过对患者的询问、观察及在用药前后进行血常规(白细胞、红细胞、血红蛋白、血小板),尿常规(尿蛋白、红细胞、白细胞、尿糖、酮体),肝功能(ALT、AST),肾功能(BUN、CREA),心电图的化验结果来发现不良事件,进行安全性评价:
通过对Ⅱ期临床试验109例,Ⅲ期临床试验345例及补充临床试验25例患者应用该药后的观察,无严重不良事件发生。经医生判断,与本药物相关的不良事件偶见:注射部位疼痛、恶心、呕吐、头痛、头晕、鼻塞、手足发热、寒战、静脉炎、腹泻、大便次数增多、双下肢及内踝水肿。经实验室检查分析,用药后血常规化验中有3例白细胞低于4.0×109/L、2例红细胞低于4.0×1012/L且血红蛋白低于130g/L,1例血小板低于100×109/L。用药后的尿常规化验中,有4例白细胞高于正常值,有3例红细胞高高于正常值。心电图检查中有3例用药前正常,用药后心电图出现心率不齐,心电图医师认为无临床意义。
【药理毒理】
药理作用
本品为核苷类抗病毒药,体外对Ι型和П型单纯性疱疹病毒有抑制作用。在病毒感染的细胞中,病毒胸腺嘧啶脱氧核苷激酶将本品磷酸化为喷昔洛韦单磷酸盐,然后细胞激酶将喷昔洛韦单磷酸盐转化为喷昔洛韦三磷酸盐。体外实验表明,喷昔洛韦三磷酸盐与脱氧鸟嘌呤核苷三磷酸盐竞争性抑制单纯疱疹病毒多聚酶,从而选择性抑制单纯疱疹病毒DNA 的合成和复制。
耐本品的单纯疱疹病毒突变株的产生是由于病毒胸腺嘧啶脱氧核苷激酶或DNA多聚酶性质发生了改变,最常见耐阿昔洛韦的病毒突变株缺乏胸腺嘧啶核苷激酶,它们对本品也耐药。
毒理研究
某些动物试验显示高浓度的喷昔洛韦可致突变,但无染色体改变的依据。在对细胞无害的浓度下喷昔洛韦未表现出致突变作用。
大鼠和兔静脉注射喷昔洛韦的I~Ш段生殖毒性试验中,大鼠最高剂量为80mg/kg/d,兔为50mg/kg/d,结果表明喷昔洛韦对受试动物的胚胎发育和生活能力、多代发育、生殖能力及生殖行为等仅有轻微或没有影响。长期大剂量注射可致动物睾丸萎缩和精子数减少,停药可部分恢复。
动物实验未见致癌依据。
【药代动力学】
10名受试者单次静脉滴注喷昔洛韦后,血浆浓度-时间曲线经WinNonLin程序采用非房室模型进行拟和计算,消除速率常数ke为0.3680 ±0.04891/hr,消除半衰期t1/2为1.91 ±0.26 hr,达峰时间Tmax为1.00 ±0.00 hr,达峰浓度Cmax为9.7745 ±1.5866 mg/L,药时曲线下面积AUC0-t为19.106 ±2.853 hr*mg/L,药时曲线下面积AUC0-∞为19.619 ±2.868 hr*mg/L,表观分布容积Vd为1.451 ±0.382 L/kg,表观清除率CL为0.520 ±0.079 L/hr/kg。
文献报道滴注相同剂量后主要药代动力学参数:消除半衰期t1/2为1.90 ±0.25 hr,达峰时间Tmax为0.95 ±0.1 hr,达峰浓度Cmax为12.1 ±3.1 mg/L,
药时曲线下面积AUC0-∞为21.1 ±3.4 hr*mg/L。本研究结果与文献报道基本一致。
文献报道滴注相同剂量后表观分布容积V为102 ±20 L,表观清除率CL为37.6 ±9.5 L/hr。经体重校正后进行对比,本研究结果与文献报道基本一致。
10 名受试者单次静脉滴注喷昔洛韦后,约50%的喷昔洛韦在给药后2小时经尿排出,10小时后排出量很少,12小时尿喷昔洛韦累积排出率为68.8±11.9%。
文献报道滴注相同剂量后72小时尿喷昔洛韦累积排出率为73.1±5.8%。因此,喷昔洛韦主要经肾排泄,本研究结果与文献报道基本一致。
表6.1 主要药代动力学参数对比表
|
参数 |
试验测定结果 |
文献数值 |
|
剂量 |
10 mg•kg-1 |
10 mg•kg-1 |
|
t1/2 |
1.91 ±0.26 hr |
1.90 ±0.25 hr |
|
Tmax |
1.00 ±0.00 hr |
0.95 ±0.1 hr |
|
Cmax |
9.775 ±1.587 mg/L |
12.1 ±3.1 mg/L |
|
AUC0-t |
19.106 ±2.853 hr*mg/L |
21.1 ±3.4 hr*mg/L |
|
Vd |
1.451 ±0.382 L/kg |
102 ±20 L |
|
CL |
0.520 ±0.079 L/hr/kg |
37.6 ±9.5 L/hr |
|
12小时尿累积排出率 |
68.8±11.9% |
- |
|
72小时尿累积排出率 |
- |
73.1±5.8% |
据文献报道,药物能通过胎盘,虽动物实验证实对胚胎无影响,但孕妇用药仍需权衡利弊。药物在乳汁中的浓度为血药浓度的0.6~4.1倍,虽未发现婴儿异常,但哺乳期妇女应慎用。
【贮藏】遮光,密闭,在阴凉处(不超过20℃)保存。
【包装】管制抗生素瓶装,1瓶/盒。
【有效期】暂定24个月。
【执行标准】YBH02122007
【批准文号】国药准字H20070186
【生产单位】
企业名称:浙江尖峰药业有限公司
地 址:浙江省金华市婺城区白汤下线高畈段58号
电 话:0579-82661998(咨询) 0579-82131973(销售)
传 真:0579-82661998
邮 编:321075
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2021
04-01
2021 is the 100 anniversary of the founding of the Communist Party of China. The Central Committee of the Communist Party of China has decided to carry out party history study and education in the whole party to encourage the whole party not to forget its original intention and keep its mission in mind. On March 17, the group company held a party committee to convey and implement the relevant spirit of the central and higher party committees, and put forward requirements for the study and education of party history. At the Party History Learning and Education Mobilization Conference held in Beijing on February 20, Xi Jinping, General Secretary of the Central Committee of the Communist Party of China, President of the State, and Chairman of the Central Military Commission, emphasized in his speech that the development of party history learning and education throughout the party is based on the party's century history. A new starting point, a major decision made to coordinate the overall strategy of the great rejuvenation of the Chinese nation and the world's unprecedented changes in a century, and to mobilize the whole party to devote confidence to fully building a modern socialist country. All comrades in the party must learn history, increase credibility, learn history, respect morality, learn history, learn history, learn party history, understand ideas, do practical things, open a new situation, and strive to start a new journey of building a modern socialist country in an all-round way with a high-spirited attitude. Greet the 100 anniversary of the founding of the party with outstanding achievements. After that, Zhejiang Province and Jinhua City successively held mobilization and deployment meetings on party history study and education, and put forward requirements for the implementation of this important work. At the party committee of the group company held on the 17th, Jiang Xiaomeng, secretary of the party committee of the group, conveyed the spirit of the central party history learning and education mobilization meeting and the speech made by Chen long, secretary of the Jinhua municipal party committee, at the municipal party history learning and education mobilization meeting. and together with all party committee members, group executives learned the special learning materials of "learning party history, knowing the party situation, and being a qualified party member. Jiang Xiaomeng pointed out that carrying out the study and education of party history is based on the new starting point of the party's century-old history of the Party Central Committee with Comrade Xi Jinping as the core, coordinating the overall strategic situation of the great rejuvenation of the Chinese nation and the great changes unseen in the world in a century, and mobilizing the whole party and the whole country to devote themselves to building a modern socialist country with confidence. Party organizations at all levels of the company must deeply understand and grasp the special significance of carrying out party history study and education, and resolutely implement it in accordance with the deployment requirements of the central, provincial and municipal party committees. According to the key points and work requirements of party history learning and education proposed by the central government, and in combination with the actual situation of the company, the group party committee decided to further strengthen the publicity of party history knowledge, organize all party members to strengthen relevant knowledge learning, and visit and study in the red education base. Organize a special lecture on party history education, and all grassroots party committees and branch secretaries should take the lead in giving party history lessons; use the "Peak News" as the carrier to carry out party history knowledge propaganda, organize the essay solicitation activity of "learning party history and welcoming a hundred years"; Organize and carry out the knowledge contest of party history for party members. The party committee of the group requires that the main responsible comrades of the company's party organizations at all levels should lead by example, set an example, and play a good role in leading learning and promoting learning; it is necessary to innovate methods and methods, and flexibly use various learning platform carriers to make party history learning and education more appealing and effective, To promote the study and education of party history to go deep into the masses, the grassroots, and the hearts of the people. (this newspaper reporter)
2021
03-22
Qiandongnan Prefecture Federation of Trade Unions "Send Warmth"
On the morning of February 25, Liang Ya, Secretary of the Party group of the Federation of trade unions of Qiandongnan Prefecture, and Yuan Shangkai, director of the Bureau of industry and information technology of Qiandongnan Prefecture, went to Huangping Jianfeng cement company to express their sympathy to the employees who stick to their posts during the Spring Festival. In the peak of Huang Ping, Liang Ya and his party had a discussion with employee representatives to understand the working and living conditions of employees. Qian Jiang, secretary of the party branch of Huang Ping Jianfeng and chairman of the trade union, briefly reported on the recent production and operation of the enterprise, the main work and achievements of the trade union organization since its establishment more than half a year ago, and said that Huang Ping Jianfeng trade union will continue to make efforts to continuously improve the capacity building of trade union staff, be a good "mother's family" of employees, earnestly safeguard the rights and interests of employees, and constantly improve their sense of satisfaction and happiness. On behalf of the State Federation of Trade Unions, Secretary Liang Ya fully affirmed the trade union work of the enterprise. She pointed out that as a key project of poverty alleviation through cooperation between the east and the west, Huangping Jianfeng must give full play to the important responsibility of trade union organizations to care for employees while doing a good job in production and operation, do more practical work for employees, solve problems, and build Huangping Jianfeng into a industry. The benchmark for poverty alleviation contributes to the promotion of Huangping's economic development. After the symposium, Liang Ya, Yuan Shangkai and other leaders distributed condolences to the representatives of the participating employees one by one, and expressed condolences to the employees of Huang Ping Jianfeng who stuck to the front line during the Spring Festival. (Pan Yi)
2021
03-12
On March 1, Wan Ding, Mayor of Daye City, Hubei Province, Jiang Longping, Deputy Secretary of the Municipal Party Committee and Secretary of the Political and Legal Committee, Cheng Wei, Minister of the United Front Work Department and Chairman of the Federation of Trade Unions, and the heads of relevant functional departments made a special visit to the peak to further strengthen cooperation, Promote development and communicate with the leaders of the group company. Group Chairman Jiang Xiaomeng, General Manager Yu Jianhong, Deputy General Manager Zhang Fengliang, Xiang Chongping and other leaders received Wanding and his party. On behalf of the peak, Jiang Xiaomeng welcomed the visit of the leaders of Daye City and thanked the local government departments at all levels in Daye for their support and affirmation of the peak. During the exchange, Mayor Wanding spoke highly of Daye Jianfeng's contribution to local economic and social development over the years. He said that Jianfeng has always been a benchmark enterprise and a major taxpayer in Daye City, and its achievements are well-known in Daye. On this good basis, he hopes to further strengthen cooperation. The leaders of Baoan Town, where Daye Peak is located, also stated on the spot during the discussion that they will adopt the attitude of "Peak Cement is no small matter", while serving the enterprise well, and at the same time, they will further strengthen the in-depth cooperation between the two parties to find development opportunities around related industries. The two parties also discussed topics such as strengthening industrial integration in building materials-related fields, further extending the upstream and downstream of the industrial chain, and coordinated green development. (this newspaper reporter)
2021
03-12
On January 16, the "2021 China Enterprise Credit Development Forum and the 12th Integrity Public Welfare Ceremony" sponsored by the China Enterprise Reform and Development Research Association and the China Cooperative Trade Enterprises Association was held in Beijing to release the 2020 China Enterprise Credit Top 500 Series of lists. Jianfeng Group ranks 358 and 355 respectively in the top 500 credit lists of Chinese enterprises and the top 500 credit lists of Chinese listed companies. It is understood that the evaluation and analysis of the top 500 Chinese corporate credit is not based on the company's operating income, profit or the value of a single indicator, but focuses on the trend research of corporate development, focusing on quantitative evaluation and analysis, and quantitative A multi-dimensional evaluation method that combines qualitative and qualitative, and adopts dynamic empowerment according to the different characteristics of different industries, is a comprehensive reflection of the company's operating status and operating capabilities, it is also an objective manifestation of the creditworthiness of the enterprise. In the analysis and research, it refers to the international rules, simulates the enterprise credit evaluation system, adopts dynamic empowerment according to the characteristics of different industries, and establishes the corresponding evaluation mathematical model to make it more scientific, objective, fair and fair. The analytical research and evaluation methods and models have three first-level evaluation elements, with "credit environment" having a weight of 14%, "credit capacity" having a weight of 72%, and "credit behavior" having a weight of 14%. Among them, "credit environment" includes economic environment, industry environment, market environment, policy and legal environment 4 secondary indicators 6 sub-elements, using a combination of quantitative and qualitative analysis of the evaluation method; "credit capacity" includes profitability, liquidity, security and growth 4 secondary indicators 11 sub-elements and 1 reference element, using quantitative analysis and evaluation methods, is the core index in the evaluation system; "Credit behavior" includes three sub-elements of three secondary indicators: social contribution, quality and safety, and social impact, and adopts a combination of quantitative and qualitative analysis. The credit evaluation and analysis of Chinese enterprises is a project supported by the China Social Science Fund. It has been carried out since 2011. Based on the analysis and research results, it has produced the top 500 Chinese enterprise credit, the top 100 Chinese manufacturing enterprise credit, and the top 100 Chinese service enterprise credit. China's top private enterprise credit 100, China's top 500 listed company credit list. According to the above scoring principles, in the list of China's top 500 credit enterprises, peak's comprehensive credit score is 92.988, ranking 358, and ranking 15th among cement enterprises on the list; at the same time, it ranks 355 among the top 500 credit companies of Chinese listed companies released in the same period. (this newspaper reporter)
2021
03-01