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VANCOMYCIN HYDROCHLORIDE I. V. Infusion（盐酸万古霉素干粉注射剂）

2013-07-23 04:39:59 作者：新特药房来源：互联网浏览次数：240 文字大小：【大】【中】【小】

简介：商品名：塩酸バンコマイシン点滴静注用キット0.5g 英名： Vancomycin 一般名：バンコマイシン塩酸塩 (Vancomycin Hydrochloride) 化学名：(1S ,2R ,18R ,19R ,22S ,25R ,28R ,40S )-50-[3-Amino-2,3,6-tri ...

关键字：盐酸万古霉素注射粉剂 VANCOMYCIN HYDROCHLORIDE Powder 糖肽抗生素制剂

英文药名：VANCOMYCIN HYDROCHLORIDE for I. V. Infusion（Vancomycin Hydrochloride）

中文名：盐酸万古霉素

生产商：小林化学公司

**バンコマイシン塩酸塩点滴静注用０．５ｇ「ＭＥＥＫ」／**バンコマイシン塩酸塩点滴静注用１．０ｇ「ＭＥＥＫ」

药物分类名称
糖肽类抗生素制剂
批准日期：2015年12月
欧文商標名
VANCOMYCIN HYDROCHLORIDE for I. V. Infusion 0.5g 「MEEK」
VANCOMYCIN HYDROCHLORIDE for I. V. Infusion 1.0g 「MEEK」
一般名：
バンコマイシン塩酸塩 (Vancomycin Hydrochloride)
化学名：
(1S ,2R ,18R ,19R ,22S ,25R ,28R ,40S )-50-[3-Amino-2,3,6-trideoxy-3-C - methyl-α-L-lyxo - hexopyranosyl-(1→2)-β-D- glucopyranosyloxy]- 22-carbamoylmethyl- 5,15-dichloro- 2,18,32,35,37-pentahydroxy-19-[(2R )- 4-methyl-2-(methylamino)pentanoylamino]- 20,23,26,42,44-pentaoxo-7,13-dioxa-21,24,27,41,43- pentaazaoctacyclo [26.14.2.23,6.214,17.18,12.129,33.010,25.034,39] pentaconta- 3,5,8,10,12(50),14,16,29,31,33(49),34,36,38,45,47- pentadecaene-40-carboxylic acid monohydrochloride
分子式：
C66H75Cl2N9O24・HCl
分子量：
1485.71
性状：
它是一种白色粉末。
易溶于水，微溶于甲酰胺，难溶于甲醇，极难溶于乙醇（95），难溶于乙腈。
它具有吸湿性。
構造式：

处理注意事项
<稳定性测试>
盐酸万古霉素用于静脉滴注0.5g“MEEK”
使用最终包装产品进行长期保存试验（25℃，3年）后，确认在正常市场流通下稳定3年。
用于静脉滴注的万古霉素盐酸盐1.0 g“MEEK”
使用最终包装产品进行加速试验（40℃，75％RH，6个月），推断它在正常市场流通下稳定3年。
批准条件
除了要使用的抓取设备之外，考虑到设施提取率和设施数量，采取以下对策。
1.继续进行适当的上市后监督（包括敏感性调查）并收集信息。
2.分析收集的信息，继续向医疗机构提供必要的信息，以确保正确使用。
3.继续按照每年一次的健康，劳动和福利部的定期安全报告提交报告。
药用药理学
在体外和体内观察到抗甲氧西林抗性葡萄球菌的优异效果。其作用是抑制细胞壁肽聚糖合成，细胞膜变性和RNA合成抑制，并且它具有杀菌作用。
适应症
1. <适应的真菌种类>
耐甲氧西林金黄色葡萄球菌（MRSA）对万古霉素敏感
<适应症>
继发感染如败血症，感染性心内膜炎，创伤·烧伤和手术伤口，骨髓炎，关节炎，肺炎，肺脓肿，脓胸，腹膜炎，化脓性脑膜炎
2. <适应性真菌物种>
耐甲氧西林凝固酶阴性葡萄球菌（MRCNS）对万古霉素敏感
<适应症>
继发感染如败血症，感染性心内膜炎，创伤·烧伤和手术伤口，骨髓炎，关节炎，腹膜炎，化脓性脑膜炎
3. <适应性真菌物种>
耐青霉素的肺炎链球菌（PRSP）对万古霉素敏感
<适应症>
脓毒症，肺炎，化脓性脑膜炎
4.伴有疑似MRSA或MRCNS感染的致热性中性粒细胞减少症
用法与用量
通常，成人每天一次分为盐酸万古霉素2g（滴度）0.5g（效力）每6小时一次或每1h一次（滴度）12h，每次超过60分钟静脉输液。
顺便提一下，应该根据年龄，体重和症状来增加或减少。
对于老年人，静脉滴注60分钟，每次0.5g（滴度）每12小时一次或每1小时一次（滴度）24小时。
另外，应该根据年龄，体重和症状来增加或减少。
对于儿童和婴儿，每天40mg（滴度）/kg分为2至4剂，并且每次静脉滴注60分钟。
对于新生婴儿，单次剂量为10至15mg（滴度）/kg，新生儿每12小时一次，出生后1周，新生儿每1个月至少8小时静脉输注超过60分钟。
包装[提醒：以下是三个生产厂家产品，采购者以咨询为准]
1.静脉滴注
0.5g“MEEK”
0.5g×10小瓶

1.0g
1.0g×10小瓶

制造供应商
小林化学公司
2.滴注万古霉素0.5
0.5g×10瓶
制药公司：
盐野义制药有限公司
3.滴注万古霉素0.5
在0.5g×10瓶
生产厂商
Mylan公司药业有限公司
注：以上中文资料仅供参考，使用者以原处方为准。
完整说明资料附件：http://www.info.pmda.go.jp/go/pack/6113400A1189_2_01/
VANCOMYCIN HYDROCHLORIDE Powder 0.5 "MEEK"（塩酸バンコマイシン散0.5「MEEK」）
Brand name : VANCOMYCIN HYDROCHLORIDE Powder 0.5 "MEEK"
　Active ingredient: Vancomycin hydrochloride
　Dosage form: white mass or powder
　Print on wrapping:
VANCOMYCIN Hydrochloride For Intravenous Drip Infusion 0.5g（塩酸バンコマイシン点滴静注用0.5g）
Brand name : VANCOMYCIN Hydrochloride For Intravenous Drip Infusion 0.5g
　Active ingredient: Vancomycin hydrochloride
　Dosage form: injection
　Print on wrapping:
VANCOMYCIN Hydrochloride Powder 0.5g（塩酸バンコマイシン散0.5g）
The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It is important to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment.
Brand name : VANCOMYCIN Hydrochloride Powder 0.5g
　Active ingredient: Vancomycin hydrochloride
　Dosage form: white powder
　Print on wrapping:
Effects of this medicine
This medicine is a glycopeptide antibiotic which inhibits cell wall synthesis of anaerobic gram-positive bacteria, denatures their cell membrane, and inhibits their DNA synthesis to suppress the growth of those bacteria.
It is usually used to treat infectious enteritis (including pseudomembranous colitis) and to decontaminate the digestive tract in preparation for bone marrow treansplantation.
Before using this medicine, be sure to tell your doctor and pharmacist
•If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines.
If you have deafness or renal disorder.
•If you are pregnant or breastfeeding.
•If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.)
Dosing schedule (How to take this medicine)
•Your dosing schedule prescribed by your doctor is <<to be written by a healthcare professional>>
•Infectious enteritis (including pseudomembranous colitis): In general, for adults, dissolve as needed and take 0.5 to 1 vial (0.125 to 0.5 g [titer] of the active ingredient) at a time, 4 times a day. The dosage may be adjusted according to the disease, age or symptoms. Strictly follow the instructions.
•Digestive decontamination for bone marrow transplantation: In general, for adults, dissolve as needed and take 1vial (0.5 g [titer] of the active ingredient) at a time, 4 to 6 times a day, together with non-absorbable antibacterial and antifungal medicines. The dosage may be adjusted according to the disease, age or symptoms. Strictly follow the instructions.
•If you miss a dose, take the missed dose as soon as possible. If it is almost time for the next dose, skip the missed dose and follow your regular dosing schedule. You should never take two doses at one time.
•If you accidentally take more than your prescribed dose, consult with your doctor or pharmacist.
•Do not stop taking this medicine unless your doctor instructs you to do so.
The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It is important to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment.