英文药名：Omegacin 0.3g Bag For Intravenous Drip Infusion（Biapenem） 中文药名：比阿培南点滴液 适 应 症：新型广谱抗生素 生产厂家：日本明治制药 药品介绍 新型抗菌药物比阿培南（Biapenem）是由日本Lederle公司和美国氰胺公司开发的注射用1β-甲基碳青霉烯类抗生素，已于2002年3月在日本批准上市，目前正在美国进行二期临床试验。本品和美罗培南一样，具有抗菌谱广、抗菌活性强的特点。比阿培南对革兰阳性菌、革兰阴性菌（包括耐药的绿脓杆菌）、厌氧菌等均具有较强的抗菌活性；对b-内酰胺酶稳定；对DHP-1的稳定性较伊米培南强。较其他已上市的碳青霉烯类品种，比阿培南肾毒性几乎为零，具有能单独给药；并且无中枢神经系统毒性，不会诱发癫痫发作，能用于细菌性脑膜炎的治疗。本品对抑制绿脓杆菌和厌氧菌比亚胺培南强2～4倍，抑制耐药绿脓杆菌比美罗培南强4～8倍，对不动杆菌、厌氧菌比头孢他啶有效。 オメガシン点滴用0.3gバッグ 药物分类名称 碳青霉烯类抗生素制剂 批准日期：2001年12月 欧文商標名 Omegacin 0.3g Bag For Intravenous Drip Infusion 性　状 Bia Penem是一种白色至微黄色的白色结晶粉末。 该产品极易溶于甲酸，微溶于水，几乎不溶于甲醇，乙醇（99.5）或乙醚。 一般名 ビアペネム　Biapenem 略　号 BIPM 化学名 （-）-6-［（4R,5S,6S）-2-carboxy-6-［（R）-1-hydroxyethyl］-4-methyl-7-oxo-1-azabicyclo［3.2.0］hept-2-ene-3-yl］thio-6,7-dihydro-5H-pyrazolo［1,2-a］［1,2,4］triazol-4-ium hydroxide inner salt 分子式 C15H18N4O4S 分子量 350.39 構造式 熔点（分解） 它从大约200°C开始略呈褐色，在218°C时变成棕色，并且没有显示出明显的熔点。 处理注意事项 1.为保持产品质量，请勿在使用前打开包装本产品的外袋。 2.请勿在下列情况下使用。 （1）当外袋破裂或溶液泄漏时。 （2）在打开舱壁之前溶解抗生素时。 （3）当抗生素变色或溶解药物前溶液着色时。 3.使用容器的液体秤作为粗略指导。 药用药理学 1.抗菌作用（体外） 与显示针对需氧革兰氏阳性菌和革兰氏阴性菌和厌氧菌，亚胺培南，美罗培南，头孢他定显示，氧氟沙星，对庆大霉素抗性绿脓杆菌对强的抗菌活性的广泛的抗菌谱和较强的抗菌活性一起比阿培南结果表明。抗菌活性是杀菌，特别是绿脓杆菌，对脆弱拟杆菌显示出比相当于亚胺培南更强大的杀菌作用。 此外，人的肾脱氢肽酶-I（DHP-I）比美罗培南更稳定。 2.治疗对小鼠实验性感染的影响 比阿培南腹膜内感染的小鼠的各种细菌，大肠杆菌，混合腹腔感染铜绿假单胞菌，铜绿假单胞菌感染的白细胞减少症，肺炎克雷伯菌，铜绿假单胞菌和耐青霉素肺炎链球菌呼吸道感染和E .Coli，显示了对铜绿假单胞菌尿路感染亚胺培南相同或更高的效果。 3.作用机制 作用机制是细菌细胞壁合成（胞壁质桥形成）抑制。青霉素结合蛋白在MSSA的PBP1,4（PBP），在大肠杆菌和铜绿假单胞菌为PBP2,4也特别高的亲和力。 适应症 <适应性真菌种类> 该药易患葡萄球菌，链球菌，肺炎球菌，肠球菌（不含屎肠球菌），莫拉氏菌，大肠杆菌，柠檬酸杆菌，克雷伯氏菌，肠杆菌，沙雷氏菌，变形杆菌，流感 细菌，铜绿假单胞菌，不动杆菌，消化链球菌，拟杆菌，Prebotera，梭杆菌 <适应症> 脓毒症，肺炎，肺脓肿，慢性呼吸道病变继发感染，并发膀胱炎，肾盂肾炎，腹膜炎，子宫营养性结膜炎 用法与用量 通常，对于成人，将0.6g（滴度）分成两个剂量作为Via Penem并在30至60分钟内静脉内注射。 另外，应根据您的年龄和症状增加或减少。 然而，剂量的上限每天高达1.2g（效力）。 包装 10个试剂盒，在1个试剂盒中含有300毫克（效力） 制造供应商 明治制药 注：以上中文不够完整，使用者以原处方资料为准。 完整说明书附件： 点滴液资料：http://www.info.pmda.go.jp/go/pack/6139401G1026_2_04/ 注射液资料：http://www.info.pmda.go.jp/go/pack/6139401D1020_2_04/ -------------------------------------------------------------------------- 产地国家: 日本 原产地英文商品名: Omegacin（オメガシン点滴用）0.3g/vials  10vials/box 原产地英文药品名: Biapenem 中文参考商品译名: Omegacin（オメガシン点滴用）0.3克/瓶 10瓶/盒 中文参考药品译名: 比阿培南 中文参考化合物名称: (-)-6-[(4R，5S，6S)-2-羧基-6-[(R)-1-羟乙基]-4-甲基-7-氧代-l-氮杂双环[3.2.0]庚-2-烯-3-基]硫代-6，7-二氢-5H-吡唑啉[1,2-α][1,2,4]三唑-4-鎓氢氧化物内盐 生产厂家中文参考译名: 日本明治治果制药株氏会社 生产厂家英文名: Meiji Seika Kaisha -------------------------------------------------------------------------- 产地国家: 日本 原产地英文商品名: Omegacin(オメガシン点滴用バッグ)0.3g/Bag 10Bag/box 原产地英文药品名: Biapenem 中文参考商品译名: Omegacin静脉滴注(オメガシン点滴用バッグ)0.3克/袋 10袋/盒（+100ｍＬ生理盐水溶液） 中文参考药品译名: 比阿培南 中文参考化合物名称: (-)-6-[(4R，5S，6S)-2-羧基-6-[(R)-1-羟乙基]-4-甲基-7-氧代-l-氮杂双环[3.2.0]庚-2-烯-3-基]硫代-6，7-二氢-5H-吡唑啉[1,2-α][1,2,4]三唑-4-鎓氢氧化物内盐 生产厂家中文参考译名: 日本明治治果制药株氏会社 生产厂家英文名: Meiji Seika Kaisha -------------------------------------------------------- Omegacin 0.3g For Intravenous Drip Infusion（オメガシン点滴用0.3g）  Brand name : Omegacin 0.3g For Intravenous Drip Infusion 　Active ingredient: Biapenem 　Dosage form: injection 　Print on wrapping: Omegacin 0.3g Bag For Intravenous Drip Infusion（オメガシン点滴用0.3gバッグ）  Brand name : Omegacin 0.3g Bag For Intravenous Drip Infusion 　Active ingredient: Biapenem 　Dosage form: injection 　Print on wrapping:  Effects of this medicine This medicine is a carbapenem antibiotic which inhibits bacterial cell wall synthesis to exert an antibacterial effect. It is usually used to treat sepsis, pneumonia, pulmonary abscess, secondary infection in chronic respiratory lesions, complicated cystitis, pyelonephritis, peritonitis and parametritis. 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 or your family have the predisposition to allergic symptoms such as bronchial asthma, rash and hives. If you have renal damage; you can hardly take food by mouth or are in a parenteral nutrition state; you are in a poor general condition; you have previously experienced convulsive disorders such as epilepsy; you have brain disease. •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>> •In general, this medicine is administered by intravenous drip infusion in two divided doses over a period of 30 to 60 minutes. •The treatment period with this medicine is determined based on your symptoms. •You should rest in bed from the start to the end of drip infusion. Precautions while taking this medicine • Possible adverse reactions to this medicine The most commonly reported adverse reactions include rash, diarrhea, liver dysfunction, itching and hives. If any of these symptoms occur, consult with your doctor or pharmacist. The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately. •feeling unwell, oral cavity discomfort, wheezing [shock, anaphylactoid symptoms] •fever, dry cough, respiratory distress [interstitial pneumonia] •fever, diarrhea, abdominal pain [serious colitis accompanied by diarrhea or bloody stool such as pseudomembranous colitis] •paroxysmal muscular contractions, decreased consciousness [convulsions, conscious disorder] •general malaise, loss of appetite, yellowing of the skin and the white of eyes [liver dysfunction, jaundice] The above symptoms do not describe all the adverse reactions to this medicine. Consult with your doctor or pharmacist if you notice any symptoms of concern other than those listed above. Storage conditions and other information •If you become unwell during an injection, you should tell your doctor immediately. Meiji Seika Pharma Co., Ltd.Injection Published: 2/2015 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.