产地国家：日本 处 方 药：是 所属类别：50克/袋 120袋/盒 包装规格：50克/袋 120袋/盒 计价单位：盒 生产厂家中文参考译名：明治制果公司 生产厂家英文名：Meiji 原产地英文商品名：ORAPENEM FINE GRANULES(オラペ ネム小児用細粒10%) 50g/sachets 120sachets/box 原产地英文药品名：Tebipenem Pivoxil 中文参考商品译名：Orapenem 細粒10% (オラペネム小児用細粒10%)50克/袋 120袋/盒 中文参考药品译名：替比培南

简介

部份中文替比培南处方资料(仅供参考) 药品名称：替比培南酯细粒剂 英文名称：Tebipenem pivoxil 商品名称：Orapenem 剂型及规格：细粒剂：10%。 适应症：用于儿科病人耳鼻喉和上呼吸道感染的治疗。 用法用量：通常情况下，按小儿体重，4mg/公斤，饭后口服，每日两次。根据情况可以提高到6mg/公斤。 国外上市信息：替比培南酯最早由美国辉瑞公司研发，替比培南酯细粒剂由惠氏立达公司原研开发，之后转让给日本明治制果制药公司，2009年4月在日本获得厚生省批准上市。 产品特点 替比培南酯的非临床特征 (1)广泛的抗菌谱，对青霉素耐药性肺炎球菌(PRSP)和氨苄青霉素耐药性流感嗜血杆菌(BLNAR)抗菌力强; 作为替比培南酯活性实体的替比培南，对需氧性革兰氏阳性及革兰氏阴性及厌氧性标准菌株表现了广泛的抗菌谱。对肺炎球菌(含PRSP )的抗菌力极强，以注射用碳青霉烯类抗菌药的1/2～1/8以及其他的β-内酰胺类，大环内酯类及新喹诺酮类抗菌药的1/8～1/256以下的浓度即表现了抗菌力。对流感嗜血杆菌的抗菌力(包括氨苄西林耐药流感嗜血杆菌)与头孢妥仑及美罗培南相当，表现了比其他β-内酰胺类及大环内酯类抗菌药强的抗菌力。 (2)表现了强的即时杀菌力; 替比培南杀菌性，特别是对肺炎球菌具有与左氧氟沙星相匹敌的极强的杀菌力，对流感嗜血杆菌的杀菌力与头孢妥仑和法罗培南相当。 替比培南酯的临床特征 (1)对导致儿童中耳炎、鼻窦炎、肺炎病原菌多数的耐药肺炎球菌和流感嗜血杆菌的杀菌性高; 替比培南酯有较强的抗菌力，对现有的口服抗菌药治疗困难的中耳炎(307例)，鼻窦炎(36例)及肺炎(59例)，有效率分别为98.0%、80.6%及98.3%，具有高临床效果。 同时，对占病原菌多数的肺炎球菌及流感嗜血杆菌耐药菌的消灭率为99.1%(227株/229株)，除流感嗜血杆菌的2株(4 mg/kg×2次/日给药组1株，6 mg/kg×2次/日给药组1株)外全部消失，表现            了高细菌学的效果。 同时，儿童临床Ⅲ期试验(双盲比较试验)1试验的结果，替比培南酯给药组对中耳炎的有效率为98.2%(108例/110例)，病原菌的消灭率为100%(69株/69株)，头孢妥仑匹酯高用量给药组的有效            率为92.6%(87例/94例)，消灭率为98.5%(64株/65株)，表现了高临床效果及细菌学的效果。根据这些结果，关于临床效果，验证了替比培南酯给药组对于头孢妥仑匹酯高用量给药组的非劣                性。 (2)对有必要住院治疗的反复病例、以前治疗无效病例和重症病例也显示了较高的有效性。 反复性中耳炎，由于延迟而难以治疗，多考虑采用注射用抗菌药治疗和住院治疗，门诊治疗中心儿童急性中耳炎诊疗方针除外。儿童临床III期试验中，对反复性中耳炎的有效率为92.9%(26                例/28例)。 (3)1日2次的给药次数能充分确保有效性，服用性好的细粒剂，能满足儿童服药的高顺应性。 (4)口服吸收性好。 替比培南酯细粒250mg饭后单次经口给药，替比培南的Cmax为4.03±1.01g/mL、AUC0-∞为8.91±1.82g･hr/mL，包括替比培南和LJC11,562(替比培南开环体)的总累积尿排泄率是74.4%，替比          培南酯细粒的口服吸收性良好。 综上所述，替比培南酯可用于现有的口服抗菌药治疗出现困难的儿童感染症治疗，同时，也用于注射用抗菌药的使用和有住院必要的重症病例，扩大了口服抗菌药门诊治疗的范围 包装规格 1g中　100mg(力価)含有 *ボトル　50g、100g 分包　0.5g×120包(2連包×60枚)

英文版说明书

ORAPENEM FINE GRANULES 10% FOR PEDIATRIC(オラペネム小児用細粒10%) Brand name : ORAPENEM FINE GRANULES 10% FOR PEDIATRIC Active ingredient: Tebipenem pivoxil Dosage form: yellowish pale red fine granule Print on wrapping: Effects of this medicine This medicine is a carbapenem antibiotic to inhibit bacterial cell wall synthesis, and shows antimicrobial effect. It is usually used to treat pneumonia, otitis media and sinusitis. 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 any of your parents or siblings are prone to allergic symptoms such as bronchial asthma, rash or hives. If you are a patient with renal disorder, poor ingestion or parenteral nutrition, or poor general status. If you have a history of convulsive diseases such as epilepsy. •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 <> •For children: In general, take 0.04 gram per kilogram of body weight (g/kg) (4 mg of the active ingredient [titer]/kg) at a time, twice a day, after meals. The dosage may be increased up           to 0.06 g/kg (6 mg [titer]/kg) as needed. Strictly follow the instructions. •Standard duration of administration is for 7 days or less. •If you miss a dose, take a dose as soon as possible. However, 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. Precautions while taking this medicine • Possible adverse reactions to this medicine The most commonly reported adverse reactions include diarrhea and loose stool. 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. •convulsion, disturbed consciousness [hypoglycemia associated with hypocarnitinemia] 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 •Keep out of reach of children. Store away from direct sunlight, heat and moisture. •Discard the remainder. Do not store them. Meiji Seika Pharma Co., Ltd.Internal Revised: 1/2013 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.