LEBENIN-S TABLETS/POWDER（长双歧杆菌/粪链球菌/嗜酸乳杆菌）-新型三种混合乳酸菌制剂 レベニンS配合散／レベニンS配合錠 治疗类别名称 三种混合乳酸菌制剂 商標名 LEBENIN-S TABLETS LEBENIN-S POWDER 一般名 ラクトミン（Lactomin）（JAN） 菌種　　　 ストレプトコッカス・フェカリス（Streptococcus faecalis） ラクトバチルス・アシドフィルス（Lactobacillus acidophilus） 性状 本产品为白色至浅黄褐色粉末，或没有异味，或者有轻微异味。 一般名 ビフィズス菌（Bifidobacterium） 菌種　　　 ビフィドバクテリウム・ロンガム（Bifidobacterium longum） 性状 本产品为白色至浅黄褐色粉末，或没有异味，或者有轻微异味。 操作注意事项 稳定性试验 Rebenin个三年6个月稳定复利下的分布式长期存放次（25±1℃，60±5％，3年6个月相对湿度）的结果，它是在正常的市场分布证实。 与Rebenin小号组合平板长期试验（25±2℃，60±5％，3年的相对湿度）的结果，可以确认，在正常的市场分配压力的3年的稳定性。 适应病症 各种症状，由于异常肠道菌群的改善 用法用量 LEBENIN-S配合片 成人，分成口服，每日口服三次，每次3-6片。应当指出的是，增加或减少取决于患者的年龄和症状。 LEBENIN-S配合散 成人，每日口服三次，每次3-6克。应当指出的是，增加或减少取决于患者的年龄和症状。 药效药理 1. 有机酸生产（体外） 作为考虑有机酸生产这种药物，粪链球菌和各乳酸菌的嗜酸乳杆菌单独培养的乳酸菌的一个结果是乳酸，长双歧杆菌分别生产乳酸和乙酸。 2. 病原体生长抑制作用（体外） レベニンS配合散散射3种病原体（肠毒素大肠杆菌，鼠伤寒沙门氏菌，金黄色葡萄球菌），并且每个混合培养，结果，显著抑制各病原体的生长。 3. 生物等效性试验 在体外试验，考虑到随着时间的推移而变化胃pH的饭后在胃的过境时间，它随着时间的推移进行比较的レベニンS配合錠配制的分散性和レベニンS配合錠生存率。计算90％置信区间为活细胞数的平均值的差异，结果证实生物等效性。 包装规格 S配合錠：120粒，600粒，1200粒（PTP） S配合散：1KG（500克×2）·5公斤（500克×10）（瓶） 制造厂商 若本药业有限公司 完整处方资料附件： 1）：http://www.info.pmda.go.jp/go/pack/2316003B1066_1_01/ 2）：http://www.info.pmda.go.jp/go/pack/2316003B1040_1_03/ LEBENIN-S TABLETS（レベニンS配合錠） Brand name : LEBENIN-S TABLETS 　Active ingredient: Lactomin  Streptococcus faecalis  Lactobacillus acidophilus  Bifidobacterium  Bifidobacterium longum 　Dosage form: white to faintly pale yellowish brown tablet 　Print on wrapping: （表）レベニンS, （裏）レベニンS配合錠, LEBENIN-S TABLETS, 11 LEBENIN-S POWDER（レベニンS散） Brand name : LEBENIN-S POWDER 　Active ingredient: Lactomin  Streptococcus faecalis  Lactobacillus acidophilus  Bifidobacterium  Bifidobacterium longum 　Dosage form: white powder 　Print on wrapping: Effects of this medicine This medicine improves abdominal symptoms such as diarrhea, loose stool, constipation or abdominal bloating by bifidobacteria/lactic acid bacteria normalizing intestinal environment. It is usually used to improve various symptoms due to abnormalities in the intestinal flora. 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 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, for adults, take 1 to 2 g at a time, 3 times a day. 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. However, if it is almost time for the next dose, skip the missed dose and follow your regular dosing schedule. You should not 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 No pertinent entries. 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. No pertinent entries. 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 the reach of children. Store away from direct sunlight, heat and moisture. •Discard the remainder. Do not store them. WAKAMOTO PHARMACEUTICAL CO., LTDInternal Revised: 8/2015 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.