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Kremezin Tablets 500mg(克里美净速崩解片,クレメジン速崩錠)
药店国别  
产地国家 日本 
处 方 药: 是 
所属类别 500毫克/片 336片/盒 
包装规格 500毫克/片 336片/盒 
计价单位: 盒 
生产厂家中文参考译名:
田辺三菱制薬
生产厂家英文名:
Mitsubishi Tanabe Pharma Corporation
该药品相关信息网址1:
http://www.info.pmda.go.jp/go/pack/3929003F1020_1_01/
该药品相关信息网址2:
该药品相关信息网址3:
原产地英文商品名:
KREMEZIN(クレメジン速崩錠)500mg/Tablets 336Tablets/box
原产地英文药品名:
Spherical absorptive carbon
中文参考商品译名:
克里美净(クレメジン速崩錠)500毫克/片 336片/盒
中文参考药品译名:
球形吸收碳
曾用名:
简介:

 

部份中文克里美净处方资料(仅供参考)
英文名:Spherical absorptive carbon
商品名:KREMEZIN Tablets
中文名:克里美净速崩解片(球形吸收碳)
生产商:田辺三菱制药
药品简介
全球新一代肾脏病/ 慢性肾功能衰竭治疗药物KREMEZIN Tablets(クレメジン速崩錠,中文别名:克里美净)快速崩解片在日本重点推荐上市。
クレメジン速崩錠500mg
药物分类名称
慢性肾功能衰竭的药剂
批准日期:2017年12月
商標名
KREMEZIN Tablets 500mg
化学名炭素
性状
它是黑色球形颗粒,直径约0.2-0.4mm,没有气味。 它几乎不溶于水和乙醇(95)。
处理注意事项
稳定性测试
使用SP包装产品和加速试验(40℃,相对湿度75%,6个月)的长期保存试验(25℃,相对湿度60%,12个月)的结果,500mg Kremezin快速崩解片剂在正常市场流通下 据推测它稳定了24个月。
药用药理学
1.对慢性肾功能衰竭的影响
(1)肾功能衰竭模型给予大鼠时,抑制肾功能不全病变的恶化(维持食物摄入量和体重,抑制血清肌酐·尿素氮升高,抑制肾小球滤过功能减少,肾组织病变恶化) 获得并延长生存天数。
(2)保存阶段当给予慢性肾功能衰竭的患者时,血清肌酐的升高受到抑制,尿毒症症状得到改善,并且直到引入透析的时间延长。
2.吸附速率试验的生物等效性试验本品和细颗粒的吲哚吸附率注
在溶解测试仪(吲哚溶液和含有牛磺胆酸的吲哚溶液)中随时间测量,结果证实了两种试剂的生物等效性。
注3)通用药品质量信息研究委员会球形吸附煤制备WG
3.慢性肾病模型大鼠血清中吲哚硫酸盐浓度的降低
通过向慢性肾病模型大鼠的大鼠单次口服强饲法施用该药物和细颗粒,在两种药物中观察到血清中吲哚氧基硫酸盐浓度的降低。
4.作用机制
该药物由于在胃肠道中口服给药而在慢性肾衰竭中吸收尿毒症毒素,并且与粪便一起排泄,从而产生改善尿毒症症状和延迟透析引入的效果。
适应症
在下列疾病中改善尿毒症症状和延迟透析引入
慢性肾功能衰竭(进展性)
用法与用量
成人,每天6克,分为三次口服给药。
临床结果
胶囊的临床结果如下所示。
1.一般临床试验
这种药物的一般临床试验中,作为目标566箱子慢性肾功能衰竭患者的保守治疗期间,这种药物的给药,从第3天〜6个克(分钟3)开始通过增大或减小主治医师的判断进行。其结果是,透析时间被发现相比于这种药物的非给药组进行扩展。肾衰竭的进展速度和剂量为6g /天主观症状医师的判断,超过55%(50/91)有效,稍微有效或85%以上(91分之77)。
2.双盲对比试验
这种药物的双盲比较研究,安慰剂作为对照药物,进行性慢性肾功能衰竭患者244例旨在用于每日6克(分钟3)(情况下,这组药物124,120在安慰剂组中),它是在24周进行。其结果是,在血清肌酸酐的倒数 - 时间绘图这种药物组倾斜(S铬倒数倾斜)显著试验(表2)后缓慢变成,也就是尿毒症症状比药物组给药后2周相比安慰剂组也表现出优异的改善。药物组的整体改善和45%或更多的改善(55/122),用71%(122分之87),安慰剂组的22%(119分之26)33%的轻微改善(119分之39)与之相比有显著更好。
3.使用效果调查,如
(1)使用绩效调查
在保守治疗期间评估了1,848名患有慢性肾衰竭的患者的功效。 结果,除了不可判断的案件之外,总体改善程度比改善率高52.3%(917 / 1,753),比轻微改善率高68.1%(1,193 / 1,753)。
其中,664例为65岁以上的老年人,除不明显病例外,老年人总体改善程度为56.9%(353/620)以上,72.1%(447/620)以上略有改善。
(2)长期使用绩效调查
在保守治疗时361名患有慢性肾衰竭的患者中评估了长期使用48周的功效和安全性。 结果,除了不可判断的病例之外,一般改善的程度为57.5%(206/358)或更高且74.6%(267/358),略微改善,不低于改善。
临床结果表
表2 S-Cr反斜率试验开始前后的比较
斜率(10-5dL/mg·周)(平均值±SD)

症例数  前  後  W検定 
A群  119  -329±245  -222±378  p<0.001 
P群  118  -293±184  -274±279  N. S. 
W测试:Wilcoxon匹配对签名排名测试
包装
快速崩解片
500毫克:336片(4片×84)
制造供应商
Mitsubishi Tanabe Pharma Corporation
注:以上中文处方资料不够完整,使用者以原处方为准。
完整说明资料附件:
https://www.info.pmda.go.jp/go/pack/3929003F1020_1_03/
KREMEZIN Tablets 500mg(Spherical absorptive carbon,クレメジン速崩錠)
Brand name:KREMEZIN Tablets 500mg
Active ingredient:Spherical carbon adsorbent obtained by oxidizing and reducing spherical activated carbon at high temperature, which is derived from hydrocarbon from petroleum.
Dosage form:black tablet, diameter: 15 mm, thickness: 7.4 mm
Print on wrapping:クレメジン速崩錠500mg, KREMEZIN Tablets 500mg, KRH103 
Effects of this medicine
This medicine adsorbs uremic toxins and the precursor in the gastrointestinal tract in patients with chronic renal failure, so that they are excreted in the feces. This alleviates uremic symptoms such as loss of appetite, bad breath, nausea and itchiness, and also delays initiation of dialysis.
It is usually used to alleviate uremic symptoms and delay dialysis initiation in patients with progressive chronic renal failure.
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 transit disorder in the digestive tract.
・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 4 tablets in one packet (2 g of the active ingredient) at a time, 3 times a day. Strictly follow the instructions.
・This medicine disintegrates with a small amount of water. Allow tablet to disintegrate with water in your mouth, then swallow it with water.
・If you are currently taking any other medicines, do not take them at the same time; you should wait more than 30 minutes to 1 hour to take this medicine after taking the other medicine. However, there may be differences in the effectiveness of medicines between individuals and between different medicines, so pay attention to the effects of the other medicine.
・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 continue 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 constipation, loss of appetite, nausea/vomiting, bloated feeling of the stomach, rash and itching. 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.
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 reach of children. Keep in the room temperature. Store away from heat, moisture and direct sunlight.
・Discard the remainder. Do not store them.
Internal
Published: 12/2017
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. 

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