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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:
田边三菱制药公司
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:
KREMEZIN
中文参考商品译名:
KREMEZIN(クレメジン速崩錠)500毫克/片 336片/盒
中文参考药品译名:
克里美净
曾用名:
简介:

 

部份中文克里美净速崩解片处方资料(仅供参考)
商品名:KREMEZIN Tablets
英文名:KREMEZIN
中文名:克里美净速崩解片
生产商:田辺三菱製薬
药品简介
2018年1月8日,由日本田辺三菱制药推出的慢性肾衰竭新型片剂"克里美净速崩解片500mg"上市。
克里美净速崩解片是一种球形微粒口服吸附剂,由
吴羽公司开发的高纯度多孔碳组成,在胃肠道中吸附慢性肾衰竭中的尿毒毒素,与粪便一起排泄,而不会被体内吸收,这是世界上第一个慢性肾衰竭药物,可延长慢性肾衰竭保存期的尿毒症症状,并延长透析的引入期。将为慢性肾功能衰竭患者提供新的治疗选择。
クレメジン速崩錠500mg
药用分类名称
慢性肾衰竭药物
批准日期:2017年12月
商標名
KREMEZIN Tablets 500mg
化学名
炭素
性状
直径为0.2至0.4mm的黑色球形颗粒,无味。几乎不溶于水和乙醇(95)。
处理注意事项
稳定性测试
使用SP包装产品进行长期储存试验(25°C,相对湿度60%,24个月)和加速试验(40°C,相对湿度75%,6个月)的结果,Cremedin速挂500mg在正常市场流通中稳定36个月。
药效药理
1. 慢性肾衰竭的影响
(1)当给肾衰竭模型大鼠施用时,肾衰竭状态恶化抑制(维持喂食量和体重,抑制血清肌氨酸和尿素氮的升高,抑制肾小球过滤功能减少,肾组织病变恶化抑制),延长存活时间。
(2)当给慢性肾衰竭患者施用时,血清肌氨酸的升高被抑制,尿毒症症状得到改善,透析引入的时间延长。
2. 通过吸附率测试进行生物等效性测试
通过随着时间的推移,在洗脱试验仪(内多尔溶液和含有牛磺酸的丁烯溶液)中分别测量了该剂和细颗粒的丁烯吸附率,从而确认了这两种剂的生物等价物。
注3) 非专利药品质量信息审查委员会球形吸附木炭制剂WG
3. 慢性肾病模型大鼠血清中硫酸浓度的降低作用
由于对慢性肾病模型大鼠进行单次强制口服,发现该制剂中血清中硫酸浓度的降低。
4. 操作机制
该制剂通过内服在胃肠道中吸附慢性肾衰竭中的尿毒毒素,并与粪便一起排泄,从而改善尿毒症症状,延缓透析的引入。
适应症
改善以下疾病的尿毒症症状和透析引入的延迟慢性肾衰竭(渐进性)
用法与用量
通常,成人每天将6g作为Cremedi原体分成三次,并口服。
包装
速崩解片
500mg:336片(4片x84)
制造供应商
吴羽公司
销售
田辺三菱製薬
注:以上中文处方资料不够完整,使用者以原处方资料为准。
完整说明附件:
http://www.info.pmda.go.jp/go/pack/3929003F1020_1_02/?view=frame&style=SGML&lang=ja
KREMEZIN Tablets 500mg(クレメジン速崩錠500mg)
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: 15mm, thickness: 7.4mm
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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