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Kiklin Granules 86.2%.100g(Bixalomer 踢磷颗粒)
药店国别  
产地国家 日本 
处 方 药: 是 
所属类别 100克/瓶 
包装规格 100克/瓶 
计价单位: 瓶 
生产厂家中文参考译名:
安斯泰来制药
生产厂家英文名:
Astellas Pharma
该药品相关信息网址1:
http://www.info.pmda.go.jp/go/pack/2190032D1027_1_02/
该药品相关信息网址2:
http://www.info.pmda.go.jp/go/pack/2190032D1027_1_03/
该药品相关信息网址3:
原产地英文商品名:
Kiklin Granules(キックリン顆粒86.2%)100g/bottles
原产地英文药品名:
Bixalomer
中文参考商品译名:
踢磷颗粒(キックリン顆粒86.2%)100克/瓶
中文参考药品译名:
比沙洛姆
曾用名:
简介:

 

部份中文踢磷颗粒处方资料(仅供参考)
商品名:Kiklin Granules 86.2%
英文名:Bixalomer
中文名:踢磷颗粒
生产商:安斯泰来制药
キックリン顆粒86.2%
治疗类别名称
高磷血症治疗剂(磷酸结合性聚合物)
批准上市日期:2016年12月
商標名
Kiklin Granules 86.2%
一般名
ビキサロマー(Bixalomer)
本質
〔日本名〕ビキサロマーは、N,N,N’,N’-テトラキス(3-アミノプロピル)ブタン-1,4-ジアミンと 2-(クロロメチル)オキシランが1:2.1-2.4の比で反応して得られた架橋重合体である。
〔英名〕Bixalomer is a cross-linked polymer which is obtained by a reaction between N,N,N’,N’-tetrakis(3-aminopropyl)butane-1,4-diamine and 2-(chloromethyl)oxirane with a ratio of 1:2.1-2.4.
性状
是一种白色到粉末的黄色。几乎不溶于水和乙醇(99.5)。它是吸湿性的。
操作注意事项
注意:
因为这个产品质量是由干燥剂持有的目的,即准备工作后,不要离开盖子打开。
条件批准
在建立药品风险管理计划的顶部,要正确实施。
药效药理
1.药理作用
(1) 血浆磷浓度和Ca×P产品降血脂作用
在高磷减肥食品5/6肾切除慢性肾脏病鼠,Bikisaroma按3%的膳食管理,降低显著血浆磷浓度(AUC值)和Ca×P产品(AUC值)。此外,在腺嘌呤诱发慢性肾病大鼠,Bikisaroma由3%的膳食给药,显著降低血浆磷浓度(AUC值)和Ca×P产品(AUC值)。
(2) 血管钙化的抑制作用
维生素D的负载腺嘌呤诱发慢性肾病大鼠,Bikisaroma由2%的膳食给药,显著减少在主动脉钙的量。
(3) 继发性甲状旁腺功能改进作用
在高磷减肥食品5/6肾切除慢性肾脏病鼠,Bikisaroma按3%的膳食管理,降低显著血浆浓度PTH(AUC值)和甲状旁腺的重量比。此外,在腺嘌呤诱发慢性肾病大鼠,Bikisaroma由3%的膳食给药,显著降低血浆PTH浓度(AUC值)和甲状旁腺重量比。
(4) 肾性骨病进步抑制作用
在腺嘌呤诱发慢性肾病大鼠,Bikisaroma由3%的膳食管理,降低了股骨的间隙面积比和纤维化面积比。对于骨质面积比,没有观察到显著的变化,由于Bikisaroma施用。
(5) 血液的pH值,对碳酸氢根离子浓度的作用
在腺嘌呤诱发慢性肾病大鼠,Bikisaroma由3%的膳食管理,是提高血液pH值和血碳酸氢根离子浓度的降低。
2. 作用机理
Bikisaroma是胺官能磷酸结合性聚合物,通过促进磷排泄到粪便结合磷酸盐在胃肠道中,从而减少了从胃肠道磷的吸收的抑制血磷浓度的。
3. 生物等效性试验
Bikisaroma颗粒2,610mg/剂量(2,250mg/倍Bikisaroma)和三木佐吕间在胶囊2,250mg/次,三次8天由交叉法健康成年男性一天(第一天只有一天两次)的饮食口服前不久,它是由尿磷排泄生物等效性研究。作为结果,已经显示Bikisaroma颗粒被锯成佐吕间超过胶囊和生物等效。(见“药理学表”)
适应病症
在慢性肾脏疾病患者的高磷血症的改善
用法与用量
成人,一次500毫克一个(此药物580mg),为起始剂量作为Bikisaroma,仅有前一天口服给药三次餐。此后,根据血清磷浓度的程度的症状,但要调整,最高剂量为1天7,500mg(这种药物8,700mg)
包装规格
瓶装
100g
制造商
安斯泰来制药公司
注:以上中文处方资料不够完整,使用者以原处方资料为准。
完整资料附件:http://www.info.pmda.go.jp/go/pack/2190032D1027_1_03/
Kiklin Granules 86.2%(Bixalomer キックリン顆粒86.2%)
Brand name:Kiklin Granules 86.2%
Active ingredient:Bixalomer
Dosage form:pale yellow granules
Print on wrapping:
Effects of this medicine
This medicine decreases blood concentration of phosphorus by binding to phosphate in the gastrointestinal tract topromote phosphate excretion into the feces and thus inhibiting the absorption of phosphate from the gastrointestinaltract.
It is usually used for the treatment of hyperphosphatemia with chronic kidney disease.
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 intestinal obstruction.
If you are prone to constipation.
If you are pregnant or breastfeeding.
If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinaleffects. 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, start with 580 mg (500 mg of the active ingredient), three times a day, immediately beforeeach meal. The dose may be adjusted according to the condition of the patient and the phosphorus concentrationlevel in the blood. The maximum daily dose should not exceed 8,700 mg (7,500 mg). Strictly follow the
instructions.
If you miss a dose, skip the missed dose and continue with the regular dosing schedule. You should not take twodoses 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
Aggravated constipation and/or bloating may occur. Monitor daily bowel movements.
Restrict phosphorus intake from food.
Possible adverse reactions to this medicine
The most commonly reported adverse reactions include constipation/aggravated constipation, hard feces, abdominaldiscomfort, abdomen enlarged feeling, nausea, abdominal pain, diarrhea and vomiting. If any of these symptomsoccur, consult with your doctor or pharmacist.
The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicatedin brackets. If any of these symptoms occur, stop taking this medicine and see your doctorimmediately.
abdominal pain, nausea, vomiting, abdomen enlarged feeling, stoppage of defecation [intestinal perforation,intestinal obstruction]
acute abdominal pain, melena, fever, nausea, vomiting [ischemic enterocolitis]
epigastric pain, heartburn, belching, nausea, vomiting, abdominal pain, hematemesis, melena, black stools
[gastrointestinal hemorrhage, gastrointestinal ulceration]
・lack or prolonged absence of bowel movements [constipation, aggravated constipation]
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.
Internal
Published: 09/2016
The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approvaldetails may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It isimportant 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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