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  药店国别: 欧洲共同体药房
产地国家: 欧洲共同体国家
所属类别: 激素内分泌药物->甲状腺激素类药及抗甲状腺激素药物
处方药:处方药
包装规格: 60毫克/片 28片/瓶
计价单位:
  点击放大  
生产厂家中文参考译名:
安进公司
生产厂家英文名:
AMGEN
该药品相关信息网址1:
http://www.medicines.org.uk/emc/medicine/15432
该药品相关信息网址2:
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000570/human_med_000903.jsp&jsenabled=true
原产地英文商品名:
MIMPARA FILM COATED TAB 60mg/tablet 28tablets/bottle
原产地英文药品名:
CINACALCET
中文参考商品译名:
MIMPARA薄膜衣片 60毫克/片 28片/瓶
中文参考药品译名:
西那卡塞
原产地国家批准上市年份:
0000/00/00
英文适应病症1:
Secondary hyperparathyroidism
英文适应病症2:
Hypercalcemia
临床试验期:
完成
中文适应病症参考翻译1:
继发性甲状旁腺机能亢进
中文适应病症参考翻译2:
高钙血症
药品信息:

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 详细处方信息以本药内容附件PDF文件(201221420344529.PDF,201221420343036.PDF)的“原文Priscribing Information”为准
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部分中文Mimpara处方资料(仅供参考)

【适应症】该药主要用于治疗肾病透析患者的继发性甲状旁腺机能亢进,或者甲状旁腺癌所致的高钙血症。

【药理及药代动力学】该药可与甲状旁腺中的钙敏感受体结合,减少甲状旁腺素的分泌,进而导致血清钙及磷酸钙产物水平的降低。通常而言,原发性甲状旁腺功能亢进患者会在服用该药第二剂后2小时内 观察到最初的治疗反应;在治疗开始后4~6周内观察到持续的治疗反应该药达峰时间为2~6小时。该药与高脂饮食同服时,可导致血药浓度和药时曲线下面积(AUC)升高。该药蛋白结合率为93%~97%,分布容积达1000升。细胞色素P4503A4、2D6和1A2均与该药代谢有关。代谢产物主要通过尿液(80%)和粪便(15%)排泄,消除半衰期为40小时。

【注意事项】 该药可降低血清钙水平,因而可能引起低钙血症。患者应注意观察是否有感觉异常、肌痛、痉挛、手足抽搐和惊厥的发生。

【药物相互作用】该药是细胞色素P4502D6(CYP2D6)同功酶的抑制剂,因此,当该药与同样通过CYP2D6代谢,且治疗指数较小的药物(如氟卡胺、长春碱、硫利达嗪和大多数三环类抗抑郁药)合用时,后者可能需要调整给药剂量。开始应用或停用CYP3A4强抑制剂(如酮康唑、红霉素或伊曲康唑)时,均有可能导致同时应用的该药的血药浓度发生较大幅度改变,因而需相应调整该药剂量。

【不良反应】临床试验中该药最常见的不良事件为恶心和呕吐。其他发生率大于5%的不良事件还包括腹泻、肌痛、高血压、无力、食欲减退、非心脏性胸痛和通路感染(accessinfection)。此外,西那卡塞治疗组和安慰剂对照组的严重感染发生率基本相当。

【剂量及用药】该药为口服片剂,规格为30mg/片。该药应整片吞服,初始剂量为30mg/天,进食时服用。随后根据患者反应情况,每2~4周调整一次剂量(按60mg/天、90mg/天、120mg/天和180mg/天顺序依次递增),直至患者PTH水平达到美国肾脏基金会临床指南推荐的标准(150~300pg/ml)。该药可单独应用或与维生素D醇和磷酸盐结合剂合用。

【患者咨询】 服用该药期间,患者应避免怀孕或哺乳。许多药物可能与该药产生药物相互作用,因此服用该药时应尽量停用其他药物,包括非处方药和营养补充剂。提醒患者在出现下述不良反应时,应尽快与医师联系,并采取相应治疗措施。这些不良反应包括:腹部痉挛或疼痛;面部、口唇、舌头和手足出现烧灼感、麻痹、刺痛、瘙痒或麻刺感;背部或腿部出现痛性痉挛;抑郁;意识错乱;吞咽或呼吸困难;幻觉;易怒;面肌抽搐;肌痛或癫痫发作。
                                    
What is Mimpara?
Mimpara is a medicine that contains the active substance cinacalcet. It is available as light green, oval tablets (30, 60 and 90 mg).

What is Mimpara used for?
Mimpara is used in adults and elderly patients in the following ways:
to treat secondary hyperparathyroidism in patients with serious kidney disease who need dialysis to clear their blood of waste products. Hyperparathyroidism is a condition in which the parathyroid glands in the neck produce too much parathyroid hormone (PTH), which can lead to bone and joint pain and deformities of the arms and legs. ‘Secondary’ means that it is caused by another condition. Mimpara can be used as part of treatment including phosphate binders or vitamin D sterols;
to reduce hypercalcaemia (high blood calcium levels) in patients with parathyroid carcinoma (cancer of the parathyroid glands) or with primary hyperparathyroidism who cannot have their parathyroid glands removed or when the doctor thinks that removal of the parathyroid glands is not appropriate. ‘Primary’ means that the hyperparathyroidism is not caused by any other condition.

The medicine can only be obtained with a prescription.

How is Mimpara used?
In secondary hyperparathyroidism, the recommended starting dose for adults is 30 mg once a day. The dose is adjusted every two to four weeks, according to the patient’s PTH levels, up to a maximum of 180 mg once a day. PTH levels should be assessed at least 12 hours after dosing and one to four weeks after each dose adjustment of Mimpara. Blood calcium levels should be measured frequently, and within one week of each dose adjustment of Mimpara. Once a maintenance dose has been established, calcium levels should be measured monthly and PTH levels should be measured every one to three months.

In patients with parathyroid carcinoma or primary hyperparathyroidism, the recommended starting dose of Mimpara for adults is 30 mg twice a day. The dose of Mimpara should be increased every two to four weeks up to 90 mg three or four times a day as necessary to reduce blood calcium to normal levels.

Mimpara is taken with food or shortly after a meal.

How does Mimpara work?
The active substance in Mimpara, cinacalcet, is a calcimimetic agent. This means that it mimics the action of calcium in the body. Cinacalcet works by increasing the sensitivity of the calcium-sensing receptors on the parathyroid glands that regulate PTH secretion. By increasing the sensitivity of these receptors, cinacalcet leads to a reduction in the production of PTH by the parathyroid glands. The reduction in PTH levels also leads to a decrease in blood calcium levels.

How has Mimpara been studied?
Mimpara has been compared with placebo (a dummy treatment) in three main studies involving 1,136 dialysis patients with serious kidney disease. The studies lasted for six months. The main measure of effectiveness was the number of patients who had a PTH level below 250 micrograms per litre at the end of the study.

Mimpara has also been studied in a study involving 46 patients with hypercalcaemia, including 29 with parathyroid carcinoma, and 17 with primary hyperparathyroidism who could not have their parathyroid glands removed or in whom surgery to remove the parathyroid glands was not effective. The main measure of effectiveness was the number of patients who had a reduction in blood calcium levels of more than 1 mg per decilitre by the time a maintenance dose had been found (between two and 16 weeks after the start of the study). The study continued for over three years. A further three studies compared Mimpara with placebo in a total of 136 patients with primary hyperparathyroidism over up to a year. Of these, 45 went on to a fourth, long-term study looking at the effectiveness of Mimpara over a total of almost six years.

What benefit has Mimpara shown during the studies?
In dialysis patients with serious kidney disease, about 40% of the patients taking Mimpara had PTH levels below 250 micrograms/l at the end of the study, compared with about 6% of those taking placebo. Mimpara brought about a 42% reduction in PTH levels compared with an increase of 8% in patients taking placebo.

Mimpara produced a decrease in blood calcium of more than 1 mg/dl in 62% of the cancer patients (18 out of 29) and in 88% of the patients with primary hyperparathyroidism (15 out of 17). The results of the additional studies supported the use of Mimpara for hypercalcaemia in patients with primary hyperparathyroidism.

What is the risk associated with Mimpara?
The most common side effects with Mimpara in secondary hyperparathyroidism (seen in more than 1 patient in 10) are nausea (feeling sick) and vomiting. In patients with parathyroid carcinoma or primary hyperparathyroidism, the side effects are similar to those seen in patients with long-standing kidney disease - the most frequent side effects are nausea and vomiting. For the full list of all side effects reported with Mimpara, see the Package Leaflet.

Mimpara should not be used in people who may be hypersensitive (allergic) to cinacalcet or any of the other ingredients.

Why has Mimpara been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Mimpara’s benefits are greater than its risks for the treatment of secondary hyperparathyroidism in patients with end-stage renal disease on maintenance dialysis therapy, and for the reduction of hypercalcaemia in patients with parathyroid carcinoma or primary hyperparathyroidism for whom parathyroidectomy would be indicated on the basis of serum calcium levels but in whom parathyroidectomy is not clinically appropriate or is contraindicated. The Committee recommended that Mimpara be given marketing authorisation.

Other information about Mimpara:
The European Commission granted a marketing authorisation valid throughout the European Union for Mimpara to Amgen Europe B.V. on 22 October 2004. The marketing authorisation was renewed on 22 October 2009.


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 详细处方信息以本药内容附件PDF文件(201221420344529.PDF,201221420343036.PDF)的“原文Priscribing Information”为准
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更新日期: 2012-2-15
附件:


201221420344529.PDF    

201221420343036.PDF    

 
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