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  药店国别: 英国药房
产地国家: 丹麦
所属类别: 神经系统药物->阿尔兹海默症
处方药:处方药
包装规格: 100毫升/瓶
计价单位:
   
生产厂家英文名:
Lundbeck Limited
该药品相关信息网址1:
https://www.lundbeck.com/au/products/our-products/ebixa
原产地英文商品名:
Ebixa 5 mg/pump actuation oral solution, 100ml
原产地英文药品名:
memantine hydrochloride
中文参考商品译名:
易倍申 5毫克/泵驱动口服液,100毫升
中文参考药品译名:
美金刚
原产地国家批准上市年份:
0000/00/00
英文适应病症1:
The treatment of Alzheimer-type dementia
临床试验期:
完成
中文适应病症参考翻译1:
治疗阿尔茨海默型痴呆
药品信息:


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 详细处方信息以本药内容附件PDF文件(201811623411238.pdf)的“原文Priscribing Information”为准
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部分中文Ebixa处方资料(仅供参考

【药品名称】
通用名:盐酸美金刚片
商品名:易倍申(Ebixa)
英文名:Memantine Hydrochloride Tablet
汉语拼音:Yansuan Meijingang Pian
化学名称:1-氨基-3,5-二甲基金刚烷胺盐酸盐

【成份】本品主要成份为盐酸美金刚:

【性状】本品为白色至类白色、双面凸起的椭圆形薄膜衣片,两面各有一条刻痕。

【适应症】治疗中重度至重度阿尔茨海默型痴呆。

【规格】10mg

【用法用量】
  本品应由对阿尔茨海默型痴呆的诊断和治疗富有经验的医生处方并指导患者的使用。患者身边有按时监督患者服药的照料者的情况下才能开始治疗。应按照现行的诊断标准和指南对痴呆进行诊断。
  成人:每日最大剂量20mg。为了减少副作用的发生,在治疗的前3周应按每周递增5mg剂量的方法逐渐达到维持剂量,具体如下:治疗第一周的剂量为每日5mg(半片,晨服),第二周每天10mg(每次半片,每日两次),第三周每天15mg(早上服一片,下午服半片),第4周开始以后服用推荐的维持剂量每天20mg(每次一片,每日两次)。
  美金刚片剂可空腹服用,也可随食物同服。

【不良反应】
  本品的不良事件总发生率与安慰剂水平相当,且所发生的不良事件通常为轻中度。
  本品的常见不良反应(发生率低于2%)有幻觉、意识混沌、头晕、头痛和疲倦。少见的不良反应(发生率为0.1-1%)有焦虑、肌张力增高、呕吐、膀胱炎和性欲增加。
  根据自发报告,有癫痫发作的报告,多发生在有惊厥病史的患者。

【禁忌】对本品的活性成分或其赋型剂过敏者禁用。

【注意事项】
  肾功能损害患者:对于肾功能轻度损害(血清肌酐水平不超过130μmol/l)患者,无需调整剂量。对于中度肾功能损害(肌酐清除率40-60ml/min/1.73m2)患者的资料,因此不推荐在这种患者中使用本品。
  肝功能损害患者:目前尚无美金刚应用于肝功能损害患者的资料。
  癫痫患者、有惊厥病史、或癫痫易感体质的患者应用美金刚时应慎重。
  尿液pH值升高的患者服用本品时必须进行密切监测。
  心肌梗塞、失代偿性充血性心力衰竭和未有效控制的高血压患者应用美金刚的资料有限,因此这些患者服用本品时应密切观察。
  中重度至重度阿尔茨海默型痴呆病通常会导致驾驶和机械操作能力的损害,而且本品可能改变患者的反应能力,因此服用本品的患者在驾车或操作机械时要特别小心。

【孕妇及哺乳期妇女用药】
  妊娠:目前尚无本品用于妊娠患者的临床资料。动物实验显示在给予相当于或略高于人体用药剂量水平的美金刚时可能导致胎儿宫内发育迟缓。对人体的潜在危险性尚不清楚。除非明确需要,在妊娠期不应服用本品。
  哺乳期:尚不明确美金刚是否能够从母乳中泌出,但是考虑到美金刚的亲脂性,这种可能性是存在的。因此哺乳期妇女服用本品时应停止哺乳。

【老年患者用药】
  65岁以上患者的推荐剂量为每日20mg(每次10mg,每日两次)。

【药物相互作用】
  根据本品的药理作用和作用机制,可能有下列相互作用:
  1、在合并使用NMDA拮抗剂时,左旋多巴,多巴胺能受体激动剂和抗胆碱能药物的作用可能会增强,巴比妥类和神经阻滞剂的作用有可能减弱。美金刚与抗痉挛药物(如丹曲洛林或巴氯芬)合用时可以改变这些药物的作用效果,因此需要进行剂量调整。
  2、因为美金刚与金刚烷胺在化学结构上都是NMDA拮抗剂,因此应避免合用,以免发生药物中毒性精神病。同样道理,也不应将美金刚与氯胺酮或右美沙芬合用。在已发表的一个报道中,美金刚与苯妥英合用可能风险增加。
  3、由于其它药物(如西咪替丁,雷尼替丁,普鲁卡因酰胺,奎尼丁、奎宁以及尼古丁)与金刚烷胺共用相同的肾脏阳离子转运系统,因此也有可能与美金刚产生相互作用,导致血浆水平升高的潜在风险。
  4、美金刚与双氢克尿噻或任何一个含双氢克尿噻的复方制剂合并应用时有可能使双氢克尿噻的血清水平降低。
  5、美金刚在离体条件下不抑制细胞色素酶(CYP1A2、2A6、2C9、2D6、2E1、3A)、环氧化物水解酶和硫酸化以及含单氧化酶的黄素的活性。

【临床试验】
  在全球已经完成的美金刚7个主要三期临床试验中,采用平行、双盲、安慰剂、对照方案设计,对2628名轻度至重度的阿尔茨海默型痴呆患者进行精神和神经量表的评估。7个主要试验的综合评估结果显示本品安全、有效。
  结论:美金刚可以减少中到重度的阿尔茨海默病临床症状的恶化,改善患者的生活质量,减轻护理人员的负担。

【药理毒理】
  越来越多的证据显示谷氨酸能神经递质功能障碍(尤其是NMDA受体功能损害时)会表现出神经退行性痴呆的临床症状和疾病进展。
  美金刚是一种电压依赖性、中等程度亲和力的非竞争性NMDA受体拮抗剂。它可以阻断谷氨酸浓度病理性升高导致的神经元损伤。
  在啮齿类动物和狗中进行的重复剂量的毒性试验中可观察到眼部的改变,但未得出一致的结论,对猴子进行的试验中未观察到上述结果。在美金刚的临床试验中进行的特定眼科检查未发现任何眼科病变。
  标准剂量的美金刚试验中未观察到遗传毒性。在大鼠和小鼠中进行的终生研究未发现任何致癌的证据。在大鼠和家兔中,美金刚即使是在母体毒性剂量下也无致畸性,对生育能力也没有副作用。在大鼠中,当美金刚剂量相当于或略高于人体剂量时,可观察到胚胎发育的迟缓。

【药代动力学】
  美金刚的绝对生物利用度约为100%,Tmax为3-8小时,食物不影响美金刚的吸收。在10-40mg剂量范围内的药代动力学呈线性。血浆蛋白结合率为45%。
  在人体内,约80%以原形存在。在人体内的主要代谢产物为N-3、5-二甲基-葡萄糖醛酸甙、4-羟基美金刚的同质异构体混合物以及1-亚硝基-3、5-二甲基-金刚烷胺。这些代谢产物都不具有NMDA拮抗活性。在离体实验中未发现本品经细胞色素P450酶系统代谢。
  在一项口服14C-美金刚的研究中,平均84%的本品在20天内排出体外,99%以上经肾脏排泄。
  本品的消除半衰期t1/2为60-100小时。在肾功能正常的志愿者中,总体清除率(Cltot)为170ml/min/1.73m2,其中部分总体肾脏清除率是通过肾小管分泌来实现的。
  肾小管还可重吸收美金刚,可能与阳离子转运蛋白的参与有关。在尿液呈碱性条件时,本品的肾脏清除率下降到1/7至1/9。而碱性尿液可见于饮食习惯骤然改变(如从肉食转为素食时)或摄入大量呈碱性的胃酸冲液时。
  特殊患者人群:在肾功能正常或减退(肌酐清除率50-100ml/min/1.73m2)的老年志愿者中,肌酐清除率与美金刚的总肾脏清除率显著相关。
  还未研究肝脏疾病对美金刚药代动力学的影响。由于美金刚只有很小部分被代谢,且代谢产物不具有NMDA拮抗剂活性,因此当存在轻中度肝功能障碍时,美金刚的药代动力学特性不会发生具有临床意义的改变。
  药代动力学/药效学关系:美金刚剂量为每日20mg时,脑脊液(CSF)中的美金刚浓度达到其ki值(ki=抑制常数),即在人体的额叶皮层为0.5μmol。

【贮藏】密封,室温(10-30oC)保存。

【有效期】48个月

 

Ebixa® (also known as memantine hydrochloride)

The purpose of this medication
Ebixa has been conditionally approved* by Health Canada to relieve the symptoms of people with moderate to advanced Alzheimer's disease. It has been approved pending the results of further studies to verify its clinical benefit.

Ebixa is one of a group of drugs called NMDA (N-methyl-D-aspartate) receptor antagonists. Receptors are molecules on cells which "receive" other molecules, so allowing those molecules to initiate important chemical reactions. The NMDA receptors are the receiving targets of glutamate molecules released from nerves; when these molecules interact with NMDA receptors they function as "neurotransmitters", passing on messages from one nerve cell to another. In a disease like Alzheimer's disease, nerve cells get sick and then massive amounts of glutamate leak out of them. This excess of glutamate leads to excessive interaction with the NMDA receptors. The consequence is a toxic one; the "receiving" nerve cells get sick and may die. Ebixa and other Memantine-like drugs work by themselves interacting with the NMDA receptors, but all they do is block them and prevent glutamate from interacting with them, thereby reducing the toxicity of excess glutamate. The result is a normalization of the transmission of nerve messages between nerve cells, and a slowing in the decline of memory and

cognition in Alzheimer's disease.
Ebixa can be used on its own or in combination with cholinesterase inhibitors (i.e., Aricept, Exelon, or ReminylER). Ongoing research is finding that combining cholinesterase inhibitors together with Ebixa seems to greatly improve outcomes, sometimes more than predicted from the sum of the effects of either drug alone. However, more and larger drug trials are needed to confirm these promising early results.

In controlled clinical trials, Ebixa has been used on its own and in combination with Aricept.

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How does it help?
Ebixa is intended to treat symptoms in people with moderate to advanced Alzheimer's disease. In clinical trials, individuals who took the drug when compared to individuals who took a placebo (a substance which looks like the drug but has no effect), showed stabilization or slower decline in cognition (including memory, orientation, language) and function (including performance of daily activities).

The medication may take as long as 12 weeks to begin working and the type and length of response as well as the time it takes for patients to respond to this medication will vary from person to person.

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Will this medication cure Alzheimer's disease?
Ebixa is not a cure for Alzheimer's disease as it does not affect the underlying degenerative process of the disease.

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Who should take this medication?
The medication is for people who have been diagnosed with moderate to advanced Alzheimer's disease.

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How do you obtain this medication?
Ebixa can only be obtained with a prescription from a doctor after a diagnosis of Alzheimer's disease has been made.

A reminder: This medication has been prescribed only for you or for the person you are caring for. It must not be given to anybody else or used for any other illness.

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Important! Things to know before taking this medication
Before taking Ebixa, give the doctor the following information:
all medical conditions, including heart problems, uncontrolled hypertension (high blood pressure), history of seizures or kidney disease
any medications, including prescriptions and non-prescriptions which you are currently taking or have
taken within the last 14 days
if you ever had an allergic reaction to any medication
if you have a urinary tract infection, kidney problems, or if you have recently changed your diet substantially (e.g., from a diet including meat to a vegetarian diet)

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How do you take this medication?
Take the medication only as instructed by the doctor.

Usually the doctor will prescribe 20 mg per day, which can be taken as two separate doses of 10 mg.
To reduce the risk of undesirable reactions, the 20 mg dose will be achieved gradually, depending on the person’s response and tolerability.

The minimum recommended interval between increasing the dose is one week, as shown in the following table:
10 mg tablet        Morning       Afternoon
Week 1              ½ tablet          None
Week 2              ½ tablet        ½ tablet
Week 3              1 tablet        ½ tablet
Week 4 and beyond   1 tablet        1 tablet 

Do not change the dose of the medication, unless the doctor instructs you to do so.
The medication can be taken with or without food.

Swallow the tablets whole, with some water.Do not chew tablets.
Stop taking the medication and contact the doctor immediately if you experience an allergic reaction or any severe reaction.

Continue to take the medication as long as directed by the doctor and you do not experience any unacceptable reactions. The doctor should monitor and assess the treatment regularly.

If you miss a dose, do not take the missed tablet, but take the next dose when it is due.

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What are the possible side effects?
Along with its beneficial effect, Ebixa may cause some undesirable reactions. These may include fatigue, dizziness, sleepiness, headache, hypertension (high blood pressure), constipation, vomiting, anxiety, confusion, hallucinations and sleep disturbance. If you develop any other side effects while taking this medication, consult the doctor. If you suffer from epileptic seizures, there is a slight possibility that the medication may increase the chances of one occurring.Also, as this product may cause sleepiness or dizziness, do not drive or operate machinery under these conditions.

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What to do if an overdose is taken
If more medication has been taken than what is prescribed, contact either your doctor, hospital emergency department, or the nearest poison control centre immediately, even if you do not feel sick.

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How do you store this medication?
Ebixa tablets contain memantine hydrochloride. The 10 mg tablets are white to off-white.
Keep this medication in a safe place, out of the reach of children.

Store the tablets at room temperature (15°-30° C) and in a dry place.

If the doctor tells you to stop taking the medication, return any leftover tablets to the pharmacist, unless the doctor tells you to keep them.


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 详细处方信息以本药内容附件PDF文件(201811623411238.pdf)的“原文Priscribing Information”为准
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更新日期: 2019-3-12
附件:


201811623411238.pdf    

 
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