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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: 神经系统药物->精神障碍抑郁
处方药:处方药
包装规格: 5毫克/糖衣丸 45糖衣丸/盒
计价单位:
  点击放大  
生产厂家中文参考译名:
辉瑞
生产厂家英文名:
PFIZER
该药品相关信息网址1:
http://www.libreriamedica8a.com/productos/2339.htm
该药品相关信息网址2:
http://www.biogenesis-antiaging.com/product_info.php?products_id=83
原产地英文商品名:
SERMION 5MG/DRAGEE 45DRAGEES/BOX
原产地英文药品名:
NICERGOLINE
中文参考商品译名:
思尔明 5毫克/糖衣丸 45糖衣丸/盒
中文参考药品译名:
尼麦角林
中文参考化合物名称:
10α-甲氧基-1,6-二甲基麦角林-8β-甲醇基-5-溴烟酸酯
原产地国家批准上市年份:
0000/00/00
英文适应病症1:
Desire to lower
英文适应病症2:
Affective disorder
英文适应病症3:
Peripheral circulatory disorders
英文适应病症4:
Vascular Dementia
临床试验期:
完成
中文适应病症参考翻译1:
意欲低下
中文适应病症参考翻译2:
情感障碍
中文适应病症参考翻译3:
周围循环障碍
中文适应病症参考翻译4:
血管性痴呆
药品信息:

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 详细处方信息以本药内容附件PDF文件(201233022020816.pdf)的“原文Priscribing Information”为准
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部分中文思尔明处方资料(仅供参考)

【药品名称】
思尔明 (原名 :脑通) 糖衣片 Sermion
通用名:尼麦角林片
英文名:Nicergoline Tablets

【思尔明成份】
思尔明主要成分为尼麦角林,化学名为10α-甲氧基-1,6-二甲基麦角林-8β-甲醇基-5-溴烟酸酯。

【思尔明性状】
思尔明10mg为白色薄膜衣片,30mg为黄色薄膜衣片,除去薄膜衣后显白色。

【思尔明药理毒理】
思尔明为半合成麦角碱衍生物。具有α-受体阻滞作用和扩血管作用。可加强脑细胞能量的新陈代谢,增加氧和葡萄糖的利用。促进神经递质多巴胺的转换而增加神经的传导,加强脑部蛋白质的合成,善脑功能。

【思尔明药代动力学】
尼麦角林在口服给药后迅速并且几乎完全吸收。绝对生物利用度小于5%。尼麦角林的主要代谢产物为MMDL(1,6-二甲基-8β-羟甲基-10α-甲氧基-尼麦角林)和MDL(6-二甲基-8β-羟甲基-10α-甲氧基-尼麦角林)。尼麦角林大部分(>90%)与血浆蛋白结合,对血α-酸糖蛋白的亲和力高于血清蛋白。在大鼠中,给[ 3 H]标记的尼麦角林(5mg/kg),肝脏的放射活性最高。其次为肾脏、肺、胰腺、唾液、淋巴、脾、肾上腺和心肌。脑中的放射活性低于血中。给[ 3 H] 和[14 C]标记的尼麦角林后,肾排泄是放射活性的主要衰减途径(约占总量的80%)。粪便中的放射活性只占总量的10~20%。在四组年轻(平均24~32岁)和老年人(平均69~70岁)的志愿者中进行研究,对得到的药代动力学参数分别比较,结果显示尼麦角林的药代动力学不受年龄影响。有严重肾功能不全的患者,尿中的MDL和MMDL的排泄显著减少。在单剂量口服给30mg尼麦角林后,轻度、中度或严重的肾功能不全的患者,与肾功能正常的相比,MDL尿中的排泄量分别平均减少32、32和59%。
在国内进行了生物利用度试验,12名健康受试者口服国产的10mg/片尼麦角林薄膜衣片后,估算的MDL的消除半衰期为8.1±1.6小时,峰时间和峰浓度分别为2.7±1.2小时和101.8±23.0μg/ml。12名健康受试者口服国产的30mg/片尼麦角林薄膜衣片后,估算的MDL的消除半衰期为8.5±2小时,峰时间和峰浓度分别为2.6±1.1小时和102.8±30.5μg/ml。

【思尔明适应征】
1、改善脑动脉硬化及脑中风后遗症引起的意欲低下和情感障碍(反应迟钝、注意力不集中、记忆力衰退、缺乏意念、忧郁、不安等)。
2、急性和慢性周围循环障碍(肢体血管闭塞性疾病、雷诺氏综合征、其它末梢循环不良症状)。也适用于血管性痴呆,尤其在早期治疗时对认知、记忆等有改善,并能减轻疾病严重程度。

【思尔明用法用量】
口服,勿咀嚼。每日20~60mg,分2~3次服用。连续给药足够的时间,至少六个月;由医生决定是否继续给药。

【思尔明不良反应】
未见严重不良反应的报道。可有低血压、头晕、胃痛、潮热、面部潮红、嗜睡、失眠等。临床试验中,可观察到血液中尿酸浓度升高,但是这种现象与给药量和给药时间无相关性。

【思尔明禁忌证】
思尔明不适用于下述情况:近期心肌梗塞、急性出血、严重的心动过缓、直立性调节功能障碍、出血倾向和对尼麦角林过敏者。

【思尔明注意事项】
应在医生指导下使用。通常思尔明在治疗剂量时对血压无影响,但对敏感患者可能会逐渐降低血压。慎用于高尿酸血症的患者或有痛风史的患者。肾功能不全者应减量。孕妇一般不宜使用,必需使用时应权衡利弊。服药期间禁止饮酒。置于儿童接触不到处!

【思尔明孕妇及哺乳期妇女用药】
毒性试验未能显示尼麦角林的致畸作用。本药的适应症显示,本药不用于孕妇及哺乳妇女。

【思尔明儿童用药】
根据目前的适应症,本药不用于儿童。

【思尔明老年患者用药】
药代动力学与耐受性试验表明,成人与老年病人的剂量与给药方法没有差别。

【思尔明药物相互作用】
尼麦角林片可能会增强降血压药的作用。由于尼麦角林是通过CYTP450 2D6代谢,不排除与通过相同代谢途径的药物有相互作用。

【思尔明药物过量】
摄入高剂量的尼麦角林可能引起血压的暂时下降。一般不需治疗,平卧休息几分钟即可。罕见的病例有大脑与心脏供血不足,建议在持续的血压监测下,给予拟交感神经药。

【思尔明规格】
10mg,30mg

【思尔明贮藏】
遮光,密封保存。

Ingredients:
Tablets: Each tablet contains 5 mg Nicergoline (I.N.N.). Excipients: Sucrose, calcium phosphate, sodium carboxymethyl cellulose, micro-crystalline cellulose, magnesium stearate, gum arabic, titanium dioxide, magnesium carbonate, flora wax, talc and Pal Super orange.
Drops: Each ml (20 drops) of prepared solution contains: 5 mg Nicergoline (I.N.N.), lactose, tartaric acid, methyparaben and water.

Properties:
Sermion (nicergoline) is a vasoactive pharmaceutical product, synthesised in Farmitalia research laboratories, with alpha-adrenolytic action to activate the brain’s metabolism. Sermion (nicergoline) acts on different levels:

On the cerebral level, it prompts a lowering of vascular resistance, an increase in arterial flow and the use of oxygen and glucose. In terms of lung circulation, it lowers vascular resistance. With regard to limb circulation, it brings about an increase in the flow, particularly evident in those patients with insufficient irrigation due to functional arteriopathies.

Studies carried out in vitro and in vivo, both experimental and on human beings, have shown that Sermion (nicergoline) inhibits platelet aggregation. Sermion (nicergoline) has proved to be effective in hospital use, regulating and improving brain disorders caused by metabolic-vascular insufficiency and alterations derived from insufficient arterial irrigation in the limbs. When the therapeutic dosage is administered, Sermion (nicergoline) does not affect arterial tension. In the case of patients suffering from hypertension, it may induce a gradual lowering of tension.

This pharmaceutical product does not induce vomiting.

Indications:
Acute and chronic cerebral metabolic-vascular disorders (cerebral arteriosclerosis, thrombosis and cerebral embolism, transitory cerebral ischaemia). Acute and chronic peripheral metabolic-vascular disorders (organic and functional arteriopathies of the limbs), Raynaud’s disease and other syndromes caused by altered peripheral irrigation.

Migraines of vascular origin

Coadjutant therapy in clinical situations accompanied by platelet hyper-aggregability, arterial tension.

Corio-retinal vascular disorders: retinal thromboses, diabetic retinopathy, macular degeneration and retinal angiosclerosis

Oto-vestibular problems of a vascular nature: dizziness, auditory hallucinations, hypoacusis.

Dosage:
By mouth: 5-10 mg (1-2 tablets or 20-40 drops) 3 times daily at regular intervals over prolonged periods of time. To facilitate absorption, take this medicine between meals.
The dosage and length of treatment are to be decided by your doctor. At times, the therapeutic effects of Sermion (nicergoline), both subjective and objective, are not immediately noticeable, but will be noted after a certain period of treatment.

Directions for using Drops:
Pour the powder into the vial containing the solvent and shake until completely dissolved. To measure out Sermion (nicergoline) in drops, use the accompanying syringe, sucking in the amount of liquid required for each dose.

Contraindications:
None known.

Precautions:
Although toxicology studies have not shown nicergoline to have any teratogenic effect, the use of this medicine during pregnancy should be limited to those cases where it is absolutely necessary.

Incompatabilities:
None known.

Interactions:
The vasoactivity of Sermion (nicergoline) may heighten the effect of pharmaceutical products that produce hypotension.

Adverse Effects:
Although very infrequently, rubeosis, a hot feeling, mild gastric upsets, hypotension and dizziness have been observed.
Should you notice any adverse reaction not described, consult your doctor or chemist.

Intoxication and Treatment:
The chances of intoxication as a result of taking this product are very remote. Only in certain cases of overdose can the symptoms described under “Adverse Effects” appear. These subside if one stops taking the product.
In cases of overdose or accidental ingestion, consult the Toxicology Information Service.

Available In:
Tablets: 45-tablet container.
Drops: Container with 1 vial of powder and 1 bottle of solvent.

Expiry Date:
This medicine must not be used after the expiry date printed on the container.

Reconstituted Solution:
Drops: Once prepared, the solution is good for 30 days at room temperature.

Keep this and all other medicines safely out of the reach of children.

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 详细处方信息以本药内容附件PDF文件(201233022020816.pdf)的“原文Priscribing Information”为准
---------------------------------------------------------------

更新日期: 2014-4-28
附件:


201233022020816.PDF    

 
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