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马根维显(钆喷酸葡胺注射剂)

2011-03-11 23:42:47  作者:新特药房  来源:中国新特药网天津分站  浏览次数:631  文字大小:【】【】【
简介: 【通用名称】 钆喷酸葡胺注射液 【商品名称】 马根维显 【英文通用名】 Dimeglumine Godopentetate 【其他名称】 加都三胺五乙酸, 钆喷酸二甲葡胺盐, 钆泮替酸葡胺, 钆-DTPA二甲葡胺, 磁显葡胺, 磁影葡 ...

【通用名称】 钆喷酸葡胺注射液
【商品名称】 马根维显
【英文通用名】 Dimeglumine Godopentetate
【其他名称】 加都三胺五乙酸, 钆喷酸二甲葡胺盐, 钆泮替酸葡胺, 钆-DTPA二甲葡胺, 磁显葡胺, 磁影葡胺, 钆喷葡胺, 马根维显, 钆喷酸葡胺注射液
英文其他名称 Magnevist, Dimeglumine Gadopentetate, Meglumine Gadopentetate, Gadopentetic Acid Dimeglumine Salt Injection, Meglumine Gadopentetic Acid, Dimeglumine Gadopentetate Injection
马根维显Magnevist
经肾排出的顺磁性造影剂
用于磁共振成像(MRI)
【成分】
1毫升以根维显水溶液中含有469mg钆喷酸葡胺(gadopentetic acid,dimeglumine salt)
【特性】
马根维显是特别为磁共振成像用经肾排出之造影剂,它具有良好的耐受性,很少发生全身性副反应,一般只是局部轻微的反应。
马根维显几乎在24小时内完全排出体外。注射马根维显后,血脑屏障遭到破坏的区域(如胶质母细胞瘤)以及其它颅内、椎管内的脑外病灶都会有强化,从而比平扫提供更多的诊断信息。
【适应证】
颅脑及脊信的磁共振成像
特别是用于肿瘤的显示及鉴别:协助诊断可疑的脑(脊)膜瘤、(听)神经鞘瘤,侵入性肿瘤(如神经胶质瘤)及转移瘤;显示较少和/或等信号肿瘤及手术或放疗后复发;鉴别诊断少见肿瘤,如:成血管细胞瘤,室管膜瘤及垂体微小腺瘤;进一步确定非脑原性肿瘤的扩散情况。
全身磁共振成像
包括面颅、颈部、胸部和腹部、女性乳房、骨盆腔、及自主性和被动性运动肢体等部位。
马根维显特别提供了诊断所需的一述资料:
-用于论证或排除肿瘤,炎症和血和损伤;
-用于确定这些损伤部位的扩散及边界;
-用于区分病变的内部结构;
-用于评估正常组织与病理组织的循环情形;
-用于区别治疗后肿瘤组织和疤痕(愈合)组织;
-用于验证手术后复发脱垂之椎产盘;
-用于肾形态学诊断和肾功能半定量评估。
【剂量及给药方法】
一般资料
患者在检查前2小时必须禁食。
使用马根维显必须遵守MRI检查的安全规范,如禁用于心脏起搏器及铁磁性植入物携带者。
将所需剂量的马根维显从静脉注入,必需时呆行团注,继之立即开始MRI强化扫描,最佳时间为注射马根维显45分钟之内。
在血管内注射造影剂时,患者最好平卧;注射完后至少半小时内,需严密观察患者。
非立即使用时,勿将马根维显抽入注射器,一次检查后剩余的造影剂务必废弃。在强化扫描中彩T1加权扫描的脉冲系列尤为适宜。
马根维显适用于0.14至1.5Tesla的磁场强度。在此范围内,不受场强影响。
【剂量】
以下剂量原则适用于成人和儿童(包括新生儿和婴儿):
头部和脊椎的磁共振成像
通常使用0.2ml/kg体重的以根维显,即可获得良好的强化效果并满足临床需要。如MRI强化扫描未见异常而临床仍高度怀疑有病灶时,可于注药后30分钟内再注射与第一次等量的马根维显。成人甚至可用至0.4ml/kg体重并再行扫描,可提高诊断的准确率。
为排除在人肿瘤转移或复发,使用0.6ml/kg体重的马根维显将提高诊断的可信度。
全身的磁共振成像
以下剂量原则适用于成人及儿童,但马根维显在2岁以下儿童“全身磁共振成像”适应症的应用尚无很多经验。
通常使用0.2ml/kg体重的马根维显,即可获得良好的强化效果并满足临床需要。
在特殊情况时,如病变内血管少,或细胞外间隙太小,对比不清,可使用0.4ml/kg体重的马根维显来增强对比是需要的,尤其是在强化扫描中,采用轻度T1加权扫描的脉冲序列检查时。
为排除成人病变或肿瘤复发,使用0.6mlkg体重的马根维显将提高诊断的可信度。
【禁忌证】
目前的知尚无禁忌证
【特别说明】
对有过敏倾向的患者,使用本品需特别慎重。因为产生过敏反应的机会较其他患者为高。
对有严重肾功能障碍的患者,决定作用本品前需特别慎重权衡利弊,因为造影剂的排出会受到延迟。除此之外,迄今所知,本品对肾功能不会影响,即使如此,对极严重肾功能障碍的患者,建议用血透方式来排除体内的马根维显。
现在尚未证明怀孕期作用马根维显是否安全,因此,对孕妇作用本品应特别慎重。
动物试验表明少量马根维显(少于注射量的0.2%)进入乳汁。
使用马根维显的部分患者,务清铁和胆红素略有升高。但无症状,可在24小时内很快恢复原值。
在马根维显强化扫描24小内采用络合定量法(如bathophenanthroline)测定血清铁,其结果可能很低,这是由于造影剂溶液中含有二亚乙撑三胺五乙酸(DTPA)的缘故。

【耐受性与副作用】
在注射马根维显后,偶有恶心、呕吐及皮肤或粘膜的过敏性反应。
有过敏倾向的患者,较他人更易发生地敏反应。在极少情况下,地敏以至休克反应均可能发生。熟知急救措施对抢救造影剂反应至关重要。检查室应配备急救药品及设备(如气管插管、除颤器)。
穿刺静脉或注射造影剂时,极少数患者在注射部位有短暂的轻度温热感与疼痛。极罕见的情况下,在注射马根维显后曾观察到惊劂。偶尔发生一过性头痛,血和扩张,头晕,寒颤及晕厥。但是否与使用此药有关仍未被证实。快速团注可能出现一过性味觉异常。
高渗注射液可能会引起注射血管周围组织疼痛,20分钟左右消失。未发现其他组织的不良反应。
进一步的资料,请医师参与马根维显的科学小册。
【包装】
10ml瓶装
15ml瓶装
20ml瓶装
请将药品妥为储存,勿使儿童拿到。

【生产商】德国先灵公司生产

Product Description
 
Magnevist is used for:
Providing a better picture with magnetic resonance imaging (MRI).
Magnevist is a diagnostic aid. When used with an MRI, it works by aiding in the detection of abnormalities in the brain, spinal cord, or whole body.

Do NOT use Magnevist if:
• you are allergic to any ingredient in Magnevist
Contact your doctor or health care provider right away if any of these apply to you.

Before using Magnevist :
Some medical conditions may interact with Magnevist . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have a history of kidney or liver problems or liver transplant, or if you receive dialysis
• if you have anemia, asthma, blood problems (eg, blood clots, blood clotting problems, hemolysis, sickle cell anemia, other anemias), breathing problems, heart problems, kidney or liver problems, or seizures
Some MEDICINES MAY INTERACT with Magnevist . However, no specific interactions with Magnevist are known at this time.
Ask your health care provider if Magnevist may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Magnevist :
Use Magnevist as directed by your doctor. Check the label on the medicine for exact dosing instructions.
• Magnevist is usually given as an injection at your doctor's office, hospital, or clinic.
• Do not use Magnevist if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
• If you miss a dose of Magnevist , contact your doctor right away.
Ask your health care provider any questions you may have about how to use Magnevist .

Important safety information:
• Magnevist may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Magnevist with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Magnevist should be used with extreme caution in CHILDREN younger than 2 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Magnevist while you are pregnant. Magnevist is found in breast milk. If you are or will be breast-feeding while you are using Magnevist , check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Magnevist :
All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Dizziness; headache; minor pain, swelling, coldness, or redness at the injection site; nausea.
Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); changes in vision; fast or irregular heartbeat; muscle weakness; numbness in an arm or leg; pain, redness, or swelling of the skin; severe stomach pain; sharp or crushing chest pain; skin lesions; sudden leg pain; sudden severe headache; sudden shortness of breath; tightness or thickening of the skin.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at .

Proper storage of Magnevist :
Magnevist is usually handled and stored by a health care provider. If you are using Magnevist at home, store Magnevist as directed by your pharmacist or health care provider. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Magnevist out of the reach of children and away from pets.

General information:
• If you have any questions about Magnevist , please talk with your doctor, pharmacist, or other health care provider.
• Magnevist is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.
This information is a summary only. It does not contain all information about Magnevist . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

药品中文名称  钆喷酸葡胺注射液 
药品名称说明  
药品英文名称  Gadopentetic Acid Dimeglumine Salt Injection 
药品中文商品名  马根维显 
药品英文商品名  Magnevist 
中文剂型  注射剂 
英文剂型  
药品规格  469.01mg/ml×10ml 
包装规格  1瓶,10瓶/盒 
注册证号  H20080144 
原注册证号  
注册证号说明  
分包装文号  
公司中文名称  
公司英文名称  Bayer Vital GmbH 
公司中文地址  
公司英文地址  D-51368 Leverkusen.Germany 
公司中文国别  德国 
公司英文国别  Germany 
生产厂商中文名  
生产厂商英文名  Bayer Schering Pharma AG 
生产厂国内地址  
生产厂国内地址  D-13342 Berlin,Germany 
生产厂中文国别  德国 
生产厂英文国别  Germany 
批准日期  2008-04-17 
注册证效期  2013-04-16 

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