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  药店国别: 美国药房
产地国家: 美国
所属类别: 抗癌药物->治疗白血病药物
处方药:处方药
包装规格: 90毫克/毫升, 180毫克/2毫升/瓶
计价单位:
  点击放大  
生产厂家中文参考译名:
TEVA
生产厂家英文名:
TEVA
该药品相关信息网址1:
http://www.treanda.com/
该药品相关信息网址2:
http://www.drugs.com/treanda.html
该药品相关信息网址3:
http://www.medilexicon.com/drugs/treanda.php
原产地英文商品名:
TREANDA 90mg/ ML, 180mg 2ML/vial
原产地英文药品名:
BENDAMUSTINE HCL
中文参考商品译名:
TREANDA 90毫克/毫升, 180毫克/2毫升/瓶
中文参考药品译名:
盐酸苯达莫司汀
原产地国家批准上市年份:
2008/10/31
英文适应病症1:
Chronic lymphocytic leukemia
英文适应病症2:
Hodgkin's disease
英文适应病症3:
Non-Hodgkin's lymphoma
英文适应病症4:
Plasmacytoma
英文适应病症5:
Breast Cancer
临床试验期:
完成
中文适应病症参考翻译1:
慢性淋巴细胞白血病
中文适应病症参考翻译2:
何杰金病
中文适应病症参考翻译3:
非何杰金淋巴瘤
中文适应病症参考翻译4:
浆细胞瘤
中文适应病症参考翻译5:
乳腺癌
药品信息:

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 详细处方信息以本药内容附件PDF文件(201011919050222.pdf)的“原文Priscribing Information”为准
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部分中文苯达莫司汀处方资料(仅供参考)

    Treanda为美国Cephalon公司研制的新型抗肿瘤药物,化学名“苯达莫司汀”,属于烷化剂的一种。其抗肿瘤作用的发挥机制是破坏癌症细胞的DNA,从而导致细胞凋亡。
    慢性淋巴细胞性白血病(CLL)是危害人类健康的恶性肿瘤之一,表现为由于淋巴细胞肿瘤样增殖,其特点为成熟形态的淋巴细胞在体内积聚使血液和骨髓中淋巴细胞增多,淋巴结、肝、脾肿大,最后累及淋巴系统以外的其他组织,CLL细胞呈单克隆性增殖,95%以上的慢淋为B细胞型,3-5%为T细胞型。
    CLL在我国发生率较低,仅占慢性白血病的10%,日本和印度与我国相似,而欧美发病率很高,占慢性白血病的50%或更多,患者多为老年人,50岁以上占90%,男女之比为2∶1。
    通过以上信息,我们也发现,尽管CLL非常罕见,但美国却是CLL相对高发的地区之一,Cephalon公司才致力于研究Treanda来攻克这一顽症。根据该公司提交的报告,美国每年大约新增15,000位CLL患者,严重影响了他们的健康。
    Cephalon公司公布的一个试验数据标明,在有301位CLL患者参加的阳性对照试验中,Treanda组患者的有效率及存活期都优于已上市的化疗药物。
    因此,美国FDA批准了该药的上市,并且,对了表彰Cephalon公司为攻克CLL这种罕见疾病所做出的贡献,FDA给了该公司一段时间的独占期。健康新闻3月20日报道:治疗慢性淋巴细胞性白血病(CLL)的新药Treanda通过了美国FDA的审核,即将在4月份上市。

1、英文名:Bendamustine

2、品种概述
  盐酸苯达莫司汀最早于19世纪60年代初期由Ozegowski和其同事在德国耶拿的微生物试验协会研制。合成的目的是使一种烷基化氮芥(一种非功能烷化剂)连接一个嘌呤和氨基酸。新合成的化合物与苯丁酸氮芥相比主要的优点是它的水溶性。Anger et al.公开了苯达莫司汀对浆细胞瘤病人成功应用的最初临床结果。苯达莫司汀从1971年到1992年以Cytostasan的商品名由耶拿制药公司生产。从1993年后,这种细胞生长抑制剂被ribosepharm GmbH公司以Ribomustine的商品名上市销售。
  最近,美国FDA于2008年3月21日批准Cephalon公司的盐酸苯达莫司汀(bendamustine,Treanda)用于慢性淋巴细胞性白血病(CLL)。CLL是1种恶性的淋巴细胞克隆性增殖性疾病,多见于老年人,平均发病年龄70岁,且男性多于女性。据美国癌症学会预计,2008年美国将有15000例CLL新发病例。分析师预计本品年销售峰值在3~5亿美元。此外,本品另一适应证-非霍奇金淋巴瘤目前正等待FDA批准。

3、药理特点
  盐酸苯达莫司汀(Bendamustine Hydrochloride)是一种双功能基烷化剂,具有抗肿瘤和杀细胞作用。本品的抗肿瘤和杀细胞作用主要归功于DNA单链和双联通过烷化作用交联,这打乱了DNA的功能和DNA的合成,也会使DNA和蛋白之间,以及蛋白和蛋白之间产生交联,从而发挥抗肿瘤作用。本品作为单用或联合化疗,对何杰金氏淋巴瘤和非何杰金氏淋巴瘤的治疗反应率分别为61%~97%和41%~48%。

4、临床应用
  本项目主要应用于单独或与其它抗肿瘤药物联合用药来治疗下列恶性肿瘤:何杰金病;非何杰金淋巴瘤;浆细胞瘤(多发性骨髓瘤);慢性淋巴细胞白血病(CLL);乳腺癌。
  本品用于何杰金病、非何杰金淋巴瘤、多发性骨髓瘤、CLL和乳腺癌。其剂量血癌为50~60 mg/m2/d,3~5天或每3~4周为100~120 mg/m2 ;实体瘤每4 周为120~150 mg/m2 ,每日1 次,30~60 min 静脉滴注。盐酸苯达莫司汀作为单用或联合化疗,对何杰金病和非何杰金淋巴瘤的治疗反应率分别为61%~97%和41%~48 %。对多发性骨髓瘤病人,苯达莫司汀/泼尼松治疗的完全反应率较高(32 %) ,美法仑/ 泼尼松疗法反应更持久。在环磷酰胺、长春新碱、泼尼松治疗方案中,苯达莫司汀取代环磷酰胺,对发展中低度毒性非何杰金淋巴瘤有相似的反应率。在环磷酰胺、甲氨蝶呤、氟尿嘧啶治疗方案中,苯达莫司汀取代环磷酰胺,使转移性乳腺癌病人的缓解期从6.2 个月延长至15.2个月。
  盐酸苯达莫司汀( bendamustine) 是双功能基烷化剂,体外对人卵巢癌和乳腺癌有细胞毒性,体外与环磷酰胺、美法仑(melphalan) 、卡莫司汀(carmustine)和顺铂有部分交叉耐受。对乳腺癌细胞系MCF7抑制细胞生长的IC50为138μmol/L,对顺铂抗药性卵巢癌细胞系A27802CP2 的IC50为157μmol/L ,对多柔比星抗药性乳腺癌细胞系MCF7AD 的IC50为187μmol/L。在等毒性浓度( IC50s)下,苯达莫司汀比美法仑、环磷酰胺或卡莫司汀引起更多的DNA 双螺旋断裂,比卡莫司汀或环磷酰胺作用更持久。体外引起浓度依赖性的B2慢性淋巴细胞白血病(B2CLL) 细胞凋亡,与氟达拉滨(fludarabine) 合用,在48 h 内凋亡率高1.4 倍。在Ⅰ期临床试验中,苯达莫司汀60~80 mg/m2每周1次,至8周,对顽固性实体瘤病人引起持久性的全淋巴细胞减少,主要为B细胞毒性。4周后,外周血B细胞、自然杀伤细胞和T 细胞分别下降90%,70%和60%以上。

Treanda
Generic Name: bendamustine (BEN da MUS teen)
Brand Names: Treanda

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What is Treanda?
Treanda (bendamustine) is a cancer medication that interferes with the growth of cancer cells and slows their growth and spread in the body.

Treanda is used to treat chronic lymphocytic leukemia. It is also used to treat indolent B-cell non-Hodgkin lymphoma after other medications have been tried without successful treatment of this condition.

Treanda may also be used for other purposes not listed here.

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Important information about Treanda
You should not receive Treanda if you are allergic to bendamustine or mannitol (Osmitrol). Do not receive Treanda if you are pregnant. It could harm the unborn baby.

Before you receive Treanda, tell your doctor if you have a weak immune system, fever or other signs of infection, a metabolic disorder or electrolyte imbalance, liver or kidney disease, or if you smoke.

Tell your caregiver right away if you have a fever, chills, itching, or skin rash during or shortly after the Treanda injection.

Other serious side effects to tell your doctor about include fever, chills, cough, sore throat, feeling short of breath, pale skin, easy bruising or bleeding, unusual weakness, severe skin rash, weak pulse, muscle weakness, fast or slow heart rate, confusion, lower back pain, blood in your urine, urinating less than usual, or swelling, redness, or signs of where Treanda was injected.

To be sure Treanda is not causing harmful effects, your blood may need to be tested often. Your kidney or liver function may also need to be tested. Visit your doctor regularly.

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Before receiving Treanda
You should not receive Treanda if you are allergic to bendamustine or mannitol (Osmitrol).

To make sure you can safely receive Treanda, tell your doctor if you have any of these other conditions:
a weak immune system;
fever or other signs of infection;
a metabolic disorder or electrolyte imbalance;
liver disease;
kidney disease; or
if you smoke.

FDA pregnancy category D. Do not receive Treanda if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment. It is not known whether bendamustine passes into breast milk or if it could harm a nursing baby. Do not receive Treanda without telling your doctor if you are breast-feeding a baby.

Some people receiving Treanda have developed certain types of cancers. It is not known whether this medication causes cancer. Talk with your doctor about the risks and benefits of using Treanda.

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How is Treanda given?
Treanda is injected into a vein through an IV. You will receive this injection in a clinic or hospital setting. Treanda must be given slowly, and the IV infusion can take at least 30 minutes to complete.

Treanda is usually given for 2 days in a row every 21 to 28 days. You may receive up to 8 treatments total, depending on the condition being treated. Follow your doctor's instructions.

You may be given other medications to help prevent certain side effects of Treanda.

Tell your caregivers if you feel any burning, pain, or swelling around the IV needle when the medicine is injected.

To be sure Treanda is not causing harmful effects, your blood may need to be tested often. Your kidney or liver function may also need to be tested. Visit your doctor regularly.

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What happens if I miss a dose?
Call your doctor for instructions if you miss an appointment for your Treanda injection.

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What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include drowsiness, tremors, slow or shallow breathing, loss of balance or coordination, or seizure (convulsions).

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What should I avoid while receiving Treanda?
Treanda may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

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Treanda side effects
Some people receiving a Treanda injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you have fever, chills, itching, or skin rash during or shortly after the injection. Get emergency medical help if you have any of these signs of an allergic reaction to Treanda: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Tell your caregivers at once if you have a serious side effect such as:
fever, chills, body aches, flu symptoms, sores in your mouth and throat;
pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;
easy bruising or bleeding, purple or red pinpoint spots under your skin, unusual weakness;
cold symptoms such as stuffy nose, sneezing, cough, sore throat;
lower back pain, blood in your urine, urinating less than usual or not at all;
numbness or tingly feeling around your mouth;
muscle weakness, tightness, or contraction, overactive reflexes;
fast or slow heart rate, weak pulse, confusion;
dry mouth, feeling very thirsty or hot, heavy sweating or hot and dry skin;
severe blistering, peeling, and red skin rash; or
pain, swelling, redness, skin changes, or signs of infection where the medicine was injected.

Less serious Treanda side effects may include:
mild nausea, vomiting, diarrhea, constipation, or upset stomach;
swelling in your hands or feet;
headache, dizziness, drowsiness;
loss of appetite, weight loss; or
mild skin rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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What other drugs will affect Treanda?
Tell your doctor about all other medications you use, especially:
allopurinol (Zyloprim);
carbamazepine (Carbatrol, Equetro, Tegretol);
cimetidine (Tagamet);
ciprofloxacin (Cipro);
fluvoxamine (Luvox);
omeprazole (Prilosec);
thiabendazole (Mintezol); or
a barbiturate such as butabarbital (Butisol), secobarbital (Seconal), phenobarbital (Solfoton), and others.

This list is not complete and other drugs may interact with Treanda. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

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Where can I get more information?
Your doctor or pharmacist can provide more information about Treanda.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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 详细处方信息以本药内容附件PDF文件(201011919050222.pdf)的“原文Priscribing Information”为准
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更新日期: 2015-03-10
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