苯达莫司汀注射粉剂TREANDA 100MG LYO SDV PWD(BENDAMUSTINE HCL)

药店国别:

产地国家:美国

处方药:是

所属类别: 100毫克/瓶

包装规格: 100毫克/瓶

计价单位:瓶

生产厂家中文参考译名:

生产厂家英文名:CEPHALON

原产地英文商品名:TREANDA 100MG LYO SDV PWD 1/EA

原产地英文药品名:BENDAMUSTINE HCL

中文参考商品译名:TREANDA冻干粉 100毫克/瓶

中文参考药品译名:盐酸苯达莫司汀

曾用名:

简介:

部份中文Treanda处方资料(仅供参考)

【中文药品】

盐酸苯达莫司汀

【商品名称】

Treanda Powder Vial

【英文名称】

Bendamustine

【药品说明】

剂型及规格:粉针,25mg;100mg适应症:非霍奇金淋巴瘤、慢性淋巴细胞性白血病、多发性骨髓瘤。剂量及用药苯达莫司汀冻干粉针呈白色至灰白色,规格为100mg/支。该药储存温度不应超过30℃,避光保存,使用前临时配制。配制流程:该药每100mg须先溶于20ml无菌注射用水,充分振摇直到完全溶解成澄清、无色或淡黄色溶液,溶解时间一般不超过5分钟,溶解后浓度为5mg/ml。在溶解后30分钟之内,根据需要抽取适量苯达莫司汀水溶液,转移至500ml氯化钠注射液(0.9%)或葡萄糖氯化钠注射液(2.5%/0.45%)中,并确保苯达莫司汀在注射液中的最终浓度在0.2~0.6mg/ml之间。配制好的注射液可在2~8℃冷藏保存24小时,或在室温及自然光下保存3小时。苯达莫司汀治疗CLL时,以28天为一个治疗周期,一般需要6个治疗周期。在每个治疗周期的第一天和第二天给药,推荐剂量为100mg/m2。该药经静脉滴注给药,每次给药时间不应少于30分钟。苯达莫司汀治疗NHL时,以21天为一个治疗周期,一般需要8个治疗周期。在每个治疗周期的第一天和第二天给药,推荐剂量为120mg/m2。每次给药时间不应少于60分钟。

【产品特点】

苯达莫司汀(bendammfine,SDX105,Treanda?)是由Astellas Pharma GmbH公司(前Fujisawa Deutschland GmbH公司)和Salmedix(Cephalon)公司开发的抗肿瘤药,属烷化剂。2003年苯达莫司汀获准在德国上市,用于治疗非霍奇金淋巴瘤(NHL)、慢性淋巴细胞白血病(CLL)、多发性骨髓瘤,临床使用者已超过20000例。目前正在日本进行苯达莫司汀治疗对美罗华耐药的非霍奇金淋巴瘤I期临床试验,在美国进行适应症为慢性淋巴细胞白血病的II期临床试验,在美国和加拿大进行治疗对美罗华耐药的惰性非霍奇金淋巴瘤的III期临床试验。苯达莫司汀作为单用或联合化疗对霍奇金病和非霍奇金淋巴瘤的治疗反应率分别为61-97%和41-48%;对于多发性骨髓瘤,苯达莫司汀/泼尼松治疗的完全反应率较高(32%),比美法仑/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,以苯达莫司汀取代环磷酰胺,对发展中低度毒性非霍奇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,以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。在美国和加拿大进行的一个Ⅱ期临床试验(SDX-105-01)发现苯达莫司汀(120mg/m2 iv)对复发的惰性或转移性对美罗华耐药的B细胞非霍奇金淋巴瘤患者ITT(n=75)的总客观反应率为74%。完全反应率为25%,部分反应率为49%,病情稳定的有12%,病情恶化的有14%。所有患者的中位反应持续时间为6.6个月。惰性患者和转移患者中位反应时间分别为9.3个月、2.4个月。而另一个Ⅱ期临床试验(SDX-105-02)结果表明苯达莫司汀(90mg/m2 iv)与美罗华联用对复发的惰性CD20阳性B细胞或套细胞非霍奇金淋巴瘤患者ITT(n=57)的总客观反应率为87%。完全反应率为33%,部分反应率为54%,病情稳定的有10%。

英文版说明书

TreandaGeneric Name: bendamustine (BEN da MUS teen)Brand Names: Treanda—————————————————————–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.—————————————————————–Important information about TreandaYou 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.—————————————————————–Before receiving TreandaYou 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 youhave 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; orif 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 breastmilk 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.—————————————————————–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.—————————————————————–What happens if I miss a dose?Call your doctor for instructions if you miss an appointment for your Treanda injection.—————————————————————–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).—————————————————————–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.—————————————————————–Treanda side effectsSome 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; orpain, 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; ormild 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.—————————————————————–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); ora 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.—————————————————————–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 beencompiled 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 coverall 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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