多西他赛冻干粉注射剂TAXOTERE ONE-VIAL 20MG/1ML SDV

产地国家:美国

处方药:是

所属类别: 20毫克/1毫升/瓶

包装规格: 20毫克/1毫升/瓶

计价单位:瓶

生产厂家英文名:SANOFI-AVENTIS

原产地英文商品名:TAXOTERE ONE-VIAL 20MG/1ML SDV 1/EA

原产地英文药品名:DOCETAXEL

中文参考商品译名:泰索帝冻干粉注射剂 20毫克/1毫升/瓶

中文参考药品译名:多西他赛

曾用名:紫杉萜

简介:

部分中文泰索帝处方资料(仅供参考)药物名称:泰索帝 Docetaxel药物类别:其他抗肿瘤药药物别名:多西他赛 Taxotere分子式:分子量807.9。

制剂规格::注射剂:20、80mg药理毒理属于紫杉类化合物抗肿瘤药。

作用机制:是加强微管蛋白聚合作用和抑制微管解聚作用,导致形成稳定的非功能性微管束,因而破坏肿瘤细胞的有丝分裂。本品在细胞内浓度比紫杉醇高3倍,并在细胞内滞留时间长,这是本品在体外试验中比紫杉醇抗肿瘤活性大的重要原因。在体内试验中,对小鼠的结肠癌、乳腺癌、肺癌、卵巢肿瘤移植物等有效。对顺铂、足叶乙苷、5Fu、或紫杉醇耐药的细胞株,本品不产生交叉耐药。药动学按剂量100mg/m2静滴本品约1~2h,体内平均分布容积为113L,t1/2α为4min,t1/2β为36min,t1/2γ约为11.2h。体内清除率约为20L/h.m2,具有高蛋白结合率和低肾排泄率。在肝中代谢,主要经胆道从粪便排出,而经尿排泄仅占所给剂量5%~7%;肝功能异常者使本品在体内清除率减少,但年龄差异对本品在体内的药动学无明显改变。

适应证:乳腺癌和非小细胞癌。肺癌、卵巢癌有效,对胰腺癌、胃癌、头颈癌等也有效

不良反应:骨髓抑制。过敏反应。体液潴留。可能发生胃肠道反应如恶心、呕吐或腹泻。脱发。乏力。粘膜炎。关节痛和肌肉痛。低血压。神经毒性和心血管副反应极少发生。

相互作用:本品和顺铂或长春瑞宾或阿霉素合用,提示有益的结果。与酮康唑合用,可能发生不良相互作用,使用时要格外小心。

用法用量:推荐剂量为每3周用75 mg/m2,静脉滴注1 hr。

注意事项:白细胞数目小于1500/m3的病人禁用。孕期、哺乳期妇女及儿童禁用。治疗前需预服糖皮质激素,如地塞米松,以减轻体液潴留的发生。治疗期间应经常监测血细胞数目包装规格

英文版说明书:

TAXOTERE ONE-VIAL 20MG/1ML SDV 1/EA DOCETAXEL SANOFI-AVENTIS 00075-8003-01TAXOTERE ONE-VIAL 80MG/4ML SDV 1/EA DOCETAXEL SANOFI-AVENTIS  TAXOTERE INJ ONE-VIAL 80MG DOCETAXEL SANOFI U.S. LLC  TAXOTERE INJ ONE-VIAL 20MG DOCETAXEL SANOFI U.S. LLC  TaxotereGeneric Name: docetaxel (doe se TAX el)Brand Names: TaxotereWhat is Taxotere?Taxotere is a cancer medicine that slows the growth and spread of cancer cells in the body.Taxotere is used to treat breast cancer, lung cancer, prostate cancer, stomach cancer, and head/neck cancer.Taxotere may also be used for other purposes not listed in this medication guide.mportant information about TaxotereDo not use this medication without your doctor’s consent if you are pregnant. It could cause harm to the unborn baby. Use an effectiveform of birth control, and tell your doctor if you become pregnant during treatment. Before being treated with Taxotere, tell your doctor if you have ever been treated with cisplatin (Platinol), or if you have liver disease, congestive heart failure, fluid retention, swelling problems, or if you have ever had an allergic reaction to docetaxel.Taxotere can be harmful if it gets on your skin during an IV infusion. If this happens, wash the skin thoroughly with soap and warm water.Some people receiving a Taxotere injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel dizzy, light-headed, warm, or itchy, or if you have chest tightness or trouble breathing during the injection.Taxotere can lower the blood cells that help your body fight infections. This can make it easier for you to get sick from being around others who are ill. To be sure your blood cells do not get too low, your blood will need to be tested on a regular basis. Your liver function may also need to be tested. It is important that you not miss any scheduled visits to your doctor.Avoid contact with people who have colds, the flu, or other contagious illnesses. Contact your doctor immediately if you develop signs of infection, especially fever.There are many other drugs that can interact with Taxotere. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.Before using TaxotereBefore being treated with Taxotere, tell your doctor if you have ever been treated with cisplatin (Platinol), or if you have:liver disease;congestive heart failure;fluid retention or swelling problems; orif you have ever had an allergic reaction to docetaxel.If you have any of these conditions, you may need a dose adjustment or special tests to safely receive Taxotere.FDA pregnancy category D. This medication can cause harm to an unborn baby. Do not use Taxotere without telling your doctor 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 Taxotere passes into breast milk or if it could harm a nursing baby. Do not receive Taxotere without telling your doctor if you are breast-feeding a baby.Adults older than 65 may be more sensitive to the side effects of Taxotere.How is Taxotere used?Taxotere is given as an injection through a needle placed into a vein. You will receive this medicine in a clinic or hospital setting. Taxotere must be given slowly through an IV and it may take up to an hour to complete your dose.Your doctor may prescribe a steroid medicine for you to take for a few days before your injection. This will help prevent swelling oran allergic reaction to Taxotere. Do not miss any doses of the steroid.Taxotere must be given slowly through an IV and it may take up to an hour to complete your dose.Taxotere can be harmful if it gets on your skin during an IV infusion. If this happens, wash the skin thoroughly with soap and warm water.Taxotere is usually given once every 3 weeks, and you may receive other cancer medicines at the same time. Your doctor will determinea treatment schedule for you based on the type of cancer being treated and other factors.Taxotere can lower the blood cells that help your body fight infections. This can make it easier for you to get sick from being around others who are ill. To be sure your blood cells do not get too low, your blood will need to be tested on a regular basis. Your liver function may also need to be tested. Do not miss any scheduled appointments.What happens if I miss a dose?Call your doctor for instructions if you miss a dose of Taxotere or the steroid medicine.What happens if I overdose?Seek emergency medical attention if you think you have received too much of this medicine.Overdose symptoms may include fever, chills, body aches, flu symptoms, numbness, burning, pain, or tingly feeling, or white patches or sores inside your mouth or on your lips.What should I avoid while using Taxotere?Avoid getting a flu shot or vaccine while you are being treated with Taxotere. Vaccines may not work as well or could make you sick whileyou are using Taxotere.Avoid contact with people who have colds, the flu, or other contagious illnesses. Contact your doctor immediately if you develop signs of infection, especially fever.Avoid allowing this medicine to get on your skin during an IV infusion. If this does happen, wash the skin thoroughly with soap and warm water.Taxotere side effectsSome people receiving a Taxotere injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel dizzy, light-headed, warm, or itchy, or if you have chest tightness or trouble breathing during the injection.Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:easy bruising or bleeding, unusual weakness;feeling like you might pass out;fever, chills, body aches, flu symptoms;severe diarrhea;skin changes or bruising where the IV was placed;nausea, stomach pain, low fever, loss of appetite, dark urine,clay-colored stools, jaundice (yellowing of the skin or eyes);feeling short of breath, even with mild exertion;swelling of your ankles or feet, weight gain;a red, blistering, peeling skin rash; ornumbness, burning, pain, or tingly feeling.Less serious side effects may include:feeling weak or tired;white patches or sores inside your mouth or on your lips;mild nausea, vomiting, diarrhea, constipation, or loss of appetite;watery eyes;changes in menstrual periods;temporary hair loss; orfingernail or toenail changes.This is not a complete list of side effects and others may occur.Tell your doctor about any unusual or bothersome side effect. Youmay report side effects to FDA at 1-800-FDA-1088.What other drugs will affect Taxotere?Do not receive “live” vaccines during treatment with Taxotere.Administration of a live vaccine may be dangerous during treatment with Taxotere.There are many other drugs that can interact with Taxotere. Tell your doctor about all the prescription and over-the-counter medications you use.This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.Where can I get more information?Your doctor or pharmacist can provide more information about Taxotere.Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.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 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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