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 详细处方信息以本药内容附件PDF文件（201231921493132.PDF,201231921492614.PDF）的“原文Priscribing Information”为准
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部分中文塞替派处方资料（仅供参考）

塞替派注射粉剂|Thioplex（thiotepa）
【药物名称】
中文通用名称：塞替派
英文通用名称：Thiotepa
其它名称：二胺硫磷、硫替哌、三胺硫磷、三乙撑硫代磷酰胺、三乙烯硫化磷酰胺、室安的宝、息安的宝、Ledertepa、NSC-6396、Onco Tuitepa、Oncotiotepa、Phosphorothionic Triethenamide、TESPA、Tespamin、Thiofosyl、Thiophosphamide、Thiophosphoramide、Thioplex、Thiotepa Lederle、Thio-TERA、Tifosyl、Tiofosamid、Tiotepum、Triethylenethiophosphoramide、TSPA

【临床应用】
主要用于治疗乳腺癌、卵巢癌、膀胱癌(局部灌注)及癌性体腔积液(腔内注射)等，也曾用于治疗原发性肝癌、子宫颈癌、黑色素瘤、胃肠道肿瘤等。

【药理】
1.药效学  本药为多功能烷化剂类抗肿瘤药，属非特异性细胞周期药物。本药在结构上具有乙撑亚胺基，在生理条件下，可形成不稳定的亚乙基亚胺基，与DNA的碱基发生交叉联结，使碱基烷基化，从而干扰DNA和RNA的功能，达到抗肿瘤的目的。体外实验显示，本药可引起染色体畸变，动物实验(小鼠)表明本药有致癌性。
2.药动学  本药不易经消化道吸收。快速静脉注射给药(低于5分钟)后5分钟内血药浓度达峰值；膀胱灌注或腔内注射后25分钟内在血循环中可检测出本药。在体内广泛分布于各组织，血浆蛋白结合率为10%(主要白蛋白、脂蛋白结合)。可透过血-脑脊液屏障，脑脊液中的药物浓度为血浆浓度的60%-100%。主要在肝脏经细胞色素P450氧化代谢为替派(tepa)。本药半衰期α相为6分钟，β相为10分钟，注射后1-4小时血药浓度下降90%。大部分药物于24-48小时内以代谢物形式经尿液排出(原形不足1%)。

【注意事项】
1.禁忌症 
(1)对本药过敏者。
(2)有严重肝、肾功能不全者。
(3)严重骨髓抑制者。
(4)孕妇。
2.慎用 
(1)有骨髓抑制或肿瘤已浸润至骨髓者。
(2)肝、肾功能不全者。
(3)感染患者。
(4)有泌尿系统结石史和痛风史者。
3.药物对妊娠的影响  本药可能有致畸性，不推荐孕妇使用，特别是妊娠初期应避免使用。
4.药物对哺乳的影响  尚不清楚本药能否分泌入人类乳汁，哺乳妇女用药时应权衡利弊。
5.药物对检验值或诊断的影响  可致血尿酸水平增加。
6.用药前后及用药时应当检查或监测  用药期间及停药后3周内应定期检查血常规、血小板计数及肝、肾功能。

【不良反应】
1.血液系统  骨髓抑制为本药剂量限制性毒性，多于用药后1-6周出现，部分患者在疗程结束后才出现，停药后大多可恢复，部分患者骨髓抑制持续时间较长。
2.胃肠道  可有食欲减退、恶心及呕吐等胃肠道反应。
3.其它  少见过敏反应，个别患者有发热、疲乏、脱发及皮疹。尚可见头痛头晕、注射部位疼痛、出血性膀胱炎、女性闭经和男性精子形成异常。

【药物相互作用】
·药物-药物相互作用
1.本药与尿激酶同时应用治疗膀胱癌时，尿激酶可增加本药在肿瘤组织中的浓度。
2.本药可抑制假胆碱酯酶的活性，而延长琥珀胆碱的作用时间。
3.使用本药时接种活疫苗(如轮状病毒疫苗)，将增加活疫苗感染的风险。

【给药说明】
1.本药稀释后如有浑浊，则不能使用。
2.为防止高尿酸血症，治疗时可大量补液、碱化尿液，必要时服用别嘌醇等抗尿酸药。
3.在放疗的同时使用本药，应适当调整剂量。
4.国外资料提示，当白细胞计数低于3×10×E9/L或血小板计数低于150×10×E9/L时，应停用本药。
5.药物过量时尚无特效解毒药。

【用法与用量】
成人
·常规剂量
·静脉注射  每次10mg(或0.2mg/kg)，每日1次，连用5日后改为每周3次，一个疗程总量为300mg。1.5-2月后可重复下一疗程。
·肌内注射  同静脉注射。
·动脉注射：每次10-20mg，用法同静脉注射。
·腔内注射(胸腹腔或心包腔)：每次10-30mg，每周1-2次。
·膀胱灌注  每次50-100mg，溶于生理盐水50-100mL中，通过导尿管将本药注入膀胱，每周1次，4周后改为每月1次，10次为一疗程。
·瘤内注射  每次5-10mg，可注射一处或多处。

【制剂与规格】
塞替派注射液  1mL:10mg。
贮法：遮光、密闭、在冷处保存。
注射用塞替派  (1)5mg。(2)10mg。
贮法：遮光、密闭、在冷处保存。

GENERIC NAME: THIOTEPA - INJECTION (thigh-oh-TEP-uh)

BRAND NAME(S): Thioplex

USES: Thiotepa is used to treat cancer. It works by slowing or stopping the growth of cancer cells. Thiotepa is often given into the bladder to treat bladder cancer.

HOW TO USE: This medication is given by injection into a vein by a health care professional, usually once a week or as directed by your doctor. Sometimes, thiotepa is injected directly into the tumor. Tell your doctor or nurse immediately if you experience pain, burning, or redness at the injection site.For treatment of bladder cancer, thiotepa is usually given into the bladder through a tube (catheter). Your doctor may direct you to limit fluids for 8 to 12 hours before the medication is given. The solution is usually left in place for 2 hours and then drained out through the bladder tube. Your doctor may direct you to change positions every 15 minutes while the solution is in your bladder to make sure the solution treats all parts of your bladder.The dosage and how often the medication is given is based on your medical condition and response to treatment. Your doctor will do blood tests (complete blood count) to find the right dose for you. Your next dose may need to be rescheduled if your white blood cell count or platelets are too low.Learn how to handle, use, and discard chemotherapy and medical supplies safely. Consult your pharmacist. Wear gloves and wash your hands carefully after handling this drug. Avoid getting this medication in your eyes or on your skin. If the medication gets in your eye, wash the affected eye(s) well with water and contact your doctor. If the medication gets on your skin, wash the area well with soap and water.

SIDE EFFECTS: Pain/redness at the injection site, dizziness, headache, blurred vision, fever, nausea, vomiting, stomach/abdominal pain, or loss of appetite may occur. Changes in diet such as eating several small meals or limiting activity may help lessen some of these effects. In some cases, drug treatment may be necessary to prevent or relieve nausea and vomiting. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.Temporary hair loss is another common side effect. Normal hair growth should return after treatment has ended.Many people using this medication have serious side effects. However, remember that your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.Painful sores on the lips, mouth, and throat may occur. To decrease the risk, limit hot foods and drinks, brush your teeth carefully, avoid using mouthwash that contains alcohol, and rinse your mouth frequently with cool water.This medication can lower the body's ability to fight an infection. Tell your doctor promptly if you develop any signs of an infection such as fever, chills, or persistent sore throat.This medication may also cause very serious bleeding. Tell your doctor immediately if any signs of serious bleeding occur, including: easy bruising/bleeding, bloody/black/tarry stools, coughing up blood, nosebleeds that are frequent or hard to stop, dizziness/fainting, fast/irregular heartbeat, pale/gray/bluish skin, unusual tiredness/weakness, vomit that is bloody or looks like coffee grounds.Tell your doctor right away if you have any serious side effects, including: severe stomach/abdominal pain, lower back/side pain, painful/difficult urination, pink/dark urine.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using thiotepa, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially: bone marrow problems (e.g., low white blood cell count/platelets from previous chemotherapy/radiation treatment), kidney disease, liver disease.Wash your hands well to prevent the spread of infections. Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose.To lower your risk of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.Before having surgery, tell your doctor or dentist that you are using this medication.This medication is not recommended for use during pregnancy. It may harm the unborn baby. If you become pregnant or think you may be pregnant, tell your doctor immediately. Males and females must use 2 reliable forms of birth control (e.g., condoms and birth control pills) during treatment with this drug. Talk with your doctor about effective forms of birth control.It is not known whether this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: aspirin and other NSAIDs (e.g., ibuprofen), drugs that may harm the immune system (e.g., chemotherapy, corticosteroids such as prednisone), live virus vaccines (e.g., oral polio vaccine, flu vaccine inhaled through the nose), nalidixic acid.Check all prescription and nonprescription medicine labels carefully since many contain pain relievers/fever reducers (NSAIDs such as ibuprofen, naproxen, or aspirin) that may increase your risk of bleeding. Low-dose aspirin should be continued if prescribed by your doctor for heart attack or stroke prevention (usually at dosages of 81-325 milligrams a day). Consult your doctor or pharmacist for more details.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Laboratory and/or medical tests (e.g., complete blood counts, kidney tests, liver tests) should be performed while you are being treated with the medication and for several weeks after your last dose to monitor your progress or check for side effects. Consult your doctor for more details.

MISSED DOSE: For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. Keep all medical/lab appointments. If you miss a dose, contact your doctor to establish a new dosing schedule.

STORAGE: Not applicable. This medication is given in a clinic and will not be stored at home.MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-800-854-1166 (USA) or 1-800-668-1507 (Canada).

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 详细处方信息以本药内容附件PDF文件（201231921493132.PDF,201231921492614.PDF）的“原文Priscribing Information”为准
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