注射用卡铂Carboplatin for I.V. Infusion

药店国别： 产地国家：日本 处方药：是 所属类别： 450毫克/瓶 包装规格： 450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：Nippon Kayaku 原产地英文商品名：Carboplatin for I.V. Infusion(カルボプラチン点滴静注液「NK」)450mg/Vial 原产地英文药品名：Carboplatin 中文参考商品译名：Carboplatin(カルボプラチン点滴静注液「NK」)450毫克/瓶 中文参考药品译名：卡铂 曾用名： 简介：部份中文卡铂处方资料(仅供参考)药品英文名Carboplatin药品别名铂尔定、卡波铂、顺羧酸铂、碳铂、顺二氨环丁烷羧酸铂、顺二氨环丁铂、Carboplatine、Carboplatinum、CBDCA、JM-8、Paraplatin、Platinum药物剂型注射剂(粉)：100mg，15mg。 药理作用 卡铂为第二代铂类抗肿瘤药，具细胞周期非特异性，作用与烷化剂类似。卡铂细胞杀伤作用可能是由于其与DNA产生链间和链内交联，导致DNA损伤，以至DNA的复制和转录受损。单用时，卡铂的剂量4倍于顺铂，且细胞中出现DNA交联作用较顺铂缓慢。药动学卡铂的分布与顺铂相似，在肝、肾、皮肤和肿瘤中浓度最高。但卡铂的血浆蛋白结合率很低，呈不可逆，结合后缓慢排出体外，半衰期γ相至少为5天。α相为1～2h，β相为2.6～5.9h。卡铂主要由肾排泄，当肌酐清除率为每分钟60ml时，24h内由肾脏清除71%，其中给药量的65%在头12h推出，6%在其次12h排出，仅有3%～5%在96h后排出。目前尚不清楚剩余药物是经胆汁还是经其他途径排出。24h尿中的铂都是有活性的卡铂，这说明仅有极少药物在体内发生代谢。肌酐清除率低的患者药物半衰期延长，因而剂量应相应调整。卡铂不经肾小管分泌，这可能是卡铂的肾毒性发生率较顺铂低的原因。 适应证 与顺铂相似。主要用于卵巢癌、小细胞肺癌、头颈部癌、生殖细胞肿瘤，也可用于甲状腺癌、宫颈癌、膀胱癌及非小细胞肺癌。 禁忌证 1.对顺铂或其他含铂化合物有过敏史者。 2.严重肾功能不全(肌酐清除率低于每分钟20ml)者。 3.孕妇及哺乳妇女。 4.老年患者。 注意事项 1.慎用：(1)感染水痘、带状疱疹等病毒者;(2)肾功能不全者;(3)严重骨髓抑制者;(4)出血性肿瘤患者。 2.药物对妊娠的影响：本药有致畸作用，为FDA妊娠分类D类药物。 3.用药前后及用药时应当检查或监测：(1)听力;(2)神经功能;(3)血尿素氮、肌酐清除率与血清肌酐;(4)血细胞比容、血红蛋白测定、白细胞分类与血小板计数，用药期间至少每周检查1次白细胞与血小板;(5)血清钙、镁、钾、钠含量。 4.由于本药注射剂配方中含有甘露醇，故不能耐受甘露醇的患者可能也不能耐受卡铂的注射剂。 5.虽然本药对肾功能的影响低于顺铂，但用过顺铂者仍应谨慎，并注意肾功能变化。 6.本药的骨髓毒性取决于剂量，并与药物的肾清除率成反比，患者肾功能受损时，毒性增加。 不良反应 1.骨髓抑制：为剂量限制性毒性。主要为血小板减少和白细胞降低。血小板最低点出现在用药后2～3周，第4周后恢复。白细胞最低点为2～4周，恢复较血小板慢，可延迟到6周左右。 2.消化道反应：常见但仅为轻度到中度，呕吐远较顺铂轻。 3.肾功能损害：很少引起肾功能损害，但与氨基苷类抗生素同时使用时能增加肾功能不全的发生率。用药期间应多饮水，使每天尿量在2000ml以上。4.其他：肝功能损害(胆红素、转氨酶或碱性磷酸酶水平升高)、变态反应、口腔炎和“流感样”综合征。 用法用量 1.静脉用药：1次给药，300～400mg/m2，静脉注射或静脉滴注，儿童可提高到560mg/m2，4周重复1次;或50～70mg/m2(一般1次100mg)，每天1次，连用5天，4周重复。近年来多主张根据AUC(血药浓度-时间曲线下面积)决定用药剂量。 2.腹腔内注射：300～400mg/m2，每4周1次。药物相应作用1.本药与环孢素合用，可增加免疫抑制作用，在出现耐药性的一些肿瘤病例中可合用。 2.本药与活疫苗(如轮状病毒疫苗)合用时，可增加感染的危险性。故接受本药治疗的患者禁止注射活疫苗。处于缓解期的白血病患者，化疗结束后至少间隔3个月才能注射活疫苗。 3.阿米卡星、庆大霉素、卡那霉素、奈替米星、链霉素、妥布霉素等氨基糖苷类抗生素与本药合用时耳毒性增加。 4.本药与苯妥英钠合用，可使苯妥英钠的胃肠道呼吸减少，作用降低。 注射用卡铂英文版说明书 Carboplatin InjectionIMPORTANT WARNING:Expand SectionCarboplatin injection must be given in a hospital or medical facility under the supervision of a doctor who is experienced in giving chemotherapy medications for cancer.Carboplatin can cause a severe decrease in the number of blood cells in your bone marrow. This increases the risk that you will develop a serious infection or bleeding. If you experience any of the following symptoms, call your doctor immediately: fever, sore throat, chills, ongoing cough and congestion, or other signs of infection; unusual bleeding or bruising; black and tarry stools; red blood in stools; bloody vomit; vomited material that looks like coffee grounds.Carboplatin may cause severe allergic reactions. If you experience an allergic reaction to carboplatin injection, it may begin within a few minutes after your infusion starts, and you may experience the following symptoms: hives; skin rash; itching; reddening of the skin; difficulty breathing or swallowing; dizziness; faintness; or fast heartbeat. Tell your doctor immediately if you experience any of these symptoms.Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests before, during, and after your treatment to check your body's response to carboplatin. Your doctor may need to stop or delay your treatment if you experience certain side effects.Why is this medication prescribed?Expand SectionCarboplatin is used alone or in combination with other medications to treat cancer of the ovaries (cancer that begins in the female reproductive organs where eggs are formed) that has spread to other parts of the body, not improved, or that has worsened after treatment with other medications or radiation therapy. Carboplatin is in a class of medications known as platinum-containing compounds. It works by stopping or slowing the growth of cancer cells.How should this medicine be used?Expand SectionCarboplatin injection comes as a solution (liquid) to be injected over at least 15 minutes intravenously (into a vein) by a doctor or nurse in a medical facility. It is usually given once every 4 weeks.Other uses for this medicineExpand SectionCarboplatin is also sometimes used to treat lung, bladder, breast, and endometrial cancer; head and neck cancer; cancer of the cervix and testicles: Wilms' tumor (a type of kidney cancer that occurs in children); certain types of brain tumors; neuroblastoma (a cancer that begins in nerve cells and occurs mainly in children); and retinoblastoma (cancer in the eye). Talk to your doctor about the risks of using this medication for your condition.This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.What special precautions should I follow?Expand SectionBefore receiving carboplatin injection,•tell your doctor and pharmacist if you are allergic to carboplatin, cisplatin (Platinol), any other medications, or any of the ingredients in carboplatin injection. Ask your pharmacist for a list of the ingredients.•tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: aminoglycoside antibiotics such as amikacin (Amikin), gentamicin (Garamycin), or tobramycin (Tobi, Nebcin). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with cisplatin, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.•tell your doctor if you have or have ever had kidney disease or if you have bleeding problems.•tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. You should not become pregnant or breast-feed while you are receiving carboplatin. If you become pregnant while receiving carboplatin, call your doctor. Carboplatin may harm the fetus.What side effects can this medication cause?Expand SectionCarboplatin may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:•nausea•vomiting•diarrhea•constipation•sores in the mouth and throat•pain, burning, or tingling in the hands or feet•pain, itching, redness, swelling, blisters, or sores in the place where the medication was injected•hair loss•pain•weakness•loss in ability to taste foodSome side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately:•pale skin•unusual tiredness or weakness•fainting•dizziness•sudden changes in vision, including color vision•decreased urination•swelling of the face, arms, hands, feet, ankles, or lower legs•shortness of breath with everyday activity or when lying flat•ringing in ears and difficulty hearingCarboplatin may increase the risk that you will develop other cancers. Talk to your doctor about the risks of taking this medication.Carboplatin may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at https://www.fda.gov/Safety/MedWatch] or by phone [1-800-332-1088].In case of emergency/overdoseExpand SectionIn case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.Symptoms of overdose may include:•black, tarry, or bloody stools•bloody vomit or vomited material that looks like coffee grounds•unusual bruising or bleeding•decreased urination•pain, burning, or tingling in the hands or feet•ringing in ears and difficulty hearingWhat other information should I know?Expand SectionIt is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.