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克必信（注射用达托霉素） 克必信(注射用达托霉素) 克必信 Generic Name: daptomycin (DAP to my sin) 通用名:达托霉素 Brand Names: Cubicin 商品名:克必信 What is Cubicin? 克必信是什么 Cubicin is an antibiotic that fights bacteria in the body. 克必信是一种能够杀灭体内细菌的抗生素。 Cubicin is used to treat bacterial infections of the skin and underlying tissues. 克必信可用于治疗皮肤和皮下组织的细菌感染。 Cubicin may also be used for other purposes not listed in this medication guide. 克必信还可用于本用药指南中未涉及到的其他一些疾病。 What is the most important information I should know about Cubicin? 关于克必信你应必须知道的信息 Before using Cubicin, tell your doctor if you are taking a blood thinner or a cholesterol-lowering medication. 如果你正接受血液稀释剂或降胆固醇药物的治疗，你应该在服用克必信前及时将此用药 情况告知你的主治医师。 Cubicin is given as an injection into a vein. You may be given instructions on how to use your injections at home. Do not use this medicine at home if you do not fully understand how to give the injection and properly dispose of needles and other items used in giving the medicine. 克必信通过静脉注射用药。你可能已经懂得如何在家里进行自我注射给药。但是，如果 你还未完全明白如何注射，如何处置针头和其他一些用药要求，那么切记不可在家独自用药。 Use Cubicin for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated. Cubicin will not treat a viral infection such as the common cold or flu. Call your doctor at once if you have any numbness or tingling, or any unusual muscle pain, tenderness, or weakness. 克必信的用药周期应达到医生处方中的要求。在完全治愈前，你可能会感觉到症状有所 减轻。克必信对病毒感染无效，比如普通感冒或流感。用药期间如果感到任何麻木、刺痛、 肌肉酸痛、肿痛或无力，应立即与你的主治医师联系。 Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or has blood in it, call your doctor. Do not use any medicine to stop the diarrhea unless your doctor has told you to. 抗生素药物可能导致腹泻，这说明你有可能又受到了新的感染。如果你的腹泻拉水或带 有血迹，应向你的主治医师咨询。 To be sure Cubicin is helping your condition, your blood will need to be tested on a regular basis. Your kidney function may also need to be tested. Do not miss any scheduled appointments. 为了确保克必信能够达到一定的治疗效果，那么你需要定期检测血药浓度和肾功能。不要忽 略任何一次主治医师对你的用药情况咨询。 What should I discuss with my healthcare provider before using Cubicin? 服用克必信前，我应该与我医生谈些什么 Do not use Cubicin if you are allergic to daptomycin. 如果你对达托霉素过敏，请不要使用克必信。 Before using Cubicin, tell your doctor if you are allergic to any drugs, or if you have: 在使用克必信前，请告诉主治医师你的药物过敏史或者你的病史:如肾脏疾病、神经或 肌肉疾病。 kidney disease; or a nerve or muscle disorder. If you have any of these conditions, you may need a dose adjustment or special tests to safely use Cubicin. 如果你正患有以上疾病，那么需要通过调整剂量或经过特殊验证来保证克必信的用药安 全。 FDA pregnancy category B. Cubicin is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether Cubicin passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. This medicine should not be used in a child younger than 18 years old. FDA将克必信归为妊娠B类，经证实克必信对胎儿没有毒害作用。应该告诉医生你正 处于妊娠期或在服药期间有怀孕的打算。目前，尚不明确克必信是否能通过母乳毒害婴儿。 若是你正处于哺乳期，切记不可将此情况告知医生。18岁以下儿童不可服用本药。 How should I use Cubicin? 如何服用克必信 Cubicin is given as an injection through a needle placed into a vein. Your doctor, nurse, or other healthcare provider will give you this injection. The medicine must be given slowly through an IV infusion, and can take up to 30 minutes to complete. 克必信通过静脉注射给药，你的医生、护士或者其他医疗机构会提供此项注射服务。应 控制缓慢的注射速度，一次剂量的注射时间最多30min。 Cubicin is usually given every 24 hours for 1 to 2 weeks. Follow your doctor's instructions. 每日一次给药，治疗周期为1~2周。严格按照医生的处方指示进行用药。 You may be shown how to use your medicine at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of needles, IV tubing, and other items used in giving the medicine. 你可能已经懂得如何在家里进行自我注射用药。但是，如果你还未完全明白如何注射， 如何处置针头和其他一些用药要求，那么切记不可在家自我单独用药。 Use each disposable needle only one time. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets. 必须使用一次性针头。将用过的针头扔到穿刺防水容器中(可以向你的药剂师咨询如何 购买和处置)。将此容器放置在儿童和宠物无法够到的地方。 Use Cubicin for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated. Cubicin will not treat a viral infection such as the common cold or flu. 克必信的用药周期应达到医生处方中的要求。在完全治愈前，你可能会感觉到症状有所 减轻。克必信对病毒感染无效，比如普通感冒或流感。 To be sure Cubicin is helping your condition, your blood will need to be tested on a regular basis. Your kidney function may also need to be tested. Do not miss any scheduled visits to your doctor. 为了确保克必信能够达到一定的治疗效果，那么你需要定期检测血药浓度和肾功能。不 要忽略任何一次医生对你的用药情况咨询。 This medication can cause you to have unusual results with certain medical tests. Tell any doctor who treats you that you are using Cubicin. 服用本药物可能会导致一些医疗检测的结果出现偏差，应该告诉医师你正服用克必信。 Cubicin must be stored in a refrigerator and kept from freezing. Each vial (bottle) of this medicine is for one use only. 应将克必信冷藏保存。每小瓶供一次剂量使用。 What happens if I miss a dose? 忘记服药，怎么办 Call your doctor if you miss a dose of this medicine. 请及时与你的主治医师联系。 What happens if I overdose? 服药过量，怎么办 Seek emergency medical attention if you think you have received too much of this medicine. Symptoms of a Cubicin overdose are not known. 如果服药远远超过规定用量，应及时联系急救医疗机构。尚不明确过量服用克必信后的症状。 如果服药远远超过规定用量，应及时联系急救医疗机构。尚不明确过量服用克必信后的症状。 What should I avoid while using Cubicin? 服药时的注意事项 Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or has blood in it, call your doctor. Do not use any medicine to stop the diarrhea unless your doctor has told you to. 抗生素药物可能导致腹泻，这说明你有可能又受到了新的感染。如果腹泻拉水或带有血迹， 应向你的主治医师咨询。应根据医生针对腹泻症状的指导用药，不得自我主张服药来控制腹 泻。 Cubicin side effects 不良反应 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: unusual muscle pain, tenderness, or weakness; numbness or tingling; pain or burning when you urinate; diarrhea that is watery or bloody; pale skin, weakness, easy bruising or bleeding; swelling; or chest pain. Less serious side effects may include: constipation, nausea, diarrhea, vomiting; redness, discomfort, or irritation where the injection was given; headache; cough, sore throat; back pain; loss of appetite; headache; anxiety, confusion, sleep problems (insomnia); or mild skin rash. This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088. 如果你有以下任何过敏性症状，请立即向急救中心求助。如:荨麻疹、呼吸困难以及脸部、嘴唇、舌头、咽喉肿胀。如果你有以下任何副反应，请与你的主治医师联系。 , 肌肉酸痛、无力或虚弱; , 麻木或刺痛感; , 小便时有刺痛或灼烧感; , 腹泻拉水或带有血迹; , 脸色苍白、虚弱，容易淤血或出血; , 水肿; , 胸部疼痛。 可能还出现比较严重的不良反应: , 便秘、恶心、腹泻、呕吐; , 注射部位出现红肿或发炎症状; , 头痛; , 咳嗽，喉咙痛; , 背部疼痛 , 没有食欲; , 焦虑、心慌，难以入眠; , 轻度皮疹。 可能还会出现以上列之外的不良症状。请及时告诉你的主治医师有关于用药后的不良 症状。你也可以拨打FDA热线1-800-FDA-1088，向他们咨询用药后的副反应。 What other drugs will affect Cubicin? 药物间的相互作用 Before taking Cubicin, talk to your doctor if you are taking any of the following medicines: 在服用克必信前，如果你正服用以下药物，一定要向主治医师详细说明。 a blood thinner such as warfarin (Coumadin); tobramycin (Nebcin); or cholesterol-lowering medicines such as lovastatin (Mevacor), simvastatin (Zocor), pravastatin (Pravachol), fluvastatin (Lescol), atorvastatin (Lipitor), or cerivastatin (Baycol). This list is not complete and there may be other drugs that can interact with Cubicin. 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. , 抗凝药物如华法林(香豆定); , 妥布霉素(硫酸妥布霉素) , 降胆固醇类药物如洛伐他汀(Mevacor)，辛伐他汀(舒降之)，普伐他汀 (Pravachol)，氟伐他汀(Lescol)，阿托伐他汀(立普妥)，或西立伐他汀(Baycol)。 以上列表尚不完全，可能还有药物能与克必信产生相互作用。应该告诉你的主治医师目 前你所服用的所有处方药和非处方药。其中包括维生素、微量元素药物、中药以及其他医生 所开的处方药。不可在没有告知主治医师的情况下擅自用药。 Where can I get more information? 如何获得关于克必信的更多信息 Your pharmacist can provide more information about Cubicin. 你的药剂师能够给你提供更多的医药信息。 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. 切记，将药品保存在儿童无法够到的地方，不可将本药与他人分享，严格按照本药说明书进 行用药。