顺氯氨铂冻干粉注射剂PLATINOL-AQ 1MG/ML 100ML(CISPLATIN)

药店国别:

产地国家:美国

处方药:

所属类别: 1毫克/毫升 100毫升/瓶

包装规格: 1毫克/毫升 100毫升/瓶

计价单位:

生产厂家中文参考译名:

生产厂家英文名:CORDEN PHARMA

原产地英文商品名:PLATINOL-AQ 1MG/ML 100MLS/VIAL

原产地英文药品名:CISPLATIN

中文参考商品译名:PLATINOL-AQ 1毫克/毫升 100毫升/瓶

中文参考药品译名:顺氯氨铂

曾用名:

简介:部份中文顺氯氨铂处方资料(仅供参考)英文药名:Platinol-AQ (CisplatinInjection)中文药名:顺氯氨铂生产厂家:CORDENPHARMA药品介绍本品为目前常用的金属铂类络合物,具有抗瘤谱广、对乏氧细胞有效的特点。但对肾、神经系统及胰腺有毒性。性状黄色结晶性粉末,无臭,微溶于水,在水溶液中可逐渐转化成反式和水解。

药理及应用能与DNA结合形成交叉键,从而破坏DNA的功能不能再复制;高浓度时也抑制RNA及蛋白质的合成。为一种周期非特异性药物。本品作用的另一特点是对乏氧细胞也有作用。进入人体后可扩散通过带电的细胞膜。在Cl离子浓度高的条件下较稳定,进入细胞后由于细胞内Cl浓度低,药物水解为阳离子水化物,具有类似烷化剂的双功能基团的作用,主要与DNA链上的碱基作用。静脉注射时在肝、肾、膀胱中分布最多。在血浆中迅速消失,呈双相型,快相t1/241~49分钟,慢相t1/257~73小时。静脉注射后1小时血浆含量为10%左右,90%中与血浆蛋白结合。排出较慢,1天内尿中排出19%~34%,4天内尿中仅排出25%~44%。

临床适应证:

顺铂对多种实体肿瘤均有效,如睾丸肿瘤、乳腺癌、肺癌、头颈部癌、卵巢癌、骨肉瘤及黑色素瘤等。为当前联合化疗中最常用的药物之一。

用法

静脉注射,1次20mg,溶于生理盐水30ml中,1日1次或隔日1次,一疗程总量100mg。或溶于氯化钠注射液500ml中滴注,连用5天,或每次30mg/m2,每日1次,连用3天,间隔3~4周可再重复给药。或以高剂量80~120mg/m2静脉滴注,每3~4周重复1次,需配合水化利尿,使尿量保持在2000~3000ml。本品亦可动脉注射或胸、腹腔内注射。

注意不良反应主要为

消化道反应、肾脏毒性、骨髓抑制及听神经毒性,与所用剂量的大小及总量有关。少数病人并有胰腺毒性可诱发糖尿。因此,在用本品前,尤其是高剂量时,应先检查肾脏功能及听力,并注意多饮水或输液强迫利尿。肾功能不全者慎用。制剂注射用顺铂(冻干粉针剂):每瓶10mg;20mg;30mg。注射液:10mg(1ml);50mg(2ml)。

顺氯氨铂冻干粉注射剂英文版说明书

GENERIC NAME: CISPLATIN – INJECTION (sis-PLAT-in)BRAND NAME(S): Platinol-AQWARNING: Cisplatin may cause severe kidney problems or very seriousallergic reactions. Hearing loss (more common in children), bleeding problems, a decrease in your body’s ability to fight infections(bone marrow suppression), and severe nausea and vomiting may occur as well. Your risk of these problems increases with higher doses or longer treatment with cisplatin.Tell your doctor immediately if you develop any of the following symptoms: change in the amount of urine, rash, trouble breathing, swelling of the face, fast heartbeat, dizziness, ringing in the ears, hearing loss, easy bruising or bleeding, unusual tiredness or weakness, signs of infection (e.g., fever or persistent sore throat), nausea, or vomiting.USES: Cisplatin is used to treat various types of cancer. It is a chemotherapy drug that contains platinum. It is used alone or in combination with other medications to slow or stop cancer cell growth.HOW TO USE: This medication is usually given by injection into a vein by a healthcare professional.The dosage is based on your medical condition, body size, and response to therapy.Courses of cisplatin treatment should not be given more often than once every 3 to 4 weeks. Consult your doctor or pharmacist for more details.During treatment with this medication, it is important that you take in more fluids than usual and pass urine frequently to help avoid kidney side effects.Intravenous fluids should be given with this medication. Also, ask your doctor how much fluid you should drink and follow these instructions carefully.If this medication comes into contact with your skin, wash your skin immediately and completely with soap and water.SIDE EFFECTS: See also Warnings.Nausea, vomiting, loss of appetite,diarrhea, and loss of taste may occur. Nausea and vomiting can be quite severe and persistent.Drug therapy is used to prevent or relieve nausea and vomiting. Not eating before your treatment may help relieve vomiting.Changes in diet such as eating several small meals or limiting activity may help lessen some of these effects.If any of these effects persist or worsen, notify your doctor or pharmacist promptly.Temporary hair loss may occur. Normal hair growth should return after treatment has ended.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects.Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: pain/burning/redness attheinjectionsite,numbness/tingling/coldness/blue discoloration of the hands or feet, loss of reflexes, loss of balance, trouble walking, muscle cramps/spasms/weakness, neck or back pain, mouth or tongue sores, joint pain, swollen legs or feet, mental/mood changes, headache, fast/irregular heartbeat, blood in urine, vomit that looks like coffee grounds, black or bloody stools, painful or difficulturination, lower back or side pain, vision changes (e.g.blurred vision, seeing colors differently).Rarely, temporary vision loss mayoccur with cisplatin use. Normal vision usually returns after the end of treatment.Consult your doctor or pharmacist for more details and report this side effect immediately if it occurs.Get medical help right away if any of these rare but very serious side effects occur: chest pain, jaw or left arm pain, confusion, slurred speech, weakness on one side of the body, seizures.This medication can lower your body’s ability to fight an infection. Notify your doctor promptly if you develop any signs of an infection such as fever, chills, persistent sore throat, or cough.A very serious allergic reaction to this drug is unlikely, but get medical help right away if it occurs.Symptoms of a serious allergic reaction may include: 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 cisplatin, tell your doctor or pharmacistif you are allergic to it; or to carboplatin; 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.This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: kidney disease, decreased bone marrow function/blood cell disorders (e.g.anemia, leukopenia, thrombocytopenia), hearing problems.Before using this medication, tell your doctor or pharmacist your medical history, especially of: mineral imbalance (low blood levels of sodium, potassium, magnesium, calcium, phosphate), numbness/tingling of the hands/feet, kidney stones, gout.Do not have immunizations/vaccinations without the consent of your doctor and avoid contact with people who have recently received oral poliovaccine.Use caution with sharp objects like safety razors or nailcutters and avoid activities such as contact sports to lower thechance of getting cut, bruised or injured.Wash your hands well to prevent the spread of infections.Caution is advised when using thisdrug in the elderly because they may be more sensitive to its sideeffects, especially to kidney problems, numbness/tingling of thehands/feet, infections, and bleeding problems.Caution is advised when using this drug in children because they may be more sensitiveto its side effects, especially hearing loss.This drug is not recommended for use during pregnancy.It may cause harm to an unborn baby.Women of childbearing age should use reliable form(s) of birthcontrol during treatment with this drug and for some time afterwards. Consult your doctor for more details.This drug passes into breast milk. Because of the potential risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.This medication can affect sperm production in men.Therefore, men should use a reliable form of birth control during treatment and for some time afterwards. Consult your doctor for more details.DRUG INTERACTIONS: Drug interactions may change how your medicationswork or increase your risk for serious side effects.This documentdoes not contain all possible drug interactions. Keep a list of allthe products you use (including prescription/nonprescription drugsand herbal products) and share it with your doctor and pharmacist.Do not start, stop, or change the dosage of any medicines withoutyour doctor’s approval.Some products that may interact with thisdrug include: aminoglycoside antibiotics (e.g., gentamicin, neomycin), amphotericin B, anti-seizure medications (e.g., phenytoin), certain “water pills” (loop diuretics such as furosemide, bumetanide, ethacrynic acid), nalidixic acid, pyridoxine when used in combination with both altretamine and cisplatin.OVERDOSE: If overdose is suspected, contact your local poisoncontrol center or emergency room immediately. US residents can callthe US national poison hotline at 1-800-222-1222. Canadian residentsshould call their local poison control center directly.NOTES: Laboratory and/or medical tests (e.g., kidney function tests,complete blood count, blood mineral levels, hearing tests) should beperformed 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. If you miss a dose, contact your doctor or pharmacist immediately to establish a new dosing schedule.STORAGE: Not applicable. This medication is given in a clinic andwill not be stored at home.MEDICAL ALERT: Your condition can causecomplications in a medical emergency.

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