顺氯氨铂冻干粉注射剂Platinol-AQ Injection 1mg/ml 50ml(Cisplatin)

药店国别:

产地国家:美国

处方药:

所属类别: 1毫克/毫升 50毫升/瓶

包装规格: 1毫克/毫升 50毫升/瓶

计价单位:瓶

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 50MLS/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 50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)英文名:cisplatin injection商品名:PLATINOL-AQ中文名:顺氯氨铂冻干粉注射剂生产商:CORDEN PHARMA药品简介PLATINOL-AQ(Cisplatin)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。

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

Platinol-AQIntroductionAntineoplastic agent; platinum-containing compound.1 7 13Proper Use of Platinol-AQThis medicine is sometimes given together with certain other medicines. If you are using a combination of medicines, it is important that you receive each one at the proper time. If you are taking some of these medicines by mouth, ask your health care professional to help you plan a way to take them at the right times.While you are receiving this medicine, your doctor may want you to drink extra fluids so that you will pass more urine. This will help prevent kidney problems and keep your kidneys working well.This medicine usually causes nausea and vomiting that may be severe. However, it is very important that you continue to receive the medicine, even if you begin to feel ill. Ask your health care professional for ways to lessen these effects, especially if they are severe.DosingThe dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.PLATINOL®-AQ (cisplatin injection)Rx onlyWARNINGPlatinol-AQ (cisplatin injection) should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. Appropriate management of therapy and complications is possible only when adequate diagnostic and treatment facilities are readily available.Cumulative renal toxicity associated with Platinol-AQ is severe. Other major dose-related toxicities are myelosuppression, nausea, and vomiting.Ototoxicity, which may be more pronounced in children, and is manifested by tinnitus, and/or loss of high frequency hearing and occasionally deafness, is significant.Anaphylactic-like reactions to Platinol-AQ have been reported. Facial edema, bronchoconstriction, tachycardia, and hypotension may occur within minutes of Platinol-AQ administration. Epinephrine, corticosteroids, and antihistamines have been effectively employed to alleviate symptoms (see WARNINGS and ADVERSE REACTIONS sections).Exercise caution to prevent inadvertent Platinol-AQ overdose. Doses greater than 100 mg/m2/cycle once every 3 to 4 weeks are rarely used. Care must be taken to avoid inadvertent Platinol-AQ overdose due to confusion with PARAPLATIN® (carboplatin) or prescribing practices that fail to differentiate daily doses from total dose per cycle.OverdosageCaution should be exercised to prevent inadvertent overdosage with Platinol-AQ. Acute overdosage with this drug may result in kidney failure, liver failure, deafness, ocular toxicity (including detachment of the retina), significant myelosuppression, intractable nausea and vomiting and/or neuritis. In addition, death can occur following overdosage.No proven antidotes have been established for Platinol-AQ overdosage. Hemodialysis, even when initiated four hours after the overdosage, appears to have little effect on removing platinum from the body because of Platinol-AQ’s rapid and high degree of protein binding. Management of overdosage should include general supportive measures to sustain the patient through any period of toxicity that may occur.Preparation of intravenous solutionsPreparation PrecautionsCaution should be exercised in handling the aqueous solution. Procedures for proper handling and disposal of anticancer drugs should be utilized. Several guidelines on this subject have been published.1-4 To minimize the risk of dermal exposure, always wear impervious gloves when handling vials and IV sets containing Platinol-AQ.Skin reactions associated with accidental exposure to cisplatin may occur. The use of gloves is recommended. If Platinol-AQ contacts the skin or mucosa, immediately and thoroughly wash the skin with soap and water and flush the mucosa with water. More information is available in the references listed below.Instructions for PreparationThe aqueous solution should be used intravenously only and should be administered by IV infusion over a 6- to 8-hour period (see DOSAGE AND ADMINISTRATION).Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.NOTE TO PHARMACIST: Exercise caution to prevent inadvertent Platinol-AQ overdosage. Please call prescriber if dose is greater than 100 mg/m2 per cycle. Aluminum and flip-off seal of vial have been imprinted with the following statement:CALL DR. IF DOSE>100 MG/M2/CYCLE.StabilityPlatinol-AQ is a sterile, multidose vial without preservatives.Store at 15° C to 25° C. Do not refrigerate. Protect unopened container from light.HOW SUPPLIEDPLATINOL®-AQ (cisplatin injection)NDC 61126-004-01—Each multidose vial contains 50 mg of cisplatinNDC 61126-004-02—Each multidose vial contains 100 mg of cisplatinhttps

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