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ZOMETA INTRAVENOUS（唑来磷酸注射液/点滴静注）

2015-09-10 10:28:09 作者：新特药房来源：互联网浏览次数：14 文字大小：【大】【中】【小】

简介： 部份中文唑来膦酸处方资料（仅供参考）唑来膦酸是二膦酸具有优异的骨吸收抑制作用具有用于骨有很强的亲和力。唑来膦酸吸附到骨被取成破骨细胞，通过抑制甲羟戊酸途径，诱导细胞凋亡和功能障碍，它被认为 ...

关键字：唑来磷酸 Zoledronic acid hydrate 药品商标名ZOMETA 骨吸收抑制剂用于治疗恶性肿瘤溶骨性骨转移引起的骨痛

部份中文唑来膦酸处方资料（仅供参考）
唑来膦酸是二膦酸具有优异的骨吸收抑制作用具有用于骨有很强的亲和力。唑来膦酸吸附到骨被取成破骨细胞，通过抑制甲羟戊酸途径，诱导细胞凋亡和功能障碍，它被认为是抑制破骨细胞骨吸收。
适应症
用于恶性肿瘤溶骨性骨转移引起的骨痛。
用法用量
静脉滴注。成人每次4mg(1支)，用100ml 0.9%氯化钠注射液或5%葡萄糖注射液稀释后静脉滴注，滴注时间应不少于15分钟。每3～4周给药一次或遵医嘱。
不良反应
注射用唑来膦酸最常见的不良反应是发热，其他不良反应主要包括：
全身反应：乏力、胸痛、腿浮肿、结膜炎；
消化系统：恶心、呕吐、便秘、腹泻、腹痛、吞咽困难、厌食；
心血管系统：低血压；
血液和淋巴系统：贫血，低钾血症、低镁血症、低磷血症、低钙血症、粒细胞减少，血小板减少，全血细胞减少；
肌肉与骨骼：骨痛，关节痛，肌肉痛；
肾脏：血清中肌酸酐值升高（与给药的时间有关）；
神经系统：失眠，焦虑，兴奋，头痛、嗜眠；
呼吸系统：呼吸困难，咳嗽，胸腔积液；
感染：泌尿道感染，上呼吸道感染；
代谢系统：厌食，体重下降，脱水；
其它：流感样症状，注射部位出现红肿，皮疹，瘙痒等。
唑来膦酸的毒副反应多为轻度和一过性的，大多数情况下无需特殊处理会在24～48小时内自动消退。
禁忌
1 对注射用唑来膦酸或其它双膦酸盐类药物过敏的患者禁用；
2 严重肾功能不全者不推荐使用；
3 孕妇及哺乳期妇女禁用。
注意事项
1 首次使用注射用唑来膦酸时应密切检测血清中钙、磷、镁以及血清肌酸酐的水平，如出现血清中钙、磷和镁的含量过低，应给予必要的补充治疗；
2 伴有恶性高钙血症患者给予注射用唑来膦酸前应充分补水，利尿剂与注射用唑来膦酸合用时只能在充分补水后使用，注射用唑来膦酸与具有肾毒性的药物合用时应慎重；
3 接受注射用唑来膦酸治疗时，如出现肾功能恶化，应停药至肾功能恢复至基线水平；
4 对阿司匹林过敏的哮喘患者应慎用注射用唑来膦酸。
药物相互作用
注射用唑来膦酸与氨基糖苷类合用时应慎重，因氨基糖苷类药物具有降低血钙的协同作用，可能延长低血钙持续的时间；与利尿剂合用时可能会增大低血钙的危险性；与沙利度胺合用时会增加多发性骨髓瘤患者肾功能异常的危险性。
药物过量
患者接受高剂量注射用唑来膦酸可能引起血清中钙、磷和镁的水平过低，可通过静脉给予葡萄糖酸钙、磷酸钾或钠以及硫酸镁来补充。此外，高剂量的注射用唑来膦酸会增加肾毒性的危险性。唑来膦酸单剂量给药不得超过4mg。
原处方资料件:
1）：http://www.info.pmda.go.jp/go/pack/3999423A1109_1_03/
2）：http://www.info.pmda.go.jp/go/pack/3999423A3047_1_02/3999423A3047_1_02?view=body

ZOLEDRONIC ACID INTRAVENOUS INFUSION 4mg/100mL-治疗骨病变和高钙血症恶性肿瘤
ZOLEDRONIC ACID INTRAVENOUS INFUSION 4mg/100mL BAG "TOWA" [bone lesion/hypercalcemia]（ゾレドロン酸点滴静注4mg/100mLバッグ「トーワ」［骨病変/高カルシウム血症］）
Brand name : ZOLEDRONIC ACID INTRAVENOUS INFUSION 4mg/100mL BAG "TOWA" [bone lesion]
　Active ingredient: Zoledronic acid hydrate
　Dosage form: injection
　Print on wrapping
Effects of this medicine
This medicine relieves bone pain or prevents bone fracture associated with bone metastasis of solid tumors or multiple myeloma.
It is usually used to treat bone lesion associated with bone metastasis of solid tumors and multiple myeloma.
Before using this medicine, be sure to tell your doctor and pharmacist
•If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines.
If you have renal disorder.
If you have recently received dental treatment such as tooth extraction or have a plan to receive it.
•If you are pregnant, possibly pregnant or breastfeeding.
•If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.)
Dosing schedule (How to take this medicine)
•Your dosing schedule prescribed by your doctor is <<to be written by a healthcare professional>>
•In general, administered by intravenous infusion once every 3 to 4 weeks.
•It may be administered over a long period according to your response to the treatment.
•Ask your doctor about your frequency of injection.
Precautions while taking this medicine
•Maintain your oral hygiene and receive your dental checkup regularly while injecting this medicine.
•Inform your dentist or oral surgeon that you are receiving this medicine treatment such as tooth extraction or dental implant.
Possible adverse reactions to this medicine
The most commonly reported adverse reactions include fever, nausea, dullness, headache, bone pain, joint pain, erythematous eruption (red rash), macular eruption (red rash), angioneurotic edema (swelling of eyelid/lip, breathing difficulty, hives), hives, erythema, bulla, rash, eczema and itch. If any of these symptoms occur, consult with your doctor or pharmacist.
The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately.
•decrease of urine volume, swelling, thirst [acute renal failure, interstitial nephritis]
•general swelling, breathing difficulty, easy breathing in a sitting position than when lying down [congestive heart failure (swelling, breathing difficulty, pulmonary edema)]
•fever, dry cough, breathing difficulty [interstitial lung disease]
•jaw/tooth pain, filling with pus, delay in healing wound after tooth extraction [osteonecrosis of the jaw, osteomyelitis of the jaw]
•pain of thigh or inguinal region [atypical subtrochanteric and diaphyseal femoral fractures]
The above symptoms do not describe all the adverse reactions to this medicine. Consult with your doctor or pharmacist if you notice any symptoms of concern other than those listed above.
TOWA PHARMACEUTICAL CO., LTD.Injection
Published: 6/2014
The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It is important to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment.

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产地国家: 日本
原产地英文商品名:
ZOMETA INTRAVENOUS(ゾレドロン酸点滴静注/バッグ「トーワ」)4mg/100ml/bag 1bag/box
原产地英文药品名:
Zoledronic acid hydrate
中文参考商品译名:
ZOMETA(ゾレドロン酸点滴静注)4毫克/100毫升/袋 1袋/盒
中文参考药品译名:
唑来磷酸
生产厂家中文参考译名:
TOWA PHARMACEUTICAL CO
生产厂家英文名:
TOWA PHARMACEUTICAL CO
---------------------------------------------------------------
产地国家: 日本
原产地英文商品名:
ZOMETA INTRAVENOUS(ゾレドロン酸点滴静注/バッグ「トーワ」)4mg/100ml/bag 10bag/box
原产地英文药品名:
Zoledronic acid hydrate
中文参考商品译名:
ZOMETA(ゾレドロン酸点滴静注/バッグ「トーワ」)4毫克/100毫升/袋 10袋/盒
中文参考药品译名:
唑来磷酸
生产厂家中文参考译名:
TOWA PHARMACEUTICAL CO
生产厂家英文名:
TOWA PHARMACEUTICAL CO
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产地国家: 日本
原产地英文商品名:
ZOLEDRONIC ACID I.V. INFUSION(ゾレドロン酸点滴静注/バッグ「ニプロ」)4mg/100ml/bag 1bag/box
原产地英文药品名:
Zoledronic Acid Hydrate
中文参考商品译名:
ZOMETA(ゾレドロン酸点滴静注/バッグ「ニプロ」)4毫克/100毫升/袋 1袋/盒
中文参考药品译名:
唑来磷酸
生产厂家中文参考译名:
Nipro Corporation
生产厂家英文名:
Nipro Corporation
---------------------------------------------------------------
产地国家: 日本
原产地英文商品名:
ZOLEDRONIC ACID I.V. INFUSION(ゾレドロン酸点滴静注/バッグ「ニプロ」)4mg/100ml/bag 10bag/box
原产地英文药品名:
Zoledronic Acid Hydrate
中文参考商品译名:
ZOMETA(ゾレドロン酸点滴静注/バッグ「ニプロ」)4毫克/100毫升/袋 10袋/盒
中文参考药品译名:
唑来磷酸
生产厂家中文参考译名:
Nipro Corporation
生产厂家英文名:
Nipro Corporation
---------------------------------------------------------------
产地国家: 日本
原产地英文商品名:
ZOLEDRONIC ACID I.V. INFUSION(ゾレドロン酸点滴静注/バッグ「ニプロ」)4mg/5ml/vials
原产地英文药品名:
Zoledronic Acid Hydrate
中文参考商品译名:
ZOMETA(ゾレドロン酸点滴静注/バッグ「ニプロ」)4毫克/5毫升/瓶
中文参考药品译名:
唑来磷酸
生产厂家中文参考译名:
Nipro Corporation
生产厂家英文名:
Nipro Corporation