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Docetaxel 80mg/4ml 1Vialx4ml(多西他赛冻干粉注射剂「トーワ」)
药店国别  
产地国家 日本 
处 方 药: 是 
所属类别 80毫克/4毫升 1瓶x4毫升 
包装规格 80毫克/4毫升 1瓶x4毫升 
计价单位: 瓶 
生产厂家中文参考译名:
Towa Pharmaceutical Co.Ltd
生产厂家英文名:
Towa Pharmaceutical Co.Ltd
该药品相关信息网址1:
http://www.info.pmda.go.jp/go/pack/4240405A3064_1_01/
该药品相关信息网址2:
该药品相关信息网址3:
原产地英文商品名:
Docetaxel(ドセタキセル点滴静注「トーワ」)80mg/4ml 1Vialx4ml
原产地英文药品名:
Docetaxel
中文参考商品译名:
Docetaxel(ドセタキセル点滴静注「トーワ」)80毫克/4毫升 1瓶x4毫升
中文参考药品译名:
多西他赛
曾用名:
简介:

 

部份中文多西他赛处方资料(仅供参考)
商品名:DOCETAXEL
英文名:Docetaxel
中文名:多西他赛冻干粉注射剂
生产商:日本东和制药

ドセタキセル点滴静注20mg/1mL「トーワ」/ドセタキセル点滴静注80mg/4mL「トーワ」
药品分类名称
紫杉类抗肿瘤药
批准日期:2013年12月
欧文商標名
DOCETAXEL INTRAVENOUS INFUSION“TOWA”
構造式:
一般名:ドセタキセル(Docetaxel)
化学名:(-)-(1S,2S,3R,4S,5R,7S,8S,10R,13S)-4-Acetoxy-2-benzoyloxy-5,20-epoxy-1,7,10-trihydroxy-9-oxotax-11-ene-13-yl(2R,3S)-3-tert-butoxycarbonylamino-2-hydroxy-3-phenylpropionate
分子式:C43H53NO14
分子量:807.88
性 状:
它是白色粉末。 易溶于乙醇(99.5)和二甲基亚砜,微溶于甲醇,微溶于乙腈,几乎不溶于水。
处理注意事项
1.注意
打开包装后,将小瓶放在盒子中。
2.稳定性测试
(1)多西他赛静脉滴注20mg/1mL“ TOWA”
作为使用最终包装产品的长期储存测试(25°C,相对湿度60%)的结果,估计该产品在正常的市场分销下稳定了两年。
(2)多西他赛静脉滴注80mg/4mL“ TOWA”
使用最终包装的产品进行加速测试(40°C,相对湿度75%,6个月)的结果是,在正常的市场分布下,该产品可以稳定使用三年。
适应症
乳癌、非小細胞肺癌、胃癌、頭頸部癌、卵巣癌、食道癌、子宮体癌、前立腺癌
用法与用量
乳腺癌,非小细胞肺癌,胃癌,头颈癌
通常,在1小时或更长时间内,每3到4周间隔将60mg/m2多西紫杉醇静脉注射到成年人体内。另外,根据患者的情况适当增加或减少。但是,最大单剂量为75 mg / m2。
卵巢癌
通常,对于成年人,多西他赛每天70毫克/平方米(体表面积)静脉滴注一次,间隔1至3周至4周。另外,根据患者的情况适当增加或减少。但是,最大单剂量为75mg/ m2。
食道癌,子宫内膜癌
通常,对于成年人,多西他赛每天70毫克/平方米(体表面积)静脉滴注一次,间隔1至3周至4周。应根据患者的病情减少剂量。
前列腺癌
通常,多西紫杉醇每天75毫克/平方米(体表面积),每3小时间隔1小时,每天静脉注射一次。应根据患者的病情减少剂量。
包装
静脉滴注
20mg/1mL“ Towa”:1mLx1小瓶
80mg/4mL“ TOWA”:4mLx1小瓶
制造分销商
东和制药有限公司

注:以上中文处方资料不够完整,使用者以原处方资料为准。
完整说明资料附件:
https://www.info.pmda.go.jp/go/pack/4240405A3064_1_04/ 
DOCETAXEL INTRAVENOUS INFUSION 80mg/4mL "TOWA"(ドセタキセル点滴静注80mg/4mL「トーワ」)
Brand name:DOCETAXEL INTRAVENOUS INFUSION 80mg/4mL "TOWA"
 Active ingredient: Docetaxel
 Dosage form: Injection
 Print on wrapping:
Effects of this medicine
This medicine suppresses growth of cancer cells by inhibiting the function of microtubules required for cell division.
It is usually used to treat cancers of the breast, lung, stomach, head and neck, ovary, esophagus, uterine corpus and prostate.
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 bone marrow suppression (fever, subcutaneous bleeding), infectious disease, interstitial pneumonia or pulmonary fibrosis.
If you have hepatic disorder, kidney disorder, edema or alcohol hypersensitivity.
•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, for adults, inject by intravenous infusion once a day at the interval of every 3 to 4 weeks.
•The treatment duration depends on your symptoms.
Precautions while taking this medicine
• Possible adverse reactions to this medicine
The most commonly reported adverse reactions include loss of appetite, nausea, vomiting, diarrhea, stomatitis, alopecia, numbness, general malaise and fever. 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.
•feeling weaker than usual and feverish, subcutaneous bleeding, anemia [bone marrow depression]
•breathing difficulty, decreased blood pressure, rash [shock symptoms, anaphylaxis]
•general malaise, loss of appetite, yellowness of the skin/white of the eyes [jaundice, hepatic failure, hepatic dysfunction]
•edema, small amount of urinary output, general malaise [acute renal failure]
•fever, cough, breathing difficulty [interstitial pneumonia, pulmonary fibrosis]
•shortness of breath, cough, general edema [heart failure]
•dizziness, headache, bleeding tendency (nasal bleeding, bleeding gums, subcutaneous bleeding) [disseminated intravascular coagulation]
•abdominal pain, hematemesis, melena [intestinal perforation, gastrointestinal bleeding, ischemic colitis, colitis]
•stoppage of defecation, abdominal pain, loss of appetite [ileus]
•breathing difficulty suddenly occurring in adults [acute respiratory distress syndrome]
•severe pain in the upper abdomen or lower back, fever [acute pancreatitis]
•fever, loss of appetite, red rash [mucocutaneous ocular syndrome, toxic epidermal necrosis, erythema multiforme]
•breathing difficulty, nausea, edema [cardiac tamponade, pulmonary edema, edema/body fluid retention]
•acute precordial pressure, anginal pain, cold sweat [myocardial infarction, venous thromboembolism]
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.
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
http://www.info.pmda.go.jp/go/pack/4240405A3064_1_01/ 

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