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Navelbine Injection 10mg(酒石酸长春瑞滨注射溶液,ナベルビン注)
药店国别  
产地国家 日本 
处 方 药: 是 
所属类别 10毫克/1毫升/瓶 
包装规格 10毫克/1毫升/瓶 
计价单位: 瓶 
生产厂家中文参考译名:
协和发酵麒麟
生产厂家英文名:
Kyowa Hakko Kirin
该药品相关信息网址1:
http://www.info.pmda.go.jp/go/pack/4240407A1028_1_17/
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:
Navelbine Injection(ナベルビン注)10mg/1ml/Vial
原产地英文药品名:
Vinorelbine ditartrate
中文参考商品译名:
NAVELBINE(ナベルビン注)10毫克/1毫升/瓶
中文参考药品译名:
双酒石酸长春瑞滨
曾用名:
简介:

 

 部份中文酒石酸长春瑞滨处方资料(仅供参考)
商品名:Navelbine
英文名:Vinorelbine ditartrate
中文名:酒石酸长春瑞滨注射溶液
生产商:协和发酵麒麟
药品简介
酒石酸长春瑞滨vinorelbine(Vinorelbine ditartrate)属于抗肿瘤药或细胞毒性药物,用于治疗晚期乳腺癌或可以单独使用或与其他药物联合使用来治疗癌症。
ナベルビン注10/ナベルビン注40
药品分类名称
长春花生物碱抗肿瘤药
批准日期:1999年5月
欧文商標名
Navelbine Injection 10
Navelbine Injection 40
一般名
ビノレルビン酒石酸塩
Vinorelbine ditartrate
化学名
(+)-Methyl (3aR,4R,5S, 5aR,10bR,13aR)-4-acetoxy-3a-ethyl-9- [(2R,6R,8S)-4-ethyl-1,3,6,7,8,9-hexahydro-8-methoxycarbonyl-2,6-methano -2H-azecino[4,3-b]indol-8-yl]-5-hydroxy-8-methoxy-6-methyl-3a,4,5,5a,6,11,12,13a-octahydro-1H-indolizino[8,1-cd]carbazole-5-carboxylate ditartrate
分子式
C45H54N4O8・2C4H6O6=1079.11
化学構造式
性状
白色至浅黄色白色粉末,无臭。
溶解度
极易溶于水,甲醇和无水乙醇,极易溶于丙酮,几乎不溶于乙醚和己烷。 在pH 4或更低的条件下,它极易溶于水,但在pH 7或更高的条件下,则观察到溶解度急剧下降。
熔点
它没有明显的熔点,但在约190°C时变成红棕色,在约240°C时液化。
旋光度
[Α] D20 =+17.0°
分配系数
logP'OCT =2.76
(测量方法:烧瓶摇动法,正辛醇/pH7缓冲液)
药物药理学
1.抗肿瘤
(1)对实验性肿瘤的影响
小鼠可移植肿瘤系统对实体瘤(例如B16黑色素瘤,FM3A乳腺癌,刘易斯肺癌,肉瘤180)和腹水肿瘤(例如P388和L1210白血病)表现出出色的抗肿瘤活性。另外,裸鼠移植的人肿瘤是体外人类肿瘤细胞系和非小细胞肺癌(Lu-65,Lu-99,LC-6,L-27)和乳腺癌(MX-1,Br-10)。另外,它显示了优异的生长抑制作用。
(2)细胞学作用
它在细胞的中期起作用,并在细胞周期的G2 + M阶段积聚细胞。
2.作用机制
它选择性地作用于有丝分裂微管的组成蛋白微管蛋白,并通过抑制其聚合而表现出抗肿瘤作用。
适应症
非小细胞肺癌,无法手术或复发的乳腺癌
用法与用量
于非小细胞肺癌
通常,成人每周以长春瑞滨20到25mg/m2的剂量缓慢静脉内注射。
剂量可以根据年龄和症状进行调整。但是,最大单剂量为25mg/m2。
无法手术或复发的乳腺癌
通常,对于成年人,连续2周每周服用一次长春瑞滨,剂量为25mg/m2,并从第3周退出。
剂量可根据年龄和症状而减少。
包装
注射
10毫克:1瓶
40毫克:1瓶
制造分销商
协和麒麟有限公司
提 携
Pierre Fabre Medicamen-CNRS(法国)
製造元
ピエール ファーブル メディカメン(フランス)
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/4240407A1028_1_19/
Navelbine Injection 40(Vinorelbine ditartrate,ナベルビン注10)
Navelbine Injection 10(ナベルビン注10)
Brand name : Navelbine Injection 10
 Active ingredient: Vinorelbine ditartrate
 Dosage form: injection
 Print on wrapping:
Effects of this medicine
This medicine exerts an anti-tumor effect by stopping the function of microtubules that play an important role in cell division.
It is usually used for the treatment of non-small cell lung cancer, and inoperable or recurrent breast cancer.
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 decrease in bone marrow function, infections, liver disorder, history of interstitial pneumonia or pulmonary fibrosis, neurological or muscular diseases or history of these conditions, ischemic heart disease or history of this condition, or a tendency for constipation.
•If you are 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>>
•Non-small cell lung cancer: In general, for adults, this medicine is administered intravenously once a week.
Inoperable or recurrent breast cancer: In general, this medicine is administered intravenously once a week for 2 consecutive weeks, then discontinued in the third week.
In any case, the dosage intervals depend on concomitant medicines or symptoms/conditions. Ask your doctor about your dosing schedule.
Precautions while taking this medicine
• Possible adverse reactions to this medicine
The most commonly reported adverse reactions include bone marrow depression, loss of appetite, general malaise, alopecia, nausea, fever, vomiting, phlebitis, stomatitis, constipation, diarrhea, paresthesia/reduced tendon reflexes, and allergy-like symptoms. 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.
•general malaise, bruise, dizziness [myelosuppression(leukopenia, anemia, and thrombocytopenia)]
•fever, headache, breathing difficulty [interstitial pneumonia, pulmonary edema]
•wheezing, crowing sound when breathing, sudden shortness of breath [bronchospasm]
•intense abdominal pain, abdominal bloating, no output of stool [paralytic ileus]
•general malaise, breathing difficulty, feeling of tight chest[cardiac failure, myocardial infarction, angina pectoris]
•rash, breathing difficulty, decreased blood pressure[shock, anaphylaxis]
•fever, cough, chest pain, breathing difficulty [pulmonary embolism]
•convulsion, impaired consciousness, loss of appetite[syndrome of inappropriate antidiuretic hormone secretion]
•general swelling, fatigability, difficulty in urination[acute renal failure]
•sudden intense pain in low back and back, fever, nausea/vomiting [acute pancreatitis]
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.
Kyowa Hakko Kirin Co.,LtdInjection
Revised: 2/2015
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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