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Isovorin Injection 5Vial×100mg(Levofolinate Calcium 左亚叶酸钙点滴静注)
药店国别  
产地国家 日本 
处 方 药: 是 
所属类别 100毫克/瓶 5瓶/盒 
包装规格 100毫克/瓶 5瓶/盒 
计价单位: 盒 
生产厂家中文参考译名:
辉瑞制药
生产厂家英文名:
Pfizer
该药品相关信息网址1:
http://www.info.pmda.go.jp/go/pack/3929407D1160_2_07/
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:
ISOVORIN(アイソボリン点滴静注用)100MG/vial 5vials/box
原产地英文药品名:
Levofolinate Calcium
中文参考商品译名:
ISOVORIN(アイソボリン点滴静注用)100毫克/瓶 5瓶/盒
中文参考药品译名:
左亚叶酸钙
曾用名:
简介:

 

http://www.info.pmda.go.jp/go/pack/3929407D1160_2_07/  http://www.info.pmda.go.jp/go/pack/3929407D1160_2_07/ 部份中文左亚叶酸钙处方资料(仅供参考)
英文名:Calcium Levofolinate Hydrate
商品名:Isovorin Injection
中文名:左亚叶酸钙注射剂
剂  型:注射液
生产商:辉瑞制药
药品简介
Isovorin(Calcium Levofolinate)是亚叶酸的钙盐,是用于癌症化疗的佐剂,本品与5-氟尿嘧啶合用,用于治疗胃癌和结直肠癌。
アイソボリン点滴静注用25mg/アイソボリン点滴静注用100mg
药效分类名称
活性型叶酸制剂
批准日期:2008年6月
商標名
ISOVORIN INJECTION 25mg
ISOVORIN INJECTION 100mg
一般的名称
レボホリナートカルシウム水和物(Calcium Levofolinate Hydrate)
化学名
Monocalcium N-[4-({[(6S)-2-amino-5-formyl-4-oxo-1,4,5,6,7,8-hexahydropteridin-6-yl]methyl}amino)benzoyl]-L-glutamate pentahydrate
分子式
C20H21CaN7O7・5H2O
分子量
601.58
性状
本品为白色~淡黄色结晶性粉末。
本品不易溶于水,几乎不溶于甲醇或乙醇(99.5)。
本品为吸湿性。
化学構造式
旋光度
〔α〕25D:-10~-15゜
(换算成脱水及脱溶剂物0.25g、pH 8.1的0.2mol/L三缓冲液、25mL、100mm)
药效药理
作用机制
Calcium Levofolinate Hydrate通过Biochemical Modulation增强氟尿嘧啶的抗肿瘤效果。氟尿嘧啶是活性代谢物氟脱氧尿嘧啶一磷酸(FdUMP)与胸苷酸合成酶(thymidylate synthase:TS)结合,通过抑制TS活性,抑制胸苷酸合成,抑制DNA合成。卵磷脂在细胞内被还原,成为5,10亚甲基四氢叶酸(5,10-CH2-THF)。该5,10-CH2-THF与FdUMP、TS形成牢固的三元复合体(ternary complex),通过延迟TS的解离,增强氟尿嘧啶的抗肿瘤效果。
抗肿瘤效果增强作用
in vitro试验
对于人结直肠癌细胞(COLO201)、人胃癌细胞(TMK-1、KATOⅢ、MKN28)μ在使用M浓度的左旋糖醇的in vitro试验中,观察到氟尿嘧啶的抗肿瘤效果增强作用。
in vivo试验
对于移植了人大肠癌Co-4细胞及人胃癌H-111细胞的裸鼠,用左旋糖甙酸酯(200mg/kg)和氟尿嘧啶(90mg/kg)并用显示抑制肿瘤细胞增殖的效果。
适应症
○左旋糖醇氟尿嘧啶疗法
氟尿嘧啶对胃癌(不能手术或复发)及结、直肠癌的抗肿瘤效果增强
○左旋糖醇·氟尿嘧啶持续静注并用疗法
氟尿嘧啶对结直肠癌、小肠癌、不能治愈切除的胰腺癌及不能治愈切除的进展、复发的胃癌的抗肿瘤效果增强
用法与用量
〈左旋糖醇氟尿嘧啶疗法〉
通常,成人用2小时静脉内注射250mg/m2(体表面积),每次作为左亚叶酸钙。静脉注射左亚叶酸钙开始1小时后,静脉注射600mg/m2(体表面积),每次静脉注射600mg/m2(体表面积)作为左亚叶酸钙,不超过3分钟。每星期重复6次后停药2周。把这个作为一个疗程。
〈针对结肠·直肠癌的左亚叶酸钙·左亚叶酸钙持续静注并用疗法〉
通常,成人用2小时静脉内注射100mg/m2(体表面积),每次作为左亚叶酸钙。静脉注射左亚叶酸钙后立即静脉注射400mg/m2(体表面积)作为左亚叶酸钙,同时静脉注射600mg/m2(体表面积)作为左亚叶酸钙持续22小时。连续进行两天,每两周重复一次。
通常,成人用2小时静脉内注射250mg/m2(体表面积),每次作为左亚叶酸钙。静脉注射左亚叶酸钙结束后,用24小时持续静脉注射2600mg/m2(体表面积)作为左亚叶酸钙。每星期重复6次后停药2周。把这个作为一个疗程。
通常,成人用2小时静脉内注射200mg/m2(体表面积),每次作为左亚叶酸钙。静脉注射左亚叶酸钙后立即静脉注射400mg/m2(体表面积)作为左亚叶酸钙,同时持续静脉注射2400~3000mg/m2(体表面积)作为左亚叶酸钙,持续46小时。每两周重复一次这个。
〈针对小肠癌、不能治愈切除的胰腺癌及不能治愈切除的进展·复发的胃癌的左亚叶酸钙·左亚叶酸钙持续静注并用疗法〉
通常,成人用2小时静脉内注射200mg/m2(体表面积),每次作为左亚叶酸钙。静脉注射左亚叶酸钙后立即静脉注射400mg/m2(体表面积)作为左亚叶酸钙,同时静脉注射2400mg/m2(体表面积)作为氟尿嘧啶,持续46小时。每两周重复一次这个。
通常,成人用2小时静脉内注射200mg/m2(体表面积),每次作为左亚叶酸钙。静脉注射左亚叶酸钙后立即静脉注射400mg/m2(体表面积)作为左亚叶酸钙,同时静脉注射2400mg/m2(体表面积)作为左亚叶酸钙,持续46小时。每两周重复一次这个。
包装
点滴静注用
25mg:10小瓶
100mg:5小瓶
制造与销售
辉瑞公司
注:以上中文处方资料不够完整,使用者以原处方资料为准。
完整说明附件
https://www.info.pmda.go.jp/go/pack/3929407D1160_3_04/ 
----------------------------------------------
ISOVORIN INJECTION 100mg(Calcium levofolinate hydrate)
Brand name:ISOVORIN INJECTION 100mg
Active ingredient:Calcium levofolinate hydrate
Dosage form:injection
Print on wrapping:
Effects of this medicine
This medicine boosts the effectiveness of antitumor effect with concomitant use of fluorouracil.
It is usually used for the purpose of enhancing the effect of fluorouracil in the treatment of gastric cancer (which isinoperable or recurrent), colorectal cancer, small intestinal cancer and pancreatic cancer not amenable to curativeresection.
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: fever, generalized dullness, diarrhea, varicella (chickenpox) or other infectious disease, ascites,pleural effusion, heart disease or its history, poor general condition, discontinuation of receiving thecombination preparation of tegafur, gimeracil and oteracil potassium (TS-1) within 7 days, liver disorder, renal
disorder, liver metastasis, gastrointestinal ulcer or bleeding, ongoing treatment by radiation.
• If you are pregnant or breastfeeding.
• If you are taking any other medicinal products.(Some medicines may interact to enhance or diminish medicinaleffects. Beware of over-the-counter medicines and dietary supplements as well as other prescriptionmedicines)
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, this medicine is administered by intravenous drip infusion at one time over the period of2 hours.
•The administration intervals depend on concomitant drugs and symptoms/condition. Contact your doctorabout the specific dosing schedule.
Precautions while taking this medicine
• If you have decreased bone-marrow function, infection or bleeding may tend to occur. However, it is difficultto find out these symptoms so that you should receive clinical examination (blood test, liver/renal functiontest, etc)regularly(frequently during early treatment period, in particular) to find any symptoms early.
Possible adverse reactions to this medicine
The most commonly reported adverse reactions include diarrhea, loss of appetite, nausea/vomiting, stomatitis,fever, rash, taste abnormality, abdominal pain, epigastric pain, thirst, constipation, gingivitis, cheilitis/angularstomatitis, glossitis, abdominal bloating, melena and heartburn.If any of these symptoms occur, consult with yourdoctor or pharmacist.
The symptoms described below are rarely seen as initial symptoms of the adversereactions indicated in brackets.If any of these symptoms occur, stop taking thismedicine and see your doctor immediately.
• persistent muddy or watery stool[severe diarrhea]
• chills, fever, bleeding tendency[bone-marrow depression]
• severe abdominal pain, diarrhea[serious enteritis]
• respiratory distress, generalized hot flashes, hives[shock, anaphylaxis]
• general dullness, loss of appetite, yellowing of the skin or whites of the eyes[liver dysfunction, jaundice]
• decreased urine output, edema of limbs, general dullness[acute renal disorder]
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 otherthan those listed above.
Injection
Revised: 07/2019
The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approvaldetails may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It isimportant 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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