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Levofolinate 5Vial×100mg(Calcium Levofolinate Hydrate 左亚叶酸钙点滴静注「NP」)
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:
尼普罗公司
生产厂家英文名:
Nipro Co.Ltd.
该药品相关信息网址1:
http://meds.qlifepro.com/detail/620005880/levofolinate-calcium
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:
Levofolinate(レボホリナート点滴静注用「NP」)100mg/vial 5vials/box
原产地英文药品名:
Calcium Levofolinate Hydrate
中文参考商品译名:
Levofolinate(レボホリナート点滴静注用「NP」)100毫克/瓶 5瓶/盒
中文参考药品译名:
亚叶酸钙
曾用名:
简介:

 

部份中文左亚叶酸钙处方资料(仅供参考)
商品名:Levofolinate injectable
英文名:Calcium Levofolinate Hydrate
中文名:左亚叶酸钙注射溶液
生产商:尼普罗公司
药品简介
Levofolinate(Calcium Levofolinate Hydrate,左亚叶酸钙水合物)是一种亚叶酸的钙盐,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。
レボホリナート点滴静注用25mg「NP」/レボホリナート点滴静注用100mg「NP」
薬效分类名
活性型叶酸制剤
批准日期:2007年7月
商標名
LEVOFOLINATE FOR I.V. INFUSION
一般名
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
構造式
性状
・白色至淡黄色结晶粉末。
・微溶于水,几乎不溶于甲醇或乙醇 (99.5)。
・吸湿性。
・旋光度[α]25D:-10至-15°(脱水和脱溶剂为0.25g,0.2mol/L Tris缓冲液,pH 8.1,25mL,100mm)。
处理注意事项
稳定性测试
(1) Revofolinate用于静脉滴注25mg "NP"
使用最终包装产品进行长期储存试验(25℃,相对湿度60%,3年),外观和含量均在标准范围内,25mg“NP”用于静脉滴注左亚叶酸在市场上是正常分布的,经证实可稳定使用3年。
(2) Revofolinate 100mg "NP" 静脉滴注
最终包装产品经长期储存试验(25℃,相对湿度60%,3年),外观和含量均在标准范围内,100mg“NP”用于静脉滴注左亚叶酸在市场上是正常分布的,经证实可稳定使用3年。
药效药理
氟尿嘧啶代谢为活性形式的氟脱氧尿苷单磷酸(FdUMP),后者与胸苷酸合酶(TS)结合并抑制其活性。结果,胸苷酸合成减少,DNA合成受到抑制。左叶酸在细胞内被还原为5,10-亚甲基四氢叶酸,与FdUMP和TS形成复合物,延迟FdUMP从TS中解离并增强氟尿嘧啶的抗肿瘤作用。
适应症
1. 左亚叶酸氟尿嘧啶治疗
氟尿嘧啶对胃癌(不能手术或复发)和结直肠癌的增强抗肿瘤作用
2.左亚叶酸/氟尿嘧啶连续静脉治疗
氟尿嘧啶增强对结直肠癌、小肠癌和不可切除胰腺癌的抗肿瘤作用
用法与用量
1. 左亚叶酸氟尿嘧啶治疗
一般而言,对于成人,250mg/m2(体表面积)作为左亚叶酸静脉输注超过2小时。左亚叶酸静脉滴注开始后1小时,3分钟内缓慢静脉注射600mg/m2(体表面积)氟尿嘧啶。每周重复6次,然后休息2周。这是一个很酷的。
2. 左叶酸和氟尿嘧啶连续静脉滴注治疗结直肠癌
(1)一般成人以100mg/m2(体表面积)的形式静脉输注2小时以上的左亚叶酸。左亚叶酸静脉滴注完成后立即静脉注射400mg/m2(体表面积)氟尿嘧啶,22小时内连续静脉注射600mg/m2(体表面积)氟尿嘧啶。连续进行2天,每2周重复一次。
(2)一般成人以250mg/m2(体表面积)的形式静脉输注2小时以上的左亚叶酸。左亚叶酸静脉滴注完成后,立即连续静脉注射2600mg/m2(体表面积)的氟尿嘧啶超过24小时。每周重复6次,然后休息2周。这是一个很酷的。
(3)一般情况下,对于成人,200mg/m2(体表面积)左亚叶酸静脉滴注2小时以上。左亚叶酸静脉滴注完成后立即静脉注射400mg/m2(体表面积)氟尿嘧啶,46小时内连续静脉注射2400~3000mg/m2(体表面积)氟尿嘧啶。每两周重复一次。
3. 左叶酸和氟尿嘧啶持续静脉滴注治疗小肠癌和不可切除的胰腺癌
一般来说,对于成人,200毫克/平方米(体表面积)的左亚叶酸静脉输注超过2小时。左亚叶酸静脉滴注完成后立即静脉注射400mg/m2(体表面积)氟尿嘧啶,46小时内连续静脉注射2400mg/m2(体表面积)氟尿嘧啶。每两周重复一次。
包装
左亚叶酸静脉滴注
25 毫克“NP”:10瓶
100毫克 "NP" :5瓶
制造和销售
尼普罗有限公司
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/3929407D1071_3_06/?view=frame&style=SGML&lang=ja
------------------------------------------------
Levofolinate for Injection 100mg(Calcium Levofolinate Hydrate)
Brand name : Levofolinate for Injection 100mg "NP"
 Active ingredient: Levofolinate calcium
 Dosage form: injection
 Print on wrapping:
Effects of this medicine
This medicine is used concomitantly with Fluorouracil (antitumor medicine) to enhance the growth-inhibitory effect against cancer cells.
It is usually used to enhance the effect of Fluorouracil for the gastric cancer (inoperable/recurrent), colorectal cancer and pancreatic cancer difficult to be removed by surgery.
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 myelosuppression, diarrhea, complication of infection, ascites, pleural effusion, heart disease or a history of it, poor general condition.
If you are receiving the combination preparation of Tegafur, Gimeracil and Oteracil Potassium or had discontinued receiving it within 7 days.
If you have hepatic disorder, renal disorder, hepatic metastasis.
If you have gastrointestinal ulcer or haemorrhage.
If you are receiving radiotherapy.
•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>>
•In general, this medicine is administered by intravenous drip infusion at one time over the period of 2 hours.
•Duration of administration may vary by other concomitant drug and your condition. Ask your doctor about your dosing schedule.
Precautions while taking this medicine
•Treatment with this medicine may cause decreased bone-marrow function. If you have decreased bone-marrow function, infection or bleeding may tend to occur. However, it is difficult to find out these symptoms so that you should receive clinical examination (blood test, liver/renal function test, 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 loss of appetite, nausea, vomiting, taste abnormality, abdominal pain, epigastric pain, dry mouth, constipation, gum inflammation, cheilitis, melena, angular cheilitis, glossitis, heart burn, abdominal bloating or rash. 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.
•intense abdominal pain, diarrhea, hematochezia [serious enterocolitis]
•general malaise, bruise, dizziness [myelosuppression]
•rash, breathing difficulty, decreased blood pressure [shock, anaphylaxis]
•unsteady gait, numbness of terminal portion of extremities, impaired tongue movement [leukoencephalopathy, mental/nerve disorder]
•chest pain, cold sweat, feeling of strong pressure in chest [congestive heart failure, myocardial infraction, angina at rest]
•general swelling, fatigability, difficulty in urination [acute renal failure]
•fever, dry cough, difficult to breathe [interstitial pneumonia]
•general malaise, loss of appetite, yellowing in skin and white of eyes [hepatic function disorder, jaundice]
•nausea, vomiting, gastric pain, oral erosion and pain [gastrointestinal ulcer, serious stomatitis]
•sudden intense pain in low back and back , fever, nausea, vomiting[acute pancreatitis]
•impaired consciousness, flapping tremor in hands, tremor in limbs[hyperammonemia]
•hypesthesia and supersensitivity, pain, skin exfoliation in volar[hand-foot syndrome]
•difficult to smell, feel no smell[anosmia]
•sweating, intense abdominal pain, watery stool[severe diarrhea]
•nasal bleeding, palpitation, shortness of breath, bruise, yellow urine [disseminated intravascular coagulation]
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: 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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