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Papilock Mini Ophthalmic Solution 0.1% 90tube×0.4ml(环孢素滴眼液)
药店国别  
产地国家 日本 
处 方 药: 是 
所属类别 1毫克 0.4毫升×90管/盒 
包装规格 1毫克 0.4毫升×90管/盒 
计价单位: 盒 
生产厂家中文参考译名:
参天制药
生产厂家英文名:
Santen Pharmaceutical Co.Ltd.
该药品相关信息网址1:
http://www.info.pmda.go.jp/go/pack/1319750Q1025_1_09/
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:
Papilock(パピロックミニ点眼液0.1%)1mg 0.4ml×90tube
原产地英文药品名:
Ciclosporin
中文参考商品译名:
Papilock(パピロックミニ点眼液0.1%)1毫克 0.4毫升×90管/盒(注:三盒起订)
中文参考药品译名:
环孢素
曾用名:
简介:

 

部份中文环孢素处方资料(仅供参考)
商品名:Papilock Mini Ophthalmic Solution
英文名:Ciclosporin
中文名:环孢素滴眼液
生产厂家:参天制药
药品简介
Papilock(Ciclosporin,环孢素)滴眼液是一种局部免疫调节剂,用于与角结膜干燥症相关的眼部炎症所导致的泪液生成减少的患者。
パピロックミニ点眼液0.1%
治疗类别名称
角结膜炎的治疗药物
批准日期:2005年12月
商標名
PAPILOCK Mini ophthalmic solution 0.1%
一般名
シクロスポリン(Ciclosporin)
化学名
cyclo{-[(2S,3R,4R,6E)-3-Hydroxy-4-methyl-2-methylaminooct-6-enoyl]-L-2-aminobutanoyl-N-methylglycyl-N-methyl-L-leucyl-L-valyl-N-methyl-L-leucyl-L-alanyl-D-alanyl-N-methyl-L-leucyl-N-methyl-L-leucyl-N-methyl-L-valyl-}
構造式
分子式
C62H111N11O12
分子量
1202.61
性状
本品为白色粉末。
本品极易溶于乙腈、甲醇或乙醇(95),溶于乙醚,几乎不溶于水。
处理注意事项
1、铝枕包装开封后,避光保存,常温保存,6个月内用完。 如果放入附带的遮光加药袋中并在2-8°C下保存,1年内使用。 (被光和氧气分解)应先使用已打开铝枕包装的产品。
2. 液体变混浊时请勿使用。
3. 为保证质量,本产品在铝枕包装中含有除氧剂,因此请小心误食。
药效药理
1. 细胞因子产生抑制作用
环孢素在体外抑制人外周血来源的单核细胞产生细胞因子(IL-2、IL-4、IL-5、IFN-γ)(IC50 值:0.021至0.173μM)。
2. 对实验性过敏性结膜炎模型的作用
(1) 环孢素滴注在立即过敏性结膜炎模型(豚鼠)中以0.1%或更高的浓度抑制组胺从结膜组织释放。
(2)在迟发性过敏性结膜炎模型(豚鼠)中,以0.05%或更高的浓度滴注环孢菌素抑制中性粒细胞浸润到结膜组织中。
适应症
春季角结膜炎(当抗过敏药不足时)
用法与用量
通常一次滴注 1滴,每天3次。
临床结果
1. 单药研究(开放标签研究)
在对春季角结膜炎患者(9-33岁)进行的早期II期研究中,观察到改善率为57.1%(8/14例)(一般改善程度“改善”或更高)。
2. II/III期研究(安慰剂对照、双盲、平行组抗过敏滴眼液对比研究)
在抗过敏眼药水不足的春季角结膜炎患者(7-39岁)中进行的II/III期研究(在联合抗过敏眼药水的条件下)与安慰剂组相比,睑结膜乳头显着。观察到发现分数的改善。
包装
塑料吸管:0.4毫升×90本(1袋30瓶×3袋铝枕头)


制造厂商
参天制药有限公司
注:以上中文处方资料不够完整,使用以原处方资料为准!
完整说明资料附件:
https://www.info.pmda.go.jp/go/pack/1319750Q1025_1_13/
-----------------------------------------------
PAPILOCK MINI ophthalmic solution 0.1%(Ciclosporin)
PAPILOCK MINI ophthalmic solution 0.1%(パピロックミニ点眼液0.1%)
Brand name : PAPILOCK MINI ophthalmic solution 0.1%
 Active ingredient: Ciclosporin
 Dosage form: colorless, limpid ophthalmic solution, 0.4mL, (bottle) very pale yellow green, (label) white
 Print on wrapping:
Effects of this medicine
This medicine suppresses cytokine production to improve allergic symptoms of the eye, or suppress ulcer growing in conjunctiva.
It is usually used to treat spring catarrh (vernal conjunctivitis), used when other anti-allergic medication is insufficient.
Before using this medicine, be sure to tell your doctor and pharmacist
•If you ever experienced any allergic reaction (itch, rash etc) to any medicine.
If you are a patient with eye infection.
If you wear contact lenses.
•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>>
•General dosage regimen: Apply 1 drop at a time, 3 times a day. Strictly follow the instructions of your doctor/pharmacist.
•Before using, wash your hands thoroughly with soap and running water. Next, twist and remove the tip of the vial and discard 1-2 drops. Then, pull down your lower eyelid so that the dropper tip does not touch eye or eyelashes. After dropping the solution into your eye, do not blink, and keep your eyes closed for 1-5 minutes pressing the inner corner of the eye lightly. Wipe off any excess liquid with a clean gauze or tissue. After the dose, make sure to dispose the dropper. Once the cap is open, remaining solution must not be stored for later use. If you need to use other eye drops at the same time, wait more than 5 minutes.
•Apply as soon as possible.If it is almost time for the next dose, skip the missed dose and continue your regular applying schedule. DO NOT use a double dose to make up for the missed dose.
•If you used too much of this medicine(more than ordered), check with your doctor/pharmacist.
•Do not stop using this medicine without the instructions of your doctor.
Precautions while taking this medicine
• Possible adverse reactions to this medicine
Common side effects are reported as below. If any of them occurs, check with your doctor/pharmacist: itchy/stinging eyes, corneal erosion, corneal ulcer, unstoppable tears, blepharitis (erosion of eyelids), etc.
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.
No pertinent entries.
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.
Storage conditions and other information
•Keep out the reach of children. Store away from heat, being put in a shading sachet.
•Do not use this medicine if you notice clouding of the solution.
•Discard the remainder. Do not store them. Ask your pharmacist how to discard.
External
Revised: 1/2010
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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