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英文药名：CEDARTOLEN SUBLINGUAL DROP（Standardization of sika pollen）
中文药名：标准化花粉提取物原液
生产厂家：鸟居药业
シダトレンスギ花粉舌下液200JAU/mLボトル／シダトレンスギ花粉舌下液2,000JAU/mLボトル／シダトレンスギ花粉舌下液2,000JAU/mLパック
治疗类别名称
杉树花粉过敏的脱敏治疗（过敏原免疫疗法）药
批准日期：2014年10月
有効成分
標準化スギ花粉エキス原液10,000JAU/mL
性状
淡黄色透明液体
操作注意事项
1.药物将被存储在寒冷的地方（2〜8℃）。
2.药物能够让儿童接触不到的地方。
3. Shidatorensugi花粉舌下解决方案200JAU/毫升瓶（用于膨胀阶段），
Shidatorensugi花粉舌下解决方案2,000JAU/毫升瓶（用于膨化相）
与附连到所述容器的分配器，按压泵（推）嵌合被要求舌下被丢弃量。
应当指出的是，后在第一次安装分配器的时间五倍盲工装（推）的使用。也在下一次和其后一次盲工装（推）后使用。
1按（1推）为0.2毫升。
4. Shidatorensugi花粉舌下解决方案2,000JAU /毫升包（维持阶段）
打开铝层压容器在服用该药物的时间，（1毫升）的总量舌下下降到它。
条件批准
用是处方药和仅由与关于由舌下给药的脱敏疗法，只在医生和医疗机构使用的足够的知识和经验的医师可全面管理的，并描述该试剂的风险，等中使用，从而使确认后，医生配药和医疗机构在药房发药之前进行，参加生产销售的必要措施。
药效药理
作用机序
脱敏疗法的机制的作用尚不完全清楚，与舌下给药的脱敏治疗发生在口腔粘膜树突细胞捕获过敏原，但据信，免疫应答诱导。作为免疫反应的抑制和增加Th1细胞增加Th2细胞，调节性T细胞的诱导已经报道在抗原特异性IgG和IgA的增加，它被假定为抑制的过敏症状的表达结果。
适应病症
花粉过敏（脱敏治疗）
用法用量
1.增加期间（1-2周）
成人和12岁及以上儿童，行政管理两周为一个膨胀阶段开始后，一旦剂量以下的一天，是在舌头底下下降，保持2分钟后，咽下。然后5分钟漱口。
[1一周增加生活Shidatorensugi花粉舌下解决方案200JAU/毫升瓶]
第1天0.2毫升
第2天0.2毫升
第3天0.4毫升
第4天0.4毫升
第5天0.6毫升
第6天为0.8ml
第7天1毫升
[2周开始升高生活Shidatorensugi花粉舌下解决方案2,000JAU/毫升瓶]
第1天0.2毫升
第2天0.2毫升
第3天0.4毫升
第4天0.4毫升
第5天0.6毫升
第6天为0.8ml
第7天1毫升
2.维护阶段（3周后）
増量期期末，作为维护阶段后，Shidatorensugi花粉舌下解决方案2,000JAU/总量（1毫升），每日一次毫升包装，它是在舌头底下下降，保持2分钟后，咽下。然后5分钟，距离漱口和餐厅避免。
包装规格
1周延长使用
Shidatorensugi花粉舌下解决方案200JAU/毫升瓶
PET瓶10毫升的容器：1本（包括饮水机）
2周延长使用
Shidatorensugi花粉舌下解决方案2,000JAU/毫升瓶
PET瓶10毫升的容器：1本（包括饮水机）
对于维护阶段3周后
Shidatorensugi花粉舌下解决方案2,000JAU/ mL的包
小袋商品铝层压容器1毫升：14包（1页：1包×7系列的第2张）
制造厂商
鸟居药业有限公司
完整处方资料附件：http://www.info.pmda.go.jp/go/pack/4490029S1020_1_06/
CEDARTOLEN SUBLINGUAL DROP -Japanese Cedar Pollen 2,000 JAU/mL bottle（シダトレンスギ花粉舌下液2,000JAU/mLボトル）
Brand name : CEDARTOLEN SUBLINGUAL DROP -Japanese Cedar Pollen 2,000 JAU/mL bottle
Active ingredient: Standardized Japanese cedar pollen extract original solution 10,000 JAU/mL
Dosage form: Clear and colorless solution
Print on wrapping: シダトレンスギ花粉舌下液2,000JAU/mLボトル
CEDARTOLEN SUBLINGUAL DROP -Japanese Cedar Pollen 2,000 JAU/mL pack（シダトレンスギ花粉舌下液2,000JAU/mLパック）
Brand name : CEDARTOLEN SUBLINGUAL DROP -Japanese Cedar Pollen 2,000 JAU/mL pack
Active ingredient: Standardized Japanese cedar pollen extract original solution 10,000 JAU/mL
Dosage form: Clear and colorless solution
Print on wrapping: シダトレンスギ花粉舌下液2,000JAU/mLパック
CEDARTOLEN SUBLINGUAL DROP -Japanese Cedar Pollen 200 JAU/mL bottle（シダトレンスギ花粉舌下液200JAU/mLボトル）
Brand name : CEDARTOLEN SUBLINGUAL DROP -Japanese Cedar Pollen 200 JAU/mL bottle
Active ingredient: Standardized Japanese cedar pollen extract original solution 10,000 JAU/mL
Dosage form: Clear and colorless solution
Print on wrapping: シダトレンスギ花粉舌下液200JAU/mLボトル
Effects of this medicine
This medicine, made from cedar pollen, is started at a low concentration/dose to make your body accustomed to the pollen for amelioration of allergic symptoms caused by cedar pollen (symptoms of cedar pollinosis).
It is usually used to improve the symptoms of cedar pollinosis.
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 experienced shock by taking this medicine.
If you have bronchial asthma, cancer or a systemic disease that affects immune system.
•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, for adults and children over 12 years of age, the following dose will be administered sublingually once daily for 2 weeks after the initiation of administration: Day 1, 0.2 mL; Day 2, 0.2 mL; Day 3, 0.4 mL; Day 4, 0.4 mL; Day 5, 0.6 mL; Day 6, 0.8 mL; and Day 7, 1 mL. The medicine should be retained for 2 minutes, and then swallowed. Gargling, eating and drinking should be avoided for the next 5 minutes. This medicine is to be taken in the second week of the updosing period. Strictly follow the instructions.
•It is recommended that you take the medicine in the presence of a family member or during daytime in case anaphylaxis develops and treatment becomes necessary.
•If you have cold, asthma or are not feeling well, ask your doctor whether you can take the medicine.
•Consult with your doctor before taking the medicine if you have received surgery or treatment for your mouth, such as tooth extraction or if you have a wound or inflammation inside the mouth, such as stomatitis.
•If the medicine gets on your hands, wash it off immediately. Symptoms such as itching may appear if you rub your eyes with the medicine on your hands.
•If you miss a dose and realize that you have missed a dose by the end of that day, take the dose for that day. However, if you realize on the next day that you have missed a dose, take the medicine at the dose for the day before. Even if you cannot keep a drop under your tongue for 2 minutes before swallowing, do not take another dose on the same day. Take it on the next day at the dose for the day before. You should never take two doses at one time.
•If you accidentally take more than your prescribed dose, spit it out and gargle. On the next day, take the medicine at the dose for the day before. If you notice any abnormality, visit a medical institution immediately.
•Do not stop taking this medicine unless your doctor instructs you to do so.
Precautions while taking this medicine
•Do not get involved in heavy exercise, drink alcohol or take a bath within 2 hours before and after taking this medicine. Improved blood circulation in the body may promote the absorption of this medicine, leading to development of adverse reactions.
Possible adverse reactions to this medicine
The most commonly reported adverse reactions include stomatitis, swelling under the tongue, throat itching, oral swelling, ear itching and headache. If any of these symptoms occurs, 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.
•facial pallor, cold sweat, respiratory distress [shock, anaphylaxis]
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
•Store this medicine in a cold place (at 2 to 8 degrees Celsius).
•Keep out of the reach of children.
•Discard the remainder. Do not store them.
Torii Pharmaceutical Co.,LtdInternal
Published: 11/2014
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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