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Actair Sublingual 100un IR×2Tablets(抗原过敏舌下含片)
药店国别  
产地国家 日本 
处 方 药: 是 
所属类别 100单位/片 2片/盒 
包装规格 100单位/片 2片/盒 
计价单位: 盒 
生产厂家中文参考译名:
盐野义制药有限公司
生产厂家英文名:
Shionogi & Co
该药品相关信息网址1:
http://www.info.pmda.go.jp/go/pack/4490030F1024_1_04/
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:
Actair Sublingual(アシテアダニ舌下錠)100UI/tab 2tabs/box
原产地英文药品名:
Dermatophagoides farinae
中文参考商品译名:
Actair舌下含片(アシテアダニ舌下錠)100单位/片 2片/盒
中文参考药品译名:
抗原过敏
曾用名:
简介:

 

部份中文抗原过敏处方资料(仅供参考)
商品名:Actair
英文名:Dermatophagoides farinae
中文名:抗原过敏
剂  型:舌下含片
生产商:塩野义制薬

药品简介
Actair®是世界上第一款用于治疗屋尘螨过敏的舌下免疫片剂
近日,日本推出Actair(STG320)片,这是第一款由Shionogi&Co.Ltd生产的用于治疗屋尘螨(HDM)引起的青少年和成人过敏的免疫治疗(特别对久治不愈的过敏性鼻炎有奇效)。
アシテアダニ舌下錠100単位(IR)/アシテアダニ舌下錠300単位(IR)
药用类别名称
脱敏治疗药物 (过敏原免疫治疗)
批准日期:2015年5月
欧文商標名
Actair
1. yakehyovhidaniekis Harue
特性: 棕色粉末
2. konahyouhidaniekis Harue
特性: 棕色粉末
批准条件
1. 制定药品风险管理计划并予以适当实施。
2. 它只用于在通过舌下管理脱敏治疗方面有足够知识和经验的医生, 并且只用于能够充分管理和解释药物风险等的医生和医疗机构。 药店应采取必要措施制造和销售药品, 确保医生和医疗机构在配药前得到确认。
药用药理学
作用机制
虽然舌下给药脱敏治疗的明确作用表达机制尚不清楚, 如抗原特异性抗体的产生和T细胞反应的调节, 但众所周知, 变应性鼻炎的症状是由免疫变化抑制的。
适应症
螨抗原脱敏治疗变应性鼻炎
用法与用量
通常, 一旦每天从舌下管理开始100个单位(IR), 一个剂量就会增加100个单位(IR), 300个单位(IR)。原则上, 升级期为三天, 但将根据患者病情适当延长。舌下给药后, 直到完全溶解, 吞咽。此后 5分钟, 不要口吃、吃饭或喝酒。
包装
舌下片
100单位(IR): PTP1片 (1片x1),
PTP2片(2片x1)
300单位 (IR): PTP30 片(10 片 x3)
制造和销售
塩野义制薬

注:以上中文不够完整,使用者以原处方资料为准。
完整说明附件:http://www.info.pmda.go.jp/go/pack/4490030F1024_1_07/ 
Stallergenes Greer Announces the Launch of Actair® in Japan
Actair® is the First Sublingual Immunotherapy Tablet Launched in the World for the Treatment of House Dust Mite Allergy
Stallergenes Greer plc (Euronext:STAGR) today announced the launch in Japan of Actair® (STG320), the first immunotherapy tablet for the treatment of House Dust Mite (HDM)-induced allergy in adolescents and adults, by Shionogi & Co., Ltd.. Actair® has been developed by Stallergenes Greer who has granted an exclusive license to Shionogi & Co., Ltd. for Japan.
Fereydoun Firouz, Chairman and Chief Executive Officer of Stallergenes Greer plc, said:
“We are delighted about the launch of Actair® in Japan, which marks a key milestone for Stallergenes Greer, as it is the first launch worldwide for a house dust mite allergy immunotherapy tablet. This launch is a further proof of our successful long-term collaboration with Shionogi & Co., Ltd., as well as our worldwide leadership in the allergy immunotherapy HDM segment. This marks a significant step for our globalization strategy and the roll-out of our portfolio.”
Since September 2010, Shionogi & Co., Ltd. has been the exclusive partner of Stallergenes Greer for the clinical development, registration, marketing and sales of sublingual HDM immunotherapy tablets and sublingual Japanese cedar pollen immunotherapy tablets in Japan. Stallergenes Greer will receive payments on sales of Actair® in Japan.
In addition, Shionogi & Co., Ltd. has started a phase III trial to eva luate the efficacy and safety of Actair® in allergic rhinitis in children (5 to 16 years of age).The trial is expected to enroll approximately 400 subjects.
ABOUT RESPIRATORY ALLERGIES IN JAPAN
Allergic rhinitis affects 25% of Japan’s population. HDM and Japanese cedar pollen are the two main causes of respiratory allergies in this country. From early childhood, HDM can trigger allergic rhinitis, which worsens over time with a natural progression towards asthma. The symptoms may be severe, significantly impairing patients’ quality of life.
With 32 million respiratory allergy sufferers, there is a strong, and as yet unmet, demand for allergy treatment in Japan where sublingual allergen immunotherapy tablets have not been available.
ABOUT ACTAIR® (STG320) HDM TABLET
With a unique galenic form and tailored to the sublingual route, Actair® (STG320) is a sublingual immunotherapy tablet consisting of D.pte/D.far purified and calibrated HDM extracts corresponding to the epidemiological characteristics of patient exposure. Actair® is indicated for the treatment of HDM allergic rhinitis, confirmed by clinically relevant symptoms, a positive cutaneous test for HDM allergies and/or a positive test for the specific IgE to HDM.
Actair® (STG320) has been the subject of a phase II / III clinical study in Japan (1501D1732). This randomized, double-blind and placebo-controlled study has eva luated the efficacy and safety of a 12 month course of treatment with sublingual HDM immunotherapy tablets. On 3 February 2014, Shionogi reported that the study met its primary efficacy endpoint, as each of the active treatment groups demonstrated a statistically significant difference on the Average Adjusted Symptom Score after one year of treatment versus the placebo group. Overall, the safety and tolerability profile were favorable.
Shionogi & Co., Ltd. has announced it has received the approval of Actair® (STG320) from the Japanese health authorities (PMDA - Pharmaceuticals and Medical Devices Agency) on 30 March 2015.
https://www.c-notes.jp/medicines/4490030F2020/document
https://www.shionogi.co.jp/med/products/drug_a/qdv9fu000000o1th.html#medicine-guide

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