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当前位置:药品说明书与价格首页 >> 呼吸系统病 >> 气管炎与哮喘药品目录 >> Grazax(花粉过敏症的疫苗片)

Grazax(花粉过敏症的疫苗片)

2009-05-28 22:39:22  作者:新特药房  来源:新特药房药讯  浏览次数:331  文字大小:【】【】【
简介:Grazax 片已获美国FDA 的批准,用于5~17 岁儿童和青少年患者花粉过敏的预防和治疗。 本品是唯一非注射型的免疫治疗药物,被许可用于因严重花粉过敏导致的过敏性鼻炎、结膜炎及严重枯草热的儿童...

用于儿童花粉过敏Grazax(R)获FDA批准

GRAZAX®ALK是全球首间成功研究及生产舌下免疫治疗片剂的公司, 足见ALK在免疫治疗领域的领导地位。

全球首种舌下免疫治疗片剂GRAZAX® , GRAZAX®是专为草花粉过敏的病人而制的舌下免疫治疗药片,每天服用一次便可。GRAZAX® 是一种快速溶化的舌下(在舌头之下)的片剂,病人能自行服用,方便安全。

抗花粉过敏的疫苗Grazax片已获美国FDA的批准,用于5~17岁儿童和青少年患者花粉过敏的预防和治疗。

本品是唯一非注射型的免疫治疗药物,被许可用于因严重花粉过敏导致的过敏性鼻炎、结膜炎及严重枯草热的儿童患者的治疗。此外,本品是目前第1个只需每日服用1次的抗花粉过敏的免疫类舌下速溶片药物。Grazax 已经于2007年1月在英国获得批准。

伦敦儿科免疫学顾问医生Adam Fox博士,就Grazax在英国获得上市批准时发表评论称:Grazax 给了我们从根本上治疗患者过敏症状的机会,而不是仅仅去控制症状,它的上市对于英国儿科医生和其他患者来说都具有非同凡响的意义。

在儿童患者临床研究中Grazax 与标准治疗药物如抗阻胺药和鼻用甾体类联合使用与单独使用标准药物相比:患者枯草热的症状减少了27%,不发生过敏症状的日期数增加了22%。而且,在花粉过敏高峰期,Grazax与标准治疗药物联合使用,可以使其他治疗药物减少64%的使用率。本品具有良好的耐受性,绝大多数的不良反应为短暂的一过性局部不良反应如口腔瘙痒症,其程度较轻为轻度和中度。

Grazax可以用来改善花粉患者的症状,同时也用于严重过敏性鼻炎和过敏性结膜炎患者的治疗,此外它也可用于对传统治疗药物如抗组胺药物与鼻用甾体类药物无效的患者。

Grazax含梯牧草Phleumpratense花粉中蛋白过敏原冻干提取物,其制备采用了CarSnal Health公司的速溶Zydis技术,为1日1次的速溶片,于花粉季节来临前至少8周开始服用即可,较传统的注射用过敏症疫苗更方便使用。据此ALK-Abelló公司希望通过将本品引入家庭药疗而拓展其免疫治疗市场。尽管所含过敏原只来自一种草本,本品仍有望适用于除儿童患者之外更广泛的枯草热患者,因为不同种类的草本植物中过敏原均相似。

Grazax

As the first company to introduce tablet-based allergy immunotherapy, ALK has demonstrated its leadership position within immunotherapy innovation.

In 2007, the company launched GRAZAX® the first registered allergy tablet.

Tablets are a convenient and popular way for patients to take treatment and it is expected that the availability of tablet vaccines will allow many more patents suffering from allergy to benefit from immunotherapy.

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GRAZAX is a fast dissolving allergy immunotherapy tablet (AIT) that is placed under the tongue. 

Make sure that you are suffering from grass pollen allergy

Never start treatment without consulting your doctor first to find out if you are suffering from grass pollen allergy and to make sure that GRAZAX is the right medication for your allergic reactions. Always take GRAZAX® tablet exactly as your doctor has told you and check with your doctor or pharmacist if you are not sure.

You are advised to take the first oral lyophilisate under medical supervision. This gives you the opportunity to discuss possible side effects with the doctor.

Start medication before the grass pollen season

The usual dose is one oral lyophilisate daily. To get the best effect start taking the oral lyophilisates 4 months prior to the expected start of the grass pollen season and continue throughout the pollen season.

GRAZAX® is an oral lyophilisate. Take the oral lyophilisates like this:


1. Make sure your hands are dry before handling the GRAZAX® tablet


2. Tear off the strip marked with triangles at the top of the oral lyophilisate pack


3. Tear a square off the oral lyophilisate pack along the perforated lines.


4. Do not force the oral lyophilisate through the foil. It may damage the oral lyophilisate as it easily breaks. Instead, fold back the marked corner of the foil and then pull it off


5. Remove the oral lyophilisate carefully from the foil and take the oral lyophilisate immediately


6. Place the oral lyophilisate under the tongue. Allow it to remain there for a few seconds until it has dissolved. Do not swallow during the first minute. Do not eat or drink for at least 5 minutes

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