英文药名: Grazax(Grass Pollen Allergen Tablet)

中文药名: 花粉过敏症的疫苗片

生产厂家: Not available

药品简介
Grazax含有过敏原提取花粉。治疗的目的是增加对花粉的免疫耐受，从而减少过敏症状。
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。
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®
GRAZAX® is a fast-dissolving, once-daily grass allergy immunotherapy pill (tablet) that is suitable for home administration (you are advised to take the first tablet under medical supervision, see PIL).
GRAZAX® contains an allergen extract of grass pollen. It is the grass pollen which causes the allergic reactions leading to symptoms such as runny, itchy or blocked nose and/or gritty or watery eyes. The treatment is intended to increase the immunological tolerance towards grass pollen, and thereby reducing the allergic symptoms. GRAZAX® is used to treat rhinitis and conjunctivitis (also commonly called “hay fever”) caused by grass pollen in people suffering from allergy.
Grazax sublingual tablets contain a standardised extract of grass pollen allergen from Timothy grass (Phleum pratenase). The tablets are a type of medicine called immunotherapy. They are used to treat hayfever caused specifically by an allergy to grass pollen.
It is not fully understood how the medicine works. However, the grass pollen extract is thought to stimulate the body’s immune system to produce antibodies against grass pollen. These antibodies can then bind to any grass pollen that you encounter during the grass pollen season and prevent it from causing allergic symptoms.
The medicine is used to prevent hayfever symptoms such as a blocked or runny nose (allergic rhinitis) and itchy, red watery eyes (allergic conjunctivitis) that are caused by a grass pollen allergy. The allergy must be diagnosed with a positive skin prick test and/or specific IgE test to grass pollen. The therapy will only work in people with this specific allergy.
To have the greatest effect, the tablets should ideally be started four months before the grass pollen season starts. However, some effect will still be seen if they are started two to three months before the season begins. The tablets are taken once a day and should be continued all year round.
If your allergic symptoms do not improve during the first years pollen season your doctor will not continue to prescribe the tablets, because they are unlikely to be effective for the following years pollen season.
In adults, if your symptoms do improve in the first year of treatment they are likely to continue to improve, and it is recommended that you continue the treatment for three years. The medicine has not been studied for longer than one year in children.
Grazax tablets are known as oral lyophilisates. They are designed to dissolve in the saliva underneath the tongue, so the medicine can be absorbed from the rich supply of blood vessels in this area.
What is it used for?
Hay fever symptoms such as a runny or blocked nose (allergic rhinitis) and itchy, red, watery eyes (allergic conjunctivitis) caused by grass pollen allergy in adults and children aged five years and over. (The allergy must be diagnosed with a positive skin prick test and/or specific IgE test).
Warning!
Grazax tablets are fragile and should not be forced through the foil on the blister pack as they will break easily. Instead, fold back the marked corner of the foil and pull it off. Remove the tablet using dry fingers and immediately place it under the tongue. Leave it there for a few seconds until it dissolves and is absorbed from under the tongue. Try not to swallow for a minute. You should not eat or drink for at least five minutes after taking the tablet.
The first dose of this medicine should be taken under medical supervision, so if you get any side effects they can be treated if necessary, or discussed with your doctor.
This medicine contains the allergen that you are allergic to. As a result, it may initially cause mild local side effects that are allergic responses. These usually settle down within a week of starting the treatment. The most common allergic responses are itching in the mouth and ears, throat irritation, sneezing and swelling in the mouth. These may last for a few minutes to a few hours after taking a tablet. If side effects are troublesome you could talk to your doctor about taking an antihistamine. If you experience symptoms of a more severe allergic reaction, such as swelling of the face, mouth or throat, difficulty swallowing or breathing, voice changes, worsening of asthma, or a rash, you should stop taking this medicine and consult your doctor or hospital immediately.
Do not exceed the prescribed dose. If you take more tablets than you should they may cause severe allergic symptoms, including symptoms in the mouth and throat.
If you have a tooth removed, or any other dental surgery or surgery on your mouth, or if a child's milk tooth falls out, this medicine should be stopped for seven days afterwards to allow the mouth to heal.
You should not give this medicine to anyone else, even if they have the same symptoms as you, because it may not be suitable or effective for their allergy.
This medicine has not been studied fully in people aged over 65 years or in children aged under five years, and it is not recommended for these age groups.
Use with caution in
People who have recently had surgery on the mouth, a tooth removed, or a tooth fall out (this medicine should be stopped for seven days - see warning above).
Asthma. (If it seems like your asthma is getting worse you should stop taking this medicne and consult your doctor straight away. If a child with asthma gets an infection in their airways they should stop taking this medicine until the infection has cleared up.)
Severe allergy to fish (Grazax tablets contain gelatine derived from fish).
Not to be used in
Diseases affecting the immune system, for example autoimmune diseases, immune complex diseases or immune deficiency diseases.
Cancer.
Uncontrolled or severe asthma.
Severe inflammation of the mouth, for example due to lichen planus or severe fungal infections.
This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.
If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.
Pregnancy and breastfeeding
Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.
Treatment with Grazax should not be started in pregnant women, as the effects of Grazax during pregnancy are not yet known.
If you get pregnant while taking this medicine you should tell your doctor. They will let you know if you can continue this treatment after assessing your general condition and how you have reacted to the medicine in the past.
If you have asthma your doctor will want to monitor you more closely if you continue this treatment during pregnancy.
This medicine has not been studied in women who are breastfeeding. The manufacturer states that no effects on breastfed infants are expected. Seek medical advice from your doctor.
Side effects
Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here does not mean that all people using this medicine will experience that or any side effect. The following are some of the side effects that are known to be associated with this medicine.
Very common (affect more than 1 in 10 people)
Swelling and itching in the mouth.
Sneezing.
Itching in the ears.
Throat irritation.
Common (affect between 1 in 10 and 1 in 100 people)
Itchy eyes.
Conjunctivitis.
Runny or blocked nose.
Swelling in the mouth or throat.
Throat tightness.
Cough.
Asthma.
Tingling or numb sensations in the mouth.
Blistering in the mouth.
Swollen or painful tongue.
Headache.
Indigestion.
Feeling sick (nausea).
Itching.
Feeling tired (fatigue).
Uncommon (affect between 1 in 100 and 1 in 1000 people)
Dizziness.
Eye swelling.
Upper airway infection.
Mouth ulcers or sores.
Dry mouth and throat.
Vomiting.
Diarrhoea.
Abdominal pain.
Swollen glands.
Shortness of breath, wheezing or asthma attack.
Voice changes/hoarseness.
Difficulty or pain when swallowing.
Nettle-type rash (hives or urticaria).
Chest pain or tightness.
Severe swelling of the face, mouth, tongue and throat (angioneurotic oedema).
Fever or feeling hot.
If you experience any swelling of the face, mouth or throat, feeling of fullness in the throat, difficulty swallowing or breathing, voice changes, worsening of asthma, or a rash after taking this medicine, you should consult your doctor or hospital immediately.
The side effects listed above may not include all of the side effects reported by the medicine's manufacturer.
For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.