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  药店国别: 美国药房
产地国家: 美国
所属类别: 作用于呼吸系统药物->平喘药物
处方药:处方药
包装规格: (80/4.5)微克/吸入剂 6.9克/吸入器
计价单位: 吸入器
  点击放大  
生产厂家中文参考译名:
阿斯利康
生产厂家英文名:
ASTRAZENECA
该药品相关信息网址1:
http://www.mysymbicort.com/
该药品相关信息网址2:
http://www.drugs.com/symbicort.html
原产地英文商品名:
SYMBICORT (80/4.5)MCG/INHALATION 6.9G/INHALER
原产地英文药品名:
BUDESONIDE/FORMOTEROL FUMARATE DIHYDRATE
中文参考商品译名:
吸必扩 (80/4.5)微克/吸入剂 6.9克/吸入器
中文参考药品译名:
布地奈德/富马酸福莫特罗二水合物
原产地国家批准上市年份:
2006/07/21
英文适应病症1:
Asthma
英文适应病症2:
Chronic obstructive pulmonary disease
临床试验期:
完成
中文适应病症参考翻译1:
气喘
中文适应病症参考翻译2:
慢性阻塞性肺疾病
药品信息:

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 详细处方信息以本药内容附件PDF文件(201242218483926.pdf)的“原文Priscribing Information”为准
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部分中文吸必擴处方资料(仅供参考)

藥品中文名稱:吸必擴、都保定量粉狀吸入劑

藥品英文名稱:Symbicort Turbuhaler

主成分及含量:EACH DOSE CONTAINS含有:BUDESONIDE 160.0MCG;FORMOTEROL FUMARATE(DIHYDRATE) 4.5MCG

適應症:適合使用類固醇及長效β2作用劑(β2-agonist)合併治療的支氣管氣喘(Bronchial Asthma)。

用法用量:成人及青少年(12歲及以上): 1.Symbicort Turbuhaler 80/4.5ug/劑,每天2次,每次吸入1-2劑。 2.Symbicort Turbuhaler 160/4.5ug/劑,每天2次,每次吸入1-2劑。

副作用 常見:(>1/100)頭痛、心悸、顫抖、口咽念珠菌感染、喉嚨輕微刺激、咳嗽、嘶啞。

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主成分及含量:Budesonide/formoterol=160/4.5μg/dose

用 途:氣喘、慢性阻塞性肺疾病患有較嚴重之慢性阻塞肺疾病
 
用 法:口內吸入
 
副作用:長期使用,吸完後若不漱口,易感染白色念珠菌
 
警 語:吸完後請漱口
 
保存方式:室溫
 
藥品中文商品名:吸必擴 

藥品英文商品名:Symbicort
 
藥 廠:ASTRAZENECA AB
 
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Important Safety Information, including boxed warning
WARNING: Long-acting beta2-adrenergic agonists (LABA), such as formoterol, one of the active ingredients in SYMBICORT, increase the risk of asthma-related death. A placebo-controlled study with another LABA (salmeterol) showed an increase in asthma-related deaths in patients receiving salmeterol. This finding with salmeterol is considered a class effect of LABA, including formoterol. Currently available data are inadequate to determine whether concurrent use of inhaled corticosteroids or other long-term asthma control drugs mitigates the increased risk of asthma-related death from LABA. Available data from controlled clinical trials suggest that LABA increase the risk of asthma-related hospitalization in pediatric and adolescent patients
When treating patients with asthma, prescribe SYMBICORT only for patients not adequately controlled on a long-term asthma control medication, such as an inhaled corticosteroid or whose disease severity clearly warrants initiation of treatment with both an inhaled corticosteroid and LABA. Once asthma control is achieved and maintained, assess the patient at regular intervals and step down therapy (eg, discontinue SYMBICORT) if possible without loss of asthma control, and maintain the patient on a long-term asthma control medication, such as an inhaled corticosteroid. Do not use SYMBICORT for patients whose asthma is adequately controlled on low- or medium-dose inhaled corticosteroids

SYMBICORT is NOT a rescue medication and does NOT replace fast-acting inhalers to treat acute symptoms.
It is possible that systemic corticosteroid effects such as hypercorticism and adrenal suppression may occur, particularly at higher doses. Particular care is needed for patients who are transferred from systemically active corticosteroids to inhaled corticosteroids. Deaths due to adrenal insufficiency have occurred in asthmatic patients during and after transfer from systemic corticosteroids to less systemically available inhaled corticosteroids.

Patients who are receiving SYMBICORT should not use additional formoterol or other LABA for any reason.

Due to possible immunosuppression, potential worsening of infections could occur; a more serious course of chickenpox or measles can occur in susceptible patients.

Excessive beta-adrenergic stimulation has been associated with central nervous system and cardiovascular effects. SYMBICORT, like all products containing sympathomimetic amines, should be used with caution in patients with convulsive disorders, thyrotoxicosis, and cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension. Beta-adrenergic agonist medications may produce hypokalemia and hyperglycemia in some patients. As with other inhaled medications, paradoxical bronchospasm may occur with SYMBICORT. Use with caution in patients with diabetes mellitus.

Long-term use of orally inhaled corticosteroids, such as budesonide, a component of SYMBICORT, may result in a reduction in growth velocity and/or a loss of bone mineral density.

Glaucoma, increased intraocular pressure, and cataracts have been reported following the inhaled administration of corticosteroids, including budesonide, a component of SYMBICORT.

In rare cases, patients on inhaled corticosteroids may present with systemic eosinophilic conditions.

SYMBICORT should be administered with caution to patients being treated with MAO inhibitors or tricyclic antidepressants, or within 2 weeks of discontinuation of such agents. Caution should also be exercised in patients on long-term ketoconazole and other known potent CYP3A4 inhibitors.

Additional Information Specific to Asthma
The most common adverse reactions ≥3% reported in clinical trials included nasopharyngitis, headache, upper respiratory tract infection, pharyngolaryngeal pain, sinusitis, influenza, back pain, nasal congestion, stomach discomfort, vomiting, and oral candidiasis.

Additional Information Specific to COPD
For patients with COPD, the approved dosage of SYMBICORT is 160/4.5 mcg, 2 inhalations twice daily
The most common adverse events ≥3% reported in COPD clinical trials included nasopharyngitis, oral candidiasis, bronchitis, sinusitis, and upper respiratory tract infection
Lower respiratory tract infections, including pneumonia, have been reported following the inhaled administration of corticosteroids
In 2 placebo-controlled SYMBICORT COPD clinical studies, pneumonia did not occur with greater incidence in the SYMBICORT 160/4.5 group, compared with placebo, while the incidence of lung infections other than pneumonia (eg, bronchitis) was higher for SYMBICORT than placebo

Indications
SYMBICORT is indicated for the treatment of asthma in patients 12 years and older (also see boxed WARNING).

SYMBICORT 160/4.5 is indicated for the maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

SYMBICORT is NOT indicated for the relief of acute bronchospasm and should not be initiated in patients during rapidly deteriorating or potentially life-threatening episodes of asthma or COPD.

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 详细处方信息以本药内容附件PDF文件(201242218483926.pdf)的“原文Priscribing Information”为准
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更新日期: 2013-4-23
附件:




201242218483926.PDF    

 
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