優游250優氟吸入劑

国家: 台湾

语言: 中文

来源: 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)

资料单张 资料单张 (PIL)
01-07-2020
公众评估报告 公众评估报告 (PAR)
01-07-2020

有效成分:

SALMETEROL XINAFOATE MICRONIZED;;FLUTICASONE PROPIONATE MICRONIZED

可用日期:

荷商葛蘭素史克藥廠股份有限公司台灣分公司 台北市中正區忠孝西路一段66號23-24樓 (86927438)

ATC代码:

R03AK06

药物剂型:

口腔吸入劑

组成:

SALMETEROL XINAFOATE MICRONIZED (1216002920) (equivalent to 25mcg of Salmeterol)MCG; FLUTICASONE PROPIONATE MICRONIZED (8406002220) MCG

每包单位数:

金屬罐裝附吸入器

类:

製 劑

处方类型:

須由醫師處方使用

厂商:

GLAXO WELLCOME PRODUCTION 23 RUE LAVOISIER, ZONE INDUSTRIELLE NO.2, 27000 EVREUX, FRANCE FR

治疗领域:

salmeterol and fluticasone

疗效迹象:

EVOFLO適用於可逆性呼吸道阻塞疾病(ROAD)之常規治療,包括適合使用支氣管擴張劑及皮質類固醇組合療法之患有氣喘的兒童與成人。這可能包括:正在使用長效乙型作用劑(β-AGONIST)及吸入型皮質類固醇之有效維持劑量的患者。正在接受吸入型皮質類固醇療法,而仍有症狀之患者。接受支氣管擴張劑之常規治療,而需要吸入型皮質類固醇之患者。EVOFLO適用於嚴重慢性阻塞性肺部疾病(FEV1 50%預期值,FEV1/FVC 70%)之維持治療,包括慢性支氣管炎和肺氣腫。

產品總結:

註銷日期: 2018/12/03; 註銷理由: 自請註銷; 有效日期: 2019/02/19; 英文品名: Evoflo 250 Evohaler

授权状态:

已註銷

授权日期:

2014-02-19

资料单张

                                EVOFLO™ 125, 250 EVOHALER™
Salmeterol/fluticasone propionate
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each single actuation of
_EVOFLO_
provides:
Salmeterol xinafoate equivalent to 25 micrograms of salmeterol and
125 or 250 micrograms of fluticasone propionate.
PHARMACEUTICAL FORM
Inhalation aerosol.
CLINICAL PARTICULARS
INDICATIONS
ASTHMA - REVERSIBLE OBSTRUCTIVE AIRWAYS DISEASE (ROAD)
_EVOFLO_
is indicated in the regular treatment of reversible obstructive
airways disease (ROAD), including asthma in children and adults,
where use of a combination (bronchodilator and inhaled corticosteroid)
is appropriate.
This may include:
Patients on effective maintenance doses of long-acting
beta-agonists and inhaled corticosteroids.
Patients who are symptomatic on current inhaled
corticosteroid therapy.
Patients on regular bronchodilator therapy who require
inhaled corticosteroids.
CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
_EVOFLO_
is indicated for the maintenance treatment of severe chronic
obstructive pulmonary disease (COPD) (FEV
1
<50% predicted normal,
FEV
1
/FVC<70%) including chronic bronchitis and emphysema.
DOSAGE AND ADMINISTRATION
_EVOFLO_
Evohaler is for inhalation only.
Patients should be made aware that
_EVOFLO_
Evohaler must be used
regularly for optimum benefit, even when asymptomatic.
Patients should be regularly reassessed by a doctor, so that the
strength
of
_EVOFLO_
they are receiving remains optimal and is only changed on
medical advice.
ASTHMA - REVERSIBLE OBSTRUCTIVE AIRWAYS DISEASE (ROAD)
The dose should be titrated to the lowest dose at which effective
control
of symptoms is maintained. Where the control of symptoms is
maintained with twice daily
_EVOFLO_
, titration to the lowest effective
dose could include
_EVOFLO_
given once daily.
Patients should be given the strength of
_EVOFLO_
containing the
appropriate fluticasone propionate dosage for the severity of their
disease.
Recommended Doses:
Adults and adolescents 12 years and older:-
Two inhalations of 25 micrograms salmeterol and 125 micro
                                
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