BUFOMIX EASYHALER 200/6 budesonide/formoterol (eformoterol) fumarate dihydrate 160 ug/4.5 ug per inhalation powder for inhalation dry powder inhaler

국가: 오스트레일리아

언어: 영어

출처: Department of Health (Therapeutic Goods Administration)

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공공 평가 보고서 공공 평가 보고서 (PAR)
28-10-2022

유효 성분:

budesonide, Quantity: 160 microgram/actuation; formoterol fumarate dihydrate, Quantity: 4.5 microgram/actuation

제공처:

Orion Pharma (AUS) Pty Limited

약제 형태:

Inhalation, powder for

구성:

Excipient Ingredients: lactose monohydrate

관리 경로:

Inhalation

패키지 단위:

60 inhalations

처방전 유형:

(S4) Prescription Only Medicine

치료 징후:

Asthma,BUFOMIX EASYHALER is indicated in adults and adolescents (12 years and older), for the treatment of asthma, to achieve overall asthma control, including the relief of symptoms and the reduction of the risk of exacerbations (see Section 4.2 Dose and method of administration).,Chronic obstructive pulmonary disease (COPD),BUFOMIX EASYHALER is indicated for the symptomatic treatment of moderate to severe COPD (FEV1 less than or equal to 50 percent predicted normal) in adults with frequent symptoms despite long-acting bronchodilator use, and/or a history of recurrent exacerbations. BUFOMIX EASYHALER is not indicated for the initiation of bronchodilator therapy in COPD.

제품 요약:

Visual Identification: white to yellowish white powder for inhalation in a device metered inhaler with red overcap and dark purple/blue dustcap; Container Type: Inhaler - dry powder; Container Material: Plastic; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

승인 상태:

Registered

승인 날짜:

2022-10-28