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

מדינה: אוסטרליה

שפה: אנגלית

מקור: Department of Health (Therapeutic Goods Administration)

מרכיב פעיל:

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

זמין מ:

Orion Pharma (AUS) Pty Limited

טופס פרצבטיות:

Inhalation, powder for

הרכב:

Excipient Ingredients: lactose monohydrate

מסלול נתינה (של תרופות):

Inhalation

יחידות באריזה:

60 inhalations

סוג מרשם:

(S4) Prescription Only Medicine

סממני תרפויטית:

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.

leaflet_short:

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

מצב אישור:

Registered

תאריך אישור:

2022-10-28