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

Țară: Australia

Limbă: engleză

Sursă: Department of Health (Therapeutic Goods Administration)

Ingredient activ:

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

Disponibil de la:

Orion Pharma (AUS) Pty Limited

Forma farmaceutică:

Inhalation, powder for

Compoziție:

Excipient Ingredients: lactose monohydrate

Calea de administrare:

Inhalation

Unități în pachet:

60 inhalations

Tip de prescriptie medicala:

(S4) Prescription Only Medicine

Indicații terapeutice:

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.

Rezumat produs:

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

Statutul autorizaţiei:

Registered

Data de autorizare:

2022-10-28