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

Riik: Austraalia

keel: inglise

Allikas: Department of Health (Therapeutic Goods Administration)

Osta kohe

Laadi alla Avaliku hindamisaruande (PAR)
28-10-2022

Toimeaine:

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

Saadav alates:

Orion Pharma (AUS) Pty Limited

Ravimvorm:

Inhalation, powder for

Koostis:

Excipient Ingredients: lactose monohydrate

Manustamisviis:

Inhalation

Ühikuid pakis:

60 inhalations

Retsepti tüüp:

(S4) Prescription Only Medicine

Näidustused:

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.

Toote kokkuvõte:

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

Volitamisolek:

Registered

Loa andmise kuupäev:

2022-10-28