EVOCAIR ACCUHALER 100/50 fluticasone propionate 100 microgram/salmeterol (as xinafoate) 50 microgram powder for inhalation blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

salmeterol xinafoate, Quantity: 72.5 microgram/actuation (Equivalent: salmeterol, Qty 50 microgram/actuation); fluticasone propionate, Quantity: 100 microgram/actuation

Available from:

GlaxoSmithKline Australia Pty Ltd

INN (International Name):

fluticasone propionate,Salmeterol xinafoate

Pharmaceutical form:

Inhalation, powder for

Composition:

Excipient Ingredients: lactose monohydrate

Administration route:

Oral

Units in package:

28 dose, 60 dose, 28 dose (sample)

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

For the regular treatment of asthma, where the use of a combination product is appropriate. This may include:,*Patients on effective maintenance doses of long-acting beta-2-agonists and inhaled corticosteroids.,*Patients who are symptomatic on current inhaled corticosteroid therapy.,*Initiation of maintenance therapy in those patients with moderate persistent asthma not adequately controlled on "as needed" reliever medication, and who have moderate/severe airway limitation and daily symptoms requiring medication every day (see CLINICAL TRIALS).,For the symptomatic treatment of patients with severe COPD (FEV1<50% predicted normal) and a history of repeated exacerbations who have significant symptoms despite regular beta-2 agonist bronchodilator therapy. Evocair is not indicated for the initiation of bronchodilator therapy in COPD.

Product summary:

Visual Identification: A two-tone purple, circular device in moulded plastic, approximately 8.5cm in diameter and approximately 3cm high, with a dose counter indicating 28 or 60 doses.; Container Type: Blister Pack; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2014-05-07