1. Name of the medicinal product
Fostair 100/6 micrograms per actuation pressurised inhalation solution.
2. Qualitative and quantitative composition
Each metered dose (ex-valve) contains:
100 micrograms of beclometasone dipropionate and 6 micrograms of formoterol fumarate dihydrate. This is equivalent to a delivered dose (ex-actuator) of 84.6 micrograms of beclometasone dipropionate and 5.0 micrograms of formoterol fumarate dihydrate.
For the full list of excipients see section 6.1.
3. Pharmaceutical form
Pressurised inhalation solution.
4. Clinical particulars
4.1 Therapeutic indications
Fostair is indicated in the regular treatment of asthma where use of a combination product (inhaled corticosteroid and long-acting beta2-agonist) is appropriate:
- patients not adequately controlled with inhaled corticosteroids and 'as needed' inhaled rapid-acting beta2-agonist or
- patients already adequately controlled on both inhaled corticosteroids and long-acting beta2-agonists.
Symptomatic treatment of patients with severe COPD (FEV1 < 50% predicted normal) and a history of repeated exacerbations, who have significant symptoms despite regular therapy with long-acting bronchodilators.