Ország: Írország
Nyelv: angol
Forrás: HPRA (Health Products Regulatory Authority)
SALMETEROL XINAFOATE
Profind Wholesale Ltd.
25 Base Micrograms
Pressurised Inhalation Suspension
2011-12-09
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Serevent Evohaler 25 micrograms per actuation pressurised inhalation suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One metered dose (ex-valve) contains 25 micrograms salmeterol (as xinafoate). This is equivalent to a delivered dose (ex-actuator) of 21 micrograms salmeterol (as xinafoate). For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Pressurised inhalation suspension _Product imported from Italy:_ White to off white suspension sealed in an aluminium canister in a green actuator. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Regular symptomatic add-on treatment of reversible airways obstruction in patients with asthma, including those with nocturnal asthma, who are inadequately controlled on inhaled corticosteroids in accordance with current treatment guidelines. Treatment of chronic obstructive pulmonary disease (COPD). Prevention of exercise-induced asthma. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Serevent Evohaler is for inhalation use only. Serevent Evohaler should be used regularly. The full benefits of treatment will be apparent after several doses of the medicinal product. As there may be adverse reactions associated with excessive dosing with this class of medicinal product, the dosage or frequency of administration should only be increased on medical advice. Recommended Doses: ASTHMA _Adults and adolescents 12 years and older:_ Two actuations of 25 micrograms salmeterol twice daily. Two actuations of 25 micrograms salmeterol twice daily. Serevent Evohaler is not recommended for use in children below four years of age due to insufficient data on safety and efficacy. In asthma patients with more severe airways obstruction up to four inhalations of 25 micrograms of salmeterol twice Olvassa el a teljes dokumentumot