Țară: Singapore
Limbă: engleză
Sursă: HSA (Health Sciences Authority)
Beclometasone dipropionate anhydrous (micronized); Formoterol fumarate dihydrate (micronized)
ORIENT EUROPHARMA PTE LTD
R03AK08
POWDER, METERED
Beclometasone dipropionate anhydrous (micronized) 100mcg/dose; Formoterol fumarate dihydrate (micronized) 6mcg/dose
RESPIRATORY (INHALATION)
Prescription Only
Chiesi Farmaceutici SpA
ACTIVE
2017-09-19
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Foster NEXThaler 100 micrograms/6 micrograms per dose inhalation powder. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each metered dose of 10 mg inhalation powder contains: 100 micrograms of beclometasone dipropionate anhydrous and 6 micrograms of formoterol fumarate dihydrate. This is equivalent to a delivered dose (the dose leaving the mouthpiece) of 81.9 micrograms of beclometasone dipropionate anhydrous and 5.0 micrograms of formoterol fumarate dihydrate. Excipients with known effect: Each inhalation contains 9.9 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Inhalation powder. The multidose inhaler contains a white or almost white powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ASTHMA Foster NEXThaler is indicated in the regular treatment of asthma where use of a combination product (inhaled corticosteroid and long-acting beta 2 -agonist) is appropriate: - patients not adequately controlled with inhaled corticosteroids and 'as needed' inhaled short-acting beta 2 -agonist or - patients already adequately controlled on both inhaled corticosteroids and long-acting beta 2 - agonists. Foster NEXThaler is indicated for adult patients. COPD Symptomatic treatment of patients with severe COPD (FEV 1 < 50% predicted normal) and a history of repeated exacerbations, who have significant symptoms despite regular therapy with long-acting bronchodilators. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Foster NEXThaler is for inhalation use. ASTHMA Foster NEXThaler is not intended for the initial management of asthma. The dosage of Foster NEXThaler is individual and should be adjusted to the severity of the disease. This should be considered not only when treatment with combination products is initiated but also when the dose is adjusted. If an individual patient should require a combination of doses other than those available in the combination inhaler, appropriate doses of beta 2 -agonists and/or cor Citiți documentul complet