Nazione: Australia
Lingua: inglese
Fonte: Department of Health (Therapeutic Goods Administration)
fluticasone propionate, Quantity: 50 microgram/actuation; salmeterol xinafoate, Quantity: 36.3 microgram/actuation (Equivalent: salmeterol, Qty 25 microgram/actuation)
GlaxoSmithKline Australia Pty Ltd
fluticasone propionate,Salmeterol xinafoate
Inhalation, pressurised
Excipient Ingredients: norflurane
Inhalation
120 doses
(S4) Prescription Only Medicine
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 CLNICAL 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. Pavtide is not indicated for the initiation of bronchodilator therapy in COPD.
Visual Identification: Actuator & metal can with concave base fitted with a metering valve. The canister contains a white to off-white suspension. The internal surfaces of the can & the valve are free from obvious defects.; Container Type: Aerosol Can - Metered Dose; Container Material: Al; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
1 AUSTRALIAN PRODUCT INFORMATION PAVTIDE (FLUTICASONE PROPIONATE/ SALMETEROL XINAFOATE) ACCUHALER AND MDI 1 NAME OF THE MEDICINE Fluticasone propionate/ salmeterol xinafoate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION PAVTIDE ACCUHALER: Each a foil strip contains regularly placed blisters each containing 100, 250 or 500 micrograms of fluticasone propionate and 50 micrograms of salmeterol (as xinafoate). PAVTIDE metered dose inhaler (MDI): Each single actuation provides 50, 125 or 250 micrograms of fluticasone propionate and 25 micrograms of salmeterol (as xinafoate). LIST OF EXCIPIENTS WITH KNOWN EFFECT PAVTIDE ACCUHALER also contains the excipient lactose monohydrate (which contains milk protein) (see Section 4.3 CONTRAINDICATIONS). For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM PAVTIDE ACCUHALER: Powder for inhalation PAVTIDE MDI: Pressurised inhalation 4 CLINICAL PARTICULARS 4.1 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 reliever medication every day (see Section 5.1 PHARMACODYNAMIC PROPERTIES, 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 2 beta-2 agonist bronchodilator therapy. PAVTIDE is not indicated for the initiation of bronchodilator therapy in COPD. 4.2 DOSE AND METHOD OF ADMINISTRATION PAVTIDE ACCUHALER and MDI are for inhalation only. PAVTIDE ACCUHALER and MDI must be used regularly for optimum benefit, even when asymptomatic. Leggi il documento completo