Χώρα: Νέα Ζηλανδία
Γλώσσα: Αγγλικά
Πηγή: Medsafe (Medicines Safety Authority)
Fluticasone propionate 8mg equivalent to 50 µg/dose; ; Salmeterol xinafoate 5.8mg equivalent to 25 µg/dose salmeterol;
GlaxoSmithKline NZ Limited
Fluticasone propionate 8 mg (equivalent to 50 µg/dose)
50µg/25µg
Aerosol inhaler, metered dose
Active: Fluticasone propionate 8mg equivalent to 50 µg/dose Salmeterol xinafoate 5.8mg equivalent to 25 µg/dose salmeterol Excipient: Norflurane
Inhaler, metered, Sample pack, with actuation counter, 28 dose units
Prescription
Prescription
Glaxo Wellcome Manufacturing Pte Ltd
SERETIDE is indicated in the regular treatment of reversible obstructive airways disease (ROAD), including asthma in children and adults, where use of a combination (bronchodilator and inhaled corticosteroid) is appropriate. This may include: Patients on effective maintenance doses of long-acting ?-agonists and inhaled corticosteroids. Patients who are symptomatic on current inhaled corticosteroid therapy. Patients who are symptomatic on "as needed" short-acting betaagonists, as an alternative to initiation of maintenance therapy with moderate or high doses of inhaled corticosteroid alone.
Package - Contents - Shelf Life: Inhaler, metered, Sample pack, with actuation counter - 28 dose units - 24 months from date of manufacture stored at or below 30°C - Inhaler, metered, with actuation counter - 120 dose units - 24 months from date of manufacture stored at or below 30°C
2000-02-23
SERETIDE ® 1 SERETIDE _Fluticasone propionate/Salmeterol xinafoate _ NEW ZEALAND CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you start using SERETIDE. This leaflet answers some common questions about SERETIDE. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking SERETIDE against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT SERETIDE IS USED FOR SERETIDE is available as a dry powder device called an ACCUHALER and a Metered Dose Inhaler (MDI) also known as an" inhaler". • SERETIDE ACCUHALER: 100/50, 250/50 • SERETIDE MDI: 50/25, 125/25, 250/25 SERETIDE is used to help with asthma and chronic obstructive pulmonary disease (COPD) in people who need regular treatment. Asthma is a condition affecting the lungs. Symptoms of asthma include shortness of breath, wheezing, chest tightness and cough. Two main causes of asthma symptoms are bronchoconstriction (tightening of the muscle surrounding the airways) and inflammation (swelling and irritation of the airways). Chronic obstructive pulmonary disease (COPD) is a long-term condition affecting the lungs, resulting from chronic bronchitis or emphysema. Symptoms of COPD include shortness of breath, cough, chest discomfort and coughing up phlegm. The COPD symptoms are mainly due to bronchoconstriction (tightening of the muscle surrounding the airways) and inflammation (swelling and irritation of the airways). SERETIDE contains two medicines, fluticasone propionate and salmeterol xinafoate. Fluticasone propionate belongs to a group of medicines known as corticosteroids, frequently called 'steroids'. They are not 'anabolic steroids' which are the steroids sometimes misused by athletes. Corticosteroids have an anti-inf Διαβάστε το πλήρες έγγραφο
1 NEW ZEALAND DATA SHEET 1. PRODUCT NAME SERETIDE Inhaler (with counter), 25 mcg/50 mcg, aerosol inhaler, metered dose SERETIDE Inhaler (with counter), 25 mcg/125 mcg, aerosol inhaler, metered dose SERETIDE Inhaler (with counter), 25 mcg/250 mcg, aerosol inhaler, metered dose 2. QUALITATIVE AND QUANTITATIVE COMPOSITION SERETIDE Inhaler 25 mcg/50 mcg: Each single actuation provides salmeterol xinafoate equivalent to 25 micrograms of salmeterol and 50 micrograms of fluticasone propionate. SERETIDE Inhaler 25 mcg/125 mcg: Each single actuation provides salmeterol xinafoate equivalent to 25 micrograms of salmeterol and 125 micrograms of fluticasone propionate. SERETIDE Inhaler 25 mcg/250 mcg: Each single actuation provides salmeterol xinafoate equivalent to 25 micrograms of salmeterol and 250 micrograms of fluticasone propionate. For the full list of excipients, see Section 6.1 List of excipients 3. PHARMACEUTICAL FORM Aerosol inhaler, metered dose. The canisters are fitted into plastic actuators incorporating an atomising orifice and fitted with dustcaps. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Asthma: SERETIDE is indicated for the regular treatment of asthma (Reversible Obstructive Airways Disease) in adults, adolescents and children aged 4 years and over, where use of a combination product (bronchodilator and inhaled corticosteroid) is appropriate. This may include: • Patients on effective maintenance doses of both long-acting beta-agonists and inhaled corticosteroids using separate products._ _ • Patients who are not adequately controlled on current inhaled corticosteroid therapy. 2 • Patients who are not adequately controlled on “as needed” short-acting beta- agonists, as an alternative to initiation of maintenance therapy with moderate or high doses of inhaled corticosteroid alone. SERETIDE should not typically be used for the initial management of asthma, unless symptoms are severely uncontrolled, nor in patients whose asthma can be managed by occasional use of short-acting beta-2 agonist Διαβάστε το πλήρες έγγραφο