Country: New Zealand
Bahasa: Inggeris
Sumber: Medsafe (Medicines Safety Authority)
Fluticasone propionate 125ug;
GlaxoSmithKline NZ Limited
Fluticasone propionate 125 µg
125 mcg/dose
Aerosol inhaler, metered dose
Active: Fluticasone propionate 125ug Excipient: Norflurane
Inhaler, metered, (not marketed), 60 dose units
Prescription
Prescription
Glaxo Wellcome Manufacturing Pte Ltd
Fluticasone propionate has a marked anti-inflammatory effect in the lungs. It reduces symptoms and exacerbations of asthma in patients previously treated with bronchodilator alone or with other prophylactic therapy. Severe asthma requires regular medical assessment as death may occur. Patients with severe asthma have constant symptoms and frequent exacerbations, with limited physical capacity, and PEF values below 60% predicted at baseline with greater than 30% variability, usually not returning entirely to normal after a bronchodilator. These patients will require high dose inhaled (see dosage instructions) or oral corticosteroid therapy. Sudden worsening of symptoms may require increased corticosteroid dosage which should be administered under urgent medical supervision.
Package - Contents - Shelf Life: Inhaler, metered, - 60 dose units - 24 months from date of manufacture stored Store below 30°C. Protect from frost, avoid storage in direct sunlight or heat - Inhaler, metered, sample pack - 120 dose units - 24 months from date of manufacture stored Store below 30°C. Protect from frost, avoid storage in direct sunlight or heat - Inhaler, metered, - 120 dose units - 24 months from date of manufacture stored Store below 30°C. Protect from frost, avoid storage in direct sunlight or heat
1970-01-01
1 FLIXOTIDE INHALER _Fluticasone propionate (CFC-Free) Inhaler 50, 125 or 250 _ _micrograms _ _per actuation _ _ _ CONSUMER MEDICINE INFORMATION Please read this leaflet carefully before you start using FLIXOTIDE (CFC-free) Inhaler. WHAT IS IN THIS LEAFLET? This leaflet answers some common questions about FLIXOTIDE Inhaler. It does not contain all of 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 using FLIXOTIDE Inhaler against the benefits this medicine is expected to 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 FLIXOTIDE INHALERS (‘PUFFERS’) ARE USED FOR You may know your Inhaler better as a ‘puffer’. FLIXOTIDE puffers contain a medicine called fluticasone propionate. This medicine 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. Your FLIXOTIDE puffer provides a measured amount of steroid for you to breathe into your lungs. By using your FLIXOTIDE puffer regularly every day, the medicine reduces the swelling and irritation in the walls of the small air passages in your lungs. Your FLIXOTIDE puffer contains the type of asthma medicine known as a ‘preventer’. It does not give immediate relief from an asthma attack and may take up to a week to start to work. If your shortness of breath or wheeze does not get better after 7 days, tell your doctor. When used every day, your FLIXOTIDE puffer helps to ease breathing problems and prevent asthma attacks. This medicine is only one part of a general plan to help you manage your asthma. You should discuss this plan with your doctor. You may also be using a ‘reliever puffer’. Keep using it according to your doctor’s advice. Ask your doctor to check your treatment regularly. A Baca dokumen lengkap
1 NEW ZEALAND DATA SHEET 1. PRODUCT NAME FLIXOTIDE Inhaler (CFC-Free) 50 micrograms/dose, aerosol inhaler, metered dose. FLIXOTIDE Inhaler (CFC-Free) 125 micrograms/dose, aerosol inhaler, metered dose. FLIXOTIDE Inhaler (CFC-Free) 250 micrograms/dose, aerosol inhaler, metered dose. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _ _ FLIXOTIDE 50 Inhaler is a pressurised metered-dose inhaler which delivers 50 mcg of fluticasone propionate per actuation into the mouthpiece of a specially designed actuator. FLIXOTIDE 125 Inhaler is a pressurised metered-dose inhaler which delivers 125 mcg of fluticasone propionate per actuation into the mouthpiece of a specially designed actuator. FLIXOTIDE 250 Inhaler is a pressurised metered-dose inhaler which delivers 250 mcg of fluticasone propionate per actuation. For 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 FLIXOTIDE is indicated in adults and children aged from 1 year and above for prophylactic treatment of asthma. Fluticasone propionate has a marked anti-inflammatory effect in the lungs. It reduces symptoms and exacerbations of asthma in patients previously treated with bronchodilator alone or with other prophylactic therapy. Severe asthma requires regular medical assessment as death may occur. Patients with severe asthma have constant symptoms and frequent exacerbations, with limited physical capacity, and PEF values below 60% predicted at baseline with greater than 30% variability, usually not returning entirely to normal after a bronchodilator. These patients will require high dose inhaled (see dosage 2 instructions) or oral corticosteroid therapy. Sudden worsening of symptoms may require increased corticosteroid dosage which should be administered under urgent medical supervision. Adults: _Prophylactic management in: _ - Mild asthma (PE Baca dokumen lengkap