Страна: Австралія
мова: англійська
Джерело: Department of Health (Therapeutic Goods Administration)
salmeterol xinafoate, Quantity: 72.5 microgram/actuation (Equivalent: salmeterol, Qty 50 microgram/actuation); fluticasone propionate, Quantity: 100 microgram/actuation
GlaxoSmithKline Australia Pty Ltd
fluticasone propionate,Salmeterol xinafoate
Inhalation, powder for
Excipient Ingredients: lactose monohydrate
Oral
28 dose (sample), 60 dose, 28 dose
(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 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 beta-2 agonist bronchodilator therapy. Airzate is not indicated for the initiation of bronchodilator therapy in COPD.
Visual Identification: A two-tone purple, circular device in moulded plastic, approximately 8.5cm in diameter and approximately 3cm high, with a dose counter indicating 28 or 60 doses.; Container Type: Blister Pack; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius
Licence status A
2014-05-07
AIRZATE 1 AIRZATE CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I USING AIRZATE? AIRZATE contains the active ingredients fluticasone propionate and salmeterol xinafoate. AIRZATE is used to help with asthma and chronic obstructive pulmonary disease (COPD) in people who need regular treatment. For more information, see Section 1. Why am I using AIRZATE? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE AIRZATE? Do not use if you have ever had an allergic reaction to any medicine containing fluticasone propionate or salmeterol xinafoate or lactose monohydrate or milk proteins (this applies to ACCUHALER only) or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I use AIRZATE? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with AIRZATE and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE AIRZATE? • Follow dosage directions given to you by your doctor or pharmacist and continue taking it for as long as your doctor tells you. • AIRZATE should be inhaled into your lungs through the mouth, through one of two presentations; the ACCUHALER or the Metered Dose Inhaler (MDI). More instructions can be found in Section 4. How do I use AIRZATE? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING AIRZATE? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are using AIRZATE. • If you are going to have surgery, tell the surgeon or anesthetist that you are taking this medicine. • Tell your doctor if you become, or are trying to become, pregnant. • Tell your doctor if you are using AIRZATE, if you have any blood tests. Прочитайте повний документ