AIRZATE MDI 125/25 fluticasone propionate 125 mcg/salmeterol (as xinafoate) 25 mcg inhalation pressurised aerosol can metered dose (with counter)
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
07-05-2014
Public Assessment Report
(PAR)
27-11-2017
Send request.
Active ingredient:
fluticasone propionate, Quantity: 125 microgram/actuation; salmeterol xinafoate, Quantity: 36.3 microgram/actuation (Equivalent: salmeterol, Qty 25 microgram/actuation)
Available from:
GlaxoSmithKline Australia Pty Ltd
INN (International Name):
fluticasone propionate,Salmeterol xinafoate
Pharmaceutical form:
Inhalation, pressurised
Composition:
Excipient Ingredients: norflurane
Administration route:
Inhalation
Units in package:
Sample Pack, 120 doses
Prescription type:
(S4) Prescription Only Medicine
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 beta2-agonists and inhaled corticosteroids.,*Patients who are symptomatic on current inhaled corticosteroid therapy.,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.
Product summary:
Visual Identification: Actuator & metal can with concave base fitted with a metering valve and a plastic dose counter. 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
Authorization status:
Licence status A
Authorization date:
2014-05-07
Patient Information leaflet
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.
Read the complete document
