Land: Australien
Sprog: engelsk
Kilde: Department of Health (Therapeutic Goods Administration)
beclometasone dipropionate, Quantity: 200 microgram; formoterol fumarate dihydrate, Quantity: 6 microgram
Chiesi Australia Pty Ltd
Inhalation, pressurised
Excipient Ingredients: norflurane; ethanol absolute; hydrochloric acid
Inhalation
Each pressurised container provides 120 actuations. Pack size is 1 x 120 actuations or 2 x 120 actuations
(S4) Prescription Only Medicine
Asthma FOSTAIR is indicated in adults (18 years and older) in the treatment of asthma where use of a combination product (inhaled corticosteroid and long-acting beta2-agonist) is appropriate: - patients not adequately controlled with inhaled corticosteroids (ICS) and 'as needed' inhaled rapid-acting beta2-agonist or - patients already adequately controlled on both ICS and long-acting beta2-agonists (LABA). (See section 4.2 DOSE AND METHOD OF ADMINISTRATION for treatment approaches).
Visual Identification: An aluminium canister with metering valve and light purplish-red polypropylene actuator with a dark green cap and a dose counter or dose indicator; Container Type: Aerosol - Pump Actuated Metered Dose; Container Material: PP/Al; Container Life Time: 17 Months; Container Temperature: Store at 2 to 8 degrees Celsius
Registered
2022-08-05
FOSTAIR CMI V3.0 1 FOSTAIR ® 100/6 AND 200/6 _Beclometasone dipropionate 100 or 200 micrograms and formoterol (eformoterol) fumarate dihydrate _ _6 micrograms pressurised inhalation solution _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some of the more common questions about FOSTAIR. 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 being given this medicine 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 FOSTAIR IS USED FOR FOSTAIR is a pressurised metered dose inhaler containing two active substances which are inhaled through your mouth and delivered directly into your lungs. The two active substances are beclometasone dipropionate and formoterol (eformoterol) fumarate dihydrate. Beclometasone dipropionate is a corticosteroid, a medicine used to treat swelling and irritation in your lungs. Formoterol (eformoterol) fumarate dihydrate is a long-acting bronchodilator, a medicine which relaxes the muscles in your airways and helps you to breathe more easily. Together these two active substances make breathing easier, by providing relief from symptoms such as shortness of breath, wheezing and cough in patients with asthma or Chronic Obstructive Pulmonary Diseases (COPD). They can also help to prevent the symptoms of asthma. ASTHMA FOSTAIR used for the treatment of asthma in adult patients in whom: • asthma is not adequately controlled by using inhaled corticosteroids and “as needed” short-acting bronchodilators or • asthma is responding well to treatment with both corticosteroids and long-acting bronchodilators. COPD (FOSTAIR 100/6 ONLY) FOSTAIR 100/6 can also be used to treat the symptoms of severe COPD in adult patients. COPD is a long- term disease of the a Læs hele dokumentet
FOSTAIR PI v6.0 1 AUSTRALIAN PRODUCT INFORMATION - FOSTAIR (BECLOMETASONE DIPROPIONATE AND FORMOTEROL (EFORMOTEROL) FUMARATE DIHYDRATE) PRESSURISED INHALATION SOLUTION 1. NAME OF THE MEDICINE Beclometasone dipropionate and formoterol (eformoterol) fumarate dihydrate. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION FOSTAIR is a pressurised metered dose inhaler (pMDI). FOSTAIR 100/6 Each metered dose (the dose leaving the valve) contains 100 micrograms of beclometasone dipropionate and 6 micrograms of formoterol fumarate dihydrate. Each delivered dose (the dose leaving the mouthpiece) contains 84.6 micrograms of beclometasone dipropionate and 5.0 micrograms of formoterol fumarate dihydrate. FOSTAIR 200/6 Each metered dose (the dose leaving the valve) contains 200 micrograms of beclometasone dipropionate and 6 micrograms of formoterol fumarate dihydrate. Each delivered dose (the dose leaving the mouthpiece) contains 177.7 micrograms of beclometasone dipropionate and 5.1 micrograms of formoterol fumarate dihydrate. Excipient with known effect: ethanol absolute. For the full list of excipients see section 6.1 LIST OF EXCIPIENTS. 3. PHARMACEUTICAL FORM Pressurised inhalation solution. Colourless to yellowish solution. The inhalation solution is contained in a pressurised aluminium container sealed with a metering valve. The canister is inserted into a polypropylene plastic actuator which incorporates a mouthpiece and is fitted with a plastic protective cap. The actuator is light purplish-red with a dark purplish-red cap (FOSTAIR 100/6) or dark green cap (FOSTAIR 200/6). The actuator has a dose counter. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ASTHMA FOSTAIR is indicated in adults (18 years and older) in the treatment of asthma where use of a combination product (inhaled corticosteroid and long-acting beta 2 -agonist) is appropriate: FOSTAIR PI v6.0 2 - patients not adequately controlled with inhaled corticosteroids (ICS) and 'as needed' inhaled rapid-acting beta 2 -agonist or - patients already adequately contro Læs hele dokumentet