Země: Austrálie
Jazyk: angličtina
Zdroj: Department of Health (Therapeutic Goods Administration)
beclometasone dipropionate, Quantity: 100 microgram; formoterol fumarate dihydrate, Quantity: 6 microgram
Chiesi Australia Pty Ltd
Inhalation, pressurised
Excipient Ingredients: norflurane; ethanol absolute; hydrochloric acid
Inhalation
1 x 120 actuations 1 x180 actuations 2 x120 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). COPD (FOSTAIR 100/6 only) Symptomatic treatment of adults with severe COPD (FEV1 less than 50% predicted normal) and a history of repeated exacerbations, who have significant symptoms despite regular therapy with long-acting bronchodilators.
Visual Identification: An aluminium canister with metering valve and light purplish-red polypropylene actuator with a dark purplish-red 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
2020-02-12
FOSTAIR AU CMI v2.0 1 FOSTAIR ® _Beclomethasone dipropionate and formoterol (eformoterol) fumarate dihydrate _ _(100/6 micrograms per spray) 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 of the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have benefits and risks. 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, YOU MAY NEED TO READ IT AGAIN. WHAT FOSTAIR IS USED FOR FOSTAIR is an 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, redness or pain.in your lungs. Formoterol 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 COPD and also help to prevent the symptoms of asthma. Asthma FOSTAIR is indicated in the treatment of asthma in adult patients (18 years and older) 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 can also be used to treat the symptoms of severe chronic obstructive pulmonary disease (COPD) in adult patients. COPD is a long-term disease of the airways in the lungs which is primarily caused by cigarette smoking. ASK YOUR Přečtěte si celý dokument
FOSTAIR Product Information FOSTAIR AU PI v4.0 1 AUSTRALIAN PRODUCT INFORMATION - FOSTAIR 100/6 (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). Each metered dose (ex-valve) contains: 100 micrograms of beclometasone dipropionate and 6 micrograms of formoterol fumarate dihydrate. This is equivalent to a delivered dose (ex-actuator) of 84.6 micrograms of beclometasone dipropionate and 5.0 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. 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: - patients not adequately controlled with inhaled corticosteroids (ICS) and 'as needed' inhaled rapid-acting beta 2 -agonist or - patients already adequately controlled on both ICS and long-acting beta 2 -agonists (LABA). (see section 4.2 DOSE AND METHOD OF ADMINISTRATION for treatment approaches). COPD Symptomatic treatment of adults with severe COPD (FEV 1 < 50% predicted normal) and a history of repeated exacerbations, who have significant symptoms despite regular therapy with long-acting bronchodilators. 4.2 DOSE AND METHOD OF ADMINISTRATION FOSTAIR is Přečtěte si celý dokument