Land: Australien
Sprog: engelsk
Kilde: Department of Health (Therapeutic Goods Administration)
formoterol fumarate dihydrate, Quantity: 2.25 microgram; budesonide, Quantity: 40 microgram
AstraZeneca Pty Ltd
Budesonide,formoterol (eformoterol)
Inhalation, pressurised
Excipient Ingredients: apaflurane; macrogol 1000; povidone
Inhalation
120 doses, 2 x 120-dose inhalers
(S4) Prescription Only Medicine
Asthma Symbicort Rapihaler is indicated in adults and adolescents (12 years and older), for the treatment of asthma to achieve overall asthma control, including the relief of symptoms and the reduction of the risk of exacerbations (see Section 4.2 Dose and method of administration). Chronic obstructive pulmonary disease (COPD) Symbicort 200/6 is indicated for the symptomatic treatment of moderate to severe COPD (FEV1 < or = 50% predicted normal) in adults with frequent symptoms despite long-acting bronchodilator use, and/or a history of recurrent exacerbations. Symbicort is not indicated for the initiation of bronchodilator therapy in COPD.
Visual Identification: Contents held in metal can fitted with plastic valve. After evaporation of the propellant a residue remains which is free from visible contaminants. The external & internal can and valve surfaces are free from corrosion and significant defects.; Container Type: Inhaler - Metered Dose; Container Material: Other plastic laminate/Al; Container Life Time: 12 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2011-04-20
SYMBICORT RAPIHALER ® _Budesonide and formoterol (eformoterol) fumarate dihydrate_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Symbicort Rapihaler. It does not contain all 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 using Symbicort Rapihaler against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH YOUR SYMBICORT RAPIHALER. You may need to read it again. WHAT SYMBICORT RAPIHALER IS USED FOR? Symbicort Rapihaler is a pressurised metered dose inhaler (pMDI) or puffer. The medicine inside Symbicort Rapihaler is inhaled into the lungs for the treatment of asthma in adults and adolescents (12 years and over) or Chronic Obstructive Pulmonary Disease (COPD) in adults (18 years and over). Symbicort Rapihaler contains two active ingredients in one inhaler: budesonide and formoterol (as formoterol fumarate dihydrate, which was previously known as eformoterol fumarate dihydrate). • Budesonide belongs to a group of medicines called corticosteroids. Budesonide acts directly on your airways to reduce inflammation. • Formoterol belongs to a group of medicines called beta-2-agonists. Formoterol opens up the airways to help you breathe more easily. ASTHMA Asthma is a disease where the airways of the lungs become narrow and inflamed (swollen), making it difficult to breathe. This may for example be due to exercise, or exposure to allergens (eg an allergy to house dust mites, smoke or air pollution), or other things that irritate your lungs. The budesonide in Symbicort Rapihaler helps to improve your condition and to prevent asthma attacks from occurring. The formoterol in Symbicort Rapihaler helps you breathe more easily. Some people can take Symbicort Rapihaler when they need it - They use Symbicort Rapihaler as an anti- inflammatory rel Læs hele dokumentet
1 of 21 AUSTRALIAN PRODUCT INFORMATION SYMBICORT RAPIHALER ® (BUDESONIDE/FORMOTEROL (EFORMOTEROL) FUMARATE DIHYDRATE) PRESSURISED INHALATION 1 NAME OF THE MEDICINE Budesonide Formoterol (eformoterol) fumarate dihydrate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Symbicort Rapihaler is a pressurised metered dose inhaler (pMDI). For ease of reference, formoterol, formoterol fumarate or formoterol fumarate dihydrate have been used throughout the rest of this document. The following strengths are registered: • _Symbicort Rapihaler 50/3: _ Each delivered dose (the dose that leaves the mouthpiece) contains as active constituents: budesonide 40 μg/inhalation and formoterol 2.25 μg/inhalation. • _Symbicort Rapihaler 100/3: _ Each delivered dose (the dose that leaves the mouthpiece) contains as active constituents: budesonide 80 μg/inhalation and formoterol 2.25 μg/inhalation. • _Symbicort Rapihaler 100/6**: _ Each delivered dose (the dose that leaves the mouthpiece) contains as active constituents: budesonide 80 μg/inhalation and formoterol 4.5 μg/inhalation. • _Symbicort Rapihaler 200/6: _ Each delivered dose (the dose that leaves the mouthpiece) contains as active constituents: budesonide 160 μg/inhalation and formoterol 4.5 μg/inhalation. To avoid confusion, Symbicort Rapihaler is labelled as metered dose like Symbicort Turbuhaler ® . The following table gives the corresponding dose delivered to the patient. TABLE 1 SYMBICORT RAPIHALER METERED DOSE ( G) CORRESPONDING DOSE DELIVERED TO PATIENT ( G)* BUDESONIDE FORMOTEROL BUDESONIDE FORMOTEROL 50/3 50 3 40 2.25 100/3 100 3 80 2.25 100/6** 100 6 80 4.5 200/6 200 6 160 4.5 _* doses referred to in Symbicort publications _ _** Not supplied in Australia _ For the full list of excipients, see Section 6.1 List of excipients. 2 of 21 3 PHARMACEUTICAL FORM Inhalation, pressurised. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ASTHMA Symbicort Rapihaler is indicated in adults and adolescents (12 years and older), for the treatment of asthma to achiev Læs hele dokumentet