Ülke: Avustralya
Dil: İngilizce
Kaynak: Department of Health (Therapeutic Goods Administration)
budesonide, Quantity: 80 microgram; formoterol fumarate dihydrate, Quantity: 4.5 microgram
AstraZeneca Pty Ltd
Budesonide,formoterol (eformoterol)
Inhalation, pressurised
Excipient Ingredients: povidone; macrogol 1000; apaflurane
Inhalation
120 doses, 2 x 120 doses
(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 in metal can with plastic valve & actuation counter. After evaporation of the propellant the residue is free from visible contaminants. The external & internal can & 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
Licence status A
2006-02-22
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 Belgenin tamamını okuyun