Riik: Singapur
keel: inglise
Allikas: HSA (Health Sciences Authority)
BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE
ASTRAZENECA SINGAPORE PTE LTD
R03AK07
160 mcg/dose
POWDER, METERED
BUDESONIDE 160 mcg/dose; FORMOTEROL FUMARATE DIHYDRATE 4.5 mcg/dose
RESPIRATORY (INHALATION)
Prescription Only
ASTRAZENECA AB
ACTIVE
2001-09-24
1(17) PROPOSED PACKAGE INSERT - CLEAN SYMBICORT TURBUHALER 160/4.5 G/DOSE _Budesonide/Formoterol _ INHALATION POWDER COMPOSITION Each delivered dose (the dose that leaves the mouthpiece) contains: budesonide 160 micrograms/inhalation and formoterol fumarate dihydrate 4.5 micrograms/inhalation. Symbicort Turbuhaler 160/4.5 micrograms/inhalation delivers the same amount of budesonide and formoterol as the corresponding Turbuhaler monoproducts, i.e. budesonide 200 micrograms/inhalation (metered dose) and formoterol 6 micrograms/inhalation (metered dose) alternatively labelled as 4.5 micrograms/inhalation (delivered dose). Excipient: Lactose monohydrate 730 micrograms per dose. THERAPEUTIC INDICATIONS ASTHMA Symbicort is indicated in the regular treatment of asthma where use of a combination (inhaled corticosteroid and long acting beta-agonist) is appropriate: - patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short acting beta 2 -agonists or - patients already adequately controlled on both inhaled corticosteroids and long acting beta 2 -agonists. COPD Symptomatic treatment of patients with severe COPD (FEV1<50% predicted normal) and a history of repeated exacerbations, who have significant symptoms despite regular therapy with long-acting bronchodilators. POSOLOGY AND METHOD OF ADMINISTRATION_ _ ASTHMA Symbicort is not intended for the initial management of asthma. The dosage of the components of Symbicort is individual and should be adjusted to the severity of the disease. This should be considered not only when treatment with combination products is initiated but also when the maintenance dose is adjusted. If an individual patient should require a combination of doses other than those available in the combination inhaler, appropriate doses of beta 2 -agonists and/or corticosteroids by Lugege kogu dokumenti
1 SYMBICORT TURBUHALER ® (BUDESONIDE/FORMOTEROL FUMARATE DIHYDRATE) 1. NAME OF THE MEDICINAL PRODUCT Symbicort Turbuhaler 80/4.5, 160/4.5 and 320/9 µg/dose _budesonide/formoterol _ Inhalation powder 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each delivered dose (the dose that leaves the mouthpiece) contains: budesonide 80 or 160 or 320 micrograms/inhalation and formoterol fumarate dihydrate 4.5 or 9 micrograms/inhalation. Symbicort Turbuhaler 80/4.5 micrograms/inhalation delivers the same amount of budesonide and formoterol as the corresponding Turbuhaler monoproducts, i.e. budesonide 100 micrograms/inhalation (metered dose) and formoterol 6 micrograms/inhalation (metered dose) alternatively labelled as 4.5 micrograms/inhalation (delivered dose). Excipient: Lactose monohydrate 810 micrograms per dose. Symbicort Turbuhaler 160/4.5 micrograms/inhalation delivers the same amount of budesonide and formoterol as the corresponding Turbuhaler monoproducts, i.e. budesonide 200 micrograms/inhalation (metered dose) and formoterol 6 micrograms/inhalation (metered dose) alternatively labelled as 4.5 micrograms/inhalation (delivered dose). Excipient: Lactose monohydrate 730 micrograms per dose. Symbicort Turbuhaler 320/9 micrograms/inhalation delivers the same amount of budesonide and formoterol as the corresponding Turbuhaler monoproducts, i.e. budesonide 400 micrograms/inhalation (metered dose) and formoterol 12 micrograms/inhalation (metered dose) alternatively labelled as 9 micrograms/inhalation (delivered dose). Excipient: Lactose monohydrate 491 micrograms per dose. Formoterol fumarate dihydrate is hereafter referred to as “formoterol”. 3. PHARMACEUTICAL FORM Inhalation powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS TABLE 1. THERAPEUTIC INDICATIONS SYMBICORT TURBUHALER 80/4.5 ΜG/DOSE SYMBICORT TURBUHALER 160/4.5 ΜG/DOSE SYMBICORT TURBUHALER 320/9 ΜG/DOSE Asthma Symbicort is indicated in the regular treatment of Symbicort Turbuhaler is indicated in the Symbicort is indicated in the regular treatmen Lugege kogu dokumenti