United States - English - NLM (National Library of Medicine)

astrazeneca pharmaceuticals lp - budesonide (unii: q3oks62q6x) (budesonide - unii:q3oks62q6x), formoterol fumarate (unii: w34shf8j2k) (formoterol - unii:5zz84gcw8b) - budesonide 160 ug - symbicort is indicated for the treatment of asthma in patients 6 years of age and older. symbicort should be used for patients not adequately controlled on a long-term asthma-control medication such as an inhaled corticosteroid (ics) or whose disease warrants initiation of treatment with both an inhaled corticosteroid and long-acting beta2-adrenergic agonist (laba). important limitations of use: symbicort 160/4.5 is indicated for the maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (copd) including chronic bronchitis and/or emphysema. symbicort 160/4.5 is also indicated to reduce exacerbations of copd. symbicort 160/4.5 is the only strength indicated for the treatment of copd. important limitations of use: the use of symbicort is contraindicated in the following conditions: risk summary there are no adequate and well-controlled studies of symbicort or one of its individual components, formoterol fumarate, in pregnant women; however studies are available for t

Australia - English - Department of Health (Therapeutic Goods Administration)

astrazeneca pty ltd - budesonide, quantity: 80 microgram; formoterol fumarate dihydrate, quantity: 2.25 microgram - inhalation, pressurised - excipient ingredients: apaflurane; macrogol 1000; povidone - 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.

Australia - English - Department of Health (Therapeutic Goods Administration)

astrazeneca pty ltd - formoterol fumarate dihydrate, quantity: 2.25 microgram; budesonide, quantity: 40 microgram - inhalation, pressurised - excipient ingredients: apaflurane; macrogol 1000; povidone - 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.

United States - English - NLM (National Library of Medicine)

remedyrepack inc. - budesonide (unii: q3oks62q6x) (budesonide - unii:q3oks62q6x), formoterol fumarate (unii: w34shf8j2k) (formoterol - unii:5zz84gcw8b) - symbicort is indicated for the treatment of asthma in patients 6 years of age and older. symbicort should be used for patients not adequately controlled on a long-term asthma-control medication such as an inhaled corticosteroid (ics) or whose disease warrants initiation of treatment with both an inhaled corticosteroid and long-acting beta2-adrenergic agonist (laba). important limitations of use: - symbicort is not indicated for the relief of acute bronchospasm. symbicort 160/4.5 is indicated for the maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (copd) including chronic bronchitis and/or emphysema. symbicort 160/4.5 is also indicated to reduce exacerbations of copd. symbicort 160/4.5 is the only strength indicated for the treatment of copd. important limitations of use: - symbicort is not indicated for the relief of acute bronchospasm. the use of symbicort is contraindicated in the following conditions: - primary treatment of status asthmaticus or other acu

Israel - English - Ministry of Health

astrazeneca (israel) ltd - budesonide micronized; formoterol fumarate - powder for inhalation - budesonide micronized 160 mcg/dose; formoterol fumarate 4.5 mcg/dose - formoterol and budesonide - formoterol and other drugs for obstructive airway diseases - asthmasymbicort turbuhaler 160/4.5 mcg/dose 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.chronic obstructive pulmonary disease (copd)symbicort turbuhaler 160/4.5 mcg/dose is indicated in adults, aged 18 years and older, for the symptomatic treatment of patients with copd with forced expiratory volume in 1 second (fev1) < 70% predicted normal (post-bronchodilator) and an exacerbation history despite regular bronchodilator therapy.

New Zealand - English - Medsafe (Medicines Safety Authority)

chiesi new zealand limited t/a emerge health - budesonide 3mg - modified release capsule - 3 mg - active: budesonide 3mg excipient: acetyl tributyl citrate ethylcellulose gelatin methacrylic acid - ethyl acrylate copolymer polysorbate 80 purified talc simeticone sugar spheres triethyl citrate - entocort capsules are indicated for the induction of remission in patients with mild to moderate crohn's disease affecting the ileum and/or the ascending colon.

Israel - English - Ministry of Health

astrazeneca (israel) ltd - budesonide micronized; formoterol fumarate - powder for inhalation - budesonide micronized 80 mcg/dose; formoterol fumarate 4.5 mcg/dose - formoterol and budesonide - formoterol and other drugs for obstructive airway diseases - symbicort turbuhaler is indicated in the regular treatment of asthma where use of a combination (inhaled corticosteroid and long acting beta-agonist) is appropriate: - patients not adequaterly controlled with inhaled corticosteroids and " as needed" inhaled short acting beta2- agonists. - or patients already adequately controlled on both inhaled corticosteroids and long acting beta2- agonists. note: symbicort turbuhaler 80/4.5 mcg/dose is not appropriate in patients with severe asthma.

Israel - English - Ministry of Health

astrazeneca (israel) ltd - budesonide micronized; formoterol fumarate - powder for inhalation - budesonide micronized 320 mcg/dose; formoterol fumarate 9 mcg/dose - formoterol and budesonide - formoterol and other drugs for obstructive airway diseases - symbicort turbuhaler 320/9 mcg/dose is indicated in adults and adolescents, age 12 -17 for the regular treatment of asthma where use of a combination (inhaled corticosteroid and long acting β2 adrenoceptor-agonist) is appropriate:-patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short acting β2 adrenoceptor-agonists.or- patients already adequately controlled on both inhaled corticosteroids and long acting β2 adrenoceptoragonists.chronic obstructive pulmonary disease (copd)symbicort turbuhaler 320/9 mcg/dose is indicated in adults, aged 18 years and older, for the symptomatic treatment of patients with copd with forced expiratory volume in i second (fev1) < 70% predicted normal (post-bronchodilator) and an exacerbation history despite regular bronchodilator therapy

United States - English - NLM (National Library of Medicine)

physicians total care, inc. - budesonide (unii: q3oks62q6x) (budesonide - unii:q3oks62q6x) - budesonide 3 mg - entocort ec is indicated for - the treatment of mild to moderate active crohn's disease involving the iluem and/or the ascending colon and - the maintenance of clinical remission of mild to moderate crohn's disease involving the ileum and/or the ascending colon for up to 3 months. the maintenance of clinical remission of mild to moderate crohn's disease involving the ileum and/or the ascending colon for up to 3 months. entocort ec is contraindicated in patients with known hypersensitivity to budesonide.

United States - English - NLM (National Library of Medicine)

padagis us llc - budesonide (unii: q3oks62q6x) (budesonide - unii:q3oks62q6x) - budesonide 3 mg - entocort ec is indicated for the treatment of mild to moderate active crohn's disease involving the ileum and/or the ascending colon in patients 8 years of age and older. entocort ec is indicated for the maintenance of clinical remission of mild to moderate crohn’s disease involving the ileum and/or the ascending colon for up to 3 months in adults. entocort ec is contraindicated in patients with hypersensitivity to budesonide or any of the ingredients of entocort ec. serious hypersensitivity reactions, including anaphylaxis have occurred [see adverse reactions (6.2)] . risk summary limited published studies report on the use of budesonide in pregnant women; however, the data are insufficient to inform a drug-associated risk for major birth defects and miscarriage. there are clinical considerations [see clinical considerations] . in animal reproduction studies with pregnant rats and rabbits, administration of subcutaneous budesonide during organogenesis at doses approximately 0.5 times or 0.05 times, respecti