Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

teva pharma belgium sa-nv - budesonide 0,5 mg - nebuliser suspension - 0,25 mg/ml - budesonide 0.25 mg/ml - budesonide

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

teva pharma belgium sa-nv - budesonide 1 mg - nebuliser suspension - 0,5 mg/ml - budesonide 0.5 mg/ml - budesonide

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

rpk pharmaceuticals, inc. - budesonide (unii: q3oks62q6x) (budesonide - unii:q3oks62q6x), formoterol fumarate (unii: w34shf8j2k) (formoterol - unii:5zz84gcw8b) - budesonide and formoterol fumarate dihydrate inhalation aerosol is indicated for the treatment of asthma in patients 6 years of age and older. budesonide and formoterol fumarate dihydrate inhalation aerosol 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: budesonide and formoterol fumarate dihydrate inhalation aerosol 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. budesonide and formoterol fumarate dihydrate inhalation aerosol 160/4.5 is also indicated to reduce exacerbations of copd. budesonide and formoterol fumarate dihydrate inhalation aerosol 160/4.5 is the only strength indicated for the treatment of copd. important limitat

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

rpk pharmaceuticals, inc. - budesonide (unii: q3oks62q6x) (budesonide - unii:q3oks62q6x), formoterol fumarate (unii: w34shf8j2k) (formoterol - unii:5zz84gcw8b) - budesonide and formoterol fumarate dihydrate inhalation aerosol is indicated for the treatment of asthma in patients 6 years of age and older. budesonide and formoterol fumarate dihydrate inhalation aerosol 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: budesonide and formoterol fumarate dihydrate inhalation aerosol 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. budesonide and formoterol fumarate dihydrate inhalation aerosol 160/4.5 is also indicated to reduce exacerbations of copd. budesonide and formoterol fumarate dihydrate inhalation aerosol 160/4.5 is the only strength indicated for the treatment of copd. important limitat

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

a-s medication solutions - budesonide (unii: q3oks62q6x) (budesonide - unii:q3oks62q6x), formoterol fumarate (unii: w34shf8j2k) (formoterol - unii:5zz84gcw8b) - budesonide and formoterol fumarate dihydrate inhalation aerosol is indicated for the treatment of asthma in patients 6 years of age and older. budesonide and formoterol fumarate dihydrate inhalation aerosol 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: budesonide and formoterol fumarate dihydrate inhalation aerosol 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. budesonide and formoterol fumarate dihydrate inhalation aerosol 160/4.5 is also indicated to reduce exacerbations of copd. budesonide and formoterol fumarate dihydrate inhalation aerosol 160/4.5 is the only strength indicated for the treatment of copd. important limitat

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

a-s medication solutions - budesonide (unii: q3oks62q6x) (budesonide - unii:q3oks62q6x), formoterol fumarate (unii: w34shf8j2k) (formoterol - unii:5zz84gcw8b) - budesonide and formoterol fumarate dihydrate inhalation aerosol is indicated for the treatment of asthma in patients 6 years of age and older. budesonide and formoterol fumarate dihydrate inhalation aerosol 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: budesonide and formoterol fumarate dihydrate inhalation aerosol 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. budesonide and formoterol fumarate dihydrate inhalation aerosol 160/4.5 is also indicated to reduce exacerbations of copd. budesonide and formoterol fumarate dihydrate inhalation aerosol 160/4.5 is the only strength indicated for the treatment of copd. important limitat

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

dr falk pharma australia pty ltd - budesonide, quantity: 2 mg - foam - excipient ingredients: propylene glycol; purified water; emulsifying wax; cetyl alcohol; citric acid monohydrate; disodium edetate; butane; isobutane; propane; steareth-10 - budenofalk foam is indicated in the treatment of active rectal and rectosigmoid disease in ulcerative colitis.

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

dr falk pharma australia pty ltd - budesonide, quantity: 3 mg - capsule, enteric - excipient ingredients: sodium lauryl sulfate; purified talc; lactose monohydrate; ammonio methacrylate copolymer; methacrylic acid copolymer; titanium dioxide; erythrosine; iron oxide red; gelatin; iron oxide black; povidone; triethyl citrate; maize starch; sucrose - budenofalk enteric capsules are indicated for: induction of remission in patients with mild to moderately active crohn's disease affecting the ileum and/or the ascending colon (see clinical trials).

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

bryant ranch prepack - budesonide (unii: q3oks62q6x) (budesonide - unii:q3oks62q6x) - budesonide delayed-release capsules are 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.  budesonide delayed-release capsules are 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.  budesonide delayed-release capsules are contraindicated in patients with hypersensitivity to budesonide or any of the ingredients of budesonide delayed-release capsules. 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

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

ritedose pharmaceuticals, llc - budesonide (unii: q3oks62q6x) (budesonide - unii:q3oks62q6x) - 1.1 maintenance treatment of asthma budesonide inhalation suspension is indicated for the maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age. limitations of use: - budesonide inhalation suspension is not indicated for the relief of acute bronchospasm. the use of budesonide inhalation suspension is contraindicated in the following conditions: - primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required. - hypersensitivity to budesonide or any of the ingredients of budesonide inhalation suspension [see warnings and precautions (5.3), description (11), adverse reactions (6.2)] . 8.1 pregnancy risk summary there are no adequate well-controlled studies of budesonide inhalation suspension in pregnant women. however, there are published studies on the use of budesonide, the active ingredient in budesonide inhalation suspension, in pregnant women. in animal reproduction studies, budesonide, administered by the su