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astrazeneca pharmaceuticals lp - 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)

remedyrepack 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 is not indicated for the relief of acute bronchospasm. 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

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mayne pharma inc. - budesonide (unii: q3oks62q6x) (budesonide - unii:q3oks62q6x) - budesonide 3 mg - budesonide capsules (enteric coated) 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 capsules (enteric coated) 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 capsules (enteric coated) are contraindicated in patients with hypersensitivity to budesonide or any of the ingredients of budesonide capsules (enteric coated). 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)

rising pharmaceuticals, inc. - budesonide (unii: q3oks62q6x) (budesonide - unii:q3oks62q6x) - budesonide 3 mg - budesonide capsules is indicated for the treatment of mild to moderate active crohn's disease involving the ileum and/or the ascending colon. pediatric use information is approved for perrigo pharma international dac’s entocort ec (budesonide) capsules. however, due to perrigo pharma international dac’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. budesonide capsules 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. budesonide capsules is contraindicated in patients with hypersensitivity to budesonide or any of the ingredients of budesonide 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 miscarr

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

mylan pharmaceuticals inc. - budesonide (unii: q3oks62q6x) (budesonide - unii:q3oks62q6x) - budesonide 3 mg - 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) ]. 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 bu

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

golden state medical supply, inc. - budesonide (unii: q3oks62q6x) (budesonide - unii:q3oks62q6x) - budesonide 3 mg - 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) ]. 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 rep

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apotex corp. - budesonide (unii: q3oks62q6x) (budesonide - unii:q3oks62q6x) - budesonide 32 ug - budesonide nasal spray is indicated for the treatment of nasal symptoms of seasonal or perennial allergic rhinitis in adults and children six years of age and older. budesonide nasal spray is contraindicated in patients with hypersensitivity to any of its ingredients [see warnings and precautions (5.2) ]. teratogenic effects: pregnancy category b. the impact of budesonide on human pregnancy outcomes has been evaluated through assessments of birth registries linked with maternal usage of inhaled budesonide (i.e., pulmicort turbuhaler) and intranasally administered budesonide (i.e., budesonide nasal spray). the results from population-based prospective cohort epidemiological studies reviewing data from three swedish registries covering approximately 99% of the pregnancies from 1995- 2001 (i.e., swedish medical birth registry; registry of congenital malformations; child cardiology registry) indicate no increased risk for overall congenital malformations from the use of inhaled or intranasal budesonide during ea

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

preferred pharmaceuticals inc. - budesonide (unii: q3oks62q6x) (budesonide - unii:q3oks62q6x) - budesonide 0.5 mg in 2 ml - budesonide inhalation suspension is indicated for the maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age. important 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: pregnancy category b studies of pregnant women, have not shown that inhaled budesonide increases the risk of abnormalities when administered during pregnancy. the results from a large population-based prospective cohort epidemiological study reviewing data from three swedish registries covering approximately 99% of the pregnancies from 1995 to 1997 (i.e., swedish medical birth registry; registry of congenital malformations; child cardiology registry) indicate no increased risk for congenital malformations from the use of inhaled budesonide during early pregnancy. congenital malformations were studied in 2014 infants born to mothers reporting the use

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sandoz inc - budesonide (unii: q3oks62q6x) (budesonide - unii:q3oks62q6x) - budesonide 0.25 mg in 2 ml - 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: 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 subcutaneous route, caused structural abnormalities, was embryocidal, and reduced fetal weights in rats and rabbits at less than the maximum recommended human daily inhalation dose (mrhdid), but these effects were not seen in rats that received inhaled doses approximately 2 times the mrhdid (see data) . studies of pregnant women have not show

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

preferred pharmaceuticals inc. - budesonide (unii: q3oks62q6x) (budesonide - unii:q3oks62q6x) - budesonide 0.5 mg in 2 ml - budesonide inhalation suspension is indicated for the maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age. important limitations of use: the use of budesonide inhalation suspension is contraindicated in the following conditions: teratogenic effects: pregnancy category b studies of pregnant women, have not shown that inhaled budesonide increases the risk of abnormalities when administered during pregnancy. the results from a large population-based prospective cohort epidemiological study reviewing data from three swedish registries covering approximately 99% of the pregnancies from 1995 to 1997 (i.e., swedish medical birth registry; registry of congenital malformations; child cardiology registry) indicate no increased risk for congenital malformations from the use of inhaled budesonide during early pregnancy. congenital malformations were studied in 2014 infants born to mothers reporting the use of inhaled budesonide for asthma in early pregnancy (usually 10 to 1