États-Unis - anglais - 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 (ie, 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

États-Unis - anglais - NLM (National Library of Medicine)

alvogen, 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. 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 (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 insuffici

États-Unis - anglais - NLM (National Library of Medicine)

teva pharmaceuticals usa, 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. 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 (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)]. limited published studies report on the use of budesonide in pregnant women; however, the data are insufficient to inform a

États-Unis - anglais - NLM (National Library of Medicine)

lake erie medical dba quality care products llc - 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. 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 (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 insufficien

États-Unis - anglais - NLM (National Library of Medicine)

teva pharmaceuticals usa, 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: - 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) ]. 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, wa

États-Unis - anglais - NLM (National Library of Medicine)

versapharm incorporated - desonide (unii: j280872d1o) (desonide - unii:j280872d1o) - desonide 0.5 mg in 1 g - desonide ointment, 0.05% is a low potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. it should not be used for longer than two weeks unless directed by a physician. desonide ointment, 0.05% is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

États-Unis - anglais - NLM (National Library of Medicine)

rebel distributors corp - desonide (unii: j280872d1o) (desonide - unii:j280872d1o) - desonide 0.5 mg in 1 g - desonide cream, 0.05% is a low potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. it should not be used for longer than two weeks unless directed by a physician. desonide cream, 0.05% is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

États-Unis - anglais - NLM (National Library of Medicine)

proficient rx lp - desonide (unii: j280872d1o) (desonide - unii:j280872d1o) - desonide 0.5 mg in 1 g - desonide cream and lotion are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations.

États-Unis - anglais - NLM (National Library of Medicine)

cosette pharmaceuticals, inc. - desonide (unii: j280872d1o) (desonide - unii:j280872d1o) - desonide 0.5 mg in 1 g - desonide cream, 0.05% is a low potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. it should not be used for longer than two weeks unless directed by a physician. desonide cream, 0.5% is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation. safety and effectiveness in pediatric patients have not been established. because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of hpa axis suppression and cushing’s syndrome when they are treated with topical corticosteroids. they are therefore also at greater risk of adrenal insufficiency during or after withdrawal of treatment. adverse effects including striae have been reported with inappropriate use of topical corticosteroids in infants and children. hpa axis suppression, cushing’s syndrome, linear growth retardation

États-Unis - anglais - NLM (National Library of Medicine)

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