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

amneal pharmaceuticals llc - 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)] .  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)

zydus pharmaceuticals usa inc. - budesonide (unii: q3oks62q6x) (budesonide - unii:q3oks62q6x) - budesonide 3 mg - budesonide delayed-release 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 delayed-release 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

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

mylan institutional 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 preg

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

northstar rxllc - budesonide (unii: q3oks62q6x) (budesonide - unii:q3oks62q6x) - 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,

Israel - English - Ministry of Health

abic marketing ltd, israel - budesonide - suspension for inhalation - budesonide 0.25 mg / 1 ml - budesonide - budesonide - bronchial asthma especially in cases where other therapy is insufficient or insuitable.

Israel - English - Ministry of Health

abic marketing ltd, israel - budesonide - suspension for inhalation - budesonide 0.5 mg / 1 ml - budesonide - budesonide - bronchial asthma especially in cases where other therapy is insufficient of unsuitable.

Malta - English - Medicines Authority

kleva s.a. 189 parnithos avenue, 13671 acharnai, attiki, greece - budesonide - nasal spray, suspension - budesonide 100 µg - nasal preparations

Malta - English - Medicines Authority

teva pharma b.v. swensweg 5, 2031 ga haarlem, netherlands - budesonide - nebuliser suspension - budesonide 0.25 mg - drugs for obstructive airway diseases

Malta - English - Medicines Authority

teva pharma b.v. swensweg 5, 2031 ga haarlem, netherlands - budesonide - nebuliser suspension - budesonide 0.5 mg - drugs for obstructive airway diseases

Malta - English - Medicines Authority

teva pharma b.v. swensweg 5, 2031 ga haarlem, netherlands - budesonide - nebuliser suspension - budesonide 1 mg - drugs for obstructive airway diseases