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

golden state medical supply, inc. - budesonide (unii: q3oks62q6x) (budesonide - unii:q3oks62q6x) - budesonide extended-release tablets are indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis. budesonide extended-release tablets are contraindicated in patients with hypersensitivity to budesonide or any of the ingredients of budesonide extended-release tablets. anaphylactic reactions have occurred with other budesonide formulations [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, subcutaneous administration of budesonide during organogenesis at doses 0.5 times and 0.05 times, respectively, the maximum recommended human dose, resulted in increased fetal loss, decreased pup weights, and skeletal abnormalities. maternal toxicity was obs

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

padagis us llc - 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 sub

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

northstar rx llc. - budesonide (unii: q3oks62q6x) (budesonide - unii:q3oks62q6x) - 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)

major pharmaceuticals - 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)

oceanside pharmaceuticals - budesonide (unii: q3oks62q6x) (budesonide - unii:q3oks62q6x) - budesonide rectal foam is indicated for the induction of remission in patients with active mild to moderate distal ulcerative colitis extending up to 40 cm from the anal verge. budesonide rectal foam is contraindicated in patients with a history of a known hypersensitivity to budesonide or any of the ingredients of budesonide rectal foam. reactions have included anaphylaxis [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, subcutaneous administration of budesonide during organogenesis at doses 1.2 times and 0.12 times, respectively, the human intrarectal dose of 4 mg/day, resulted in increased fetal loss, decreased pup weights, and skeletal abnormalities. maternal toxicity was observed in both rats and r

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

bryant ranch prepack - budesonide (unii: q3oks62q6x) (budesonide - unii:q3oks62q6x) - budesonide extended-release tablets are indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis. budesonide extended-release tablets are contraindicated in patients with hypersensitivity to budesonide or any of the ingredients of budesonide extended-release tablets. anaphylactic reactions have occurred with other budesonide formulations [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, subcutaneous administration of budesonide during organogenesis at doses 0.5 times and 0.05 times, respectively, the maximum recommended human dose, resulted in increased fetal loss, decreased pup weights, and skeletal abnormalities. maternal toxicity was observed in both rats a

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

padagis israel pharmaceuticals ltd - budesonide (unii: q3oks62q6x) (budesonide - unii:q3oks62q6x) - budesonide rectal foam is indicated for the induction of remission in patients with active mild to moderate distal ulcerative colitis extending up to 40 cm from the anal verge. budesonide rectal foam is contraindicated in patients with a history of a known hypersensitivity to budesonide or any of the ingredients of budesonide rectal foam. reactions have included anaphylaxis [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, subcutaneous administration of budesonide during organogenesis at doses 1.2 times and 0.12 times, respectively, the human intrarectal dose of 4 mg/day, resulted in increased fetal loss, decreased pup weights, and skeletal abnormalities. maternal toxicity was observed in both rats and ra

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

amerisource bergen - budesonide (unii: q3oks62q6x) (budesonide - unii:q3oks62q6x) - budesonide 32 ug - nasal allergy symptom reliever temporarily relieves these symptoms of hay fever or other upper respiratory allergies: • nasal congestion • runny nose • itchy nose • sneezing

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

apotex corp. - budesonide (unii: q3oks62q6x) (budesonide - unii:q3oks62q6x) - budesonide 32 ug - nasal allergy symptom reliever temporarily relieves these symptoms of hay fever or other upper respiratory allergies: • nasal congestion • runny nose • itchy nose • sneezing

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.