USA - engelsk - NLM (National Library of Medicine)

zydus lifesciences limited - mesalamine (unii: 4q81i59gxc) (mesalamine - unii:4q81i59gxc) - mesalamine 1.2 g - mesalamine delayed-release tablets are indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis and for the maintenance of remission of ulcerative colitis. mesalamine delayed-release tablets are contraindicated in patients with known hypersensitivity to salicylates or aminosalicylates or to any of the ingredients of mesalamine delayed-release tablets [see warnings and precautions (5.3), description (11), adverse reactions (6.2) ]. risk summary published data from meta-analyses, cohort studies, and case series on the use of mesalamine during pregnancy have not reliably informed an association with mesalamine and major birth defects, miscarriage, or adverse maternal or fetal outcomes (see data). there are adverse effects on maternal and fetal outcomes associated with ulcerative colitis in pregnancy (see clinical considerations). in animal reproduction studies, there were no adverse developmental outcomes with administration of oral mesalamine during organogenesis to

USA - engelsk - NLM (National Library of Medicine)

zydus lifesciences limited - mesalamine (unii: 4q81i59gxc) (mesalamine - unii:4q81i59gxc) - mesalamine delayed-release tablets are indicated for the treatment of moderately active ulcerative colitis in adults. limitations of use: safety and effectiveness of mesalamine delayed-release tablets beyond 6 weeks have not been established. mesalamine delayed-release tablets are contraindicated in patients with known or suspected hypersensitivity to salicylates or aminosalicylates or to any of the ingredients of mesalamine delayed-release tablets [see warnings and precautions (5.3), adverse reactions (6.2), and description (11)] . risk summary limited published data on mesalamine use in pregnant women are insufficient to inform a drug-associated risk. no fetal harm was observed in animal reproduction studies of mesalamine in rats and rabbits at oral doses approximately 0.97 times (rat) and 1.95 times (rabbit) the recommended human dose [see data ]. the estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. in the u.s. general population, the estimated back

USA - engelsk - NLM (National Library of Medicine)

zydus lifesciences limited - mesalamine (unii: 4q81i59gxc) (mesalamine - unii:4q81i59gxc) - mesalamine suppositories are indicated in adults for the treatment of mildly to moderately active ulcerative proctitis. mesalamine suppositories are contraindicated in patients with known or suspected hypersensitivity to salicylates or aminosalicylates or to any ingredients in the suppository vehicle [see warnings and precautions (5.3), adverse reactions (6.2), and description (11)] . risk summary limited published data on mesalamine use in pregnant women are insufficient to inform a drug-associated risk. no evidence of teratogenicity was observed in rats or rabbits when treated during gestation with orally administered mesalamine at doses greater than the recommended human intra-rectal dose [see data] . the estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. adverse outcomes in pregnancy occur regardless of the health of the mother or the use of medications. in the u.s. general population, the estimated background risk of major birth defects and miscarri

USA - engelsk - NLM (National Library of Medicine)

allergan, inc. - mesalamine (unii: 4q81i59gxc) (mesalamine - unii:4q81i59gxc) - mesalamine 800 mg - asacol hd is indicated for the treatment of moderately active ulcerative colitis in adults. limitations of use : safety and effectiveness of asacol hd beyond 6 weeks have not been established. asacol hd is contraindicated in patients with known or suspected hypersensitivity to salicylates or aminosalicylates or to any of the ingredients of asacol hd [see warnings and precautions (5.3) , adverse reactions (6.2) , and description (11) ]. risk summary limited published data on mesalamine use in pregnant women are insufficient to inform a drug-associated risk. no fetal harm was observed in animal reproduction studies of mesalamine in rats and rabbits at oral doses approximately 0.97 times (rat) and 1.95 times (rabbit) the recommended human dose ( see data ) . the estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2

USA - engelsk - NLM (National Library of Medicine)

american health packaging - mesalamine (unii: 4q81i59gxc) (mesalamine - unii:4q81i59gxc) - mesalamine 800 mg - mesalamine delayed-release tablets is indicated for the treatment of moderately active ulcerative colitis in adults. limitations of use: safety and effectiveness of mesalamine delayed-release tablets beyond 6 weeks have not been established. mesalamine delayed-release tablets is contraindicated in patients with known or suspected hypersensitivity to salicylates or aminosalicylates or to any of the ingredients of mesalamine delayed-release tablets [see warnings and precautions ( 5.3), adverse reactions ( 6.2), and description ( 11)] . risk summary limited published data on mesalamine use in pregnant women are insufficient to inform a drug-associated risk. no fetal harm was observed in animal reproduction studies of mesalamine in rats and rabbits at oral doses approximately 0.97 times (rat) and 1.95 times (rabbit) the recommended human dose [see data]. the estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. in the u.s. general population, the es

USA - engelsk - NLM (National Library of Medicine)

zydus pharmaceuticals usa inc. - mesalamine (unii: 4q81i59gxc) (mesalamine - unii:4q81i59gxc) - mesalamine 1.2 g - mesalamine delayed-release tablets are indicated for the: - induction and maintenance of remission in adult patients with mildly to moderately active ulcerative colitis. - treatment of mildly to moderately active ulcerative colitis in pediatric patients weighing at least 24 kg. mesalamine delayed-release tablets are contraindicated in patients with known or suspected hypersensitivity to salicylates, aminosalicylates, or to any of the ingredients of mesalamine delayed-release tablets [see warnings and precautions (5.3), adverse reactions (6.2), description (11) ]. risk summary published data from meta-analyses, cohort studies, and case series on the use of mesalamine during pregnancy have not reliably informed an association with mesalamine and major birth defects, miscarriage, or adverse maternal or fetal outcomes (see data). there are adverse effects on maternal and fetal outcomes associated with ulcerative colitis in pregnancy (see clinical considerations). in animal reproduction studies, there were no adv

USA - engelsk - NLM (National Library of Medicine)

zydus pharmaceuticals (usa) inc. - mesalamine (unii: 4q81i59gxc) (mesalamine - unii:4q81i59gxc) - mesalamine 800 mg - mesalamine delayed-release tablets is indicated for the treatment of moderately active ulcerative colitis in adults. limitations of use: safety and effectiveness of mesalamine delayed-release tablets beyond 6 weeks have not been established. mesalamine delayed-release tablets is contraindicated in patients with known or suspected hypersensitivity to salicylates or aminosalicylates or to any of the ingredients of mesalamine delayed-release tablets [see warnings and precautions (5.3), adverse reactions (6.2), and description (11)] . risk summary limited published data on mesalamine use in pregnant women are insufficient to inform a drug-associated risk. no fetal harm was observed in animal reproduction studies of mesalamine in rats and rabbits at oral doses approximately 0.97 times (rat) and 1.95 times (rabbit) the recommended human dose [see data]. the estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. in the u.s. general population, the estimated backgro

USA - engelsk - NLM (National Library of Medicine)

actavis pharma, inc. - mesalamine (unii: 4q81i59gxc) (mesalamine - unii:4q81i59gxc) - mesalamine 1.2 g - mesalamine delayed-release tablets are indicated for the: - induction and maintenance of remission in adult patients with mildly to moderately active ulcerative colitis. - treatment of mildly to moderately active ulcerative colitis in pediatric patients weighing at least 24 kg. mesalamine is contraindicated in patients with known or suspected hypersensitivity to salicylates, aminosalicylates, or to any of the ingredients of mesalamine delayed-release tablets [ see  warnings and precautions (5.3), adverse reactions (6.2), description (11) ]. risk summary published data from meta-analyses, cohort studies, and case series on the use of mesalamine during pregnancy have not reliably informed an association with mesalamine and major birth defects, miscarriage, or adverse maternal or fetal outcomes (see data ). there are adverse effects on maternal and fetal outcomes associated with ulcerative colitis in pregnancy (see clinical considerations) . in animal reproduction studies, there were no adverse developmental out

USA - engelsk - NLM (National Library of Medicine)

takeda pharmaceuticals america, inc. - mesalamine (unii: 4q81i59gxc) (mesalamine - unii:4q81i59gxc) - mesalamine 1.2 g - mesalamine delayed-release tablets are indicated for the: - induction and maintenance of remission in adult patients with mildly to moderately active ulcerative colitis. - treatment of mildly to moderately active ulcerative colitis in pediatric patients weighing at least 24 kg. mesalamine delayed-release tablets are contraindicated in patients with known or suspected hypersensitivity to salicylates, aminosalicylates, or to any of the ingredients of mesalamine delayed-release tablets [see warnings and precautions (5.3), adverse reactions (6.2), description (11)] . risk summary published data from meta-analyses, cohort studies, and case series on the use of mesalamine during pregnancy have not reliably informed an association with mesalamine and major birth defects, miscarriage, or adverse maternal or fetal outcomes (see data ). there are adverse effects on maternal and fetal outcomes associated with ulcerative colitis in pregnancy (see clinical considerations) . in animal reproduction studies, there were no ad

USA - engelsk - NLM (National Library of Medicine)

ani pharmaceuticals, inc. - mesalamine (unii: 4q81i59gxc) (mesalamine - unii:4q81i59gxc) - mesalamine 4 g in 60 ml - mesalamine rectal suspension enema is indicated for the treatment of active mild to moderate distal ulcerative colitis, proctosigmoiditis or proctitis in adults. mesalamine rectal suspension enema is contraindicated in patients with known or suspected hypersensitivity to salicylates, aminosalicylates, sulfites or any other component of this medication.