アメリカ合衆国 - 英語 - NLM (National Library of Medicine)

avkare, inc. - darifenacin hydrobromide (unii: cr02eyq8gv) (darifenacin - unii:apg9819vlm) - darifenacin 7.5 mg - darifenacin hydrobromide extended-release tablets are a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency. darifenacin hydrobromide extended-release tablets are contraindicated in patients with, or at risk for, the following conditions: - urinary retention - gastric retention, or - uncontrolled narrow-angle glaucoma. pregnancy category c there are no studies of darifenacin in pregnant women. darifenacin was not teratogenic in rats and rabbits at plasma exposures of free drug (via auc) up to 59 times and 28 times, respectively (doses up to 50 and 30 mg/kg/day, respectively) the maximum recommended human dose [mrhd] of 15 mg. at approximately 59 times the mrhd in rats, there was a delay in the ossification of the sacral and caudal vertebrae which was not observed at approximately 13 times the auc. dystocia was observed in dams at approximately 17 times the auc (10 mg/kg/day). slight developmental delays were observed in pups

アメリカ合衆国 - 英語 - NLM (National Library of Medicine)

macleods pharmaceuticals limited - darifenacin hydrobromide (unii: cr02eyq8gv) (darifenacin - unii:apg9819vlm) - darifenacin 7.5 mg - darifenacin is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency. darifenacin is contraindicated in patients with, or at risk for, the following conditions: • urinary retention • gastric retention, or • uncontrolled narrow-angle glaucoma. risk summary there are no available data on darifenacin use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. in animal studies, darifenacin was not teratogenic in rats and rabbits at plasma exposures of free drug (via auc) up to 59 and 28 times the maximum recommended human dose (mrhd) of 15 mg, respectively. effects on embryofetal development were observed following administration of darifenacin during pregnancy (dilated ureter and/or kidney pelvis in rabbits at about 9 times the mrhd, post-implantation loss in rabbits at about 28 times, and delayed ossification in rats at about 59 times) and during pregnan

アメリカ合衆国 - 英語 - NLM (National Library of Medicine)

polygen pharmaceuticals inc. - darifenacin hydrobromide (unii: cr02eyq8gv) (darifenacin - unii:apg9819vlm) - darifenacin extended-release tablets are muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency. darifenacin is contraindicated in patients with, or at risk for, the following conditions: - urinary retention - gastric retention, or - uncontrolled narrow-angle glaucoma. pregnancy category c there are no studies of darifenacin in pregnant women. darifenacin was not teratogenic in rats and rabbits at plasma exposures of free drug (via auc) up to 59 times and 28 times, respectively (doses up to 50 and 30 mg/kg/day, respectively) the maximum recommended human dose [mrhd] of 15 mg. at approximately 59 times the mrhd in rats, there was a delay in the ossification of the sacral and caudal vertebrae which was not observed at approximately 13 times the auc. dystocia was observed in dams at approximately 17 times the auc (10 mg/kg/day). slight developmental delays were observed in pups at this dose. at five times the auc (3 mg/kg/day), th

アメリカ合衆国 - 英語 - NLM (National Library of Medicine)

alan laboratories, inc. - darifenacin hydrobromide (unii: cr02eyq8gv) (darifenacin - unii:apg9819vlm) - darifenacin extended-release tablets are a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency. darifenacin extended-release tablets are contraindicated in patients with, or at risk for, the following conditions: - urinary retention - gastric retention, or - uncontrolled narrow-angle glaucoma. pregnancy category c there are no studies of darifenacin in pregnant women. darifenacin was not teratogenic in rats and rabbits at plasma exposures of free drug (via auc) up to 59 times and 28 times, respectively (doses up to 50 and 30 mg/kg/day, respectively) the maximum recommended human dose [mrhd] of 15 mg. at approximately 59 times the mrhd in rats, there was a delay in the ossification of the sacral and caudal vertebrae which was not observed at approximately 13 times the auc. dystocia was observed in dams at approximately 17 times the auc (10 mg/kg/day). slight developmental delays were observed in pups at this dose. at five tim

アメリカ合衆国 - 英語 - NLM (National Library of Medicine)

xiromed, llc - darifenacin hydrobromide (unii: cr02eyq8gv) (darifenacin - unii:apg9819vlm) - darifenacin extended-release tablets are muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency. darifenacin extended-release tablets are contraindicated in patients with, or at risk for, the following conditions: - urinary retention - gastric retention, or - uncontrolled narrow-angle glaucoma. pregnancy category c there are no studies of darifenacin in pregnant women. darifenacin was not teratogenic in rats and rabbits at plasma exposures of free drug (via auc) up to 59 times and 28 times, respectively (doses up to 50 and 30 mg/kg/day, respectively) the maximum recommended human dose [mrhd] of 15 mg. at approximately 59 times the mrhd in rats, there was a delay in the ossification of the sacral and caudal vertebrae which was not observed at approximately 13 times the auc. dystocia was observed in dams at approximately 17 times the auc (10 mg/kg/day). slight developmental delays were observed in pups at this dose. at five times

アメリカ合衆国 - 英語 - NLM (National Library of Medicine)

proficient rx lp - darifenacin hydrobromide (unii: cr02eyq8gv) (darifenacin - unii:apg9819vlm) - darifenacin extended-release tablets are muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency. darifenacin extended-release tablets are contraindicated in patients with, or at risk for, the following conditions: pregnancy category c there are no studies of darifenacin in pregnant women. darifenacin was not teratogenic in rats and rabbits at plasma exposures of free drug (via auc) up to 59 times and 28 times, respectively (doses up to 50 and 30 mg/kg/day, respectively) the maximum recommended human dose [mrhd] of 15 mg. at approximately 59 times the mrhd in rats, there was a delay in the ossification of the sacral and caudal vertebrae which was not observed at approximately 13 times the auc. dystocia was observed in dams at approximately 17 times the auc (10 mg/kg/day). slight developmental delays were observed in pups at this dose. at five times the auc (3 mg/kg/day), there were no effects on dams or pups. in rabbits, an expo

アメリカ合衆国 - 英語 - NLM (National Library of Medicine)

aurobindo pharma limited - darifenacin hydrobromide (unii: cr02eyq8gv) (darifenacin - unii:apg9819vlm) - darifenacin 7.5 mg - darifenacin extended-release tablets are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency. darifenacin extended-release tablets are contraindicated in patients with, or at risk for, the following conditions: - urinary retention - gastric retention, or - uncontrolled narrow-angle glaucoma. risk summary there are no available data on darifenacin extended-release tablets use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. in animal studies, darifenacin was not teratogenic in rats and rabbits at plasma exposures of free drug (via auc) up to 59 and 28 times the maximum recommended human dose (mrhd) of 15 mg, respectively. effects on embryofetal development were observed following administration of darifenacin during pregnancy (dilated ureter and/or kidney pelvis in rabbits at about 9 times the mrhd, post-implantation loss in rabbits at about 28 times, and del

カナダ - 英語 - Health Canada

jamp pharma corporation - darifenacin (darifenacin hydrobromide) - tablet (extended-release) - 7.5mg - darifenacin (darifenacin hydrobromide) 7.5mg - antimuscarinics

カナダ - 英語 - Health Canada

jamp pharma corporation - darifenacin (darifenacin hydrobromide) - tablet (extended-release) - 15mg - darifenacin (darifenacin hydrobromide) 15mg - antimuscarinics

アメリカ合衆国 - 英語 - NLM (National Library of Medicine)

physicians total care, inc. - darifenacin (unii: apg9819vlm) (darifenacin - unii:apg9819vlm) - darifenacin 7.5 mg - enablex®   (darifenacin) extended-release tablets are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency. enablex®   (darifenacin)  extended-release tablets  are contraindicated in patients with urinary retention, gastric retention or uncontrolled narrow-angle glaucoma and in patients who are at risk for these conditions. enablex is also contraindicated in patients with known hypersensitivity to the drug or its ingredients.