Australia - English - Department of Health (Therapeutic Goods Administration)

accord healthcare pty ltd - solifenacin succinate, quantity: 5 mg - tablet, orally disintegrating - excipient ingredients: sucralose; hypromellose; lactose monohydrate; polacrilin potassium; croscarmellose sodium; mannitol; sodium stearylfumarate; flavour - vesican odt is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency or increased urinary frequency.

Australia - English - Department of Health (Therapeutic Goods Administration)

accord healthcare pty ltd - solifenacin succinate, quantity: 10 mg - tablet, orally disintegrating - excipient ingredients: lactose monohydrate; hypromellose; sucralose; croscarmellose sodium; mannitol; polacrilin potassium; sodium stearylfumarate; flavour - vesican odt is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency or increased urinary frequency.

Australia - English - Department of Health (Therapeutic Goods Administration)

astellas pharma australia pty ltd - solifenacin succinate, quantity: 10 mg - tablet, film coated - excipient ingredients: hypromellose; lactose monohydrate; maize starch; magnesium stearate; titanium dioxide; macrogol 8000; purified talc; iron oxide red - vesicare is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency or increased urinary frequency.

Australia - English - Department of Health (Therapeutic Goods Administration)

astellas pharma australia pty ltd - solifenacin succinate, quantity: 5 mg - tablet, film coated - excipient ingredients: magnesium stearate; hypromellose; lactose monohydrate; maize starch; titanium dioxide; iron oxide yellow; purified talc; macrogol 400 - vesicare is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency or increased urinary frequency.

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

alliance pharmaceuticals ltd - sodium chloride - intravesical solution - 9mg/1ml

Australia - English - Department of Health (Therapeutic Goods Administration)

endotherapeutics pty ltd - hexaminolevulinate hydrochloride, quantity: 100 mg (equivalent: hexaminolevulinate, qty 85 mg) - diluent, not applicable - excipient ingredients: sodium hydroxide; dibasic sodium phosphate dihydrate; monobasic potassium phosphate; sodium chloride; water for injections; hydrochloric acid - this medicinal product is for diagnostic use only.,hexvix blue light fluorescence cystoscopy is indicated as adjunct to standard white light cystoscopy to contribute to the diagnosis and management of bladder cancer in patients with known or high suspicion of bladder cancer.

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

astellas pharma us, inc. - solifenacin succinate (unii: kka5dld701) (solifenacin - unii:a8910sqj1u) - solifenacin succinate 5 mg - vesicare® is indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency. vesicare is contraindicated in patients: risk summary there are no studies with the use of solifenacin succinate in pregnant women to inform a drug-associated risk of major birth defects, miscarriages, or adverse maternal or fetal outcomes. no adverse developmental outcomes were observed in animal reproduction studies with oral administration of solifenacin succinate to pregnant mice during the period of organogenesis at a dose resulting in 1.2 times the systemic exposure at the maximum recommended human dose (mrhd) of 10 mg/day. however, administration of doses 3.6 times and greater than the mrhd during organogenesis produced maternal toxicity in the pregnant mice and resulted in developmental toxicity and reduced fetal body weights in offspring [see data] . in the u.s. general population, the estimated background risk of major birth defects or miscarriage in

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

cardinal health - solifenacin succinate (unii: kka5dld701) (solifenacin - unii:a8910sqj1u) - solifenacin succinate 5 mg - vesicare is a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency. vesicare is contraindicated in patients with: pregnancy category c there are no adequate and well-controlled studies in pregnant women. reproduction studies have been performed in mice, rats and rabbits. after oral administration of 14 c-solifenacin succinate to pregnant mice, drug-related material was shown to cross the placental barrier. no embryotoxicity or teratogenicity was observed in mice treated with 1.2 times (30 mg/kg/day) the expected exposure at the maximum recommended human dose [mrhd] of 10 mg. administration of solifenacin succinate to pregnant mice at 3.6 times and greater (100 mg/kg/day and greater) the exposure at the mrhd, during the major period of organ development resulted in reduced fetal body weights. administration of 7.9 times (250 mg/kg/day) the mrhd to pregnant mice resulted in an increased incidence of cleft palate. in ut

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

cardinal health - solifenacin succinate (unii: kka5dld701) (solifenacin - unii:a8910sqj1u) - vesicare® is a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency. vesicare is contraindicated in patients with: pregnancy category c there are no adequate and well-controlled studies in pregnant women. reproduction studies have been performed in mice, rats and rabbits. after oral administration of 14 c-solifenacin succinate to pregnant mice, drug-related material was shown to cross the placental barrier. no embryotoxicity or teratogenicity was observed in mice treated with 1.2 times (30 mg/kg/day) the expected exposure at the maximum recommended human dose [mrhd] of 10 mg. administration of solifenacin succinate to pregnant mice at 3.6 times and greater (100 mg/kg/day and greater) the exposure at the mrhd, during the major period of organ development resulted in reduced fetal body weights. administration of 7.9 times (250 mg/kg/day) the mrhd to pregnant mice resulted in an increased incidence of cleft palate. in

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

remedyrepack inc. - solifenacin succinate (unii: kka5dld701) (solifenacin - unii:a8910sqj1u) - vesicare ® is a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency. vesicare is contraindicated in patients with: - urinary retention [see warnings and precautions ( 5.2)] , - gastric retention [see warnings and precautions ( 5.3)] , - uncontrolled narrow-angle glaucoma [see warnings and precautions ( 5.5)] , and - in patients who have demonstrated hypersensitivity to the drug [see adverse reactions ( 6.2)] . pregnancy category c there are no adequate and well-controlled studies in pregnant women. reproduction studies have been performed in mice, rats and rabbits. after oral administration of 14 c-solifenacin succina