USA - engelsk - NLM (National Library of Medicine)

heritage pharmaceuticals inc. - ibandronate sodium (unii: j12u072ql0) (ibandronic acid - unii:umd7g2653w) - ibandronic acid 3 mg in 3 ml - ibandronate sodium injection is indicated for the treatment of osteoporosis in postmenopausal women. in postmenopausal women with osteoporosis, ibandronate increases bone mineral density (bmd) and reduces the incidence of vertebral fractures [see clinical studies(14)]. the safety and effectiveness of ibandronate for the treatment of osteoporosis are based on clinical data of one year duration. the optimal duration of use has not been determined. all patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis. patients at low-risk for fracture should be considered for drug discontinuation after 3 to 5 years of use. patients who discontinue therapy should have their risk for fracture re-evaluated periodically. ibandronate is contraindicated in patients with the following conditions: - hypocalcemia [see warnings and precautions (5.1)] - known hypersensitivity to ibandronate sodium injection or to any of its excipients. cases of anaphylaxis, including fatal event

USA - engelsk - NLM (National Library of Medicine)

auromedics pharma llc - ibandronate sodium (unii: j12u072ql0) (ibandronic acid - unii:umd7g2653w) - ibandronic acid 3 mg in 3 ml - ibandronate sodium injection is indicated for the treatment of osteoporosis in postmenopausal women. in postmenopausal women with osteoporosis, ibandronate sodium injection increases bone mineral density (bmd) and reduces the incidence of vertebral fractures [see clinical studies (14)] . the safety and effectiveness of ibandronate sodium injection for the treatment of osteoporosis are based on clinical data of one year duration. the optimal duration of use has not been determined. all patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis. patients at low-risk for fracture should be considered for drug discontinuation after 3 to 5 years of use. patients who discontinue therapy should have their risk for fracture re-evaluated periodically. ibandronate sodium injection is contraindicated in patients with the following conditions: - hypocalcemia [see warnings and precautions (5.1)] - known hypersensitivity to ibandronate sodium injection or to any of its ex

USA - engelsk - NLM (National Library of Medicine)

mylan institutional llc - ibandronate sodium (unii: j12u072ql0) (ibandronic acid - unii:umd7g2653w) - ibandronic acid 3 mg in 3 ml - ibandronate sodium injection is indicated for the treatment of osteoporosis in postmenopausal women. in postmenopausal women with osteoporosis, ibandronate sodium injection increases bone mineral density (bmd) and reduces the incidence of vertebral fractures [see clinical studies(14)] . the safety and effectiveness of ibandronate sodium injection for the treatment of osteoporosis are based on clinical data of one year duration. the optimal duration of use has not been determined. all patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis. patients at low-risk for fracture should be considered for drug discontinuation after 3 to 5 years of use. patients who discontinue therapy should have their risk for fracture re-evaluated periodically. ibandronate is contraindicated in patients with the following conditions: risk summary ibandronate is not indicated for use in women of reproductive potential. there are no data with ibandronate use in pregnant women to

USA - engelsk - NLM (National Library of Medicine)

sun pharmaceutical industries, inc. - ibandronate sodium (unii: j12u072ql0) (ibandronic acid - unii:umd7g2653w) - ibandronic acid 3 mg in 3 ml - ibandronate sodium injection is indicated for the treatment of osteoporosis in postmenopausal women. in postmenopausal women with osteoporosis, ibandronate sodium injection increases bone mineral density (bmd) and reduces the incidence of vertebral fractures [see clinical studies (14)] . the safety and effectiveness of ibandronate sodium injection for the treatment of osteoporosis are based on clinical data of one year duration. the optimal duration of use has not been determined. all patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis. patients at low-risk for fracture should be considered for drug discontinuation after 3 to 5 years of use. patients who discontinue therapy should have their risk for fracture re-evaluated periodically. ibandronate sodium injection is contraindicated in patients with the following conditions: - hypocalcemia [see warnings and precautions (5.1)] - known hypersensitivity to ibandronate sodium injection or to any of its ex

Israel - engelsk - Ministry of Health

teva medical marketing ltd. - sodium chloride - solution for infusion - sodium chloride 0.9 %w/v - sodium chloride - sodium chloride - treatment of isotonic extracellular dehydration. treatment of sodium depletion. vehicle or diluent of compatible drugs for parenteral administration.

Israel - engelsk - Ministry of Health

teva medical marketing ltd. - sodium chloride - solution for infusion - sodium chloride 0.9 %w/v - sodium chloride - sodium chloride - treatment of isotonic extracellular dehydration. treatment of sodium depletion. vehicle or diluent of compatible drugs for parenteral administration.

USA - engelsk - NLM (National Library of Medicine)

apotex corp. - ibandronate sodium (unii: j12u072ql0) (ibandronic acid - unii:umd7g2653w) - ibandronic acid 3 mg in 3 ml - ibandronate sodium injection is indicated for the treatment of osteoporosis in postmenopausal women. in postmenopausal women with osteoporosis, ibandronate sodium injection increases bone mineral density (bmd) and reduces the incidence of vertebral fractures [see clinical studies (14)] . the safety and effectiveness of ibandronate sodium injection for the treatment of osteoporosis are based on clinical data of one year duration. the optimal duration of use has not been determined. all patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis. patients at low-risk for fracture should be considered for drug discontinuation after 3 to 5 years of use. patients who discontinue therapy should have their risk for fracture re-evaluated periodically. ibandronate sodium is contraindicated in patients with the following conditions: - hypocalcemia [see warnings and precautions (5.1)] - known hypersensitivity to ibandronate sodium injection or to any of its excipients. cases of anaphylaxis, including fatal events, have been reported. [ see warnings and precautions (5.2) , adverse reactions (6.2) ] risk summary ibandronate sodium is not indicated for use in women of reproductive potential. there are no data with ibandronate sodium use in pregnant women to inform any drug-associated risks. in reproductive toxicity studies in the rat, ibandronate sodium caused obstruction of labor, with maternal periparturient mortality, pup loss and reduced pup weight at greater than or equal to 2 times human exposure at the recommended human intravenous dose of 3 mg. abnormal pup odontogeny was observed at greater than or equal to 18 times human exposure. in rats dosed during pregnancy, kidney developmental toxicity occurred in offspring at greater than or equal to 47 times human exposure. also, fetal weight and pup growth were reduced at greater than or equal to 5 times human exposure. in reproductive studies in the rabbit, ibandronate sodium caused maternal mortality, reduced maternal body weight gain, decreased litter size due to increased resorption rate, and decreased fetal weight at 19 times the recommended human dose (see data ). data animal data in pregnant rats given intravenous doses producing greater than or equal to 2 times human exposure from day 17 post­-coitum until day 20 post-partum, ibandronate treatment resulted in dystocia, maternal mortality, and early postnatal pup loss in all dose groups. reduced body weight at birth was observed at greater than or equal to 4 times the human exposure. pups exhibited abnormal odontogeny that decreased food consumption and body weight gain at greater than or equal to 18 times human exposure. periparturient mortality has also been observed with other bisphosphonates and appears to be a class effect related to inhibition of skeletal calcium mobilization resulting in hypocalcemia and dystocia. exposure of pregnant rats during the period of organogenesis resulted in an increased fetal incidence of rpu (renal pelvis ureter) syndrome at an intravenous dose producing greater than or equal to 47 times human exposure. in this spontaneous delivery study, dystocia was counteracted by perinatal calcium supplementation. in rat studies with intravenous dosing during gestation, fetal weight and pup growth were reduced at doses producing greater than or equal to 5 times human exposure.  in pregnant rabbits given intravenous doses during the period of organogenesis, maternal mortality, reduced maternal body weight gain, decreased litter size due to increased resorption rate, and decreased fetal weight were observed at 19 times the recommended human intravenous dose. exposure multiples for the rat studies were calculated using human exposure at the recommended intravenous dose of 3 mg every 3 months and were based on cumulative area under the curve (auc) comparison. exposure multiples for the rabbit study were calculated for the recommended human intravenous dose of 3 mg every 3 months and were based on cumulative dose/[body surface area] comparison. doses in pregnant animals were 0.05, 0.1, 0.15, 0.3, 0.5 or 1 mg/kg/day in rats, and 0.03, 0.07, or 0.2 mg/kg/day in rabbits. risk summary ibandronate sodium is not indicated for use in women of reproductive potential. there is no information on the presence of ibandronate in human milk, the effects of ibandronate on the breastfed infant, or the effects of ibandronate on milk production. ibandronate is present in rat milk (see data). the clinical relevance of this data is unclear. data animal data in lactating rats treated with intravenous doses of 0.08 mg/kg, ibandronate was present in breast milk at concentrations of 8.1 to 0.4 ng/ml from 2 to 24 hours after dose administration. concentrations in milk averaged 1.5 times plasma concentrations. safety and effectiveness of ibandronate sodium injection in pediatric patients have not been established. of the patients receiving ibandronate sodium injection 3 mg every 3 months for 1 year, 51% were over 65 years of age. no overall differences in effectiveness or safety were observed between these patients and younger patients, but greater sensitivity in some older individuals cannot be ruled out. ibandronate sodium injection should not be administered to patients with severe renal impairment (creatinine clearance less than 30 ml/min) [see warnings and precautions (5.3)] .

USA - engelsk - NLM (National Library of Medicine)

sagent pharmaceuticals - ibandronate sodium (unii: j12u072ql0) (ibandronic acid - unii:umd7g2653w) - ibandronic acid 3 mg in 3 ml - ibandronate sodium injection is indicated for the treatment of osteoporosis in postmenopausal women. in postmenopausal women with osteoporosis, ibandronate sodium increases bone mineral density (bmd) and reduces the incidence of vertebral fractures [see clinical studies (14)] . the safety and effectiveness of ibandronate sodium injection for the treatment of osteoporosis are based on clinical data of one year duration. the optimal duration of use has not been determined. all patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis. patients at low-risk for fracture should be considered for drug discontinuation after 3 to 5 years of use. patients who discontinue therapy should have their risk for fracture re-evaluated periodically. ibandronate sodium is contraindicated in patients with the following conditions: - hypocalcemia [see warnings and precautions (5.1)] - known hypersensitivity to ibandronate sodium injection or to any of its excipients. cases of a

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

wockhardt bio pty ltd - sodium valproate, quantity: 1000 mg - injection, solution - excipient ingredients: dibasic sodium phosphate dodecahydrate; monobasic sodium phosphate dihydrate; phosphoric acid; sodium hydroxide; water for injections - sodium valproate wockhardt is used for the treatment of patients with epilepsy or mania, who would normally be maintained on oral sodium valproate, and for whom oral therapy is temporarily not possible.

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

wockhardt bio pty ltd - sodium valproate, quantity: 400 mg - injection, solution - excipient ingredients: dibasic sodium phosphate dodecahydrate; monobasic sodium phosphate dihydrate; phosphoric acid; sodium hydroxide; water for injections - sodium valproate wockhardt is used for the treatment of patients with epilepsy or mania, who would normally be maintained on oral sodium valproate, and for whom oral therapy is temporarily not possible.