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

golden state medical supply, inc. - ibandronate sodium (unii: j12u072ql0) (ibandronic acid - unii:umd7g2653w) - ibandronic acid 150 mg - ibandronate sodium tablets are indicated for the treatment and prevention of osteoporosis in postmenopausal women. ibandronate sodium increases bone mineral density (bmd) and reduces the incidence of vertebral fractures. theoptimalduration of use has not been determined. the safety and effectiveness of ibandronate sodium tablets for the treatment of osteoporosis are based on clinical data of three years duration. 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 tablets are contraindicated in patients with the following conditions: - abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia (see warnings and precautions [5.1]) - inability to stand or sit upright for at least 60 minutes

United States - English - 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

United States - English - 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

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

aurobindo pharma limited - ibandronate sodium (unii: j12u072ql0) (ibandronic acid - unii:umd7g2653w) - ibandronic acid 150 mg - ibandronate sodium tablets are indicated for the treatment and prevention of osteoporosis in postmenopausal women. ibandronate sodium tablets increase bone mineral density (bmd) and reduce the incidence of vertebral fractures. the optimal duration of use has not been determined. the safety and effectiveness of ibandronate sodium tablets for the treatment of osteoporosis are based on clinical data of three years duration. 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 tablets are contraindicated in patients with the following conditions: - abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia (see warnings and precautions [5.1]) - inability to stand or sit upright for at least 60 minutes (see dosage and administration [2.2], and warnings and precautions [5.1]) - hypocalcemia (see warnings and precautions [5.2]) - known hypersensitivity to ibandronate sodium tablets or to any of its excipients. cases of anaphylaxis have been reported (see 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 post-implantation loss and obstruction of labor with maternal and fetal periparturient mortality at greater than or equal to 3 times human exposure at the recommended 2.5 mg daily oral dose, or at greater than or equal to 1 times human exposure at the recommended 150 mg once-monthly oral dose. in pregnant rats, kidney developmental toxicity occurred in offspring at greater than or equal to 30 times the daily 2.5 mg human dose or at greater than or equal to 9 times the once-monthly 150 mg human dose. in rat reproductive studies, impaired pup neuromuscular development was observed at 45 times the daily 2.5 mg dose and 13 times the once-monthly 150 mg dose. in reproductive studies in the rabbit, ibandronate sodium caused maternal mortality at greater than or equal to 8 times the daily 2.5 mg dose and greater than or equal to 4 times the once-monthly 150 mg dose (see data ). data animal data in female rats given ibandronate at oral doses greater than or equal to 3 times human exposure at the recommended daily oral dose of 2.5 mg or greater than or equal to 1 times human exposure at the recommended once-monthly oral dose of 150 mg beginning 14 days before mating and continuing through lactation, maternal deaths were observed at the time of delivery in all dose groups. perinatal pup loss in dams given doses producing 45 times human exposure at the recommended daily dose and 13 times human exposure at the recommended once-monthly dose was likely related to maternal dystocia. calcium supplementation did not completely prevent dystocia and periparturient mortality in any of the treated groups at greater than or equal to 16 times the recommended daily dose and greater than or equal to 4.6 times the recommended once-monthly dose. a low incidence of postimplantation loss was observed in rats treated from 14 days before mating throughout lactation or during gestation, only at doses causing maternal dystocia and periparturient mortality. in pregnant rats dosed orally from gestation day 17 through lactation day 21 (following closure of the hard palate through weaning), maternal toxicity, including dystocia and mortality, fetal perinatal and postnatal mortality, were observed at doses equivalent to human exposure at the recommended daily dose and greater than or equal to 4 times the recommended once-monthly dose. 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 oral doses producing 30 times human exposure at the recommended daily oral dose of 2.5 mg and greater than or equal to 9 times human exposure at the recommended once-monthly oral dose of 150 mg. impaired pup neuromuscular development (cliff avoidance test) was observed at 45 times human exposure at the daily dose and 13 times the once-monthly dose. in pregnant rabbits treated orally with ibandronate during gestation at doses greater than or equal to 8 times the recommended human daily oral dose of 2.5 mg and greater than or equal to 4 times the recommended human once-monthly oral dose of 150 mg, dose-related maternal mortality was observed in all treatment groups. the deaths occurred prior to parturition and were associated with lung edema and hemorrhage. no significant fetal anomalies were observed. exposure multiples for the rat studies were calculated for the recommended daily oral dose of 2.5 mg or once-monthly dose of 150 mg based on area under the curve (auc) comparison. exposure multiples for the rabbit study were calculated for the recommended human daily oral dose of 2.5 mg or once-monthly dose of 150 mg based on dose/body surface area comparison. doses used in pregnant animals were 1, 4, 5, 6, 16, 10, 20, 30, 60 or 100 mg/kg/day in rats, and 1, 4 or 20 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 these data is unclear. data animal data in lactating rats treated with intravenous doses of 0.08 mg/kg, ibandronate was present in breast milk from 2 to 24 hours after dose administration. concentrations in milk averaged 1.5 times plasma concentrations. safety and effectiveness in pediatric patients have not been established. of the patients receiving ibandronate sodium 2.5 mg (ibandronate) daily in postmenopausal osteoporosis studies, 52% were over 65 years of age, and 10% were over 75 years of age. of the patients receiving ibandronate sodium 150 mg (ibandronate) once-monthly in the postmenopausal osteoporosis 1-year study, 52% were over 65 years of age, and 9% were over 75 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 is not recommended for use in patients with severe renal impairment (creatinine clearance less than 30 ml/min).

United States - English - 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

Ireland - English - HPRA (Health Products Regulatory Authority)

rowa pharmaceuticals limited - ibandronate sodium monohydrate - film-coated tablet - 150 milligram(s) - bisphosphonates; ibandronic acid

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

eg sa-nv - sodium ibandronate monohydrate 168,75 mg - eq. ibandronic acid 150 mg - film-coated tablet - 150 mg - ibandronate sodium monohydrate - ibandronic acid

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

eg sa-nv - sodium ibandronate monohydrate - eq. ibandronic acid 1 mg/ml - solution for injection - 3 mg/3 ml - ibandronate sodium monohydrate - ibandronic acid

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

viatris gx bv-srl - sodium ibandronate monohydrate 169,32 mg - eq. ibandronic acid 150 mg - film-coated tablet - 150 mg - ibandronate sodium monohydrate - ibandronic acid

United States - English - 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)] .