United States - English - 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

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

apotex corp - 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. 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 (

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

atnahs pharma australia pty ltd - ibandronate sodium, quantity: 1.125 mg/ml (equivalent: ibandronic acid, qty 1 mg/ml) - injection, concentrated - excipient ingredients: sodium chloride; glacial acetic acid; sodium acetate; water for injections - indicated for the treatment of: tumor-induced hypercalcaemia with or without metastases. metastatic bone disease in patients with breast cancer.

Ireland - English - HPRA (Health Products Regulatory Authority)

vaia s.a. - ibandronate sodium monohydrate - film coated tablet - 150 milligram

New Zealand - English - Medsafe (Medicines Safety Authority)

roche products (nz) ltd - ibandronate sodium monohydrate 1.125 mg/ml equivalent to 1 mg/ml ibandronic acid - solution for infusion - 1 mg/ml - active: ibandronate sodium monohydrate 1.125 mg/ml equivalent to 1 mg/ml ibandronic acid excipient: acetic acid sodium acetate sodium chloride water for injection

New Zealand - English - Medsafe (Medicines Safety Authority)

roche products (nz) ltd - ibandronate sodium monohydrate 2.813mg equivalent to ibandronic acid 2.5 mg;   - film coated tablet - 2.5 mg - active: ibandronate sodium monohydrate 2.813mg equivalent to ibandronic acid 2.5 mg   excipient: colloidal silicon dioxide crospovidone hypromellose/titanium dioxide/talc (60.5%/29%/10.5%) lactose monohydrate macrogols microcrystalline cellulose povidone stearic acid

Ireland - English - HPRA (Health Products Regulatory Authority)

vaia s.a. - ibandronate sodium monohydrate - film coated tablet - 50 milligram

Ireland - English - HPRA (Health Products Regulatory Authority)

actavis group ptc ehf - ibandronate sodium monohydrate - film-coated tablet - 150 milligram(s) - bisphosphonates; ibandronic acid

Ireland - English - HPRA (Health Products Regulatory Authority)

accord healthcare ireland ltd. - ibandronate sodium monohydrate - film-coated tablet - 150 milligram(s) - bisphosphonates; ibandronic acid

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

atnahs pharma australia pty ltd - ibandronate sodium, quantity: 56.25 mg (equivalent: ibandronic acid, qty 50 mg) - tablet, film coated - excipient ingredients: povidone; crospovidone; stearic acid; hypromellose; colloidal anhydrous silica; purified talc; macrogol 6000; lactose monohydrate; microcrystalline cellulose; titanium dioxide - the treatment of metastatic bone disease in patients with breast cancer.