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

accord healthcare pty ltd - zoledronic acid monohydrate, quantity: 4.264 mg (equivalent: zoledronic acid, qty 4 mg) - injection, concentrated - excipient ingredients: sodium citrate dihydrate; mannitol; water for injections - zoledronic acid accord is indicated:,for the prevention of skeletal-related events (pathological fracture, spinal cord compression, radiation to bone or surgery to bone) in patients with advanced malignancies involving bone.,for treatment of tumour-induced hypercalcaemia.,as an adjunct to adjuvant treatment for women with early breast cancer who are in established menopause.

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

sun pharma anz pty ltd - zoledronic acid monohydrate, quantity: 5.33 mg (equivalent: zoledronic acid, qty 5 mg) - injection, solution - excipient ingredients: sodium citrate dihydrate; mannitol; water for injections - treatment of paget?s disease of bone.

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

medis pharma pty ltd - zoledronic acid monohydrate, quantity: 4.264 mg (equivalent: zoledronic acid, qty 4 mg) - injection, concentrated - excipient ingredients: sodium citrate dihydrate; mannitol; water for injections - prevention of skeletal-related events (pathological fracture, spinal cord compression, radiation to bone or surgery to bone) in patients with advanced malignancies involving bone.,treatment of tumour induced hypercalcaemia.

New Zealand - English - Medsafe (Medicines Safety Authority)

viatris limited - zoledronic acid monohydrate 0.8528 mg/ml equivalent to zoledronic acid 0.8 mg/ml;   - concentrate for infusion - 4 mg/5ml - active: zoledronic acid monohydrate 0.8528 mg/ml equivalent to zoledronic acid 0.8 mg/ml   excipient: hydrochloric acid sodium citrate sodium hydroxide water for injection - · treatment of tumour-induced hypercalcaemia.

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

par pharmaceutical companies, inc. - zoledronic acid (unii: 6xc1pad3kf) (zoledronic acid anhydrous - unii:70hz18ph24) - zoledronic acid anhydrous 5 mg in 100 ml - zoledronic acid injection is indicated for treatment of paget's disease of bone in men and women. treatment is indicated in patients with paget’s disease of bone with elevations in serum alkaline phosphatase of two times or higher than the upper limit of the age-specific normal reference range, or those who are symptomatic, or those at risk for complications from their disease [see clinical studies (14.5) ]. zoledronic acid injection is contraindicated in patients with the following conditions: - hypocalcemia [see warnings and precautions (5.2) ] - creatinine clearance less than 35 ml/min and in those with evidence of acute renal impairment due to an increased risk of renal failure [see warnings and precautions (5.3) ]. - known hypersensitivity to zoledronic acid or any components of zoledronic acid injection. hypersensitivity reactions including urticaria, angioedema, and anaphylactic reaction/shock have been reported [see post-marketing experience (6.2) ]. pregnancy category d [see warnings and precautions

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

mylan institutional llc - zoledronic acid (unii: 6xc1pad3kf) (zoledronic acid anhydrous - unii:70hz18ph24) - zoledronic acid anhydrous 5 mg in 100 ml - zoledronic acid injection is indicated for treatment of paget's disease of bone in men and women. treatment is indicated in patients with paget’s disease of bone with elevations in serum alkaline phosphatase of two times or higher than the upper limit of the age-specific normal reference range, or those who are symptomatic, or those at risk for complications from their disease [see clinical studies (14.5)] . zoledronic acid is contraindicated in patients with the following conditions: in female rats given daily subcutaneous doses of 0.01, 0.03, or 0.1 mg/kg, beginning 15 days before mating and continuing through gestation, parturition and lactation, dystocia and periparturient mortality were observed in pregnant rats allowed to deliver starting at 0.01 mg/kg/day (0.1 times the human 5 mg intravenous dose, based on auc). also, there was an increase in stillbirths and a decrease in neonate survival starting at 0.03 mg/kg/day (0.3 times the human 5 mg dose), while the number of viable newborns and pup body weig

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

eugia us llc - zoledronic acid (unii: 6xc1pad3kf) (zoledronic acid anhydrous - unii:70hz18ph24) - zoledronic acid anhydrous 5 mg in 100 ml - zoledronic acid injection is indicated for treatment of paget’s disease of bone in men and women. treatment is indicated in patients with paget’s disease of bone with elevations in serum alkaline phosphatase of two times or higher than the upper limit of the age-specific normal reference range, or those who are symptomatic, or those at risk for complications from their disease [see clinical studies (14.5) ] . zoledronic acid is contraindicated in patients with the following conditions: - hypocalcemia [see warnings and precautions (5.2) ] - creatinine clearance less than 35 ml/min and in those with evidence of acute renal impairment due to an increased risk of renal failure [see warnings and precautions (5.3) ] . - known hypersensitivity to zoledronic acid or any components of zoledronic acid injection. hypersensitivity reactions including urticaria, angioedema, and anaphylactic reaction/shock have been reported [see adverse reactions (6.2) ] . risk summary available data on the use of zoledronic acid in p

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

gland pharma limited - zoledronic acid (unii: 6xc1pad3kf) (zoledronic acid anhydrous - unii:70hz18ph24) - zoledronic acid anhydrous 5 mg in 100 ml - zoledronic acid injection is indicated for treatment of osteoporosis in postmenopausal women. in postmenopausal women with osteoporosis, diagnosed by bone mineral density (bmd) or prevalent vertebral fracture, zoledronic acid injection reduces the incidence of fractures (hip, vertebral and non-vertebral osteoporosis-related fractures). in patients at high risk of fracture, defined as a recent low-trauma hip fracture, zoledronic acid injection reduces the incidence of new clinical fractures [see clinical studies (14.1)]. zoledronic acid injection is indicated for prevention of osteoporosis in postmenopausal women [see clinical studies (14.2)]. zoledronic acid injection is indicated for treatment to increase bone mass in men with osteoporosis [see clinical studies (14.3)]. zoledronic acid injection is indicated for the treatment and prevention of glucocorticoid-induced osteoporosis in men and women who are either initiating or continuing systemic glucocorticoids in a daily dosage equivalent to 7.5 mg or greater

New Zealand - English - Medsafe (Medicines Safety Authority)

viatris limited - zoledronic acid monohydrate 5.33mg equivalent to zolendronic acid (anhydrous) 5mg - solution for infusion - 5 mg/100ml - active: zoledronic acid monohydrate 5.33mg equivalent to zolendronic acid (anhydrous) 5mg excipient: mannitol sodium citrate water for injection - · treatment of osteoporosis in postmenopausal women to reduce the incidence of hip, vertebral and non-vertebral fractures and to increase bone mineral density. · prevention of postmenopausal osteoporosis.

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

fresenius kabi usa, llc - zoledronic acid (unii: 6xc1pad3kf) (zoledronic acid anhydrous - unii:70hz18ph24) - zoledronic acid anhydrous 5 mg in 100 ml - zoledronic acid injection is indicated for treatment of osteoporosis in postmenopausal women. in postmenopausal women with osteoporosis, diagnosed by bone mineral density (bmd) or prevalent vertebral fracture, zoledronic acid injection reduces the incidence of fractures (hip, vertebral and non-vertebral osteoporosis-related fractures). in patients at high risk of fracture, defined as a recent low-trauma hip fracture, zoledronic acid injection reduces the incidence of new clinical fractures [ see clinical studies (14.1) ]. zoledronic acid injection is indicated for prevention of osteoporosis in postmenopausal women [ see clinical studies (14.2) ]. zoledronic acid injection is indicated for treatment to increase bone mass in men with osteoporosis [ see clinical studies (14.3) ]. zoledronic acid injection is indicated for the treatment and prevention of glucocorticoid-induced osteoporosis in men and women who are either initiating or continuing systemic glucocorticoids i