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

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: mannitol; sodium citrate dihydrate; 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.

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

actavis uk ltd - zoledronic acid monohydrate - solution for infusion - 800microgram/1ml

New Zealand - English - Medsafe (Medicines Safety Authority)

pfizer new zealand limited - zoledronic acid monohydrate 4.3mg (equiv 4 mg zoledronic acid) - solution for infusion - 4 mg/100ml - active: zoledronic acid monohydrate 4.3mg (equiv 4 mg zoledronic acid) excipient: mannitol sodium chloride sodium citrate dihydrate - prevention of skeletal-related events (pathological fracture, spinal cord compression, radiation to bone or surgery to bone) in patients with advanced malignancies involving bone.

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

Canada - English - Health Canada

sandoz canada incorporated - zoledronic acid (zoledronic acid monohydrate) - solution - 5mg - zoledronic acid (zoledronic acid monohydrate) 5mg - bone resorption inhibitors

Canada - English - Health Canada

juno pharmaceuticals corp. - zoledronic acid (zoledronic acid monohydrate) - solution - 4mg - zoledronic acid (zoledronic acid monohydrate) 4mg - bone resorption inhibitors

Canada - English - Health Canada

sandoz canada incorporated - zoledronic acid (zoledronic acid monohydrate) - solution - 4mg - zoledronic acid (zoledronic acid monohydrate) 4mg - bone resorption inhibitors

Ireland - English - HPRA (Health Products Regulatory Authority)

clonmel healthcare ltd - zoledronic acid monohydrate - concentrate for soln for inf - 4 mg/5ml - biphosphonates

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