यूरोपीय संघ - अंग्रेज़ी - EMA (European Medicines Agency)

teva b.v. - zoledronic acid - osteoporosis; osteitis deformans; osteoporosis, postmenopausal - drugs for treatment of bone diseases - treatment of osteoporosis: , in post-menopausal women;, in men; , at increased risk of fracture including those with a recent low-trauma hip fracture. treatment of osteoporosis associated with long-term systemic glucocorticoid therapy: , in post-menopausal women;, in men; , at increased risk of fracture. treatment of paget’s disease of the bone in adults.,

माल्टा - अंग्रेज़ी - Medicines Authority

actavis group ptc ehf revkjavikurvegi 76-78, 220 hafnarfjordur, iceland - alendronic acid - tablet - alendronic acid 70 mg - drugs for treatment of bone diseases

माल्टा - अंग्रेज़ी - Medicines Authority

mylan ireland limited unit 35/36, grange parade, baldoyle industrial estate, dublin 13, ireland - ibandronic acid - film-coated tablet - ibandronic acid 150 mg - drugs for treatment of bone diseases

ऑस्ट्रेलिया - अंग्रेज़ी - 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.

संयुक्त राज्य - अंग्रेज़ी - NLM (National Library of Medicine)

heritage pharmaceuticals inc. - zoledronic acid (unii: 6xc1pad3kf) (zoledronic acid anhydrous - unii:70hz18ph24) - 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 adverse reactions (6.2) ]. pregnancy category d [see warnings and precautions (5.6)

संयुक्त राज्य - अंग्रेज़ी - NLM (National Library of Medicine)

mylan institutional llc - zoledronic acid (unii: 6xc1pad3kf) (zoledronic acid anhydrous - unii:70hz18ph24) - 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

संयुक्त राज्य - अंग्रेज़ी - NLM (National Library of Medicine)

hospira, inc. - zoledronic acid (unii: 6xc1pad3kf) (zoledronic acid anhydrous - unii:70hz18ph24) - zoledronic acid 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: risk summary available data on the use of zoledronic acid in pregnant women are insufficient to inform a drug-associated risk of adverse maternal or fetal outcomes. discontinue zoledronic acid when pregnancy is recognized. in animal reproduction studies, daily subcutaneous administration of zoledronic acid to pregnant rats during organogenesis resulted in increases in fetal skeletal, visceral, and external malformations, decreases in postimplantation survival, and decreases in viable fetuses and fetal weight starting at doses equivalent t

संयुक्त राज्य - अंग्रेज़ी - NLM (National Library of Medicine)

fosun pharma usa inc - zoledronic acid (unii: 6xc1pad3kf) (zoledronic acid anhydrous - unii:70hz18ph24) - 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 o

संयुक्त राज्य - अंग्रेज़ी - NLM (National Library of Medicine)

meitheal pharmaceuticals inc. - zoledronic acid (unii: 6xc1pad3kf) (zoledronic acid anhydrous - unii:70hz18ph24) - 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 pregnant

न्यूज़ीलैंड - अंग्रेज़ी - 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.