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.

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

gland pharma limited - zoledronic acid (unii: 6xc1pad3kf) (zoledronic acid anhydrous - unii:70hz18ph24) - zoledronic acid injection is indicated for the treatment of hypercalcemia of malignancy defined as an albumin-corrected calcium (cca) of greater than or equal to 12 mg/dl [3.0 mmol/l] using the formula: cca in mg/dl =ca in mg/dl + 0.8 ( 4.0 g/dl – patient albumin [g/dl]). zoledronic acid injection is indicated for the treatment of patients with multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy. prostate cancer should have progressed after treatment with at least one hormonal therapy. limitation of use the safety and efficacy of zoledronic acid injection in the treatment of hypercalcemia associated with hyperparathyroidism or with other non-tumor-related conditions have not been established. hypersensitivity to zoledronic acid or any components of zoledronic acid injection hypersensitivity reactions including rare cases of urticaria and angioedema, and very rare cases of anaphylactic reaction/shock have been reported

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

bluepoint laboratories - zoledronic acid (unii: 6xc1pad3kf) (zoledronic acid anhydrous - unii:70hz18ph24) - zoledronic acid injection is indicated for the treatment of hypercalcemia of malignancy defined as an albumin-corrected calcium (cca) of greater than or equal to 12 mg/dl [3.0 mmol/l] using the formula: cca in mg/dl=ca in mg/dl + 0.8 (4.0 g/dl - patient albumin [g/dl]). zoledronic acid injection is indicated for the treatment of patients with multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy. prostate cancer should have progressed after treatment with at least one hormonal therapy. limitations of use the safety and efficacy of zoledronic acid injection in the treatment of hypercalcemia associated with hyperparathyroidism or with other non-tumor-related conditions have not been established. hypersensitivity to zoledronic acid or any components of zoledronic acid injection hypersensitivity reactions including rare cases of urticaria and angioedema, and very rare cases of anaphylactic reaction/shock have been reported [see adver

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

bluepoint laboratories - zoledronic acid (unii: 6xc1pad3kf) (zoledronic acid anhydrous - unii:70hz18ph24) - zoledronic acid injection is indicated for the treatment of hypercalcemia of malignancy defined as an albumin-corrected calcium (cca) of greater than or equal to 12 mg/dl [3.0 mmol/l] using the formula: cca in mg/dl=ca in mg/dl + 0.8 (4.0 g/dl - patient albumin [g/dl]). zoledronic acid injection is indicated for the treatment of patients with multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy. prostate cancer should have progressed after treatment with at least one hormonal therapy. limitations of use the safety and efficacy of zoledronic acid injection in the treatment of hypercalcemia associated with hyperparathyroidism or with other non-tumor-related conditions have not been established. hypersensitivity to zoledronic acid or any components of zoledronic acid injection hypersensitivity reactions including rare cases of urticaria and angioedema, and very rare cases of anaphylactic reaction/shock have been reported [see adver

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

pfizer australia pty ltd - zoledronic acid monohydrate -

Israel - English - Ministry of Health

neopharm (israel) 1996 ltd - zoledronic acid as monohydrate - concentrate for solution for infusion - zoledronic acid as monohydrate 4 mg - zoledronic acid - treatment of hypercalcaemia of malignancy. treatment of patients with multiple myeloma and patients with documented bone metastases from solid tumors , in conjunction with standard antineoplastic therapy. prostate cancer should have progressed after treatment with at least one hormonal therapy.

Israel - English - Ministry of Health

taro international ltd, israel - zoledronic acid - concentrate for solution for infusion - zoledronic acid 4 mg / 5 ml - zoledronic acid - treatment of hypercalcaemia of malignancy.treatment of patients with multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy.prostate cancer should have progressed after treatment with at least one hormonal therapy.

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.

European Union - English - 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.,

European Union - English - EMA (European Medicines Agency)

teva generics b.v - zoledronic acid monohydrate - osteoporosis; osteitis deformans - bisphosphonates - treatment of osteoporosisin post-menopausal womenin adult menat increased risk of fracture, including those with recent low-trauma hip fracture.treatment of osteoporosis associated with long-term systemic glucocorticoid therapyin post-menopausal womenin adult menat increased risk of fracture.treatment of paget's disease of the bone in adults.