Canada - English - Health Canada

fresenius kabi canada ltd - zoledronic acid (zoledronic acid monohydrate) - solution - 4mg - zoledronic acid (zoledronic acid monohydrate) 4mg - bone resorption inhibitors

Canada - English - Health Canada

marcan pharmaceuticals inc - zoledronic acid (zoledronic acid monohydrate) - solution - 4mg - zoledronic acid (zoledronic acid monohydrate) 4mg - bone resorption inhibitors

Canada - English - Health Canada

omega laboratories limited - zoledronic acid (zoledronic acid monohydrate) - solution - 4mg - zoledronic acid (zoledronic acid monohydrate) 4mg - bone resorption inhibitors

Canada - English - Health Canada

apotex inc - zoledronic acid (zoledronic acid monohydrate) - solution - 4mg - zoledronic acid (zoledronic acid monohydrate) 4mg - bone resorption inhibitors

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

jhp pharmaceuticals, llc. - zoledronic acid (unii: 6xc1pad3kf) (zoledronic acid anhydrous - unii:70hz18ph24) - zoledronic acid anhydrous 4 mg in 5 ml - 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. the safety and efficacy of zoledronic acid injection in the treatment of hypercalcemia associated with hyperparathyroidism or with other nontumor-related conditions have not been established. hypersensitivity reactions including rare cases of urticaria and angioedema, and very rare cases of anaphylactic reaction/shock have been reported [see adverse reactions (6.2) ]. pregnancy category d [see warnings and precautions (5.9)] there are no adequate a

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

breckenridge pharmaceutical, 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 adverse reactions (6.2) ]. pregnancy category d [see warnings and precautions (5.6) ].

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

heritage pharmaceuticals 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 precautio

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

pfizer australia pty ltd - zoledronic acid monohydrate, quantity: 4.3 mg (equivalent: zoledronic acid, qty 4 mg) - injection, concentrated - excipient ingredients: water for injections; mannitol; 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.,? treatment of tumour-induced hypercalcaemia

United States - English - 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)

European Union - English - EMA (European Medicines Agency)

accord healthcare s.l.u. - zoledronic acid monohydrate - hypercalcemia; fractures, bone; cancer - bisphosphonates - prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in adult patients with advanced malignancies involving bone.treatment of adult patients with tumour-induced hypercalcaemia (tih).