Malta - English - Medicines Authority

fair-med healthcare gmbh planckstr. 13, 22765 hamburg, germany - zoledronic acid, monohydrate - concentrate for solution for infusion - zoledronic acid monohydrate 4 mg/5ml - drugs for treatment of bone diseases

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)

apotex pty ltd - zoledronic acid monohydrate -

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

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.

Ireland - English - HPRA (Health Products Regulatory Authority)

intrapharm laboratories limited - zoledronic acid monohydrate - concentrate for solution for infusion - 4 mg/5ml - bisphosphonates; zoledronic acid

Ireland - English - HPRA (Health Products Regulatory Authority)

intrapharm laboratories limited - zoledronic acid monohydrate - concentrate for solution for infusion - 4 mg/5ml - bisphosphonates; zoledronic acid

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.

Ireland - English - HPRA (Health Products Regulatory Authority)

wockhardt uk limited - zoledronic acid monohydrate - concentrate for solution for infusion - 4 mg/5ml - bisphosphonates; zoledronic acid

Ireland - English - HPRA (Health Products Regulatory Authority)

fair-med healthcare gmbh - zoledronic acid monohydrate - concentrate for soln for inf - 4/5 mg/ml - tiludronic acid