Zoledronic acid 5mg/5ml.

Concentrated solution for infusion.

Treatment of osteoporosis and osteoporosis associated with long-term systemic glucocorticoid therapy.

Treatment of Paget's disease of the bone.

Osteoporosis:
For the treatment of post-menopausal osteoporosis, osteoporosis in men and the treatment of osteoporosis associated with long-term systemic glucocorticoid therapy, the recommended dose is a single intravenous infusion of 5 mg ZOLEDRO-BFS administered once a year.
The optimal duration of bisphosphonate treatment for osteoporosis has not been established. The need for continued treatment should be re-evaluated periodically based on the benefits and potential risks of ZOLEDRO-BFS on an individual patient basis, particularly after 5 or more years of use.
In patients with a recent low-trauma hip fracture, it is recommended to give the ZOLEDRO-BFS infusion at least two weeks after hip fracture repair. In patients with a recent low-trauma hip fracture, a loading dose of 50 000 to 125 000 IU of vitamin D given orally or via the intramuscular route is recommended prior to the first ZOLEDRO-BFS infusion.
Paget's disease:
For the treatment of Paget's disease, ZOLEDRO-BFS should be prescribed only by physicians with experience in the treatment of Paget's disease of the bone. The recommended dose is a single intravenous infusion of 5 mg ZOLEDRO-BFS. In patients with Paget's disease, it is strongly advised that adequate supplemental calcium corresponding to at least 500 mg elemental calcium twice daily is ensured for at least 10 days following ZOLEDRO-BFS administration.
Re-treatment of Paget's disease: After initial treatment with ZOLEDRO-BFS in Paget's disease, an extended remission period is observed in responding patients. Re-treatment consists of an additional intravenous infusion of 5 mg ZOLEDRO-BFS after an interval of one year or longer from initial treatment in patients who have relapsed. Limited data on re-treatment of Paget's disease are available.
Special populations:
Patients with renal impairment:
ZOLEDRO-BFS is contraindicated in patients with creatinine clearance < 35 ml/min.
No dose adjustment is necessary in patients with creatinine clearance ≥ 35 ml/min.
Patients with hepatic impairment:
No dose adjustment is required.
Elderly (≥ 65 years)
No dose adjustment is necessary since bioavailability, distribution and elimination were similar in elderly patients and younger subjects.
Paediatric population:
The safety and efficacy of ZOLEDRO-BFS in children and adolescents below 18 years of age have not been established. No data are available.