ZOLEDRONIC ACID HOSPIRA 5mg/100ml Solution for infusion Ref.[7898] Active ingredients: Zoledronic acid

Posology

Patients must be appropriately hydrated prior to administration of Zoledronic Acid Hospira. This is especially important for the elderly (≥65 years) and for patients receiving diuretic therapy.

Adequate calcium and vitamin D intake are recommended in association with Zoledronic Acid Hospira administration.

For the treatment of Paget’s disease, zoledronic acid 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 zoledronic acid. 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 Zoledronic Acid Hospira administration (see section 4.4).

Re-treatment of Paget’s disease: After initial treatment with zoledronic acid in Paget’s disease, an extended remission period is observed in responding patients. Re-treatment consists of an additional intravenous infusion of 5 mg zoledronic acid 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 (see section 5.1).

Special populations

Patients with renal impairment

Zoledronic acid is contraindicated in patients with creatinine clearance <35 ml/min (see sections 4.3 and 4.4).

No dose adjustment is necessary in patients with creatinine clearance ≥35 ml/min.

Patients with hepatic impairment

No dose adjustment is required (see section 5.2).

Elderly (≥65 years)

No dose adjustment is necessary since bioavailability, distribution and elimination were similar in elderly patients and younger subjects.

Paediatric population

Zoledronic acid Hospira should not be used in children and adolescents below 18 years of age. There are no data available for children under 5 years of age. Currently available data for children aged 5 to 17 years are described in section 5.1.

Method of administration

Intravenous use.

Zoledronic Acid Hospira (5 mg in 100 ml ready-to-infuse solution) is administered via an infusion line and given at a constant infusion rate. The infusion time must not be less than 15 minutes. For information on the infusion of Zoledronic Acid Hospira, see section 6.6.

Patients treated with Zoledronic Acid Hospira should be given the package leaflet and the patient reminder card.

Clinical experience with acute overdose is limited. Patients who have received doses higher than those recommended should be carefully monitored. In the event of overdose leading to clinically significant hypocalcaemia, reversal may be achieved with supplemental oral calcium and/or an intravenous infusion of calcium gluconate.

Unopened bag:</u. 2 years.

After opening: 24 hours at 2°C-8°C.

From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C-8°C.