Zoledronic Acid 4mg/5ml

Concentrate for solution for infusion
4mg/5ml
 

    Details

    Zoledronic Acid Fresenius Kabi focus:

    • Belongs to the class of bisphosphonates and acts primarily on bone
    • Inhibition of osteoclastic activity
    • Also possesses several anti-tumour properties that could contribute to its overall efficacy in the treatment of metastatic bone disease
    Prevention of skeletal related events:
    • Pathological fractures
    • Spinal compression
    • Radiation or surgery to the bone
    • Tumour-induced hypercalcaemia
    Treatment of adult patients with:
    • Tumour-induced hypercalcaemia (TIH)

    Composition:
    One vial with 5 ml concentrate contains 4 mg of zoledronic acid (as monohydrate). One ml concentrate contains 0.8 mg of zoledronic acid (as monohydrate) 

    Indications:
    • 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) 

    5ml vials

    Stability:
    Each vial is for single use and should be used immediately after opening. If not used immediately, in-use storage times
    and conditions are the responsibility of the user.

    Once added as recommended into the infusion bag, the zoledronic acid infusion solution condition prior to use would
    normally not be longer than 24 hours at 2 °C – 8 °C. The refrigerated solution should then be equilibrated to room temperature prior to administration.
     

    Composition: 1 ml of concentrate contains 0.8 mg zoledronic acid as monohydrate.

    Pharmaceutical form: Concentrate for solution for infusion. The concentrate is a colorless polypropylene plastic vial, closed with bromobutyl rubber stopper and a blue flip-off aluminium over seal.

    Excipients: Mannitol, sodium citrate, water for injections.

    Shelf life: 30 months (before opening the vial)