Apo-Zoledronic Acid

New Zealand - English - Medsafe (Medicines Safety Authority)

Active ingredient:
Zoledronic acid monohydrate 0.853 mg/mL equivalent to zoledronic acid 0.80 mg/ml;  
Available from:
Apotex NZ Ltd
INN (International Name):
Zoledronic acid monohydrate 0.853 mg/mL (= zoledronic acid 0.80 mg/ml)
Dosage:
4 mg/5mL
Pharmaceutical form:
Concentrate for infusion
Composition:
Active: Zoledronic acid monohydrate 0.853 mg/mL equivalent to zoledronic acid 0.80 mg/ml   Excipient: Mannitol Sodium citrate dihydrate Water for injection
Prescription type:
Prescription
Manufactured by:
Jubilant Generics Limited
Therapeutic indications:
Prevention of skeletal-related events (pathological fracture, spinal cord compression, radiation to bone or surgery to bone) in patients with advanced malignancies involving bone.
Product summary:
Package - Contents - Shelf Life: Vial, plastic, 5 ml clear PET resin with bromo-butyl rubber stopper, Al crimp seal and PP "flip off" cap in carton - 1 dose units - 36 months from date of manufacture stored at or below 25°C 24 hours diluted stored at 2° to 8°C (Refrigerate, do not freeze) - Vial, plastic, 5 ml clear PET resin with bromo-butyl rubber stopper, Al crimp seal and PP "flip off" cap in carton - 4 dose units - 36 months from date of manufacture stored at or below 25°C 24 hours diluted stored at 2° to 8°C (Refrigerate, do not freeze) - Vial, plastic, 5 ml clear PET resin with bromo-butyl rubber stopper, Al crimp seal and PP "flip off" cap in carton - 10 dose units - 36 months from date of manufacture stored at or below 25°C 24 hours diluted stored at 2° to 8°C (Refrigerate, do not freeze)
Authorization number:
TT50-9223
Authorization date:
2013-02-26

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