Apo-Zoledronic Acid

Country: Նոր Զելանդիա

language: անգլերեն

source: Medsafe (Medicines Safety Authority)

active_ingredient:

Zoledronic acid monohydrate 0.853 mg/mL equivalent to zoledronic acid 0.80 mg/ml;  

MAH:

Apotex NZ Ltd

INN:

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_indication:

Prevention of skeletal-related events (pathological fracture, spinal cord compression, radiation to bone or surgery to bone) in patients with advanced malignancies involving bone.

leaflet_short:

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_date:

2013-02-26