Pays: Nouvelle-Zélande
Langue: anglais
Source: Medsafe (Medicines Safety Authority)
Zoledronic acid monohydrate 0.8528 mg/mL equivalent to zoledronic acid 0.8 mg/mL;
Viatris Limited
Zoledronic acid monohydrate 0.8528 mg/mL (= zoledronic acid 0.8 mg/mL)
4 mg/5mL
Concentrate for infusion
Active: Zoledronic acid monohydrate 0.8528 mg/mL equivalent to zoledronic acid 0.8 mg/mL Excipient: Hydrochloric acid Sodium citrate Sodium hydroxide Water for injection
Vial, glass, single dose, 15 ml clear Type 1 with TFE/ethylene polymer coated bromo-butyl stopper, Al crimp seal and flip-cap, 1
Prescription
Prescription
Sun Pharmaceutical Industries Ltd
· Treatment of tumour-induced hypercalcaemia.
Package - Contents - Shelf Life: Vial, glass, single dose, 15 ml clear Type 1 with TFE/ethylene polymer coated bromo-butyl stopper, Al crimp seal and flip-cap - 1 dose units - 24 months from date of manufacture stored at or below 25°C 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) - Vial, glass, single dose, 15 ml clear Type 1 with TFE/ethylene polymer coated bromo-butyl stopper, Al crimp seal and flip-cap - 4 dose units - 24 months from date of manufacture stored at or below 25°C 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) - Vial, glass, single dose, 15 ml clear Type 1 with TFE/ethylene polymer coated bromo-butyl stopper, Al crimp seal and flip-cap - 10 dose units - 24 months from date of manufacture stored at or below 25°C 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze)
2011-11-18
Page 1 of 5 NEW ZEALAND CONSUMER MEDICINE INFORMATION ZOLEDRONIC ACID VIATRIS _ZOLEDRONIC ACID CONCENTRATE FOR INFUSION 4MG/5ML_ WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you start being given Zoledronic Acid Viatris. This leaflet answers some common questions about Zoledronic Acid Viatris. The information in this leaflet was last updated on the date listed on the final page. More recent information on the medicine may be available. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you being given Zoledronic Acid Viatris against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT ZOLEDRONIC ACID VIATRIS IS USED FOR Zoledronic Acid Viatris is used to lower the amount of calcium in the blood when it becomes too high, as may happen in some forms of cancer. Some cancers can speed up normal changes in bone so that the amount of calcium released from the bones into the blood is increased. Zoledronic Acid Viatris is also used to slow down the spread of cancers in bone, helping to prevent changes to the bones that may cause them to weaken. Zoledronic Acid Viatris contains the active ingredient zoledronic acid. It belongs to a group of medicines called bisphosphonates, which strongly bind to bone. These medicines slow down the rate of bone change and help to restore the amount of calcium in the blood to normal levels. It is used in people with advanced cancer of the bone marrow (called multiple myeloma) and other advanced cancers that have spread to the bone. This medicine is used in addition to other standard cancer treatments. Your doctor may have prescribed it for another reason. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. This medicine is available Lire le document complet
Page 1 of 17 NEW ZEALAND DATA SHEET ZOLEDRONIC ACID VIATRIS 1. PRODUCT NAME ZOLEDRONIC ACID VIATRIS, 4 mg/ 5 mL, concentrate for infusion. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL of concentrate for infusion contains 0.8 mg of zoledronic acid (calculated as the anhydrous form, corresponding to 0.8528 mg zoledronic acid monohydrate). Each 5 mL vial contains 4 mg of zoledronic acid (calculated as the anhydrous form, corresponding to 4.264 mg zoledronic acid monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM ZOLEDRONIC ACID VIATRIS concentrate for infusion is a sterile clear and colourless solution. 4. CLINICAL PARTICULARS _4.1 _ _THERAPEUTIC INDICATIONS_ ADULTS Prevention of skeletal-related events (pathological fracture, spinal cord compression, radiation to bone or surgery to bone) in patients with advanced malignancies involving bone. Treatment of tumour-induced hypercalcaemia. _4.2_ _DOSE AND METHOD OF ADMINISTRATION_ ZOLEDRONIC ACID VIATRIS concentrate for infusion must not be mixed with calcium or other divalent cation-containing infusion solutions, such as Lactated Ringer’s solution, and should be administered as a single intravenous solution in a line separate from all other drugs. PREVENTION OF SKELETAL RELATED EVENTS IN PATIENTS WITH ADVANCED MALIGNANCIES INVOLVING BONE In adults and elderly patients the recommended dose in the prevention of skeletal related events in patients with advanced malignancies involving bone is 4 mg zoledronic acid. The concentrate must be further diluted with 100 mL 0.9% w/v sodium chloride or 5% w/v glucose solution and given as an intravenous infusion lasting no less than 15 minutes every 3 to 4 weeks. Patients should also be administered an oral calcium supplement of 500 mg and 400 IU vitamin D daily. Page 2 of 17 TREATMENT OF TUMOUR-INDUCED HYPERCALCEMIA (TIH) In adults and elderly patients the recommended dose in hypercalcemia (albumin-corrected serum calcium ≥12.0 mg/dL or 3.0 mmol/L) is 4 mg zoledronic acid. The Lire le document complet