Land: Nýja-Sjáland
Tungumál: enska
Heimild: Medsafe (Medicines Safety Authority)
Pamidronic acid 25.27mg equivalent to 30 mg disodium pamidronate
Boucher & Muir (New Zealand) Limited t/a BNM Group
Pamidronic acid 25.27 mg (equivalent to 30 mg disodium pamidronate)
30 mg/10mL
Solution for infusion
Active: Pamidronic acid 25.27mg equivalent to 30 mg disodium pamidronate Excipient: Mannitol Phosphoric acid Sodium hydroxide Water for injection
Vial, single dose, type I glass with Bromobutyl rubber stopper, 1x 10ml, 10 mL
Prescription
Prescription
Orchid Chemicals and Pharmaceuticals Limited
Treatment of conditions associated with increased osteoclast activity: · Predominantly lytic bone metastases from breast cancer and advanced multiple myeloma
Package - Contents - Shelf Life: Vial, single dose, type I glass with Bromobutyl rubber stopper, 1x 10ml - 10 mL - 24 months from date of manufacture stored at or below 25°C 8 hours diluted stored at or below 25°C. Shelf life includes infusion time
2011-08-18
1 PAMIDRONATE BNM 31052012 New Zealand Consumer Medicine Information PAMIDRONATE BNM _DISODIUM PAMIDRONATE _ Solution for infusion 15 mg/5 mL, 30 mg/10 mL, 60 mg/10 mL and 90 mg/10 mL WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you start using Pamidronate BNM. This leaflet answers some common questions about Pamidronate BNM. It does not contain all the available information. The most up-to-date Consumer Medicine Information can be downloaded from www.medsafe.govt.nz. Reading this leaflet 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 using Pamidronate BNM against the benefits this medicine is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may want to read it again. WHAT PAMIDRONATE BNM IS USED FOR Pamidronate BNM contains disodium pamidronate, which belongs to a group of medicines called bisphosphonates. It works by slowing down the rate of bone change and helps restore the amount of calcium in the blood to normal. Pamidronate BNM is used in conditions with increased bone changes or pain, including Paget’s disease, advanced cancer of the bone marrow (called multiple myeloma) and advanced breast cancer where the cancer has spread to the bone. Pamidronate BNM can also be used when the amount of calcium in the blood 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. Your doctor may have prescribed this medicine for another reason. ASK YOUR DOC Lestu allt skjalið
1 PAMIDRONATE BNM 31052012 New Zealand Data Sheet PAMIDRONATE BNM Disodium pamidronate 15 mg/5 mL, 30 mg/10 mL, 60 mg/10 mL and 90 mg/10 mL Solution for infusion PRESENTATION(S) Pamidronate BNM solution for infusion is a clear, colourless, sterile solution of disodium pamidronate, mannitol, phosphoric acid and sodium hydroxide in water for injection. Phosphoric acid is added to adjust the pH to 6.4-6.8. The vials are uncoloured, type I glass vial with bromobutyl rubber stopper and flip-off cap. INDICATIONS Treatment of conditions associated with increased osteoclast activity: • Predominantly lytic bone metastases from breast cancer and advanced multiple myeloma • Tumour-induced hypercalcaemia. Acute management of tumour-induced hypercalcaemia (Hypercalcaemia of malignancy). Paget's disease of bone. Treatment of symptomatic Paget’s disease of bone. DOSAGE AND ADMINISTRATION Pamidronate BNM must never be given as a bolus injection since severe local reactions and thrombophlebitis may occur as a result of high local concentrations. Pamidronate BNM should always be diluted and administered by slow intravenous infusion in sodium chloride 0.9% or dextrose 5%. Do not co-administer with other bisphosphonates. If other calcium lowering agents are used in conjunction with pamidronate, significant hypocalcaemia may result. Pamidronate BNM should not be added to intravenous infusion fluids containing calcium. In order to minimise local reactions at the infusion site, the cannula should be inserted carefully into a relatively large vein. _ _ 2 PAMIDRONATE BNM 31052012 _Dosage regimen _ Due to the risk of clinically significant deterioration in renal function which may progress to renal failure, single doses of Lestu allt skjalið