Страна: Австралія
мова: англійська
Джерело: Department of Health (Therapeutic Goods Administration)
zoledronic acid monohydrate
Pfizer Australia Pty Ltd
zoledronic acid monohydrate
Registered
DBL™ ZOLEDRONIC ACID IV INFUSION _contains the active ingredient zoledronic acid_ _ _ DBL™ Zoledronic Acid IV Infusion CMI 1 of 3 CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about DBL™ Zoledronic Acid IV Infusion. 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 using DBL™ Zoledronic Acid IV Infusion against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET. You may need to read it again. WHAT DBL™ ZOLEDRONIC ACID IV INFUSION IS USED FOR DBL™ Zoledronic Acid IV Infusion contains the active ingredient zoledronic acid. It belongs to a group of medicines called bisphosphonates which work by stopping the breakdown of bone which can occur in some forms of cancer. In people with advanced cancer involving the bone, DBL™ Zoledronic Acid IV Infusion is used prevent unwanted bone-related events such as fractures, severe back pain and the need for radiation or surgery to the bones. DBL™ Zoledronic Acid IV Infusion can also be used to lower high levels of calcium in the blood due to cancer. Your doctor may have prescribed DBL™ Zoledronic Acid IV Infusion for another purpose. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS REGARDING WHY DBL™ ZOLEDRONIC ACID IV INFUSION HAS BEEN PRESCRIBED FOR YOU. DBL™ Zoledronic Acid IV Infusion is not addictive. This medicine is available only with a doctor’s prescription. BEFORE YOU ARE GIVEN DBL™ ZOLEDRONIC ACID IV INFUSION _WHEN YOU MUST NOT HAVE IT _ DO NOT TAKE OR RECEIVE DBL™ ZOLEDRONIC ACID IV INFUSION IF: YOU HAVE HAD AN ALLERGIC REACTION TO: - zoledronic acid or any of the ingredients listed at the end of this leaflet - any other bisphosphonate medicine Some of the symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty breathing; s Прочитайте повний документ
Version: pfpzolai11120 Superceded: v.3.0 of DBL Zoledronic Acid Concentrated Injection and V 4.0 of DBL Zoledronic acid IV Infusion Page 1 of 23 AUSTRALIAN PRODUCT INFORMATION – DBL™ ZOLEDRONIC ACID (ZOLEDRONIC ACID) 1. NAME OF THE MEDICINE Zoledronic acid. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial of DBL Zoledronic Acid Concentrated Injection contains 4 mg anhydrous zoledronic acid/5 mL, equivalent to 4.264 mg zoledronic acid monohydrate. Each vial contains an overfill to permit withdrawal of the labelled amount of zoledronic acid from the vial. Each bag of DBL Zoledronic Acid IV Infusion contains 4 mg anhydrous zoledronic acid/100 mL, equivalent to 4.264 mg zoledronic acid monohydrate. For the full list of excipients, see section 6.1 List of excipients. 3. PHARMACEUTICAL FORM CONCENTRATED INJECTION DBL Zoledronic Acid Concentrated Injection is a sterile, colourless solution. SOLUTION FOR INFUSION DBL Zoledronic Acid IV Infusion is a clear to colourless solution free from visible particulates. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS DBL Zoledronic Acid is indicated for the: • 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. Version: pfpzolai11120 Superceded: v.3.0 of DBL Zoledronic Acid Concentrated Injection and V 4.0 of DBL Zoledronic acid IV Infusion Page 2 of 23 4.2 DOSE AND METHOD OF ADMINISTRATION DOSAGE PREVENTION OF SKELETAL-RELATED EVENTS IN PATIENTS WITH ADVANCED MALIGNANCIES INVOLVING BONE _Dosage regimen for adults (including elderly patients) _ The recommended dose is 4 mg given as an intravenous infusion lasting no less than 15 minutes, every 3 to 4 weeks. DBL Zoledronic Acid Concentrated Injection must be reconstituted and further diluted with 100 mL 0.9% w/v sodium chloride or 5% w/v glucose solution prior to administration. See Method of administration, Instructions for use and handling. DB Прочитайте повний документ