Χώρα: Αυστραλία
Γλώσσα: Αγγλικά
Πηγή: Department of Health (Therapeutic Goods Administration)
radium (223Ra) dichloride, Quantity: 6600 kBq
Bayer Australia Ltd
radium (223Ra) dichloride
Injection, solution
Excipient Ingredients: water for injections; hydrochloric acid; sodium chloride; sodium citrate dihydrate
Intravenous
1 vial
Not scheduled. Not considered by committee
XOFIGO is indicated for the treatment of castration-resistant prostate cancer patients with symptomatic bone metastases and no known visceral metastatic disease.
Visual Identification: Clear and colourless solution; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 28 Days; Container Temperature: Store below 40 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2014-05-20
190102 XOFIGO CMI Page 1 of 4 XOFIGO ® (ZO-FEE-GO) _RADIUM (223RA) DICHLORIDE _ _ _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about XOFIGO. 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 XOFIGO against the benefits your doctor expects it will have for you. IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN THIS MEDICINE, ASK YOUR DOCTOR. KEEP THIS LEAFLET. You may need to read it again. WHAT XOFIGO IS USED FOR XOFIGO is used to treat prostate cancer that has not responded to hormone therapy. XOFIGO is only used when the disease has spread to the bone but is not known to have spread to other internal organs, and is causing symptoms (e.g. pain). XOFIGO contains small amounts of the radioactive isotope radium-223 [223Ra] (as radium-223 dichloride) which mimics calcium. Radium-223 goes to where the tumour cells are growing in the bone and releases short-ranging radioactivity (alpha particles) which is toxic to the cells. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. BEFORE YOU ARE GIVEN XOFIGO _WHEN YOU MUST NOT BE _ _GIVEN IT _ IF YOU ARE NOT SURE WHETHER YOU SHOULD BE GIVEN THIS MEDICINE, TALK TO YOUR DOCTOR. You should not be given XOFIGO if you are taking abiraterone acetate together with prednisone or prednisolone. YOU MUST NOT BE GIVEN XOFIGO IF: • the packaging is torn or shows signs of tampering • the expiry date printed on the pack after “EXP” has passed If you are given XOFIGO after the expiry date has passed, it may not work as well. The hospital or clinic where you will be receiving XOFIGO will make sure that XOFIGO is not used if the expiry date printed on the pack has passed or if the packaging is torn or shows signs of tampering. XOFIGO is not to be used in women. The safety and effic Διαβάστε το πλήρες έγγραφο
1901 XOFIGO PI 1 AUSTRALIAN PRODUCT INFORMATION XOFIGO SOLUTION FOR INJECTION (Radium (223Ra) dichloride 6.6 MBq/6 mL) 1 NAME OF THE MEDICINE XOFIGO Solution for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL of solution contains 1100 kBq radium (223Ra) dichloride (Ra-223 dichloride), corresponding to 0.58 ng Ra-223, at the reference date. Radium is present in the solution as a free ion. Ra-223 is an alpha particle-emitter with a half-life of 11.4 days. The specific activity of Ra-223 is 1.9 MBq/ng. The six-stage-decay of Ra-223 to lead-207 occurs via short-lived daughters and is accompanied by a number of alpha, beta and gamma emissions with different energies and emission probabilities. The fraction of energy emitted from Ra-223 and its daughters as alpha-particles is 95.3% (energy range of 5.0 - 7.5 MeV). The fraction emitted as beta-particles is 3.6% (average energies are 0.445 MeV and 0.492 MeV), and the fraction emitted as gamma-radiation is 1.1% (energy range of 0.01 - 1.27 MeV). FIGURE 1: RADIUM-223 DECAY CHAIN WITH PHYSICAL HALF-LIVES AND MODE OF DECAY: For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 1901 XOFIGO PI 2 3 PHARMACEUTICAL FORM XOFIGO is a clear, colourless and sterile isotonic solution for injection with pH between 6 and 8. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS XOFIGO is indicated for the treatment of castration-resistant prostate cancer patients with symptomatic bone metastases and no known visceral metastatic disease. 4.2 DOSE AND METHOD OF ADMINISTRATION DOSAGE (DOSE AND INTERVAL) The dose regimen of XOFIGO is 55 kBq per kg body weight, given at 4 week intervals for 6 injections. Safety and efficacy beyond 6 injections have not been studied. For details on the calculation of the volume to be administered, see Method of administration. _Additional information on special populations _ No dose adjustment is considered necessary in the elderly or in patients with renal or hepatic impairment (see Section 5.2 PHARMACOKINETIC PROPERTIES). METHOD OF Διαβάστε το πλήρες έγγραφο