国家: 澳大利亚
语言: 英文
来源: Department of Health (Therapeutic Goods Administration)
sodium oxidronate, Quantity: 3.15 mg
Global Medical Solutions Australia Pty Limited T/A Radpharm Scientific
sodium oxidronate
Injection, powder for
Excipient Ingredients: sodium chloride; stannous chloride dihydrate; dilute hydrochloric acid; gentisic acid; sodium hydroxide
Intravenous
30 x 10 mL vials, 10 x 10 mL vials
Not scheduled. Not considered by committee
Technetium [99m Tc] Sodium Oxidronate is a diagnostic skeletal imaging agent to demonstrate areas of altered osteogenesis in adult patients.
Visual Identification: fine white powder in glass vials; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 1 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2011-08-15
RADPHARM HDP RADPHARM HDP kit for the preparation of Technetium [ 99m Tc] Oxidronate injection _Sodium Oxidronate_ _ _ _ _ Consumer Medicine Information_ _ RADPHARM SCIENTIFIC CMI 08.11 1 _What is in this Leaflet _ This leaflet answers some common questions about RADPHARM HDP. It does not contain all of the available information and does not take the place of talking to your doctor or nuclear medicine specialist. All medicines, including diagnostic agents, have risks and benefits. Your referring doctor, in consultation with the nuclear medicine specialist, has weighed the risks of giving you RADPHARM HDP injection, against the benefits they expect the procedure will have for you. IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN RADPHARM HDP, DISCUSS WITH YOUR DOCTOR AND/OR NUCLEAR MEDICINE SPECIALIST. KEEP THIS LEAFLET AS YOU MAY NEED TO REFER TO IT AGAIN. _ _ _What is RADPHARM HDP _ RADPHARM HDP belongs to a group of medicines called radiopharmaceuticals. RADPHARM HDP is only available through a doctor’s prescription. RADPHARM HDP contains the active ingredient, sodium oxidronate and is reconstituted with sodium pertechnetate ( 99m Tc) prior to injection. Once reconstituted, the product becomes radioactive. _ _ _What RADPHARM HDP is used for _ RADPHARM HDP is used in conjunction with an imaging agent to detect alterations of the skeletal system in adults. The imaging agent used is a radiotracer called Technetium-99m. Technetium-99m emits small amounts of radiation similar to x-rays which can be detected by a special camera (gamma camera) to produce an image known as a scan. A nuclear medicine specialist interprets these scans and provides information related to your referral. Your nuclear medicine specialist may be giving you RADPHARM HDP to help diagnose other conditions. Ask your nuclear medicine specialist if you have any questions about why RADPHARM HDP is being given to you and why you have been referred for a scan. _ _ _Before receiving RADPHARM HDP _ Tell your nuclear medicine specialist or technologist if; 1 阅读完整的文件
1 AUSTRALIAN PRODUCT INFORMATION – RADPHARM HDP SODIUM OXIDRONATE 3.15 MG KIT FOR THE PREPARATION OF TECHNETIUM (99M TC) OXIDRONATE FOR INJECTION (SODIUM OXIDRONATE) 1 NAME OF THE MEDICINE sodium oxidronate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Radpharm HDP is supplied as sterile, pyrogen free, lyophilised powder, under nitrogen in borosilicate Type 1 glass 10mL vial for intravenous injection following reconstitution with non-pyrogenic 99mTc as pertechnetate sodium (99mTcO4-). Each 10mL tinted vial contains: Sodium oxidronate 3.15mg as an active ingredient; Stannous chloride dihydrate 0.297mg, Gentisic acid 0.84mg and Sodium chloride 29mg as excipients. The reconstituted product is a clear, colourless liquid. Radpharm HDP contains no antimicrobial preservatives 3 PHARMACEUTICAL FORM Fine white powder in glass vials. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Technetium [99mTc] Sodium Oxidronate may be used as a skeletal imaging agent to delineate areas of altered osteogenesis in adult patients. 4.2 D OSE AND METHOD OF ADMINISTRATION ADULT: The recommended intravenous dose of Technetium [99mTc] Sodium Oxidronate for the average adult patient (70kg) is 555MBq, with a minimum administered activity of 370MBq and maximum administered activity is 740MBq. The administered dose of Sodium Oxidronate should not exceed 0.05mg/kg. GENERAL INSTRUCTIONS : The administered dose of Sodium Oxidronate is between 0.001-0.05mg/kg. The ideal administered dose of Sodium Oxidronate is 0.005mg/kg. The radioactivity of each dose should be measured by an appropriate radiation calibration system immediately prior to administration. The dose should be administered intravenously by slow injection. For optimal results bone imaging should be performed 1-4 hours post-injection. 2 RADIATION DOSIMETRY The estimated absorbed radiation doses and effective doses from an intravenous administration of Technetium [99mTc] Sodium Oxidronate are presented in Table 1 . Table 1: Estimated absorbed radiation dose per unit administered activit 阅读完整的文件