Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
sodium iodide(123I), Quantity: 100 MBq
Australian Nuclear Science and Technology Organisation T/A ANSTO
sodium iodide(123I)
Capsule
Excipient Ingredients: dibasic sodium phosphate heptahydrate; sodium bicarbonate; sodium thiosulfate pentahydrate; sodium hydroxide; purified water; sunset yellow FCF; quinoline yellow; titanium dioxide; brilliant blue FCF; carmoisine; Gelatin; ethanol; Shellac; Pharmaceutical glaze; carbon black
Oral
1 capsule
Not scheduled. Not considered by committee
Sodium Iodide [123] Diagnostic Capsules are for diagnostic imaging of thyroid tissue.
Visual Identification: Capsules - "ari" is printed on a buff opaque body. A radiation symbol is printed on the maroon cap. The print ink is black.; Container Type: Vial; Container Material: Glass; Container Life Time: 48 Hours; Container Temperature: Store below 25 degrees Celsius
Licence status A
2005-05-31
WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Sodium Iodide[ 123 I] Diagnostic Capsules. It does not contain all the available information. It does not take the place of you talking to your nuclear medicine specialist. All medicines and diagnostic agents have risks and benefits. Your referring doctor, in consultation with the nuclear medicine specialist, has weighed the small risks of you having a procedure where you are given a Sodium Iodide[ 123 I] Diagnostic Capsule against the benefits they expect the procedure will have for you. IF YOU HAVE CONCERNS ABOUT BEING GIVEN THIS CAPSULE, DISCUSS THEM WITH YOUR NUCLEAR MEDICINE SPECIALIST. KEEP THIS LEAFLET. You may need to read it again. PRODUCT DESCRIPTION Each Sodium Iodide[ 123 I] Diagnostic Capsule contains sodium iodide[ 123 I], in a solution of sodium thiosulphate, sodium bicarbonate and sodium hydroxide absorbed onto disodium hydrogen phosphate filler in a maroon gelatine capsule about 19 mm long and 6 mm thick. WHAT A SODIUM IODIDE[ 123 I] DIAGNOSTIC CAPSULE IS USED FOR Sodium Iodide[ 123 I] Diagnostic Capsules are used to measure the performance of the thyroid gland. This gland controls the body’s physical and chemical processes. Iodine-123 is a radiotracer. After swallowing, it is taken up by your thyroid gland where it emits small amounts of radiation energy similar to X-rays. This radiation can be detected by a special camera, called a “gamma camera”, and produces an image known as a scan. This scan enables the nuclear medicine specialist to determine how your thyroid gland is functioning. Ask your nuclear medicine specialist if you have any questions about why a Sodium Iodide[ 123 I] Diagnostic Capsule is being given to you or why you have been referred for a scan. BEFORE YOU ARE GIVEN IT Tell your nuclear medicine specialist or technologist if: YOU ARE PREGNANT OR INTEND TO BECOME PREGNANT It is known that this capsule may be harmful to an unborn baby when administered to a pregnant woman. Sodium iodide[ 123 I] wil Read the complete document
Sodium Iodide[ 123 I] Diagnostic Capsules are supplied for oral administration as dark maroon gelatin capsules containing sodium iodide[ 123 I] stabilised by sodium thiosulphate in a sodium bicarbonate solution. The capsule contains the sodium iodide[ 123 I] solution adsorbed on an inert filler of di-sodium hydrogen phosphate (429 – 569 mg) and are supplied with activities in the range 1 to 12 MBq or 100 to 750 MBq at the time of calibration. Each capsule is contained in a glass serum vial sealed with a rubber stopper and aluminium seal. The vial is supplied in a suitably shielded lead pot. Iodine-123 has a physical half-life of 13.2 hours, and has 83.6% disintegrations at an energy level of 159 keV. The specific gamma ray constant for iodine-123 is 7.478E-5 mSv/h per MBq at 1.0 m. The mass attenuation coefficient (µ) in lead is 1.4109 cm -2 /g, 1 and the attenuation factors for lead are as follows: THICKNESS OF LEAD (CM) FACTOR 0.0433 0.5 0.1439 0.1 0.2876 0.01 To correct for the effect of decay multiply the activity on the calibration time and date by the appropriate factor from the table below. _PI_ P RODUCT I NFORMATION HOURS FACTOR HOURS FACTOR 1 0.949 9 0.623 2 0.900 10 0.591 3 0.854 11 0.561 4 0.811 12 0.533 5 0.769 13 0.505 6 0.730 14 0.479 7 0.692 15 0.455 8 0.657 16 0.432 SODIUM IODIDE [ 123 1] DIAGNOSTIC CAPSULES DESCRIPTION PHYSICAL CHARACTERISTICS OF IODINE-123 PHARMACOLOGY PHARMACODYNAMIC PROPERTIES At doses used in diagnostic investigations, sodium iodide has not been observed to exert any pharmacodynamic effects. PHARMACOKINETIC PROPERTIES Absorption of iodide after capsule administration is virtually complete after 1 – 2 hours, but may be delayed if food is present in the stomach, which in turn will alter the radiation dose pattern. Sodium iodide is rapidly absorbed from the gastrointestinal tract into the bloodstream and distributed in the extracellular fluid. A proportion is concentrated by thyroid tissue. Some iodine is also trapped by the stomach and salivary glands. Most of the remaind Read the complete document