Nchi: Australia
Lugha: Kiingereza
Chanzo: Department of Health (Therapeutic Goods Administration)
tetrakis(2-methoxyisobutylisonitrile) copper(1) tetrafluoroborate, Quantity: 1 mg
Landauer Radiopharmaceuticals Pty Ltd
Tetrakis(2-methoxyisobutylisonitrile) copper(1) tetrafluoroborate
Injection, powder for
Excipient Ingredients: stannous chloride dihydrate; cysteine hydrochloride monohydrate; sodium citrate dihydrate; mannitol; hydrochloric acid; sodium hydroxide
Intravenous
5 vials
Not scheduled. Not considered by committee
Technetium [99m Tc] Sestamibi is indicated for use in conjunction with stress testing as an adjunct in the diagnosis of ischaemic heart disease. In these patients additional information about ventricular function may be derived by using the first pass technique. Technetium [99m Tc] Sestamibi is indicated as a second line diagnostic aid to assist in the evaluation of patients for whom mammography is inconclusive.
Visual Identification: White to almost white lyophilised powder or pellet; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Registered
2011-09-13
Technescan ® Sestamibi 1/4 TECHNESCAN ® SESTAMIBI KIT FOR THE PREPARATION OF TECHNETIUM [ 99M TC] SESTAMIBI INJECTION CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some of the common questions about TECHNESCAN ® SESTAMIBI. It does not contain all of the available information about TECHNESCAN ® SESTAMIBI. It does not replace talking to your doctor. All medicines have risks and benefits. Your doctor has weighed the risks of you or your child receiving TECHNESCAN ® SESTAMIBI against the benefits he or she expects it will have. IF YOU HAVE ANY CONCERNS ABOUT HAVING THIS MEDICINE, ASK YOUR DOCTOR. KEEP THIS LEAFLET. You may need to read it again. WHAT IS TECHNESCAN ® SESTAMIBI TECHNESCAN ® SESTAMIBI is a kit for radiopharmaceutical preparation. This kit contains an active ingredient (non-radionuclide) called tetrakis (2-methoxyisobutyl isonitrile) copper (I) tetrafluoroborate to which a solution containing another ingredient called a radionuclide is added to give the final radiopharmaceutical preparation, TECHNETIUM [ 99m Tc] SESTAMIBI INJECTION. The radiopharmaceutical preparation is administered to you as an injection. A radionuclide is radioactive. The radionuclide in TECHNETIUM [ 99m Tc] SESTAMIBI INJECTION is called pertechnetate ( 99m Tc). WHAT IS TECHNESCAN ® SESTAMIBI USED FOR TECHNESCAN ® SESTAMIBI is used to show the blood flow inside your heart during exercise and rest. It can be used to show the presence and size of any breast cancer. Your doctor may have prescribed TECHNESCAN ® SESTAMIBI for an other purpose. Ask your doctor if you have any questions about why TECHNESCAN ® SESTAMIBI has been prescribed for you. If you have any concerns, you should discuss these with your doctor. This medicine is only available with a doctors prescription. Technescan ® Sestamibi 2/4 BEFORE YOU ARE GIVEN TECHNESCAN ® SESTAMIBI Before you are given TECHNESCAN ® SESTAMIBI your doctor will explain to you the procedure you are about to undergo, and the radioactive medicine you will be Soma hati kamili
TECHNESCAN ® SESTAMIBI 1(18) AUSTRALIAN PRODUCT INFORMATION TECHNESCAN ® SESTAMIBI (TETRAKIS (2-METHOXYISOBUTYLISONITRILE) COPPER(1) TETRAFLUOROBORATE) 1 NAME OF THE MEDICINE Tetrakis (2-methoxyisobutylisonitrile) copper (I) tetrafluoroborate. The abbreviated notation is [Cu(MIBI) 4 ]BF 4 (where MIBI is 2-methoxyisobutylisonitrile). 2 QUALITATIVE AND QUANTITATIVE COMPOSITION TECHNESCAN ® SESTAMIBI is a kit for radiopharmaceutical preparation of Technetium [ 99m Tc] Sestamibi Injection. Each vial contains 1 mg of tetrakis (2-methoxyisobutylisonitrile) copper (I) tetrafluoroborate. TECHNESCAN ® SESTAMIBI is a sterile, nonpyrogenic, lyophilised white powder. After reconstitution of the radiopharmaceutical kit with sterile, non-pyrogenic, oxidant free Sodium Pertechnetate ( 99m Tc) Injection, the solution for injection is clear and colourless and a complex of the MIBI and Technetium-99m forms yielding Technetium [ 99m Tc] Sestamibi ([Tc-99m (MIBI) 6 ] + Cl - ). The pH of the reconstituted product is 5.5 (5.0 to 6.0). No bacteriostatic preservative is present. The contents of the vial are stored under nitrogen. For the full list of excipients, see section 6.1 List of Excipients _PHYSICAL CHARACTERISTICS _ Technetium ( 99m Tc) decays by isomeric transition with a physical half-life of 6 hours. Photons associated with this transition which are useful for detection and imaging studies are listed in Table 1. _Table 1. Principal Radiation Emission Data_ _1_ _ _ PRINCIPAL RADIATION M MEAN %/DISINTEGRATION MEAN ENERGY (KEV) Gamma-2 87.2 140.5 1 Browne E., Firestone R.B., and Shirley V.S., (Ed.) Table of Radioactive Isotopes, 1986, J. Wiley keV=Kilo Electron Volt _ _ TECHNESCAN ® SESTAMIBI 2(18) _Table 2. Physical Decay Chart; _ _99m_ _Tc Half-Life 6 Hours _ HOURS FRACTION REMAINING HOURS FRACTION REMAINING 0* 1.000 7 0.445 1 0.891 8 0.397 2 0.794 9 0.354 3 0.707 10 0.315 4 0.630 11 0.281 5 0.561 12 0.250 6 0.500 _*Calibration time _ _EXTERNAL RADIATION _ The specific gamma ray constant for 99m Tc is 0.19 milligray ( mGy Soma hati kamili