Land: Australien
Sprog: engelsk
Kilde: Department of Health (Therapeutic Goods Administration)
Tetrakis(2-methoxyisobutylisonitrile) copper(1) tetrafluoroborate
Lantheus MI Australia Pty Ltd
Medicine Registered
CARDIOLITE Technetium Tc-99m Sestamibi CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some of the common questions about Cardiolite. It does not contain all of the available information about Cardiolite. 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 Cardiolite 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 CARDIOLITE Cardiolite contains the active ingredient called _Technetium Tc-99m_ _Sestamibi_ and belongs to a group of medicines called radiopharmaceutical agents, which are all radioactive. Cardiolite comes in a kit, containing ingredients that are mixed with a radioactive solution before being given to you as an injection. WHAT CARDIOLITE IS USED FOR Cardiolite is used to show the blood flow inside your heart during exercise and rest. Cardiolite can be used to show the presence and size of any breast cancer. Your doctor may have prescribed Cardiolite for another purpose. Ask your doctor if you have any questions about why Cardiolite has been prescribed for you. If you have any concerns, you should discuss these with your doctor. This medicine is only available with a doctor’s prescription. BEFORE YOU ARE GIVEN CARDIOLITE Before you are given Cardiolite your doctor will explain to you the procedure you are about to undergo, and the radioactive medicine you will be given. You must discuss any concerns you have with your doctor. Cardiolite is not recommended for patients less than 18 years of age. If your doctor believes it is necessary to give Cardiolite to a patient under 18, he or she will discuss the Læs hele dokumentet
512358-0811 AUGUST 2011 CARDIOLITE® KIT FOR THE PREPARATION OF TECHNETIUM [99MTC] SESTAMIBI FOR INJECTION DESCRIPTION: Each vial contains a sterile, non-pyrogenic, lyophilized mixture of: Tetrakis (2-methoxy isobutyl isonitrile) Copper (I) Tetrafluoroborate - 1.0mg Tin (II) Chloride - 0.075mg Sodium Citrate - 2.6mg Cysteine Hydrochloride - 1.0mg Mannitol - 20mg The product contains no preservatives. Prior to lyophilization the pH is 5.3 to 5.9. The contents of the vial are lyophilized and stored under nitrogen. This drug is administered by intravenous injection for diagnostic use after reconstitution with sterile, non-pyrogenic, oxidant-free Sodium Pertechnetate 99m Tc Injection. The precise structure of the technetium complex is 99m Tc[MIBI] 6 + where MIBI is 2-methoxy isobutyl isonitrile. 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 below: TABLE 1. PRINCIPAL RADIATION EMISSION DATA Principal Mean% / Mean Radiation Disintegration Energy (keV) Gamma-2 87.2 140.5 Reference: Browne E., Firestone R.B., and Shirley V.S., (Ed.) Table of Radioactive Isotopes, 1986, J. Wiley TABLE 2. PHYSICAL DECAY CHART; 99M TC HALF-LIFE 6 HOURS Fraction Fraction Hours Remaining Hours Remaining 0* 1.000 8 .397 1 .891 9 .354 2 .794 10 .315 3 .707 11 .281 4 .630 12 .250 5 .561 6 .500 7 .445 *Calibration Time EXTERNAL RADIATION The specific gamma ray constant for 99m Tc is 0.19 mGy pe Læs hele dokumentet