Country: Australia
Bahasa: Inggeris
Sumber: Department of Health (Therapeutic Goods Administration)
tetrakis(2-methoxyisobutylisonitrile) copper(1) tetrafluoroborate, Quantity: 1 mg
Global Medical Solutions Australia Pty Limited T/A Radpharm Scientific
Injection, powder for
Excipient Ingredients: cysteine hydrochloride; stannous chloride dihydrate; sodium citrate dihydrate; mannitol
Intravenous
2, 5 and 30
Not scheduled. Not considered by committee
Technetium (99mTc) 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. INDICATIONS AS AT 23 NOVEMBER 1999: Technetium [99mTc] 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 [99mTc] Sestamibi is indicated as a second line diagnostic aid to assist in the evaluation of patients for whom mammography is inconclusive.
Visual Identification: White powder or plug.; Container Type: Vial; Container Material: Glass; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Registered
1994-10-18
CARDIOLITE 1 CARDIOLITE KIT FOR PREPARATION OF TECHNETIUM (99MTC) SESTAMIBI INJECTION CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. This medicine is new or being used differently. Please report side effects. See the full CMI for further details. 1. WHY AM I USING [MEDICINE NAME]? CARDIOLITE contains the active ingredient tetrakis(2-methoxyisobutylisonitrile) copper(1) tetrafluoroborate. CARDIOLITE is used show the blood flow inside your heart during exercise and rest and the presence and size of any breast cancer. For more information, see Section 1. Why am I using [medicine name]? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE CARDIOLITE ? Do not use if you have ever had an allergic reaction to CARDIOLITE or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, ARE PREGNANT OR PLAN TO BECOME PREGNANT AND ARE BREASTFEEDING OR PLAN TO BREASTFEED. For more information, see Section 2. What should I know before I use [medicine name]? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with CARDIOLITE and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE CARDIOLITE ? • Your doctor will decide how much you will be given. This depends on your condition and other factors, such as weight. • CARDIOLITE is given as an injection into a vein. More instructions can be found in Section 4. How do I use [medicine name]? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING CARDIOLITE ? THINGS YOU SHOULD DO • Remind any doctor you visit that you are allergic Cardiolite or any of the ingredients listed at the end of this leaflet. • Tell your doctor if you have heart disease. • Tell your doctor as soon as possible if you do not feel well during the inject Baca dokumen lengkap
1 AUSTRALIAN PRODUCT INFORMATION – CARDIOLITE KIT FOR PREPARATION OF TECHNETIUM (99MTC) SESTAMIBI INJECTION VIAL [TETRAKIS(2-METHOXYISOBUTYLISONITRILE) COPPER(1) TETRAFLUOROBORATE] INTRAVENOUS INJECTION POWDER 1 NAME OF THE MEDICINE Tetrakis (2-Methoxyisobutylisonitrile) Copper (1) Tetrafluoroborate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains a non-radioactive sterile, non-pyrogenic, lyophilized powder of Tetrakis (2- methoxyisobutyl isonitrile) Copper (I) Tetrafluoroborate, It contains no preservative. Prior to lyophilization the pH is 5.3 to 5.9. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM White powder or plug for the preparation of technetium (99mTc) sestamibi intravenous injection. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS a) Technetium [ 99m Tc] Sestamibi is indicated for use in conjunction with stress testing as an adjunct in the diagnosis of ischemic heart disease. In these patients additional information about ventricular function may be derived by using the first pass technique. b) Technetium [ 99m Tc] Sestamibi is indicated as a second line diagnostic aid to assist in the evaluation of patients for whom mammography is inconclusive. 4.2 D OSE AND METHOD OF ADMINISTRATION This drug is administered by intravenous injection for diagnostic use after reconstitution with sterile, non-pyrogenic, oxidant-free Sodium Pertechnetate 99mTc Injection. a) Dose for Cardiac Imaging: The suggested dose range for I.V. administration to be employed in the average patient (70 Kg) is: 370-1110 MBq For diagnosis of ischemic heart disease, two injections (exercise and rest) are required in order to differentiate transiently from persistently reduced myocardial uptake. After the injection, exercise if used should be encouraged for an additional one to two minutes. 2 The patient dose should be measured by a suitable radioactivity calibration system immediately prior to patient administration. Radiochemical purity should be checked prior to patient admin Baca dokumen lengkap