Country: Awstralja
Lingwa: Ingliż
Sors: Department of Health (Therapeutic Goods Administration)
pentetic acid, Quantity: 5 mg
Global Medical Solutions Australia Pty Limited T/A Radpharm Scientific
Pentetic acid
Injection, powder for
Excipient Ingredients: stannous chloride
Intravenous
8mL x 5
Not scheduled. Not considered by committee
INDICATIONS AS AT 25 SEPTEMBER 1996: Technetium (99mTc) pentetate may be used as a renal perfusion imaging pharmaceutical.
Visual Identification: Lyophilised white powder; Container Type: Vial; Container Material: Glass Type I Coloured; Container Life Time: 1 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
1991-09-05
RADPHARM DTPA 1 RADPHARM DTPA KIT FOR PRODUCTION OF TECHNETIUM (99MTC) PENTETATE POWDER FOR INJECTION MULTIDOSE VIAL 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. 1. WHY AM I USING RADPHARM DTPA? RADPHARM DTPA contains the active ingredient Pentetic acid. RADPHARM DTPA after mixing with Technetium (99mTc) is used in renal perfusion imaging. For more information, see Section 1. Why am I using RADPHARM DTPA? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE RADPHARM DTPA? Do not use if you have ever had an allergic reaction to RADPHARM DTPA 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, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I use RADPHARM DTPA? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with RADPHARM DTPA 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 RADPHARM DTPA? • Your doctor or health care provider will decide how much RADPHARM DTPA you will be given. This depends on your condition and other factors, such a weight More instructions can be found in Section 4. How do I use RADPHARM DTPA? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING RADPHARM DTPA? THINGS YOU SHOULD DO • Inform your doctor or health care provider immediately if you do not feel well during the injection or after being given RADPHARM DTPA. THINGS YOU SHOULD NOT DO • Do not take any other medicines until advised by your doctor. DRIVING OR USING MACHINES • Do not drive or operate machinery until you know how RADPHARM DTPA affects you. For more information, see Section 5. What should I know while using RADPHARM DTPA? in the full CMI. 6. ARE THERE ANY SIDE EFFECTS? Reported side effects of RADPHAR Aqra d-dokument sħiħ
1 AUSTRALIAN PRODUCT INFORMATION – RADPHARM DTPA KIT FOR THE PRODUCTION OF TECHNETIUM (99MTC) PENTETATE POWDER FOR INJECTION MULTIDOSE VIAL (PENTETIC ACID) 1 NAME OF THE MEDICINE Pentetic acid 2 QUALITATIVE AND QUANTITATIVE COMPOSITION RADPHARM DTPA Kit consists of sterile, pyrogen free, lyophilised ingredients which need reconstitution with sodium pertechnetate (99mTc) injection to produce a technetium [99mTc] pentetate complex. The precise structure of the technetium[ 99m Tc] pentetate complex is not known at this time. Each vial contains the following active ingredient and excipient as a lyophilized powder: Active Ingredient 5 mg of Pentetic acid Excipient 1 mg of stannous chloride The product contains no preservatives. 3 PHARMACEUTICAL FORM Radpharm DTPA is available as a dry white lyophilised powder in multi-dose 8mL vacuum sealed vials for intravenous injection. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Technetium[99mTc] pentetate may be used as a renal perfusion imaging pharmaceutical. 2 4.2 D OSE AND METHOD OF ADMINISTRATION Recommended intravenous dose for the normal adult is 200MBq. RADIATION DOSIMETRY Table 1. Estimated Absorbed Dose from Intravenous Administration of Technetium[ 99m Tc] Pentetate Organ mGy/200MBq Adrenals 0.28 Bladder wall 13 Bone surfaces 0.34 Breast 0.19 GI-tract: Stomach wall Small intestine ULI wall LLI wall 0.26 0.52 0.44 0.84 Kidneys 0.88 Liver 0.26 Lungs 0.2 Ovaries 0.86 Pancreas 0.3 Red marrow 0.5 Spleen 0.28 Testes 0.56 Thyroid 0.16 Uterus 1.58 Other Tissue 0.34 EFFECTIVE DOSE 1.04 MSV/200MBQ Reference for Estimated Absorbed Dose: ICRP Publication 53, Radiation Dose to Patients from Radiopharmaceuticals (1987). Reference for Effective Dose: ICRP Publication 62, Radiological Protection in Biomedical Research (1993). PROCEDURE NOTE: If there is no vacuum, discard vial and do not deliver the sodium pertechnetate[ 99m Tc] injection. 1. Place Radpharm DTPA vial in a shielding container. 2. Draw a suitable volume (1 to 4 mL) of sodium pertechnetate [ 99m Tc] injection e Aqra d-dokument sħiħ