Pays: Australie
Langue: anglais
Source: Department of Health (Therapeutic Goods Administration)
thallous(201Tl) chloride, Quantity: 74 MBq/mL
Global Medical Solutions Australia Pty Limited
thallous(201Tl) chloride
Injection, solution
Excipient Ingredients: sodium chloride; water for injections; sodium hydroxide; hydrochloric acid; benzyl alcohol
Intravenous
244MBq/3.3mL, 407MBq/5.5mL, 326MBq/4.4mL, 570MBq/7.7mL, 163MBq/2.2mL, 733MBq/9.9mL
Not scheduled. Not considered by committee
Thallous [201Tl] Chloride Injection may be useful in myocardial perfusion imaging and for the diagnosis and localization of myocardial infarction. It may also be useful in conjunction with exercise stress testing as an adjunct to the diagnosis of ischemic heart disease. Thallous [201Tl] Chloride Injection may be useful for the localization of areas of parathyroid hyperactivity and for parathyroid imaging in patients with biochemically proven hyper-parathyroidism.
Visual Identification: A clear colourless solution; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 5 Days; Container Temperature: Store below 25 degrees Celsius
Registered
2004-11-26
THALLIUM CHLORIDE TL 201 INJECTION, USP Thallous Chloride Tl 201 CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some of the common questions about Thallous Chloride Tl 201. It does not contain all of the available information about Thallous Chloride Tl 201. It does not replace talking to your doctor. All medicines have risks and benefits. Your doctor has weighed the risks of you receiving Thallous Chloride Tl 201 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 THALLOUS CHLORIDE TL 201 Thallous Chloride Tl 201 Injection contains an isotope of the element Thallium and belongs to a group of medicines called radiopharmaceutical agents, which are all radioactive. WHAT THALLOUS CHLORIDE TL 201 IS USED FOR Thallous Chloride Tl 201 is used to show the blood flow inside your heart during exercise and rest. Thallous Chloride Tl 201 can be used to show areas of increased activity in the parathyroid glands. Your parathyroid glands are situated in your neck. Your doctor may have prescribed Thallous Chloride Tl 201 for another purpose. Ask your doctor if you have any questions about why Thallous Chloride Tl 201 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 THALLOUS CHLORIDE TL 201 Before you are given Thallous Chloride Tl 201 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. Thallous Chloride Tl 201 is not recommended for patients less than 18 years of age. If your doctor believes it is necessary to give Thallous Chloride Tl 201 to a patient under 18, he or she will discuss the benefits and risks with you. 2 YOU MUST TELL YOUR DOCTOR IF YOU HAVE ALLERGIES TO: any other medicines any other substances su Lire le document complet
1 AUSTRALIAN PRODUCT INFORMATION – LANTHEUS THALLIUM (THALLOUS (201TI) CHLORIDE) SOLUTION FOR INJECTION 1 NAME OF THE MEDICINE Thallous (201Tl) chloride 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Thallous Chloride Tl 201 Injection for intravenous administration is supplied as a sterile, non- pyrogenic isotonic solution containing 74MBq/mL of Thallous Chloride Tl 201 at calibration time. It is made isotonic with 9mg/mL sodium chloride and is preserved with 9mg/mL of benzyl alcohol. The pH is adjusted to between 4.5-7.5 with hydrochloric acid and/or sodium hydroxide solution. Thallium Tl 201 is cyclotron produced with no carrier added and contains no less than 98% Thallium Tl 201 as a percentage of total activity with contaminants not greater than 0.3% Thallium Tl 200 0.84% Thallium Tl 202, and 0.2% Lead Pb 203 expressed as a percentage of Tl 201 activity at calibration. 3 PHARMACEUTICAL FORM Clear and colourless solution for intravenous injection. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Thallous Chloride Tl 201 Injection may be useful in myocardial perfusion imaging and for the diagnosis and localization of myocardial infarction. It may also be useful in conjunction with exercise stress testing as an adjunct to the diagnosis of ischemic heart disease. Thallous Chloride Tl 201 Injection may be useful for the localization of areas of parathyroid hyperactivity and for parathyroid imaging in patients with biochemically proven hyper- parathyroidism. 4.2 D OSE AND METHOD OF ADMINISTRATION The recommended adult (70 kg) dose of intravenous Thallous Chloride Tl 201 Injection is 37 to 74MBq. Thallous Chloride Tl 201 Injection is intended for intravenous administration only. As for all parenteral drug products, contents of the vial should be inspected visually for particulate matter and discoloration prior to administration. The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration. 2 MYOCARDIAL IMAGING For patients undergoing resting thallium studies Lire le document complet