País: Austrália
Língua: inglês
Origem: Department of Health (Therapeutic Goods Administration)
gallium (67Ga) citrate, Quantity: 100 MBq/mL
Australian Nuclear Science and Technology Organisation T/A ANSTO
gallium (67Ga) citrate
Injection, solution
Excipient Ingredients: benzyl alcohol; sodium hydroxide; sodium citrate dihydrate; water for injections
Intravenous
400MBq/4mL x 1 vial, 100MBq/1mL x 1 vial, 800MBq/8mLx1 vial, 200MBq/2mL x 1 vial, 300MBq/3mLx1 vial
Not scheduled. Not considered by committee
(As per R46108) Gallium (67Ga) Citrate Injection BP may be useful in demonstrating the presence and extent of Hodgkin's Disease, lymphomas and bronchogenic carcinoma. Positive intake in the absence of prior symptoms may indicate a potential disease state. New indications as specified in the letter of 18 October 1993 from Dr Alex Proudfoot: Gallium (67Ga) Citrate Injection BP may be useful in demonstrating the presence and extent of Hodgkin's Disease, lymphomas and bronchogenic carcinoma. Positive uptake in the absence of prior symptoms may indicate a potential disease state. Gallium (67Ga) may also be useful as an aid in detecting some acute inflammatory lesions. Gallium (67Ga) Citrate Injection BP may also be useful as an aid in detecting some acute inflammatory lesions. (As per R46110) Gallium (67Ga) Citrate Injection BP may be useful in demonstrating the presence and extent of Hodgkin's Disease, lymphomas and bronchogenic carcinoma. Positive uptake in the absence of prior symptoms may indicate a potent
Visual Identification: 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
1993-11-16
1 GALLIUM [ 67 GA] CITRATE INJECTION BP WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Gallium ( 67 Ga) injection. It does not contain all the available information. It does not take the place of you talking to your nuclear medicine physician or specialist. All medicines have potential risks and benefits associated with their use. Your nuclear medicine physician or specialist has weighed the small risks of you being treated with Gallium ( 67 Ga) against the benefits it is expected you will receive from it. If you have any concerns about being given this injection, discuss them with your nuclear medicine physician or specialist. KEEP THIS LEAFLET. You may need to read it again. WHAT IS GALLIUM ( 67 GA) INJECTION USED FOR Gallium ( 67 Ga) Citrate BP is a diagnostic radiopharmaceutical, which emits small amount of energy similar to the X -ray, which can be detected with a special camera, called a “gamma camera”. There are many reasons for having a Gallium scan. The most common reasons are to investigate whether there is an area of localised infection in the body or to detect the location of certain types of tumours. Ask your nuclear medicine physician or specialist to explain why you have been referred for a Gallium scan. For more information ask for a copy of the booklet “Nuclear Medicine – Answering your Questions” available from the hospital, clinic or the supplier. HOW IS GALLIUM ( 67 GA) INJECTION GIVEN It is given as an injection into a vein in your arm. You may feel a slight sting from the needle but the injection itself is painless. GALLIUM [ 67 GA] CITRATE INJECTION BP •••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••• 2 TEST PROCEDURE Gallium ( 67 Ga) Citrate Injection BP like all other radiopharmaceuticals can only be Leia o documento completo
DESCRIPTION The product is an injection containing radioactive Gallium [ 67 Ga] at an activity concentration of 100 MBq/mL at the calibration time and date. The product conforms to the British Pharmacopoeia for Gallium [ 67 Ga] Citrate Injection. 4 mL and 8 mL. As supplied the product is sterile and contains 1% benzyl alcohol as a preservative. The product is designed for diagnostic use. Use by intravenous administration PHYSICAL CHARACTERISTICS OF 67 GA Gallium-67 with a physical half life of 78.3 hours, decays by electron capture to stable zinc-67. Photons associated with this transition that are useful for detection and imaging studies are listed in Table 1. TABLE 1: PRINCIPAL RADIATION EMISSION DATA Reference: Weber D A, Eckerman K F, Dillman L T and Ryman J C.MIRD. Radionuclide Data and Decay Schemes (1989) TABLE 2: PHYSICAL DECAY CHART EXTERNAL RADIATION The specific gamma ray constant for 67 Ga is 0.21 mGy per MBq-h at 1 cm. The first half value thickness of lead (Pb) for 67 Ga is 0.066 cm. Attenuation by lead is given in the following table. TABLE 3: RADIATION ATTENUATION BY LEAD SHIELDING GALLIUM [ 67 GA] CITRATE INJECTION BP PRINCIPAL ENERGY (KEV)* ABUNDANCE RADIATION Gamma-2 37.0 93.3 Gamma-3 20.4 184.6 Gamma-5 16.0 300.2 TIME FACTOR TIME FACTOR (HR)* (HR)* 0 1.00 72 0.53 6 0.95 78 0.50 12 0.90 84 0.48 18 0.85 90 0.45 24 0.81 96 0.43 30 0.77 108 0.38 36 0.73 120 0.35 42 0.69 132 0.31 48 0.65 144 0.28 54 0.62 156 0.25 60 0.59 168 0.23 66 0.563 SHIELD THICKNESS COEFFICIENT OF ATTENUATION MM PB 0.066 0.5 0.41 0.1 1.2 0.01 2.5 0.001 4.8 0.0001 The dose sizes are made of 1mL, 2 mL , _PI_ P RODUCT I NFORMATION PHARMACOLOGY Upon intravenous injection, Gallium [ 67 Ga] Citrate concentrates in certain viable primary and metastatic tumours as well as focal sites of infection. The mechanism of concentration is unknown but investigations have shown that Gallium [ 67 Ga] accumulates in lysosomes and is bound to a soluble intracellular protein. It has been reported in scientific literature that following intravenous Leia o documento completo