Quốc gia: Singapore
Ngôn ngữ: Tiếng Anh
Nguồn: HSA (Health Sciences Authority)
GALLIUM CITRATE EQV Ga67
QT INSTRUMENTS (S) PTE LTD
V09HX01
37 MBq/ml at ART
INJECTION
GALLIUM CITRATE EQV Ga67 37 MBq/ml at ART
INTRAVENOUS
Prescription Only
Curium Netherlands B.V.
ACTIVE
1998-07-28
DRN 3103 GALLIUM CITRATE (GA-67) INJECTION DESCRIPTION Gallium Citrate (Ga-67) Injection is a clear, colourless, sterile, isotonic, aqueous solution with pH of 5.0- 8.0. At activity reference time the product has the following composition: - gallium-67 (as gallium citrate) 37 MBq (1 mCi) - sodium chloride 6.9 mg - sodium citrate 2.0 mg - benzyl alcohol 9.0 mg - sodium hydroxide (pH adjustment) q.s - hydrochloric acid 37% (pH adjustment) q.s - water for injections . q.s Gallium-67 is carrier free. It contains at reference time less than 0.2% of gallium-66. STORAGE Store below 25°C. If multi-dose use is intended, each aliquot should be removed under aseptic conditions. Store below 30°C after removal of the first aliquot. STABILITY Gallium (Ga-67) Citrate Injection expires 16 days after production. The expiry date and time is provided on the outer packaging and on each vial. After opening of the vial, the shelf-life of the product is 8 hours. ACTION Upon intravenous injection carrier-free gallium-67 initially binds to serum proteins. The mechanism of concentration in various tissues is unknown, but intracellular accumulation in lysosomes has been reported. In the first day 10-15% of the administered dose is excreted by the kidneys, thereafter the liver becomes the main route of excretuibm resyktubg ub ekunubatuib if another 15-20% with the faeces. The normal non-pathological pattern of distribution always shows uptake in the liver and spleen and in parts of the skeleton, including marrow. Further accumulation with a variable degree of intensity may be observed in the orbita, the nasopharynx and the salivary glands, the sternum and the sternoclavicular joints and in the large joints of the body. Accumulation in mammary tissue nearly always occurs in lactation but is also occasionally found in apparently normal breasts. This non-pathological distribution distinguishes itself from pathological accumulation by its symmetry. In children the thymus or remnants of thymic tissue may accumulate considerable amounts of gall Đọc toàn bộ tài liệu