ประเทศ: ออสเตรเลีย
ภาษา: อังกฤษ
แหล่งที่มา: Department of Health (Therapeutic Goods Administration)
Gallium(67Ga) citrate
DRN 3103 GALLIUM (GA67) CITRATE INJECTION AUSTRALIA PAGE 1 OF 3 03103800BYS01f.doc / 05 GGK 3103 Australia SPC 17032010 / 02 GGK 3103 Australia CMI 17032010 PRODUCT INFORMATION NAME OF MEDICINE Trade name: Gallium (Ga67) Citrate Injection (Mallinckrodt Medical catalogue number: DRN 3103) DESCRIPTION QUALITATIVE AND QUANTITATIVE COMPOSITION Composition per ml at activity reference date and time 67 Ga as gallium citrate 37 MBq. The qualitative composition is in conformity with the monograph 555 of the European Pharmacopoeia. Gallium ( 67 Ga) is a radionuclide (Atomic number 31; atomic weight 67) and has a physical half-life of 3.3 days (78.3 hours). It decays to stable zinc by electron capture emitting gamma energies of 93 keV (38%), 185 keV (21%) and 300 keV (16.8%). A small, but clinically insignificant amount of 66 Ga is present as a natural contaminant (see dosimetry). For excipients, see List of excipients. CAS #: 41183-64-6 STRUCTURE PHARMACEUTICAL FORM Solution for injections. LIST OF EXCIPIENTS Sodium citrate, benzyl alcohol, sodium chloride and water for injection. The pH of the product is 6-8. INCOMPATIBILITIES Incompatibilities are not known to exist. PHARMACOLOGY PHARMACODYNAMIC PROPERTIES Pharmacotherapeutic group: Other radiopharmaceuticals for inflammation and infection detection. ATC code: V09H X01. The accumulation of gallium in tumour tissue and in sites of inflammation is thought to be due to its behavioural similarity to iron. Incorporation of gallium in transferrin, ferritin and lactoferrin has been demonstrated in-vivo and, with respect to transferrin, also in-vitro. In the chemical dosages administered in man for imaging procedures (< 10 -7 mg/kg) it is not envisaged that gallium would have clinically important pharmacodynamic effects. High doses of gallium are known to interac อ่านเอกสารฉบับเต็ม