Země: Spojené státy
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
GALLIUM CHLORIDE GA-67 (UNII: A04B19O2B0) (GALLIUM CATION GA-67 - UNII:99T03J52W0)
Curium US LLC
GALLIUM CHLORIDE GA-67
GALLIUM CATION GA-67 2 mCi in 1 mL
INTRAVENOUS
PRESCRIPTION DRUG
Gallium Citrate Ga 67 Injection may be useful to demonstrate the presence and extent of Hodgkin's disease, lymphoma, and bronchogenic carcinoma. Positive gallium Ga-67 uptake in the absence of prior symptoms warrants follow-up as an indication of a potential disease state. Gallium Citrate Ga 67 Injection may be useful as an aid in detecting some acute inflammatory lesions. None.
Catalog Number 180. Gallium Citrate Ga 67 Injection is supplied sterile and non-pyrogenic for intravenous use. Each milliliter contains 74 megabecquerels (2 millicuries) of gallium Ga-67 on the calibration date, as a complex formed from 8.3 nanograms gallium chloride Ga-67, 1.9 milligrams of sodium citrate dihydrate, 7.8 milligrams of sodium chloride, and 0.9 percent benzyl alcohol (v/v) as a preservative. The pH is adjusted to between 5.5 to 8.0 with hydrochloric acid and/or sodium hydroxide solution. Gallium Citrate Ga 67 Injection is available in vials containing the following amounts on the calibration date. Catalog No. N180G0 222 megabecquerels (6 mCi) NDC 69945-180-06 N180M0 444 megabecquerels (12 mCi) NDC 69945-180-12 The contents of the vial are radioactive, and adequate shielding and handling precautions must be maintained. Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP]. Storage and disposal of Gallium Citrate Ga 67 Injection should be controlled in a manner that is in compliance with the appropriate regulations of the government agency authorized to license the use of this radionuclide. Curium and the Curium logo are trademarks of a Curium company. ©2018 Curium US LLC. All Rights Reserved. Manufactured by: Curium US LLC Maryland Heights, MO 63043 Made in USA A180I0 R12/2018 CURIUMTM
New Drug Application
GALLIUM CITRATE GA-67- GALLIUM CITRATE GA-67 INJECTION, SOLUTION CURIUM US LLC ---------- GALLIUM CITRATE GA 67 INJECTION RX ONLY _DIAGNOSTIC – FOR INTRAVENOUS USE_ DESCRIPTION Gallium Citrate Ga 67 Injection is supplied in a 10 milliliter vial as an isotonic, sterile, non-pyrogenic solution. Each milliliter of the isotonic solution contains 74 megabecquerels (2 millicuries) of gallium Ga-67 on the calibration date as a complex formed from 8.3 nanograms gallium chloride Ga-67, 1.9 milligrams of sodium citrate dihydrate, 7.8 milligrams of sodium chloride and 0.9 percent benzyl alcohol (v/v) as a preservative. The pH is adjusted to between 5.5 to 8.0 with hydrochloric acid and/or sodium hydroxide solution. Gallium Ga-67, with a half-life of 78.26 hours, is cyclotron produced by the proton irradiation of enriched zinc. At the time of calibration the drug contains no more than 0.02% gallium Ga-66 and no more than 0.2% zinc Zn-65. The concentration of each radionuclidic impurity changes with time. At expiration, the drug contains no more than 0.001% gallium Ga-66 and no more than 1.0% zinc Zn-65. No carrier has been added. Gallium citrate has the following chemical structure: PHYSICAL CHARACTERISTICS Gallium Ga-67 with a physical half-life of 78.26 hours decays by electron capture to stable zinc Zn-67. Photons that are useful for imaging studies are listed in Table 1. TABLE 1. PRINCIPAL RADIATION EMISSION DATA Radiation Mean Percent Per Disintegration Energy (keV) Gamma-2 2.9 91.3 Gamma-3 35.7 93.3 Gamma-4 19.7 184.6 Gamma-5 2.2 209.0 Gamma-6 16.0 300.2 Gamma-7 4.5 393.5 1 1 EXTERNAL RADIATION The specific gamma ray constant for gallium Ga-67 is 1.6 R/mCi-hour at 1 cm. The first half-value thickness of lead (Pb) is 0.066 cm. A range of values for the relative attenuation of the radiation emitted by this radionuclide that results from interposition of various thicknesses of lead is shown in Table 2. For example, the use of 1.2 cm of lead will decrease the radiation exposure by a factor of about 100. _Table 2. Radiati Přečtěte si celý dokument