GALLIUM CITRATE GA-67 injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

GALLIUM CHLORIDE GA-67 (UNII: A04B19O2B0) (GALLIUM CATION GA-67 - UNII:99T03J52W0)

Available from:

Curium US LLC

INN (International Name):

GALLIUM CHLORIDE GA-67

Composition:

GALLIUM CATION GA-67 2 mCi in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

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                                                                                                                                                 

Authorization status:

New Drug Application

Summary of Product characteristics

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