GALLIUM- gallium citrate ga-67 injection

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

GALLIUM CITRATE GA-67 (UNII: 4LJK511Z86) (GALLIUM CATION GA-67 - UNII:99T03J52W0)

Prieinama:

Lantheus Medical Imaging, Inc.

INN (Tarptautinis Pavadinimas):

GALLIUM CITRATE GA-67

Sudėtis:

GALLIUM CATION GA-67 2.0 mCi in 1 mL

Vartojimo būdas:

INTRAVENOUS

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

Gallium Citrate Ga 67 Injection may be useful in demonstrating the presence of the following malignancies: Hodgkins disease, lymphomas and bronchogenic carcinoma. Positive 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 known.

Produkto santrauka:

Gallium Citrate Ga 67 Injection is supplied sterile and non-pyrogenic for intravenous use. Each mL contains 74 MBq (2 mCi) of Gallium Ga 67 on the calibration date, as a complex formed from 9 ng Gallium Chloride Ga 67, 2 mg of sodium citrate, 6.8 mg sodium chloride, and 9 mg benzyl alcohol/mL as preservative. The pH is adjusted to between 4.5-8 with hydrochloric acid and/or sodium hydroxide solution. Vials are available in the following quantities of radioactivity: 244.2, 325.6, 488.4, and 732.6 MBq (6.6, 8.8, 13.2, and 19.8 mCi) of Gallium Citrate Ga 67 at calibration. NDC Number 11994-121 Store at controlled room temperature 20°-25°C (68°-77°F) [See USP]. The contents of the vial are radioactive and adequate shielding and handling precautions must be maintained. This radiopharmaceutical is approved for distribution to persons licensed pursuant to the Code of Massachusetts Regulations 105 CMR 120.100 for the uses listed in 105 CMR 120.547 or 120.552 or under equivalent regulations of the U.S. Nuclear Regulatory Commission, an Agreement State, or a Licensing State.

Autorizacija statusas:

New Drug Application

Prekės savybės

GALLIUM- GALLIUM CITRATE GA-67 INJECTION
LANTHEUS MEDICAL IMAGING, INC.
----------
GALLIUM CITRATE
GA 67 INJECTION
FOR DIAGNOSTIC USE
DESCRIPTION
Gallium Citrate Ga 67 Injection is supplied in isotonic solution as a
sterile, non-pyrogenic
diagnostic radiopharmaceutical for intravenous administration. Each
milliliter of the
isotonic solution contains 74 MBq (2 mCi) of Gallium Ga 67 on the
calibration date, as a
complex formed from 9 ng Gallium Chloride Ga 67, 2 mg of sodium
citrate, 6.8 mg
sodium chloride, and 9 mg benzyl alcohol/mL added as preservative. The
pH is adjusted
to between 4.5-8 with hydrochloric acid and/or sodium hydroxide
solution. Gallium Ga
67, with a half-life of 78.3 hours, is cyclotron produced by the
proton irradiation of
enriched zinc oxide, is essentially carrier-free and contains
negligible concentrations of
other radioactive isotopes.
The radionuclidic composition at calibration time is ≥99.89% Gallium
Ga 67, ≤0.01%
Gallium Ga 66 and ≤0.1% due to other radiocontaminants, each
expressed as a
percentage of total activity. The radionuclidic composition at
expiration time is ≥99.89%
Gallium Ga 67, essentially zero (0.0002%) Gallium Ga 66 and
essentially zero of other
radiocontaminants each expressed as a percentage of total activity.
The chemical structure for Gallium Citrate is shown below:
PHYSICAL CHARACTERISTICS
Gallium Ga 67 decays to stable Zinc Zn 67 by electron capture with a
physical half-life of
78.3 hours.
TABLE 1. PRINCIPAL RADIATION EMISSION DATA
RADIATION
MEAN %/DISINTEGRATION
MEAN ENERGY (KEV)
Gamma-3
35.7
93.3
1
Gamma-4
19.7
184.6
Gamma-6
16.0
300.2
1
EXTERNAL RADIATION
The specific gamma ray constant for Gallium Ga 67 is 5.58
microcoulombs/Kg-hr-MBq
(0.80R/hr-mCi) at 1 cm. The first half value thickness of lead is
0.066 cm. A range of
values for the relative attenuation of the radiation emitted by this
radionuclide that
results from the interposition of various thicknesses of Pb is shown
in Table 2. For
example, the use of 0.41 cm of Pb will decrease the external radia