GALLIAPHARM RADIONUCLIDE GENERATOR 0.74 – 1.85 GBQ

Страна: Сінгапур

мова: англійська

Джерело: HSA (Health Sciences Authority)

Активний інгредієнт:

Germanium (68Ge) chloride; gallium (68Ga) chloride

Доступна з:

LABGISTICS ASIA PTE LTD

Код атс:

V09X

Фармацевтична форма:

INJECTION, SOLUTION (RADIOPHARMACEUTICAL)

Склад:

Germanium (68Ge) chloride 0.74 – 1.85 GBq; gallium (68Ga) chloride > 60 % of the loaded activity

Адміністрація маршрут:

OTHERS

Тип рецепту:

Prescription Only

Виробник:

Eckert & Ziegler Radiopharma GmbH

Статус Авторизація:

ACTIVE

Дата Авторизація:

2023-08-23

Характеристики продукта

_August 2023, GalliaPharm PI _
_1 / 24 _
PACKAGE INSERT
1.
PRODUCT NAME
GalliaPharm, 0.74 – 1.85 GBq, radionuclide
generator
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
The radionuclide generator contains germanium (
68
Ge) as mother nuclide which decays to the daughter
nuclide gallium (
68
Ga). The germanium (
68
Ge) used for the production of the (
68
Ge/
68
Ga) generator is
carrier-free. The total radioactivity due to germanium (
68
Ge) and gamma-ray-emitting impurities is not
more than 0.001%.
The GalliaPharm 0.74 – 1.85 GBq radionuclide generator is a system
for the elution of gallium (
68
Ga)
chloride solution for radiolabelling in accordance with Ph. Eur. 2464.
This solution is eluted from a
column on which the mother nuclide germanium (
68
Ge), parent of gallium (
68
Ga), is fixed. The system
is shielded. Physical characteristics of both mother and daughter
nuclides are summarized in table 1.
TABLE 1: PHYSICAL CHARACTERISTICS OF GERMANIUM (
68
GE) AND GALLIUM (
68
GA)
PHYSICAL CHARACTERISTICS OF
68
GE
68
GA
Half-life
270.95 days
67.71 minutes
Type of physical decay
Electron capture
Positron emission
X-rays
9.225 keV (13.1 %)
9.252 keV (25.7 %)
10.26 keV (1.64 %)
10.264 keV (3.2 %)
10.366 keV (0.03%)
8.616 keV (1.37 %)
8.639 keV (2.69 %)
9.57 keV (0.55 %)
Gamma-rays
511 keV (178.28 %)
578.55 keV (0.03 %)
805.83 keV (0.09 %)
1,077.34 keV (3.22 %)
1,260.97 keV (0.09 %)
1,883.16 keV (0.14 %)
beta+
Energy max. Energy
352.60 keV 821.71 keV (1.20%)
836.00 keV 1,899.01 keV (87.94%)
Data derived from nudat (www.nndc.bnl.gov)
5 ml of the eluate contains a potential maximum of 1850 MBq of
68
Ga and 18.5 kBq of
68
Ge (0.001 %
breakthrough in the eluate). This corresponds to 1.2 ng of gallium and
0.07 ng of germanium.
The quantity of gallium (
68
Ga) chloride solution for radiolabelling Ph. Eur., that may be eluted
from
the generator is dependent on the quantity of germanium (
68
Ge) present, the volume of eluent used
(typically 5 ml) and the lapsed time since the previous elution. If
mother and daughter nuclides