GalliaPharm 0.74 – 1.85 GBq radionuclide generator

Страна: Ирландия

Език: английски

Източник: HPRA (Health Products Regulatory Authority)

Активна съставка:

GERMANIUM (68GE) CHLORIDE; Gallium (68Ga) Chloride

Предлага се от:

Eckert & Ziegler Radiopharma GmbH

АТС код:

V09X

INN (Международно Name):

GERMANIUM (68GE) CHLORIDE; Gallium (68Ga) Chloride

дозиране:

0.74-1.85 gigabecquerel(s)

Лекарствена форма:

Radionuclide generator

Вид предписание :

Product subject to prescription which may not be renewed (A)

Терапевтична област:

OTHER DIAGNOSTIC RADIOPHARMACEUTICALS

Статус Оторизация:

Marketed

Дата Оторизация:

2017-09-01

Листовка

1
B. PACKAGE LEAFLET FOR RADIOPHARMACEUTICALS
2
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
GalliaPharm, 0.74 -1.85 GBq, radionuclide generator
Gallium (
68
Ga) chloride solution
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE
BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If
you
have
any
further
questions,
ask
your
nuclear
medicine
doctor
who
will
supervise the procedure.

If you get any side effects, talk to your nuclear medicine doctor.
This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What GalliaPharm is and what it is used for
2. What
you
need
to
know
before
the
gallium
(
68
Ga)
chloride
solution
obtained
with
GalliaPharm is used
3. How gallium (
68
Ga) chloride solution obtained with GalliaPharm is used
4. Possible side effects
5. How GalliaPharm is stored
6. Contents of the pack and other information
1.
WHAT GALLIAPHARM IS AND WHAT IT IS USED FOR
This medicine is a radiopharmaceutical product for diagnostic use
only.
This medicine is a radiopharmaceutical product not intended for direct
use in patients.
GalliaPharm is a germanium (
68
Ge) / gallium (
68
Ga) radionuclide generator, a device used to
obtain a solution of gallium (
68
Ga) chloride.
The obtained gallium (
68
Ga) chloride solution is used for radiolabelling, a technique in which
a substance is tagged (radiolabelled) with a radioactive compound,
here
68
Ga.
GalliaPharm is used to label certain medicines that have been
specially developed and
approved for the use with the active substance gallium (
68
Ga) chloride. These medicines act as
carriers to take the radioactive
68
Ga to where it is needed. These may be substances that have
been designed to recognise a particular type of cell in the body,
including tumour cells
(cancer). The low amount of radioactivity administered can be detected
outside of the body by
special cameras to obtain images of the body. Please refer to the
package leaflet of the
me

Данни за продукта

Health Products Regulatory Authority
25 January 2021
CRN00C4HT
Page 1 of 17
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
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 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 %)
1077.34 keV (3.22 %)
1260.97 keV (0.09 %)
1883.16 keV (0.14 %)
beta+
Energy max. Energy
352.60 keV 821.71 keV (1.20 %)
836.00 keV 1899.01 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