Padma 28 tabletter

Land: Danmark

Sprog: dansk

Kilde: Lægemiddelstyrelsen (Danish Medicines Agency)

Aktiv bestanddel:

AEGLE MARMELOS FRUGT, pulver, Gul potentil, ISLANDSK MOS, Kaempferia galanga rhizoma, Kryddernellike, Morgenfrue blomst, MYROBALAN FRUGT, Paternostertræ, frugt

Tilgængelig fra:

Padma Europe GmbH

ATC-kode:

C04A

INN (International Name):

AEGLE MARMELOS FRUGT, pulver, Gul potentil, ISLANDSK MOS, Kaempferia galanga rhizoma, Kryddernellike, Morgenfrue blomst, MYROBALAN FRUGT, Paternostertræ, frugt

Lægemiddelform:

tabletter

Autorisation dato:

1999-03-02

Produktets egenskaber

9 JUNE 2018
SUMMARY OF PRODUCT CHARACTERISTICS
FOR
GALLIAPHARM, RADIONUCLIDE GENERATOR
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Galliapharm
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 Galliapharm radionuclide generator is a system for the elution of
gallium (
68
Ga)
chloride solution for radiolabelling Ph. Eur. This solution is eluted
from a TiO
2
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 are
summarized in Table
1.
TABLE 1: PHYSICAL CHARACTERISTICS OF
68
GE AND
68
GA
PHYSICAL CHARACTERISTICS OF
68
GE
68
GA
Half-live
270.95 days
67.71 minutes
Type of 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 %)
gammas
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
_00230_spc.docx_
_Page 1 of 22_
352.60 keV 821.71 keV (1.20 %)
836.00 keV 1899.01 keV (87.94 %)
Data derived from nudat (www.nndc.bnl.gov)
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 nuclide and daughter nuclide are in equilibrium more than 60 %
of the present
gallium (
68
Ga) can be eluted.
Table 2 su