Ultra TechneKow FM -

מדינה: נורווגיה

שפה: נורבגית

מקור: Statens legemiddelverk

מרכיב פעיל:

Natriummolybdat Mo-99 omdannet til natriumperteknetat Tc-99m

זמין מ:

Curium Netherlands B.V.

קוד ATC:

V09FX01

INN (שם בינלאומי):

Natriummolybdat Mo-99 omdannet til natriumperteknetat Tc-99m

טופס פרצבטיות:

Radionuklidegenerator

יחידות באריזה:

Radionukleidegenerator 43 GBq

סוג מרשם:

C

מצב אישור:

Markedsført

תאריך אישור:

2000-03-14

מאפייני מוצר

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Ultra-TechneKow FM, 2,15-43,00 GBq, radionuclide generator
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Sodium pertechnetate (
99m
Tc) injection is produced by means of a (
99
Mo/
99m
Tc) generator.
Technetium (
99m
Tc) decays with the emission of gamma radiation with a mean energy of
140 keV
and a half-life of 6,01 hours to technetium (
99
Tc) which, in view of its long half-life of 2.13 x 10
5
years can be regarded as quasi stable.
The radionuclide generator containing the parent isotope
99
Mo, adsorbed on a chromatographic
column delivers sodium pertechnetate (
99m
Tc) injection in sterile solution.
The
99
Mo on the column is in equilibrium with the formed daughter isotope
99m
Tc. The generators
are supplied with the following
99
Mo activity amounts at activity reference time which deliver the
following technetium (
99m
Tc) amounts, assuming a 100% theoretical elution yield and 24 hours
from previous elution and taking into account that branching ratio of
99
Mo is about 87%:
The technetium (
99m
Tc) amounts available by a single elution depend on the real yields of
the kind
of generator used itself declared by manufacturer and approved by
National Competent Authority.
Excipient(s) with known effect
Each mL of sodium pertechnetate (
99m
Tc) solution contains 3.5 mg of sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Radionuclide generator.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only.
99m
Tc activity
(maximum
theoretical
elutable activity
at ART, 06.00 h
CET)
1.90
3.81
5.71
7.62
9.53
11.43
15.24
19.05
22.86
26.67
30.48
38.10
GBq
99
Mo activity (at
ART, 06.00 h
CET)
2.15
4.30
6.45
8.60
10.75
12.90
17.20
21.50
25.80
30.10
34.40
43.00
GBq
The eluate from the radionuclide generator (sodium pertechnetate (
99m
Tc) Injection) is indicated for:

labelling of various kits for radiopharmaceutical preparation
developed and approved for
radiolabelling with such solu