Ultra-TechneKow FM 2.15-43.00 GBq radionuclide generator

国: アイルランド

言語: 英語

ソース: HPRA (Health Products Regulatory Authority)

有効成分:

Sodium Molybdate.99 Mo

から入手可能:

Curium Netherlands B.V.

ATCコード:

V09FX; V09FX01

INN（国際名）:

Sodium Molybdate.99 Mo

投薬量:

2.15-43.00 gigabecquerel(s)

医薬品形態:

Radionuclide generator

処方タイプ:

Product subject to Restricted Prescription (C)

治療領域:

Various thyroid diagnostic radiopharmaceuticals; technetium (99mTc) pertechnetate

認証ステータス:

Marketed

承認日:

2000-04-28

情報リーフレット

13 CON 4329 Ireland PIL 23092016
1
DRN 4329 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ULTRA-TECHNEKOW FM, 2.15-43.00 GBQ RADIONUCLIDE
GENERATOR
Sodium pertechnetate (
99m
Tc)
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.
IN THIS LEAFLET:
1. What Ultra-TechneKow FM is and what it is used for
2.What you need to know before the sodium pertechnetate(
99m
Tc) solution obtained with Ultra-
TechneKow FM is used
3. How sodium pertechnetate (
99m
Tc) solution obtained with Ultra-TechneKow FM is used
4. Possible side effects
5.
How Ultra-TechneKow FM is stored
6. Contents of the pack and other information
1.WHAT ULTRA-TECHNEKOW FM IS AND WHAT IT IS USED FOR
This medicine is a radiopharmaceutical product for diagnostic use
only.
Ultra-TechneKow FM is a technetium (
99m
Tc) generator, which means it is a device used to obtain a
solution for injection of sodium pertechnetate (
99m
Tc). When this radioactive solution is injected, it
temporarily collects in certain areas of the body. The low quantity of
radioactivity injected can be
detected outside of the body by special cameras. The nuclear medicine
doctor will then take an image
(scan) of the concerned organ which can give him valuable information
about the structure and the
function of this organ.
After injection the sodium pertechnetate (
99m
Tc) solution is used to obtain images of various body
parts such as the:

thyroid glands

salivary glands

Appearance of stomach tissue in an abnormal location (Meckel
diverticulum)

tear ducts of the eyes
The sodium pertechnetate (
99m
Tc) solution can also be used in combination with another product to
prepare another radiopharmaceuti

製品の特徴

Health Products Regulatory Authority
29 October 2019
CRN0098YP
Page 1 of 12
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 (99mTc) injection in sterile solution.
The 99Mo on the column is in equilibrium with the formed daughter
isotope 99mTc. The generators are supplied with the
following 99Mo activity amounts at activity reference time which
deliver the following technetium (99mTc) amounts, assuming
a 100% theoretical elution yield and 24 hours time from previous
elution and taking into account that branching ratio of 99Mo
is about 87%:
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 technetium (99mTc) 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.
3 PHARMACEUTICAL FORM
Radionuclide generator.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only.
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