DRYTEC RADIONUCLIDE GENERATOR

国: シンガポール

言語: 英語

ソース: HSA (Health Sciences Authority)

有効成分:

SODIUM MOLYBDATE (99Mo); SODIUM PERTECHNETATE (99MTc)

から入手可能:

GE HEALTHCARE PTE. LTD.

ATCコード:

V09FX01

投薬量:

2.5-100 GBq/generator

医薬品形態:

INJECTION

構図:

SODIUM MOLYBDATE (99Mo) 2.5-100 GBq/generator; SODIUM PERTECHNETATE (99MTc) variable

投与経路:

INTRAVENOUS

処方タイプ:

Prescription Only

製:

GE HEALTHCARE LIMITED (AMERSHAM SITE)

認証ステータス:

ACTIVE

承認日:

2003-12-16

情報リーフレット

PRESENTATION
DRYTEC
™
provides a source of Sodium Pertechnetate [
99m
Tc] Injection, Ph. Eur. The DRYTEC
™
generator
contains the fission-produced sodium molybdate [
99
Mo] adsorbed onto alumina contained in a shielded
sterilised glass column. Three variants of the generator are supplied,
which differ in the design of column
geometry and shielding materials. The type of generator is indicated
by the generator weight which is
given on the generator label:
11 kg designates a generator with 45 mm lead shielding
15 kg designates a generator with 54 mm lead shielding
17 kg designates a generator with depleted uranium shielding
The internal generator components are contained within a robust
plastic casing fitted with a carrying
handle.
To elute the generator a vial of Sodium Chloride Intravenous
Infusion, BP is placed onto the inlet spike.
Collection of the eluate Sodium Pertechnetate [
99m
Tc] Injection is achieved by placing a sterile evacuated
elution vial onto the collection needle. Vials of saline eluent are
supplied with the generator, which will
give elution volumes of 5ml, 10ml and 20ml.
Generators with sodium molybdate [
99
Mo] loadings between 2.5 GBq (68 mCi) and 100 GBq (2.7 Ci) are
available. The activities quoted are at the activity reference date,
which is stated on the label.
The quantity of Sodium Pertechnetate [
99m
Tc], Ph. Eur. that may be eluted from the generator at any one
time is dependent on the quantity of sodium molybdate [
99
Mo] present, the volume of eluate obtained
and the time since the previous elution.
HOLDER OF MARKETING AUTHORISATION
GE Healthcare Limited
Amersham Place
Little Chalfont
Buckinghamshire HP7 9NA
United Kingdom
MANUFACTURER
GE Healthcare Limited
Amersham Place
Little Chalfont
Buckinghamshire HP7 9NA
United Kingdom 
INDICATIONS
1. The eluate from the generator (Sodium Pertechnetate [
99m
Tc] Injection Ph. Eur.), may be used 
as a reagent for labelling of various carrier compounds supplied as
kits or administered directly 
_in vivo_.
2. When administered  i

製品の特徴

PRESENTATION
DRYTEC
™
provides a source of Sodium Pertechnetate [
99m
Tc] Injection, Ph. Eur. The DRYTEC
™
generator
contains the fission-produced sodium molybdate [
99
Mo] adsorbed onto alumina contained in a shielded
sterilised glass column. Three variants of the generator are supplied,
which differ in the design of column
geometry and shielding materials. The type of generator is indicated
by the generator weight which is
given on the generator label:
11 kg designates a generator with 45 mm lead shielding
15 kg designates a generator with 54 mm lead shielding
17 kg designates a generator with depleted uranium shielding
The internal generator components are contained within a robust
plastic casing fitted with a carrying
handle.
To elute the generator a vial of Sodium Chloride Intravenous Infusion,
BP is placed onto the inlet spike.
Collection of the eluate Sodium Pertechnetate [
99m
Tc] Injection is achieved by placing a sterile evacuated
elution vial onto the collection needle. Vials of saline eluent are
supplied with the generator, which will
give elution volumes of 5ml, 10ml and 20ml.
Generators with sodium molybdate [
99
Mo] loadings between 2.5 GBq (68 mCi) and 100 GBq (2.7 Ci) are
available. The activities quoted are at the activity reference date,
which is stated on the label.
The quantity of Sodium Pertechnetate [
99m
Tc], Ph. Eur. that may be eluted from the generator at any one
time is dependent on the quantity of sodium molybdate [
99
Mo] present, the volume of eluate obtained
and the time since the previous elution.
HOLDER OF MARKETING AUTHORISATION
GE Healthcare Limited
Amersham Place
Little Chalfont
Buckinghamshire HP7 9NA
United Kingdom
MANUFACTURER
GE Healthcare Limited
Amersham Place
Little Chalfont
Buckinghamshire HP7 9NA
United Kingdom
INDICATIONS
1.
The eluate from the generator (Sodium Pertechnetate [
99m
Tc] Injection Ph. Eur.), may be used
as a reagent for labelling of various carrier compounds supplied as
kits or administered directly
_in vivo_.
2.
When administered intravenously, th