TECHNETIUM Tc-99M GENERATOR

País: Israel

Idioma: anglès

Font: Ministry of Health

ingredients actius:

MOLYBDATE (CONTAINING MO-99)

Disponible des:

ISORAD LTD, ISRAEL

Codi ATC:

V09AA

formulario farmacéutico:

RADIO-PHARMA GENERATOR

Composición:

MOLYBDATE (CONTAINING MO-99) 400 MG

Vía de administración:

I.V

tipo de receta:

Required

Fabricat per:

ISORAD LTD., ISRAEL

Grupo terapéutico:

TECHNETIUM (99M-TC) COMPOUNDS

indicaciones terapéuticas:

Diagnostic agent for IV injection producer of Tc-99 for imaging of different organs.

Data d'autorització:

2022-04-30

Fitxa tècnica

1
SUMMARY OF PRODUCT CHARACTERISTICS
TECHNETIUM TC-99M GENERATOR
MOLYBDATE (CONTAINING MO-99)
RADIO-PHARMA GENERATOR
FOR INTRAVENOUS USE
TO BE USED IN DIAGNOSTIC INSTITUTES ONLY
DESCRIPTION:
Sodium Pertechnetate Tc 99m Injection, as eluted
according
to
the
elution
instructions
with
Soreq
Radiopharmaceutical’s Technetium Tc99m Generator,
is in Sodium Chloride 0.9% as a sterile, non-pyrogenic,
diagnostic
radiopharmaceutical
suitable
for
intravenous injection, oral administration, and direct
instillation. The pH is 4.5-7.5. The eluate should be
clear, colorless, and free from visible foreign material.
Each eluate of the Technetium Tc 99m Generator
should
not
contain
more
than
0.0056MBq
(0.15
microcuries)
of
Molybdenum
Mo99
per
37MBq
(1
millicurie) of Technetium Tc 99m per administered
dose at the time of administration, and not more than
10
micro-grams
of
aluminum
per
milliliter
of
the
Technetium Tc 99m Generator eluate, both of which
are recommended to be determined by the user before
administration. Since the eluate does not contain an
antimicrobial agent, it should not be used later than12
hours after the elution.
Soreq Radiopharmaceutical’s Technetium Tc 99m
Generator
consists
of
a
column
containing
fission
produced Molybdenum Mo99 adsorbed on alumina.
The terminally sterilized and sealed column is enclosed
in a lead shield; the shield and other components are
sealed in cylindrical plastic container with an attached
handle.
Built into the top surface are two recessed wells as it is
shown in the sketch.
Needles protruding from these two wells accommodate
supplied sterile eluant charge vials and sterile eluate
collection vials. The eluting solvent consist of 5ml or
15ml Sodium Chloride 0.9% solution, in prepacked
septum-sealed vials.
The eluate collection vial is evacuated sterile and non-
pyrogenic.
During and subsequent to elution, the eluate collection
vial should be kept in a radiation shield. The Generator
is shipped with a sterile needle seal over the charge
needle and a vented needle cover over the coll