ELUMATIC III %v/v Unknown

Kraj: Irlandia

Język: angielski

Źródło: HPRA (Health Products Regulatory Authority)

Składnik aktywny:

SODIUM PERTECHNETATE (99M TC)

Dostępny od:

CIS bio International

Kod ATC:

V09FX01

INN (International Nazwa):

SODIUM PERTECHNETATE (99M TC)

Dawkowanie:

%v/v

Forma farmaceutyczna:

Unknown

Typ recepty:

Product subject to Restricted Prescription (C)

Dziedzina terapeutyczna:

Various thyroid diagnostic radiopharmaceuticals

Status autoryzacji:

Authorised

Data autoryzacji:

1998-04-03

Charakterystyka produktu

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
ELUMATIC III
2-20 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 to 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
yield and 24 hours time from previous elution and taking into account
that
branching ratio of
99
Mo is about 87%:
Excipient with known effect:
Each mL of sodium pertechnetate (
99m
Tc) solution contains 3.6 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.
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 solution.
Thyroid scintigraphy: direct imaging and measurement of thyroid uptake
to give information on the size,
position, nodularity and function of the gland in case of thyroid
disease.
Salivary gland scintigraphy: diagnosis of chronic sialadenitis (e.g.
Sjögren's Syndrom) as well as assessment of
salivary gland function and duct patency in salivary glands disorders
and monitoring of the response to
therapeutic interventions (in particular radioiodine therapy).
99m
Tc activi