Drytec TM -

Land: Norge

Språk: norsk

Kilde: Statens legemiddelverk

Aktiv ingrediens:

Natriummolybdat Mo-99 omdannes til natriumperteknetat Tc-99m

Tilgjengelig fra:

GE Healthcare B.V.

ATC-kode:

V09FX01

INN (International Name):

Sodium Molybdate Mo-99 is converted to sodium pertechnetate Tc-99m

Legemiddelform:

Radionuklidegenerator

Enheter i pakken:

Radionukleidegenerator 100 GBq

Resept typen:

C

Autorisasjon status:

Markedsført

Autorisasjon dato:

2001-01-01

Preparatomtale

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
DRYTEC
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
The mother nuclide is:
Sodium (
99
Mo) molybdate
2.5-100 GBq/generator
(no carrier added)
at the activity reference date
The daughter nuclide is:
Sodium (
99m
Tc) pertechnetate
Variable
The quantity of Sodium Pertechnetate (
99m
Tc) Injection Ph. Eur. that may be eluted from the generator at
any one time is dependent on the quantity of sodium (
99
Mo) molybdate present, the volume of eluate
obtained and the lapsed time since the previous elution.
Technetium-99m is produced by means of a [
99
Mo/
99m
Tc] generator and decays with the emission of
gamma radiation with a mean energy of 140 keV and a half-life of 6
hours to technetium-99 which, in
view of its long half-life of 2.13 x 10
5
years can be regarded as quasi stable.
Excipients with known effect:
Sodium: 3.54 mg/ml.
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 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. _
When administered intravenously, the sterile sodium (
99m
Tc) pertechnetate solution is indicated in adults
and children as a diagnostic aid in the following:
(A)
THYROID SCINTIGRAPHY: direct imaging and measurement of thyroid uptake
to give
information on the size, position, nodularity and function of the
gland in thyroid disease.
(B)
SALIVARY GLAND SCINTIGRAPHY: to assess salivary gland function and
duct patency.
(C)
LOCATION OF ECTOPIC GASTRIC MUCOSA: Meckel’s diverticulum
(D)
CEREBRAL SCINTIGRAPHY: to identify breaches in the blood-brain barrier
caused by tumour,
infarction, haemorrhage and oedema, when no other methods are
available.
When used in conjunction with pre-treatment with a reducing agent to
effect technetium-99m-labell