Sodium Iodide [123I] Injection GE Healthcare 37 MBq/ ml

País: Noruega

Língua: norueguês

Origem: Statens legemiddelverk

Ingredientes ativos:

Natriumjodid (123I)

Disponível em:

GE Healthcare B.V.

Código ATC:

V09FX02

DCI (Denominação Comum Internacional):

Natriumjodid (123I)

Dosagem:

37 MBq/ ml

Forma farmacêutica:

Injeksjonsvæske, oppløsning

Unidades em pacote:

Hetteglass 370 MBq

Tipo de prescrição:

C

Status de autorização:

Markedsført

Data de autorização:

2017-01-12

Características técnicas

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Sodium Iodide [
123
I] injection, GE Healthcare
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Sodium Iodide [
123
I], 37 MBq/ml at reference date and hour.
At calibration time, the radionuclidic purity is at least 99.9 % and
the main radionuclidic
impurities (iodine-125 and tellurium-121) occur for less than 0.05 %.
Iodine-123 is a cyclotron product with a physical half-life of 13.2
hours. Iodine-123 decays
emitting pure gamma radiation with predominant energies of 159 keV and
27 keV.
Excipient(s) with known effect:
This medicinal product contains:Sodium 3.99 mg/ml.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only.
Sodium Iodide [
123
I] Injection is used as a diagnostic agent in the functional or
morphological
study of the thyroid gland by means of:
- Scintigraphy
- Radioactive iodine uptake test
The 24 hours uptake data are generally used in calculating the
therapeutic dose.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults_ _
The recommended activities for an adult patient (70 kg) is between 3.7
and 14.8 MBq. The
lower activity (3.7 MBq) is recommended for uptake studies and the
higher doses (11.1 - 14.8
MBq) for thyroid scintigraphy. However for each individual case, the
dose is decided by the
specialist concerned.
Determination of the rate of thyroid iodine-123 uptake should be
carried out in accordance with
well established standard procedures.
GE Healthcare B.V.
Summary of Product Characteristics
- 2/12 -
MT nr 94-193
Sodium Iodide [
123
I] Injection, GE Healthcare
Paediatric population
The use in children and adolescents has to be considered carefully,
based upon clinical needs
and assessing the risk/benefit ratio in this patient group. The
activities to be administered to
children and to adolescents may be calculated
according to the EANM Dosage Card (Versi