Sodium Iodide [123I] Injection Curiumpharma 37 MBq/ ml

Land: Norge

Språk: norsk

Kilde: Statens legemiddelverk

Aktiv ingrediens:

Natriumjodid (123I)

Tilgjengelig fra:

Curium Netherlands B.V.

ATC-kode:

V09FX02

INN (International Name):

Natriumjodid (123I)

Dosering :

37 MBq/ ml

Legemiddelform:

Injeksjonsvæske, oppløsning

Enheter i pakken:

Hetteglass i blyemballasje 10 ml

Resept typen:

C

Autorisasjon status:

Markedsført

Autorisasjon dato:

2005-05-18

Preparatomtale

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Sodium Iodide (I-123) Injection Curiumpharma
(Curiumpharma catalogue number: DRN 5375)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
2.1
ACTIVE INGREDIENT
Sodium Iodide (I-123), 37 MBq/ml at activity reference date and hour.
2.2
PHYSICAL CHARACTERISTICS
Iodine-123 is a cyclotron product with a physical half-life of 13.21
h.
Iodine-123 decays emitting pure gamma radiation with predominant
energies of 159
keV and 27 keV.
123
I is obtained by proton irradiation of enriched Xenon. The
radionuclidic purity of
the product at expiry date and time is:
123
I > 99.9%. The only detectable radionuclidic
impurities are
121
Te

900 Bq/MBq and
125
I

1500 Bq/MBq at expiry date and time.
3
PHARMACEUTICAL FORM
Solution for injections. ATC code: V10X A01
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Sodium iodide (I-123) 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
The recommended activities for an adult patient (70 kg) lies between
3.7 to 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 prescribed must be determined by the attending specialist.
Determination of the rate of thyroid iodine-123 uptake should be
carried out in
accordance with well established standard procedures. The activity
dosages for
children may be calculated from the recommended range of adult
dosages, adjusted
according to the following equation:
Paediatric dosage (MBq)= Adult dosage (MBq) x Child weight (kg)
70
In very young children the maximal adult dosage of 14.8 MBq should be
used in the
equation in order to obtain images of sufficient quality.
123
I must be given as an intravenous injection: as a routine check, the
acti