Sodium Iodide [123I] Capsules GE Healthcare -

Country: Norveġja

Lingwa: Norveġiż

Sors: Statens legemiddelverk

Ingredjent attiv:

Natriumjodid (123I)

Disponibbli minn:

GE Healthcare B.V.

Kodiċi ATC:

V09FX02

INN (Isem Internazzjonali):

Natriumjodid (123I)

Għamla farmaċewtika:

Kapsel, hard

Unitajiet fil-pakkett:

Beholder av plast med blyemballasje 1 stk

Tip ta 'preskrizzjoni:

C

L-istatus ta 'awtorizzazzjoni:

Markedsført

Data ta 'l-awtorizzazzjoni:

2006-07-14

Karatteristiċi tal-prodott

_ _
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Sodium Iodide [
123
I] Capsules, GE Healthcare
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Sodium Iodide(123-I), 3.7, 7.4, 11.1, 18.5 and 37 MBq/capsule at
reference date and hour.
Iodine-123 is a cyclotron product with a physical half-life of 13.2 h.
Iodine-123 decays
emitting pure gamma radiation with predominant energies of 159 keV and
27 keV.
Excipient(s) with known effect:
Sodium 97.4 mg/capsule
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsule, hard.
Colourless gelatine capsule.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only.
Sodium Iodide [123-I] Capsules are used as a diagnostic agent in the
functional or morpho-
logical 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) lies 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.
_ _
Renal/hepatic impairment
Sodium Iodide has not been studied in patients with significant renal
or hepatic impairment.
Careful consideration of the activity to be administered is required
since an increased
radiation exposure is possible in these patients (see section 4.4).
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.
Method of administration.
The capsule is administered orally together with a drink. It should be
swallowed whole.
Imaging is carried out 3-6