MIBG [123I] 74 MBq/ ml

Maa: Norja

Kieli: norja

Lähde: Statens legemiddelverk

Aktiivinen ainesosa:

Jobenguansulfat (123I)

Saatavilla:

Curium Netherlands B.V.

ATC-koodi:

V09IX01

INN (Kansainvälinen yleisnimi):

Jobenguansulfat (123I)

Annos:

74 MBq/ ml

Lääkemuoto:

Injeksjonsvæske, oppløsning

Kpl paketissa:

Hetteglass 5 ml

Prescription tyyppi:

C

Valtuutuksen tilan:

Markedsført

Valtuutus päivämäärä:

1999-11-01

Valmisteyhteenveto

1
NAME OF THE MEDICINAL PRODUCT
MIBG (
123
I) 74 MBq/mL solution for injection
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 mL contains 74 MBq of iobenguane (
123
I) at the date and time of calibration and
iobenguane sulfate 0.5 mg. Iodine-123 (
123
I) decays to stable Tellurium-123 with a
half-life of 13.2 hours by emitting pure gamma radiations with
predominant energies
of 159 keV (83.6%) and X-rays of 27 keV.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Solution for injection (injection)
Clear, colourless or slightly yellow solution.
The pH of the product is 4.0 - 5.0.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only

Detection of neuroendocrine tumours such as pheochromocytomas,
paragangliomas, chemodectomas and ganglioneuromas.

Detection, staging and follow-up on therapy of neuroblastomas.

Evaluation of the uptake of iobenguane (
123
I) for therapy planning.

Functional studies of the adrenal medulla (hyperplasia) and the
myocardium
(sympathetic innervation).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_ _
_Adults _
The recommended activity range is 110-400 MBq based on a patient of
average
weight (70 kg).
_Elderly population_
No special dosage-scheme is required for the elderly patient.
_ _
_Renal impairment _
Careful consideration of the activity to be administered is required
since an increased
radiation exposure is possible in these patients.
_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 (2016) by using the following formula:
_A_[_MBq_]Administered = Baseline activity x Multiple (with a baseline
activity of 28.0)
Weight (kg)
Multiple
Weight (kg)
Multiple
Weight (kg)
Multiple
3
1
22
5.29
42
9.14
4
1.14
24
5.71
44
9.57
6
1.71
26
6.14
46
10.00
8
2.14
28
6.43
48
10