Adreview-Iobenguane (123I) Injection 74 MBq/ ml

País: Noruega

Idioma: noruec

Font: Statens legemiddelverk

ingredients actius:

Jobenguansulfat (123I)

Disponible des:

GE Healthcare B.V.

Codi ATC:

V09IX01

Designació comuna internacional (DCI):

Jobenguansulfat (123I)

Dosis:

74 MBq/ ml

formulario farmacéutico:

Injeksjonsvæske, oppløsning

Unidades en paquete:

Hetteglass 555 MBq

tipo de receta:

C

Estat d'Autorització:

Markedsført

Data d'autorització:

1997-06-25

Fitxa tècnica

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_Page 1 of 12_
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1.
NAME OF THE MEDICINAL PRODUCT
AdreView, Iobenguane (
123
I) Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Iobenguane (
123
I), 37 – 740 MBq/vial (74 MBq/ml at calibration date and hour)
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.
Excipients with known effect:
Benzyl alcohol: 10.4 mg/ml
Sodium: 4.23 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.
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4.1.1
ONCOLOGY: DETECTION AND STAGING OF NEURAL CREST TUMOURS

Diagnostic scintigraphic localisation of tumours originating in tissue
that embryologically
stems from the neural crest. These are pheochromocytomas,
paragangliomas,
chemodectomas and ganglioneuromas.

Detection, staging and follow-up on therapy of neuroblastomas.

Evaluation of the uptake of iobenguane. The sensitivity to diagnostic
visualisation is different
for the listed pathological entities.
The sensitivity is approximately 90% for the detection of
pheochromocytoma and
neuroblastoma, 70% in case of carcinoid and only 35% in case of
medullary thyroid carcinoma
(MTC).

Functional studies of the adrenal medulla (hyperplasia).
4.1.2
CARDIOLOGY: IMAGING OF SYMPATHETIC MYOCARDIAL INNERVATION

AdreView is a radiopharmaceutical indicated for assessment of
sympathetic innervation of the
myocardium as a prognostic indicator of risk for progression of
symptomatic heart failure,
potentially fatal arrhythmic events, or cardiac death in patients with
NYHA class II or class III
heart failure and LV dysfunction.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
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4.2.1
ONCOLOGY
POSOLOGY
_ADULTS_
The recommended dosage in oncology studies is 80-200 MBq, higher
activities may be justifiable.
_ELDERLY POPULATION _
No special dosage scheme is req