META-IODOBENZYLGUANIDINE FOR DIAGNOSTIC USE 9.25-18.5MBQ/ML SOLUTION FOR INJECTION

Country: Cyprus

Language: Greek

Source: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας

Active ingredient:

IOBENGUANE (131 I)

Available from:

GE HEALTHCARE BUCHLER GMBH & CO KG (0000003641) GIESELWEG 1, BRAUNSCHWEIG, 38110

ATC code:

V09IX02

INN (International Name):

IOBENGUANE (131I)

Dosage:

9.25-18.5MBQ/ML

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

IOBENGUANE (131 I) (8000003407) 9,25MBq

Administration route:

INTRAVENOUS USE

Prescription type:

Ειδική άδεια άρθρο 126A

Product summary:

Νομικό καθεστώς: Με Ιατρική Συνταγή; 1 VIAL X 4ML X 37MBq () 1 VIAL - Εγκεκριμένο - Με Ιατρική Συνταγή

Patient Information leaflet

PACKAGE LEAFLET:
INFORMATION FOR THE HEALTHCARE PROFESSIONAL
(
131
I) META-IODOBENZYL-
GUANIDINE
FOR DIAGNOSTIC USE,
GE HEALTHCARE,
SOLUTION FOR
INTRAVENOUS INJECTION
14473882
IBS6711-DK0119-SPC
(
131
I) Meta-Iodobenzylguanidine for Diagnostic
Use, GE Healthcare
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
[
131
I]Iobenguane: 9.25-18.5MBq/ml
(0.05-0.5mg/ml).
Summary of the physical characteristics of the
radioactive isotope in the active substance:
Iodine-131: physical half-life 8.02 days.
The most important radiation emissions are as
below:
Energy level
Abundance %)
b
-247 keV
1.8
b
-334 keV
7.2
b
-606 keV
89.7
b
-806 keV
0.7
g
-364 keV
82.0
Excipients with known effect:
• Benzyl alcohol: 10 mg/ml
• Sodium: 3.54 mg/ml
For the full list of excipients, see section 6.1.
sap1193219_ch14473882_x_gehealthcare_PP28512.qxp_# 30.01.19 11:12
Seite 1
3.
PHARMACEUTICAL FORM
Solution for intravenous injection
Clear colourless solution
4.
CLINICAL PARTICULARS
4.1
INDICATION
This medicinal product is for diagnostic use only.
Calculation of a therapeutic [
131
I]iobenguane
dose from a prior tracer-dose.
The sensitivity to diagnostic visualisation, and
therefore also to therapeutic efficacy, is different
for the listed pathologic entities.
Pheochromocytomas and neuroblastomas are
sensitive in approximately 90 % of patients,
carcinoids in 70 % and medullary carcinomas of
the thyroid glands (MCT) in only 35 %.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults_
"Tracer"-dose to acquire dosimetric information
(20-40 MBq).
Distribution measurement prior to administration
of a therapeutic dose is recommended in order to
establish the retention time of the radiopharma-
ceutical in organs, tumour tissue and normal
structures.
_Elderly population_
No special dosage scheme is required for the
elderly patient.
_Paediatric population_
The recommended dosages are identical for
children and adults. Metaiodobenzylguanidine
(
131
I) for Diagnostic Use is contraindicated in
premature babies and neonates.
Method of administration
The