OCTREOSCAN FOR INJECTION

Krajina: Singapur

Jazyk: angličtina

Zdroj: HSA (Health Sciences Authority)

Aktívna zložka:

INDIUM (IN 111) CHLORIDE; PENTETREOTIDE

Dostupné z:

QT INSTRUMENTS (S) PTE LTD

ATC kód:

NA

Dávkovanie:

122 MBq/1.1 ml (in vial A)

Forma lieku:

INJECTION, POWDER, FOR SOLUTION

Zloženie:

INDIUM (IN 111) CHLORIDE 122 MBq/1.1 ml (in vial A); PENTETREOTIDE 10 mcg/vial (in vial B)

Spôsob podávania:

INTRAVENOUS

Typ predpisu:

Prescription Only

Výrobca:

Curium Netherlands B.V.

Stav Autorizácia:

ACTIVE

Dátum Autorizácia:

1999-12-16

Súhrn charakteristických

DRN 4920
OCTREOSCAN SINGAPORE
PAGE 1 OF 3
04920706BYS04a / 06 CON 4920 Singapore PI 22082023
DATASHEET/DIRECTIONS FOR USE
1.
TRADE NAME OF THE MEDICINAL PRODUCT
OCTREOSCAN
(Curium catalogue number: DRN 4920)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
OctreoScan is supplied as two vials which cannot be used separately.
Contents of vial 4920/A:
111
In as InCl
3
122 MBq/1.1 ml at activity reference time/date
Contents of vial 4920/B:
Pentetreotide 10 µg
After reconstitution and labelling the solution contains
111
In-pentetreotide.
3.
PHARMACEUTICAL FORM
Vial A: Precursor solution.
Vial B: Powder for solution for injection.
4.
CLINICAL PARTICULARS
I.
INDICATIONS
111
In pentetreotide specifically binds to receptors for somatostatin.
OctreoScan is indicated for use as adjunct in the diagnosis and
management of receptor bearing gastro-entero-pancreatic
neuroendocrine (GEP) tumours and carcinoid tumours, by aiding in their
localisation. Tumours which do not bear receptors will not be
visualised.
In a number of patients suffering from GEP or carcinoid tumours the
receptor density is insufficient to allow visualisation with
OctreoScan.
Notably in approximately 50% of patients suffering from insulinoma the
tumour cannot be visualised.
II.
POSOLOGY AND METHOD OF ADMINISTRATION
The dose for planar scintigraphy is 110 MBq in one single intravenous
injection. Careful administration is necessary to avoid paravasal
deposition of activity. For single photon emission tomography the dose
depends on the available equipment. In general, an activity dose of
110 to 220 MBq in one single intravenous injection should be
sufficient.
No special dosage regimen for elderly patients is required.
There is limited experience on administrations in paediatric patients,
but
when the use in a child is considered to be necessary, the amount of
activity administered should be reduced according to standard body
weight or body surface calculations. A practical approach is to adopt
the
recommendations of the Paediatric Task Group, European Association
o