Octreoscan 111 MBq/ ml / 10 mikrog

Land: Norge

Språk: norska

Källa: Statens legemiddelverk

Aktiva substanser:

Indium (111In) klorid / Pentetreotid

Tillgänglig från:

Curium Netherlands B.V.

ATC-kod:

V09IB01

INN (International namn):

Indium (111In) chloride / Pentetreotide

Dos:

111 MBq/ ml / 10 mikrog

Läkemedelsform:

Preparasjonssett til radioaktive legemidler

Enheter i paketet:

1 sett

Receptbelagda typ:

C

Bemyndigande status:

Markedsført

Tillstånd datum:

2014-07-15

Produktens egenskaper

1.
NAME OF THE MEDICINAL PRODUCT
Octreoscan111 MBq/mL, kit for radiopharmaceutical preparation
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Octreoscan is supplied as two vials which cannot be used separately.
Vial A with 1.1 mL solution contains at activity reference time:
Indium(
111
In) chloride
122 MBq (111 MBq/mL)
Vial B contains:
Pentetreotide
10 microgram
After reconstitution and labelling the obtained solution contains
indium(
111
In)-pentetreotide 111 MBq/
mL.
Indium(
111
In) decays with a half-life of 2.83 days to stable cadmium(
111
Cd).
Emission characteristics:
Gamma-rays
172 keV
(90 % abundance)
Gamma-rays
247 keV
(94 % abundance)
X-rays
23-26 keV
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Kit for radiopharmaceutical preparation. The kit consists of two
vials:
Vial A: Radiopharmaceutical precursor. Clear and colourless solution.
Vial B: Powder for solution for injection. White lyophylised powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only.
Indium(
111
In)-pentetreotide specifically binds to receptors for somatostatin.
After radiolabelling pentetreotide with indium(
111
In) chloride, the solution obtained 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
somatostatin 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.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults and elderly population
The activity to be administered for single photon emission tomography
(SPECT) depends on the available
equipment. In general for an adult of 70 kg, an activity of 110 to 220
MBq in one single intravenous
injection should be sufficient.