Octreoscan 111 MBq/mL, kit for radiopharmaceutical preparation

País: Irlanda

Língua: inglês

Origem: HPRA (Health Products Regulatory Authority)

Ingredientes ativos:

Indium (111 in) chloride solution; Pentetreotide

Disponível em:

Curium Netherlands B.V.

Código ATC:

V09AX01

DCI (Denominação Comum Internacional):

Indium (111 in) chloride solution; Pentetreotide

Dosagem:

111 megabecquerel(s)/millilitre

Forma farmacêutica:

Kit for radiopharmaceutical preparation

Tipo de prescrição:

Product subject to Restricted Prescription (C)

Área terapêutica:

indium (111In) pentetic acid

Status de autorização:

Marketed

Data de autorização:

1995-06-08

Folheto informativo - Bula

ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
18 APP 4920 Ireland SPC 15052019_clean
1.
NAME OF THE MEDICINAL PRODUCT
Octreoscan 111 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 micrograms
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
18 APP 4920 Ireland SPC 15052019_clean
Posology
Adults and elderly population
The activity to be administered for single photon emission tomography
(SPECT) depends on the available
equipment. I

Características técnicas

Health Products Regulatory Authority
20 September 2019
CRN009C3N
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Octreoscan 111 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:
(
111
In) Indium(III)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