NeoSpect
Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Indlægsseddel
(PIL)
18-11-2010
Produktets egenskaber
(SPC)
18-11-2010
Offentlige vurderingsrapport
(PAR)
19-11-2010
Aktiv bestanddel:
depreotide trifluoroacetate
Tilgængelig fra:
CIS bio international
ATC-kode:
V09IA05
INN (International Name):
depreotide
Terapeutisk gruppe:
Diagnostic radiopharmaceuticals
Terapeutisk område:
Radionuclide Imaging
Terapeutiske indikationer:
This medicinal product is for diagnostic use only.For scintigraphic imaging of suspected malignant tumours in the lung after initial detection, incombination with CT scan or chest X-ray, in patients with solitary pulmonary nodules.
Produkt oversigt:
Revision: 10
Autorisation status:
Withdrawn
Autorisation dato:
2000-11-29
Indlægsseddel
Medicinal product no longer authorised
18
B. PACKAGE LEAFLET
Medicinal product no longer authorised
19
PACKAGE LEAFLET: INFORMATION FOR THE USER
NEOSPECT 47 MICROGRAMS. KIT FOR RADIOPHARMACEUTICAL PREPARATION
Depreotide
PLEASE READ THIS LEAFLET CAREFULLY. IT TELLS YOU ABOUT YOUR MEDICINE.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor.
-
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor.
IN THIS LEAFLET:
1.
What NeoSpect
is and what it is used for.
2.
Before you use
NeoSpect.
3.
How to use
NeoSpect.
4.
Possible side effects.
5.
How to store
NeoSpect.
6.
Further information.
1.
WHAT NEOSPECT
IS AND WHAT IT IS USED FOR
PRODUCT TYPE
NeoSpect is a radiopharmaceutical product used for diagnostic
purposes. A diagnostic
radiopharmaceutical is a product which, when injected, temporarily
collects in a particular part of the
body (for example a tumour). Because the substance contains a small
amount of radioactivity it can be
detected from outside the body using special cameras, and a picture,
known as a scan, can be taken.
This scan will show exactly the distribution of the radioactivity
within the body. This can give the
doctor valuable information such as the location of a tumour.
WHAT NEOSPECT
IS USED FOR
NeoSpect
is for diagnostic use only. NeoSpect is used to provide pictures which
show the location of
suspected malignant cancer tissue (a tumour) in the lung. When
injected, the radiolabelled compound
binds to malignant cancer tissue. Your doctor will then take a picture
(scan) of your lungs using a
special camera. The area where the radioactive compound is collected,
will light up on the picture and
give information on the location of the tumour. The evaluation also
includes examinations by CT-scan
or chest X-ray.
2.
BEFORE YOU USE NEOSPECT
DO NOT USE
NEOSPECT
-
if you are allergic (hypersensitive) to depreotide or any of the other
ingredients of NeoSpect or
to the radioactive techneti
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Produktets egenskaber
Medicinal product no longer authorised
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
NeoSpect
_ _
47 micrograms, kit for radiopharmaceutical preparation.
2.
QUALITATIVE
AND
QUANTITATIVE
COMPOSITION
Each vial contains 47 micrograms depreotide as depreotide
trifluoroacetate.
For a full list of excipients, see section 6.1
To be reconstituted with sodium pertechnetate (
99m
Tc) solution for injection (not included in this kit).
3.
PHARMACEUTICAL
FORM
Kit for radiopharmaceutical preparation. White powder for solution for
injection.
4.
CLINICAL
PARTICULARS
4.1
THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only.
For scintigraphic imaging of suspected malignant tumours in the lung
after initial detection, in
combination with CT scan or chest X-ray, in patients with solitary
pulmonary nodules.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The medicinal product is for hospital use or in designated Nuclear
Medicine Facilities only, by persons
experienced in radioisotope diagnostic imaging.
Instructions for reconstitution, handling and disposal are given in
section 12.
After reconstitution with sodium pertechnetate (
99m
Tc) solution for injection,
99m
Tc-depreotide
is
formed.
99m
Tc-depreotide is administered intravenously in a single dose. The
solution may be diluted with
sodium chloride 0.9% w/v solution for injection for more convenient
injection. SPECT images (Single
Photon Emission Computed Tomography) obtained between 2 and 4 hours
following
99m
Tc-depreotide
injection are required for optimal image interpretation.
DOSAGE FOR ADULTS
The recommended dosage is approximately 47 micrograms depreotide (one
vial) labelled with
555-740 MBq of technetium-99m.
DOSAGE FOR ELDERLY (>65 YEARS)
Experience from clinical trials indicates that no dose adjustment is
required.
CHILDREN
99m
Tc-depreotide is not recommended for use in patients below the age of
18 as data are not available
for this age group.
RENAL IMPAIRMENT
No dose adjustment is
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