Ceretec - Kit for the preparation of Technetium [99mTc] Exametazime Injection

Country: Malta

Tungumál: enska

Heimild: Medicines Authority

Virkt innihaldsefni:

EXAMETAZIME

Fáanlegur frá:

GE Healthcare AS Nycoveien 1, NO-0485 Oslo, Norway

ATC númer:

V09AA01

INN (Alþjóðlegt nafn):

EXAMETAZIME 0.5 mg

Lyfjaform:

POWDER FOR SOLUTION FOR INJECTION

Samsetning:

EXAMETAZIME 0.5 mg

Gerð lyfseðils:

POM

Lækningarsvæði:

DIAGNOSTIC RADIOPHARMACEUTICALS

Leyfisstaða:

Withdrawn

Leyfisdagur:

2007-08-01

Upplýsingar fylgiseðill

1
CERETEC™ 2 VIAL PACK 5 VIAL PACK
N109 – 2 VIAL PACK
N109 – 5 VIAL PACK
KIT FOR THE PREPARATION OF TECHNETIUM [
99M
TC] EXAMETAZIME INJECTION
PRESENTATION
Each vial of Ceretec™ contains exametazime (HM-PAO or
[RR.SS]-4,8-diaza-3,6,6,9-
tetramethylundecane-2,10-dione bisoxime) (0.5mg), stannous chloride
dihydrate (7.6μg) and
sodium chloride (4.5mg) as a freeze-dried mixture sealed under
nitrogen.
Powder for injection following reconstitution with 5ml of sterile
Sodium Pertechnetate
[
99m
Tc] Injection Ph. Eur. at a radioactive concentration of 74- 222MBq/ml
(2-6 mCi/ml).
The pH of the injection is 9.0 - 9.8. This yields Technetium [
99m
Tc] Exametazime injection, a
diagnostic radio-pharmaceutical imaging agent for single dose use.
Packs of 2 and 5 vials are available. Labels for the reconstituted
product and sanitizing
swabs (containing 70% isopropyl alcohol BP) are provided.
HOLDER OF MARKETING AUTHORISATION
GE Healthcare AS
Nycoveien 1,
0485 Oslo,
0301 Oslo,
Norway
MANUFACTURER
GE Healthcare AS
P.O.Box 4220 Nydalen
NO-0401 Oslo
Norway
INDICATIONS
(i) Technetium [
99m
Tc] Exametazime is indicated for brain scintigraphy. The product is to
be
used for the diagnosis of abnormalities of regional cerebral blood
flow, such as those
occurring following stroke and other cerebrovascular disease,
epilepsy, Alzheimer’s Disease
and other forms of dementia, transient ischaemic attack, migraine and
tumours of the brain.
(ii) Technetium [
99m
Tc] Exametazime is also indicated for
_in vitro_
technetium-99m-leucocyte
labelling, the labelled leucocytes subsequently being re-injected and
scintigraphy carried out
to image the sites of localisation. This procedure may be used in the
detection of sites of
focal infection (e.g. abdominal abscess), in the investigation of
pyrexia of unknown origin
and in the evaluation of inflammatory conditions not associated with
infection such as
inflammatory bowel disease.
CONTRAINDICATIONS
There are no specific contra-indications
PRECAUTIONS FOR USE
This product is not to be administere

Vara einkenni

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Ceretec™
Kit for the preparation of Technetium [
99m
Tc] Exametazime Injection
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Exametazime 0.5 mg.
3
PHARMACEUTICAL FORM
Powder for injection.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
(1)
Technetium [
99m
Tc] Exametazime Injection is indicated for brain scintigraphy. The
product is to be used for the diagnosis of abnormalities of regional
cerebral blood flow,
such as those occurring following stroke and other cerebrovascular
disease, epilepsy,
Alzheimer’s Disease and other forms of dementia, transient ischaemic
attack, migraine
and tumours of the brain.
(2)
Technetium [
99m
Tc] Exametazime Injection is also indicated for
_in vitro _
technetium-
99m leucocyte labelling, the labelled leucocytes subsequently being
re-injected and
scintigraphy carried out to image the sites of localisation. This
procedure may be used
in the detection of sites of focal infection (e.g. abdominal abscess),
in the investigation
of pyrexia of unknown origin and in the evaluation of inflammatory
conditions not
associated with infection such as inflammatory bowel disease.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The route of administration is direct intravenous injection for brain
scintigraphy studies and
intravenous injection of labelled leucocytes post labelling
_in vitro_
.
Dose for adults and the elderly:
(1)
for brain scintigraphy, 350-500MBq
(2)
for
_in vivo _
localisation of technetium-99m-labelled leucocytes, 200MBq
Normally a once-only diagnostic procedure.
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Technetium [
99m
Tc]-Exametazime and Technetium-99m-labelled leucocytes are not
recommended for administration to children.
4.3
CONTRAINDICATIONS
There are no specific contra-indications.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Radiopharmaceutical agents should only be used by qualified personnel
with the appropriate
government authorisation for the use and manipulation of
radionuclides. They may be
received, used and adminis