MYOVIEW 0.23MG KIT FOR RADIOPHARMACEUTICAL PREPARATION

国家: 塞浦路斯

语言: 希腊文

来源: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας

有效成分:

TETROFOSMIN

可用日期:

GE HEALTHCARE AS (NYDALEN) (0000010815) NYDALEN, OSLO, NO-0401, 4220

ATC代码:

V09GA02

INN（国际名称）:

TECHNETIUM (99MTC) TETROFOSMIN

剂量:

0.23MG

药物剂型:

KIT FOR RADIOPHARMACEUTICAL PREPARATION

组成:

TETROFOSMIN (8000001935) 0,23MG

给药途径:

INTRAVENOUS USE

处方类型:

Εθνική Διαδικασία

治疗领域:

TECHNETIUM (99mTc) TETROFOSMIN

產品總結:

Νομικό καθεστώς: Με Ιατρική Συνταγή; PACK WITH 5 VIALS X 0.23MG (230025202) 5 VIAL - Εγκεκριμένο - Με Ιατρική Συνταγή

产品特点

than 5% of the administered activity remains in whole blood at 10
minutes post-
injection. Background tissue clearance is rapid from lung and liver
and activity is
reduced in these organs following exercise, with enhanced
sequestration in skeletal
muscle. Approximately 66% of the injected activity is excreted within
48 hours post-
injection, with approximately 40% excreted in the urine and 26% in the
faeces.
MYOCARDIAL UPTAKE:
Uptake in the myocardium is rapid, reaching a maximum of about 1.2% of
injected
dose with sufficient retention to allow imaging of the myocardium by
planar or SPECT
techniques from 15 minutes up to 4 hours post-administration.
PRECLINICAL SAFETY DATA
Acute toxicity studies employing Myoview at dosage levels of
approximately 1050
times the maximum human single dose failed to reveal mortality or any
significant
signs of toxicity in rats or rabbits. In repeated dose studies some
evidence of toxicity
was observed in rabbits, but only at cumulative doses exceeding 10,000
times the
maximum human single dose. In rats receiving these doses there was no
significant
evidence of toxicity. Studies on reproductive toxicity have not been
conducted.
Tetrofosmin
showed
no
evidence
of
mutagenic
potential
in
_in _
_vitro_ or
_in _
_vivo_
mutagenicity studies. Studies to assess the carcinogenic potential of
Myoview have
not been performed.
RADIATION DOSIMETRY
Estimated
absorbed
radiation
doses
for
an
average
adult
patient
(70kg)
from
intravenous
injections
of
99mTc-tetrofosmin
are
listed
below.
The
values
are
calculated assuming urinary bladder emptying at 3.5 hour intervals.
Frequent bladder
emptying should be encouraged after dosing to minimise radiation
exposure.
6.
Cut the strip into 3 pieces at the marked cutting positions and
measure the
activity
on
each
using
suitable
counting
equipment.
Try
to
ensure
similar
counting geometry for each piece and minimize equipment dead time
losses.
7.
Calculate the radiochemical purity from:
%
99m
Tc-tetrofosmin = Activity of centre piece x 100
Total activity of all