Isotonix Calcium Plus Formula

Country: Australia

Bahasa: Inggeris

Sumber: Department of Health (Therapeutic Goods Administration)

Bahan aktif:

Ascorbic acid,Calcium carbonate,Calcium citrate hydrate,Calcium lactate pentahydrate,Calcium phosphate,Calcium sulfate,Cholecalciferol,Magnesium carbonate - heavy,Magnesium oxide,Manganese sulfate monohydrate,Potassium citrate,Riboflavine

Boleh didapati daripada:

Market Australia Inc

Kelas:

Medicine Listed

Risalah maklumat

1-020605
CERETEC™
_FOR PREPARATION OF TECHNETIUM [_
_99M_
_TC] EXAMETAZIME INJECTION _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET?
This
leaflet
answers
some
common
questions about CERETEC. It does not
contain all the available information,
nor does it take the place of talking to
your doctor or treatment provider.
All
medicines
and
diagnostic
preparations
have
risks
and
benefits.
Your doctor has weighed the risks of
you
being
treated
with
CERETEC
against the expected benefits.
IF YOU HAVE ANY CONCERNS ABOUT BEING
GIVEN
THIS
PREPARATION,
ASK
YOUR
DOCTOR, OR TREATMENT PROVIDER.
KEEP THIS LEAFLET. You may need to
read it again.
WHAT CERETEC IS USED
FOR
CERETEC is used in the preparation of
a
radiopharmaceutical
which
is
a
medicinal product containing a small
amount of radioactivity.
Such radiopharmaceuticals are given in
small amounts to find or rule out a
disease.
The
radiation
your
body
receives is very low and is considered
safe. After the radioactive liquid is
given
to
you,
it
is
taken
up
by
the
organs of interest or just passes through
your body. The radiation is taken up
by a special camera and pictures are
prepared.
These
pictures
allow
the
nuclear medicine doctor to detect any
problems.
In
particular,
CERETEC
is
used
to
produce images of the brain of patients
who have fits or seizures. They occur
when
the
brain's
electrical
currents
become disordered from time to time in
some
people.
This
disease
is
called
epilepsy There is a number of different
types of epilepsy. CERETEC is used
particularly for the imaging of patients
with epilepsy which originates in the
parts
of
the
brain
just
centre
and
slightly behind the ears.
CERETEC is used to help find or rule
out a diagnosis only. It is not used to
treat or cure epilepsy.
Your
doctor
may
have
prescribed
CERETEC for another reason.
CERETEC
is
not
recommended
normally for use in children because
studies have not been performed on the
use
of
CERETEC
in
children.
Nevertheless,
your
doctor
may
have
decided to still use it and will have
weighed
up
the
risks

Ciri produk

PAGE 1 OF 12
CERETEC® PRODUCT INFORMATION
PRODUCT INFORMATION
CERETEC
®
FOR THE PREPARATION OF TECHNETIUM [
99M
TC] EXAMETAZIME INJECTION
DIAGNOSTIC RADIOPHARMACEUTICAL
FOR INTRAVENOUS SINGLE USE ONLY
DESCRIPTION
The Ceretec® kit is supplied as packs of two or five single dose vial
units for use in the
preparation of a technetium [
99m
Tc]-exametazime intravenous injection. Each single dose
vial unit contains a pre-dispensed sterile, non-pyrogenic, lyophilized
mixture of 0.5 mg
exametazime [(RR,SS)-4,8-diaza-3,6,6,9-tetramethylundecane-2,10-dione
bisoxime], 7.6 μg
stannous chloride dihydrate (minimum stannous tin 0.6 μg; maximum
total stannous and
stannic tin 4.4 μg per vial) and 4.5 mg sodium chloride, sealed under
nitrogen atmosphere at a
pressure
just
below
atmospheric,
with
a
rubber
closure.
The
product
contains
no
antimicrobial preservative.
Exametazime was formerly known as hexamethylpropylene amine oxime
(HM-PAO). (The
name HM-PAO appears in many publications).
The structural formula of exametazime is:
When sterile pyrogen-free sodium pertechnetate [
99m
Tc] in isotonic saline is added to the vial,
PAGE 2 OF 12
CERETEC® PRODUCT INFORMATION
a [
99m
Tc]-complex of exametazime is formed.
Administration is by intravenous injection for diagnostic use.
PHYSICAL CHARACTERISTICS
Technetium-99m decays by isomeric transition with a physical half-life
of 6 hours. Photons
associated with this transition which are useful for detection and
imaging studies are listed
below:
TABLE 1: PRINCIPAL RADIATION EMISSION DATA
Principal
Mean Percent per
Mean Energy
Radiation
Disintegration
(keV)
Gamma-2
87.2
140.5
Reference:
Brown, E, Firestone, R B and Shirley, V S (Ed): Table of
Radioactive Isotopes, 1986, J Wiley
TABLE 2: PHYSICAL DECAY CHART FOR
99M
TC
Hours
Fraction
Hours
Fraction
Remaining
Remaining
0
1.000
7
0.445
1
0.891
8
0.397
2
0.794
9
0.354
3
0.707
10
0.315
4
0.630
11
0.281
5
0.561
12
0.250
6
0.500
EXTERNAL RADIATION
The specific gamma ray constant for
99m
Tc is 0.19 mGy per MBq-h at 1 cm.
The half-value thicknes