ULTRATAG RBC kit for the preparation of Technetium [99mTc] labelled red blood cells

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

stannous chloride dihydrate, Quantity: 19.2 microgram/mL

Tilgjengelig fra:

Landauer Radiopharmaceuticals Pty Ltd

Legemiddelform:

Injection, powder for

Sammensetning:

Excipient Ingredients: sodium citrate dihydrate; glucose

Administreringsrute:

Intravenous

Enheter i pakken:

1 x vial powder 96 micrograms, 1 x syringe 0.6mL, 1 x syringe 1mL

Resept typen:

Not scheduled. Not considered by committee

Indikasjoner:

Technetium Tc99m- labelled red blood cells are used for cardiac first pass & gated equilibrium imaging

Produkt oppsummering:

Visual Identification: White lyophilized powder; Container Type: Multiple containers; Container Material: Glass; Container Life Time: 15 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Autorisasjon status:

Registered

Autorisasjon dato:

1994-02-02

Informasjon til brukeren

Page 1 of 4
ULTRATAG™ RBC
_Ultratag RBC (Kit for the Preparation of Technetium (_
_99m_
_Tc)-Labelled _
_Red Blood Cells) _
CONSUMER MEDICINE INFORMATION
_WHAT IS IN THIS LEAFLET _
This leaflet answers some of the common questions about Ultratag RBC.
It does not
contain all of the available information about Ultratag RBC. It does
not replace talking to
your doctor.
All medicines have risks and benefits. Your doctor has weighed the
risks of you or your
child receiving Ultratag RBC against the benefits he or she expects it
will have.
IF YOU HAVE ANY CONCERNS ABOUT HAVING THIS MEDICINE, ASK YOUR DOCTOR.
KEEP THIS LEAFLET.
You may need to read it again.
_WHAT IS ULTRATAG RBC _
Ultratag RBC is a kit consisting of 3 separate components which are
used in combination
to prepare radiolabeled red blood cells. Ultratag RBC belongs to a
group of medicines
called radiopharmaceutical agents, which are all radioactive.
Ultratag RBC comes as a kit containing a 10 mL reaction vial and 2
syringes. There are
5 units in a multi-dose kit.
_WHAT IS ULTRATAG RBC USED FOR _
Ultratag RBC is an imaging agent that is used primarily in cardiac
function studies.
Ultratag RBC is also used in detecting sites of gastrointestinal
bleeding.
Your doctor may have prescribed Ultratag RBC for another purpose. Ask
your doctor if
you have any questions about why Ultratag RBC has been prescribed for
you. If you have
any concerns, you should discuss these with your doctor.
This medicine is only available with a doctor’s prescription.
_BEFORE YOU ARE GIVEN ULTRATAG RBC_
_ _
Before you are given Ultratag RBC, your doctor will explain to you the
procedure you are
about to undergo, and the radioactive medicine you will be given. You
must discuss any
concerns you have with your doctor.
Page 2 of 4
Ultratag RBC is recommended for patients 18 years of age and older. If
your doctor
believes it is necessary to give Ultratag RBC to a patient under 18,
he or she will discuss
the benefits and risks with you.
YOU MUST TELL YOUR DOCTOR IF YOU HAVE ALLERGIES TO:
�

Preparatomtale

Page 1 of 10
AUSTRALIAN PRODUCT INFORMATION
ULTRATAG™ RBC (STANNOUS CHLORIDE DIHYDRATE) POWDER
FOR INJECTION
1
NAME OF THE MEDICINE
Stannous chloride dihydrate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ultratag™ RBC Kit for the Preparation of Technetium Tc 99m-Labelled
Red Blood Cells, a diagnostic
radiopharmaceutical agent.
Ultratag RBC is a sterile, non-pyrogenic, diagnostic kit for the
_in vitro_
preparation of Technetium Tc 99m-
Labelled Red Blood Cells.
Each kit consists of three separate non-radioactive components. A
reaction vial containing the active
ingredient stannous chloride dihydrate, the contents of the vial are
lyophilised and stored under argon. There
are two syringes containing diluent solutions for reconstitution.
For the full list of excipients, see section
6.1 LIST OF EXCIPIENTS
.
PHYSICAL CHARACTERISTICS
Technetium Tc 99m decays by isomeric transition with a physical
half-life of 6.02 hours.
1
The principal
photon that is useful for detection and imaging is listed in
TABLE 1
.
_Table 1. Principal Radiation Emission Data_
_1 _
_ _
RADIATION
M
MEAN PERCENT/
DISINTEGRATION
ENERGY
(KEV)
Gamma-2
89.07
140.5
The specific gamma ray constant for Technetium Tc 99m is 0.78 R/mCi-hr
at 1 cm. The first half-value
thickness of lead (Pb) for Technetium Tc 99m is 0.017 cm. A range of
values for the relative attenuation of
the radiation emitted by this radionuclide resulting from the
interposition of various thicknesses of lead
(Pb) is presented in
TABLE 2
. For example, the use of 0.25 cm of lead will decrease the external
radiation
exposure by a factor of about 1000.
_ _
1
Kocher, David C., “Radioactive Decay Data Tables,” DOE/TIC-11026,
108 (1981).
Page 2 of 10
_Table 2. Radiation Attenuation by Lead Shielding _
_ _
SHIELD THICKNESS
(PB) CM
COEFFICIENT OF
ATTENUATION
0.017
0.08
0.16
0.25
0.33
0.5
10
-1
10
-2
10
-3
10
-4
To correct for physical decay of this radionuclide, the fractions that
remain at selected time intervals after
the time of calibration are shown in
TABLE 3
.
_Table 3. Physical D