Thallous(201Tl) chloride 85MBq/2.3mL injection

Maa: Australia

Kieli: englanti

Lähde: Department of Health (Therapeutic Goods Administration)

Aktiivinen ainesosa:

thallous(201Tl) chloride

Saatavilla:

Landauer Radiopharmaceuticals Pty Ltd

luokka:

Medicine Registered

Valtuutuksen tilan:

Registered

Pakkausseloste

Thallous(TI201) Chloride CMI 201511-01
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THALLOUS(TL201) CHLORIDE INJECTION
_Thallous(Tl 201) Chloride Injection_
CONSUMER MEDICINE INFORMATION
_WHAT IS IN THIS _
_LEAFLET _
This leaflet answers some of
the common questions about
Thallous(TI201) Chloride
Injection. It does not contain
all of the available information
about Thallous(TI201)
Chloride Injection. 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
Thallous(TI201) Chloride
Injection 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 _
_THALLOUS(TI201) _
_CHLORIDE INJECTION_
_ _
Thallous(TI201) Chloride
Injection contains the active
ingredient called Thallous
Chloride and belongs to a
group of medicines called
radiopharmaceutical agents,
which are all radioactive.
The
radioactivity can be
detected from outside of the
body by using special
cameras.
The image produced is
known as a scan. This scan
will show the accumulation of
radioactivity within the body,
within an organ or within a
mass or lump. This can give
the doctor valuable
information about the
structure and the
function of an organ or the
location of e.g., a tumour.
Thallous(TI201) Chloride
Injection comes in a 10 mL
vial and is available in five
different radioactivities. It is
ready for intravenous
injection as packaged.
_WHAT THALLOUS _
_(TI201) CHLORIDE _
_INJECTION IS USED _
_FOR_
_ _
Thallous(TI201) Chloride
Injection is used to show the
blood flow inside your heart
during exercise and rest.
Thallous(TI201) Chloride
Injection can also be used to
image the thyroid for
abnormalities as well as the
parathyroid and the brain for
signs of tumours.
Thallous(TI201) Chloride has
not been adequately
demonstrated to be effective
for the localization of normal
parathyroid glands.
Your doctor may have
prescribed Thallous(TI201)
Chloride Injection for another
purpose. Ask your do

Valmisteyhteenveto

Thallous-chloride-PI-TGA approved 16Dec19.doc
1
DRN 8103 THALLOUS (TL201) CHLORIDE INJECTION
PRODUCT INFORMATION
NAME OF THE MEDICINE
Thallous (Tl201) Chloride Injection
(Curium Netherlands catalogue number: DRN 8103)
CAS number: 7791-12-0
Molecular Formula: ThCl
DESCRIPTION
QUALITATIVE AND QUANTITATIVE COMPOSITION
201
Tl-Thallium as thallous chloride 37 MBq
The specific activity is more than 18.5 GBq (500 mCi)/mg
thallium.
201
Tl decays to
201
Hg by electron capture with a half-
life of 73.1 hours.
Most important radiation emitted Energy level Abundance (%)
69 keV-X-rays 27.4
80 keV-X-rays 20.5
135 keV-γ-rays 2.7
166 keV-γ-rays 1.6
167 keV-γ-rays 10.0.
LIST OF EXCIPIENTS:
Sodium chloride
Sodium hydroxide
Hydrochloric acid
Water for injections
The pH of the product is 5.0 - 7.0.
PHARMACEUTICAL FORM: Solution for injection
PHARMACOLOGY
PHARMACODYNAMIC PROPERTIES
Pharmacotherapeutic group: Other cardiovascular system,
diagnostic radiopharmaceutical.
ATC code: V 09 GX 01.
At the chemical concentrations and activities used for
diagnostic procedures Thallous (Tl201) chloride does not
appear to exert any pharmacodynamic effects.
PHARMACOKINETIC PROPERTIES
After intravenous injection of thallous (Tl201) chloride, the
thallium rapidly leaves the blood as approximately 90% is
cleared after the first pass. The relative uptake depends on
regional perfusion and on the cell extraction efficacy of
different organs. The myocardial extraction fraction of (
201
Tl) is
about 85% during the first pass and the peak myocardial
activity is 4-5% of the injected dose, relatively constant for
about 20-25 minutes.
The precise cellular uptake process is still uncertain but the
sodium-potassium ATPase pump is probably involved, at least
in part. The muscular uptake depends on workload and
compared with the resting condition, the uptake in skeletal
muscle and myocardium is increased 2-3 fold during exercise
with consequently reduction in other organs. Thallium is mainly
excreted in the faeces (80%) and in the urine (20%). The
effective ha