LANTHEUS THALLIUM[201Tl] CHLORIDE 74MBq/mL injection multidose vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

thallous(201Tl) chloride, Quantity: 74 MBq/mL

Available from:

Global Medical Solutions Australia Pty Limited

INN (International Name):

thallous(201Tl) chloride

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: sodium chloride; water for injections; sodium hydroxide; hydrochloric acid; benzyl alcohol

Administration route:

Intravenous

Units in package:

244MBq/3.3mL, 407MBq/5.5mL, 326MBq/4.4mL, 570MBq/7.7mL, 163MBq/2.2mL, 733MBq/9.9mL

Prescription type:

Not scheduled. Not considered by committee

Therapeutic indications:

Thallous [201Tl] Chloride Injection may be useful in myocardial perfusion imaging and for the diagnosis and localization of myocardial infarction. It may also be useful in conjunction with exercise stress testing as an adjunct to the diagnosis of ischemic heart disease. Thallous [201Tl] Chloride Injection may be useful for the localization of areas of parathyroid hyperactivity and for parathyroid imaging in patients with biochemically proven hyper-parathyroidism.

Product summary:

Visual Identification: A clear colourless solution; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 5 Days; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2004-11-26

Patient Information leaflet

THALLIUM CHLORIDE TL 201 INJECTION, USP
Thallous Chloride Tl 201
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the common questions about Thallous
Chloride Tl 201.
It does not contain all of the available information about Thallous
Chloride Tl 201. It
does not replace talking to your doctor.
All medicines have risks and benefits. Your doctor has weighed the
risks of you
receiving Thallous Chloride Tl 201 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 CHLORIDE TL 201
Thallous Chloride Tl 201 Injection contains an isotope of the element
Thallium and
belongs to a group of medicines called radiopharmaceutical agents,
which are all
radioactive.
WHAT THALLOUS CHLORIDE TL 201 IS USED FOR
Thallous Chloride Tl 201 is used to show the blood flow inside your
heart during
exercise and rest.
Thallous Chloride Tl 201 can be used to show areas of increased
activity in the
parathyroid glands. Your parathyroid glands are situated in your neck.
Your doctor may have prescribed Thallous Chloride Tl 201 for another
purpose. Ask
your doctor if you have any questions about why Thallous Chloride Tl
201 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 THALLOUS CHLORIDE TL 201
Before you are given Thallous Chloride Tl 201 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.
Thallous Chloride Tl 201 is not recommended for patients less than 18
years of age.
If your doctor believes it is necessary to give Thallous Chloride Tl
201 to a patient
under 18, he or she will discuss the benefits and risks with you.
2
YOU MUST TELL YOUR DOCTOR IF YOU HAVE ALLERGIES TO:

any other medicines

any other substances su

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – LANTHEUS THALLIUM
(THALLOUS (201TI) CHLORIDE) SOLUTION FOR INJECTION
1
NAME OF THE MEDICINE
Thallous (201Tl) chloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Thallous Chloride Tl 201 Injection for intravenous administration is
supplied as a sterile, non-
pyrogenic isotonic solution containing 74MBq/mL of Thallous Chloride
Tl 201 at calibration time. It is
made isotonic with 9mg/mL sodium chloride and is preserved with 9mg/mL
of benzyl alcohol. The
pH is adjusted to between 4.5-7.5 with hydrochloric acid and/or sodium
hydroxide solution.
Thallium Tl 201 is cyclotron produced with no carrier added and
contains no less than 98% Thallium
Tl 201 as a percentage of total activity with contaminants not greater
than 0.3% Thallium Tl 200
0.84% Thallium Tl 202, and 0.2% Lead Pb 203 expressed as a percentage
of Tl 201 activity at
calibration.
3
PHARMACEUTICAL FORM
Clear and colourless solution for intravenous injection.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Thallous Chloride Tl 201 Injection may be useful in myocardial
perfusion imaging and for the
diagnosis and localization of myocardial infarction.
It may also be useful in conjunction with exercise stress testing as
an adjunct to the diagnosis of
ischemic heart disease.
Thallous Chloride Tl 201 Injection may be useful for the localization
of areas of parathyroid
hyperactivity and for parathyroid imaging in patients with
biochemically proven hyper-
parathyroidism.
4.2
D
OSE AND METHOD OF ADMINISTRATION
The recommended adult (70 kg) dose of intravenous Thallous Chloride Tl
201 Injection is 37 to
74MBq. Thallous Chloride Tl 201 Injection is intended for intravenous
administration only.
As for all parenteral drug products, contents of the vial should be
inspected visually for particulate
matter and discoloration prior to administration.
The patient dose should be measured by a suitable radioactivity
calibration system immediately
prior to administration.
2
MYOCARDIAL IMAGING
For patients undergoing resting thallium studies