Thallous (Tl201) chloride injection 37 MBq/ml solution for injection

Nchi: Ayalandi

Lugha: Kiingereza

Chanzo: HPRA (Health Products Regulatory Authority)

Viambatanisho vya kazi:

Thallous chloride (201 tl)

Inapatikana kutoka:

Curium Netherlands B.V.

ATC kanuni:

V09GX; V09GX01

INN (Jina la Kimataifa):

Thallous chloride (201 tl)

Kipimo:

37 megabecquerel(s)/millilitre

Dawa fomu:

Solution for injection

Dawa ya aina:

Product subject to prescription which may not be renewed (A)

Eneo la matibabu:

Other cardiovascular system diagnostic radiopharmaceuticals; thallium (201Tl) chloride

Idhini hali ya:

Marketed

Idhini ya tarehe:

1981-08-25

Taarifa za kipeperushi

23 CON 8103 Ireland PIL 19102022_clean
DRN 8103
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
THALLOUS (TL201) CHLORIDE INJECTION
37 MBQ/ML
SOLUTION FOR INJECTION
Thallous (Tl-201) chloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE
BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your nuclear medicine doctor
who will supervise the
procedure.
•
If you get any side effects, talk to your nuclear medicine doctor.
This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1. What Thallous (Tl201) Chloride is and what it is used for
2. What you need to know before Thallous (Tl201) Chloride is used
3. How Thallous (Tl201) Chloride is used
4. Possible side effects
5. How Thallous (Tl201) Chloride is stored
6. Contents of the pack and other information
1. WHAT THALLOUS (TL201) CHLORIDE IS AND WHAT IT IS USED FOR
This medicine is a radiopharmaceutical product for diagnostic use
only.
This medicine contains thallous (Tl-201) chloride, a radioactive
substance which when injected,
collects in certain organs, such as the heart.
The radioactive substance can be photographed from outside the body,
using special cameras which
take a scan. This scan shows where the radioactivity is inside the
organ and the body. This gives the
doctor valuable information about how that organ is working.
Thallous (Tl201)
Chloride is used to make a scan of the:
•
heart muscle and blood circulation in the heart, to examine heart
diseases
•
leg muscles, to examine the blood flow in the muscles in a certain
condition where the arteries in
the limbs are narrowed (peripheral vascular disorder)
•
parathyroid gland
•
certain tumours known to take up thallium, such as brain or thyroid
tumours and metastases.
The use of Thallous (Tl201) Chloride does involve exposure to small
amounts of radioactivity. Your
doctor and the nuclear medicine doctor have considered that the
clinic

Tabia za bidhaa

Health Products Regulatory Authority
11 January 2023
CRN00DCS3
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Thallous (Tl201) chloride injection 37 MBq/ml solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml contains 37 MBq thallous (Tl-201) chloride at the date and time
of calibration.
The specific activity is more than 18.5 GBq /mg thallium. Tl-201
decays to Hg-201 by electron capture with a half-life of 3.04
days. The energy of the main gamma radiations are 167 keV (10 %) and
135 keV (2.6 %). The energies of X-rays are 69 to 83
keV.
Excipient with known effect
Each ml of thallous (Tl-201) chloride injection contains 3.5 mg of
sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless solution with pH 4.0 to 7.0.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only.
Thallous (Tl201) Chloride injection is indicated in adults for:

Myocardial scintigraphy in the evaluation of coronary perfusion and
cellular viability: ischaemic heart disease,
cardiomyopathies, myocarditis, myocardial contusions and secondary
cardiac lesions.

Scintigraphy of the muscles: muscle perfusion in peripheral vascular
disorders.

Parathyroid scintigraphy.

Thallium-avid tumour visualisation in different organs, especially for
the brain tumours and thyroid tumours and
metastases.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults and elderly_
The recommended activity for a patient of average weight (70 kg) is 50
to 80 MBq of thallous (Tl201) chloride solution,
administered by intravenous injection at stress or rest. This activity
can be increased by 50% if SPECT-imaging is considered
until a maximum activity of 110 MBq.
An additional injection of 40 MBq at rest may be considered after
initial stress injection (re-injection).
_ _
_Paediatric population_
Thallous (Tl201) chloride is contraindicated in children and
adolescents (see section 4.3).
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