ANSTO Lutetium (177Lu) Chloride Radiochemical Solution for injection vial

Nchi: Australia

Lugha: Kiingereza

Chanzo: Department of Health (Therapeutic Goods Administration)

Viambatanisho vya kazi:

lutetium (177Lu) chloride, Quantity: 10 GBq/mL

Inapatikana kutoka:

Australian Nuclear Science and Technology Organisation T/A ANSTO

Dawa fomu:

Solution

Tungo:

Excipient Ingredients: dilute hydrochloric acid; purified water

Njia ya uendeshaji:

Intravenous

Vitengo katika mfuko:

2 mL

Dawa ya aina:

exempt from scheduling - Appendix A; prescription medicine

Matibabu dalili:

Lutetium (177Lu) chloride is a radiopharmaceutical precursor, and it is not intended for direct use in patients. For the treatment of non resectable or metastatic neuroendocrine tumours (NETS) expressing somatostatin subtype 2 receptors when coupled with a suitable carrier molecule.

Bidhaa muhtasari:

Visual Identification: Clear, colourless solution; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 14 Days; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Idhini hali ya:

Registered

Idhini ya tarehe:

2022-01-11

Taarifa za kipeperushi

Lutetium Chloride*
1
LUTETIUM (
177
LU) CHLORIDE
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.

This medicine is new. Please report side effects. See the full CMI for
further details. Why am I using Lutetium (
177
Lu)
Chloride?
1.
WHY AM I USING LUTETIUM CHLORIDE?
Lutetium (
177
Lu) Chloride is used for the treatment of certain tumours and is
always used with a carrier medicine. For more
information, see Section 1. Why am I using Lutetium (
177
Lu) Chloride? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I HAVE LUTETIUM CHLORIDE?
Do not use if you have ever had an allergic reaction to Lutetium (
177
Lu) Chloride or any of the ingredients listed at the end of the
CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS,
TAKE ANY OTHER MEDICINES, PLAN TO BECOME PREGNANT OR ARE
BREASTFEEDING.
For more information, see Section 2. What should I know before I have
Lutetium (
177
Lu) Chloride? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Lutetium (
177
Lu) Chloride and affect how it works. Tell your doctor if you are
taking any other
medicines, including any vitamins or supplements that you buy without
a prescription. For more information, see Section 3. What
if I am taking other medicines? in the full CMI.
4.
HOW IS LUTETIUM CHLORIDE GIVEN?
Lutetium (
177
Lu) Chloride is given by your doctor
More instructions can be found in Section 4. How is Lutetium (
177
Lu) Chloride given? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING LUTETIUM CHLORIDE?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist that you are using Lutetium (
177
Lu) Chloride.
•
Have all medical tests recommended by your doctor.
•
Tell your doctor if you become pregnant.
•
Call your doctor immediately if you experience shortness of breath,
bruising, nose bleeds, bleeding
from your gums, or if you develop a fever.
THINGS YOU
SHOULD NOT DO
•
Do not mi

Tabia za bidhaa

Lutetium Chloride Product Information
1
This medicinal product is subject to additional monitoring in
Australia. This will allow
quick identification of new safety information. Healthcare
professionals are asked to report any
suspected adverse events at https://www.tga.gov.au/reporting-problems
AUSTRALIAN PRODUCT INFORMATION
LUTETIUM (
177
LU) CHLORIDE RADIOPHARMACEUTICAL PRECURSOR, SOLUTION
1
NAME OF THE MEDICINE
Lutetium (
177
Lu) chloride.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Lutetium (
177
Lu) chloride (lutetium chloride) is a clear, colourless solution, free
of impurities
in 0.04M hydrochloric acid. Each vial may contain between 10 GBq/mL to
200 GBq/mL
lutetium chloride
at Calibration DATE AND TIME (radioactive concentration) in required
volume of 0.04 M hydrochloric acid to make the final solution volume
of 0.5 mL.
Lutetium emits both medium-energy beta particles and imageable gamma
photons and has
a half-life of 6.647 days. The primary radiation emissions of lutetium
are shown in Table 1
below.
TABLE 1: LUTETIUM (
177
LU) PRINCIPLE RADIATION EMISSION DATA
RADIATION
ENERGY (KEV)*
ABUNDANCE (%)
Beta (β
−
)
47.66
11.61
Beta (β
−
)
111.69
9.0
Beta (β
−
)
149.35
79.4
Gamma
112.9498
6.17
Gamma
208.3662
10.36
* mean energies are listed for beta particles
3
PHARMACEUTICAL FORM
Lutetium chloride is a clear, colourless solution, free of impurities
supplied as a
radiopharmaceutical precursor.
Lutetium chloride has no therapeutic application in clinical medicine.
It is intended to be
used only when bound to a specific biological carrier as part of
peptide receptor
radionuclide therapy (PRRT).
▼
Lutetium Chloride Product Information
2
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Lutetium (
177
Lu) chloride is a radiopharmaceutical precursor, and it is not
intended for
direct use in patients. For the treatment of non resectable or
metastatic neuroendocrine
tumours (NETS) expressing somatostatin subtype 2 receptors when
coupled with a suitable
carrier molecule.
4.2
DOSE AND METHOD OF ADMINISTRAT