EndolucinBeta
Country: Evrópusambandið
Tungumál: enska
Heimild: EMA (European Medicines Agency)
Upplýsingar fylgiseðill
(PIL)
16-02-2021
Vara einkenni
(SPC)
16-02-2021
Opinber matsskýrsla
(PAR)
08-01-2019
Virkt innihaldsefni:
lutetium (177Lu) chloride
Fáanlegur frá:
ITM Medical Isotopes GmbH
ATC númer:
V10X
INN (Alþjóðlegt nafn):
lutetium (177 Lu) chloride
Meðferðarhópur:
Therapeutic radiopharmaceuticals
Lækningarsvæði:
Radionuclide Imaging
Ábendingar:
EndolucinBeta is a radiopharmaceutical precursor, and it is not intended for direct use in patients. It is to be used only for the radiolabelling of carrier molecules that have been specifically developed and authorised for radiolabelling with Lutetium (177Lu) chloride.
Vörulýsing:
Revision: 8
Leyfisstaða:
Authorised
Leyfisdagur:
2016-07-06
Upplýsingar fylgiseðill
22
B. PACKAGE LEAFLET
23
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ENDOLUCINBETA 40 GBQ/ML RADIOPHARMACEUTICAL PRECURSOR, SOLUTION
lutetium (
177
Lu) chloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THE MEDICINE
COMBINED WITH ENDOLUCINBETA
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 EndolucinBeta is and what it is used for
2.
What you need to know before the medicine radiolabelled with
EndolucinBeta is used
3.
How the medicine radiolabelled with EndolucinBeta is used
4.
Possible side effects
5.
How EndolucinBeta is stored
6.
Contents of the pack and other information
1.
WHAT ENDOLUCINBETA IS AND WHAT IT IS USED FOR
EndolucinBeta is not a medicine and it is not intended to be used on
its own. It has to be used in
combination with other medicines (carrier medicines).
EndolucinBeta is a type of product called a radiopharmaceutical
precursor. It contains the active
substance Lutetium (
177
Lu) chloride which gives off beta-radiation, allowing a localised
radiation
effect. This radiation is used to treat certain diseases.
EndolucinBeta has to be combined with a carrier medicine in a process
called radiolabelling before
administration. The carrier medicine then takes the EndolucinBeta to
the disease site in the body.
These carrier medicines have been specially developed for use with
Lutetium (
177
Lu) chloride and may
be substances that have been designed to recognise a particular type
of cell in the body.
The use of a medicine radiolabelled with EndolucinBeta does involve
exposure to radioactivity. Your
doctor and the nuclear medicine doctor have considered that the
clinical benefit that you will obtain
from the procedure with the radiopharmaceutical outweigh
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Vara einkenni
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
EndolucinBeta 40 GBq/mL radiopharmaceutical precursor, solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 mL of solution contains 40 GBq Lutetium (
177
Lu) chloride on activity reference time (ART),
corresponding to 10 micrograms of Lutetium (
177
Lu) (as chloride).
The ART is 12:00 pm (noon) on the scheduled day of radiolabelling as
indicated by the customer and
can be within 0 to 7 days starting from the day of manufacture.
Each 2 mL vial contains an activity ranging from 3 – 80 GBq,
corresponding to 0.73 – 19 micrograms
of Lutetium (
177
Lu), at ART. The volume is 0.075 – 2 mL.
Each 10 mL vial contains an activity ranging from 8 – 150 GBq,
corresponding to 1.9 –
36 micrograms of Lutetium (
177
Lu), at ART. The volume is 0.2 – 3.75 mL.
The theoretical specific activity is 4,110 GBq/mg of Lutetium (
177
Lu). The specific activity of the
medicinal product at ART is indicated on the label and always greater
than 3,000 GBq/mg.
Non carrier added (n.c.a.) Lutetium (
177
Lu) chloride is produced by the irradiation of highly enriched
(> 99 %) Ytterbium (
176
Yb) in neutron sources with a thermal neutron flux between 10
13
and
10
16
cm
−2
s
−1
. The following nuclear reaction is ongoing in the irradiation:
176
Yb(n, γ)
177
Yb →
177
Lu
The produced Ytterbium (
177
Yb) with a half-life of 1.9 h decays to Lutetium (
177
Lu). In a
chromatographic process, the accumulated Lutetium (
177
Lu) is separated chemically from the original
target material.
Lutetium (
177
Lu) 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 (
177
Lu) are shown in Table 1.
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
Lutetium (
177
Lu)
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