Lumark
Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
Листовка
(PIL)
29-09-2020
Данни за продукта
(SPC)
29-09-2020
Доклад обществена оценка
(PAR)
14-01-2019
Активна съставка:
lutetium (177Lu) chloride
Предлага се от:
I.D.B. Radiopharmacy B.V.
АТС код:
V10
INN (Международно Name):
lutetium (177 Lu) chloride
Терапевтична група:
Therapeutic radiopharmaceuticals
Терапевтична област:
Radionuclide Imaging
Терапевтични показания:
Lumark is a radiopharmaceutical precursor. It is not intended for direct use in patients. This medicinal must be used only for the radiolabelling of carrier molecules, which have been specifically developed and authorised for radiolabelling with this radionuclide.
Каталог на резюме:
Revision: 9
Статус Оторизация:
Authorised
Дата Оторизация:
2015-06-18
Листовка
21
B. PACKAGE LEAFLET
22
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LUMARK 80 GBQ/ML RADIOPHARMACEUTICAL PRECURSOR SOLUTION
Lutetium (
177
Lu) chloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THE MEDICINE
COMBINED WITH LUMARK 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 Lumark is and what it is used for
2.
What you need to know before the medicine radiolabelled with Lumark is
used
3.
How to use the medicine radiolabelled with Lumark
4.
Possible side effects
5.
How to store Lumark
6.
Contents of the pack and other information
1.
WHAT LUMARK IS AND WHAT IT IS USED FOR
Lumark is not a medicine and it is not intended to be used on its own.
Lumark is a so-called radiopharmaceutical precursor. It contains the
active substance
lutetium (
177
Lu) chloride.
Lumark is used for radiolabelling medicines, a technique in which
medicines are tagged (radiolabelled) with
a radioactive form of the element lutetium, known as lutetium (
177
Lu). These medicines can then be used in
medical procedures to carry radioactivity to where it is needed in the
body such as sites of tumour cells.
Lumark is only used to radiolabel medicines that have been
specifically developed for use with the active
substance lutetium (
177
Lu) chloride.
The use of lutetium (
177
Lu)-labelled medicines does involve exposure to small amounts of
radioactivity. Your
doctor and the nuclear medicine doctor have considered that the
clinical benefit that you will obtain from the
procedure with the radiopharmaceutical outweighs the risk due to
radiation.
Please refer to the package leaflet of the medicine that is to be
radiolabelled with Lumark.
2.
WHAT YOU NEED TO KNOW BEFORE THE MEDICINE RADIOLABELLED WITH L
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Данни за продукта
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Lumark 80 GBq/mL radiopharmaceutical precursor, solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of solution contains 80 GBq lutetium (
177
Lu) chloride at activity reference time (ART),
corresponding to at most a maximum of 160 microgram of lutetium. The
ART is defined as the end of
production.
Each vial contains a volume varying from 0.1 to 5 mL corresponding to
an activity ranging from 8 to
400 GBq (at ART)
.
The minimal specific activity is 500 GBq/mg lutetium (
177
Lu) at the ART.
Lutetium (
177
Lu) has a half-life of 6.647 days. Lutetium (
177
Lu) is produced by neutron irradiation of
enriched lutetium (
176
Lu). Lutetium (
177
Lu) decays by β
-
-emission to stable Hafnium (
177
Hf), with the most
abundant β
-
(79.3%) having a maximum energy of 0.497 MeV. Also low gamma energy is
emitted, for
instance at 113 keV (6.2%) and 208 keV (11%).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Radiopharmaceutical precursor, solution.
Clear, colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Lumark is a radiopharmaceutical precursor. It is not intended for
direct use in patients. It must be used only
for the radiolabelling of carrier molecules, which have been
specifically developed and authorised for
radiolabelling with this radionuclide.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Lumark is only to be used by specialists experienced with
_in vitro_
radiolabelling.
Posology
The quantity of Lumark required for radiolabelling and the quantity of
the medicinal product to be
radiolabelled with lutetium(
177
Lu) that is subsequently administered will depend on the medicinal
product to
be radiolabelled and its intended use. Refer to the Summary of Product
Characteristics/package leaflet of the
particular medicinal product to be radiolabelled.
_ _
3
_Paediatric population _
For more information concerning the paediatric use of lutetium (
177
Lu)-labelled medicinal products refer to
the
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