Cuprymina

Țară: Uniunea Europeană

Limbă: engleză

Sursă: EMA (European Medicines Agency)

Ingredient activ:

copper (64Cu) chloride

Disponibil de la:

A.C.O.M. - Advanced Center Oncology

Codul ATC:

Not yet assigned

INN (nume internaţional):

copper (64Cu) chloride

Grupul Terapeutică:

Various diagnostic radiopharmaceuticals

Zonă Terapeutică:

Radionuclide Imaging

Indicații terapeutice:

Cuprymina is a radiopharmaceutical precursor. It is not intended for direct use in patients. This medicinal product must be used only for the radiolabelling of carrier molecules, which have been specifically developed and authorised for radiolabelling with this radionuclide.

Rezumat produs:

Revision: 8

Statutul autorizaţiei:

Authorised

Data de autorizare:

2012-08-23

Prospect

19
B.
PACKAGE LEAFLET
20
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CUPRYMINA 925 MBQ/ML RADIOPHARMACEUTICAL PRECURSOR, SOLUTION
Copper (
64
Cu) chloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THE MEDICINE
COMBINED WITH CUPRYMINA
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 Cuprymina is and what it is used for
2.
What you need to know before the medicine radiolabelled with Cuprymina
is used
3.
How the medicine radiolabelled with Cuprymina is used
4.
Possible side effects
5.
How to store Cuprymina
6.
Contents of the pack and other information
1.
WHAT CUPRYMINA IS AND WHAT IT IS USED FOR
Cuprymina is not a medicine
_ _
and it is not intended to be used on its own.
Cuprymina is a type of medicine called a radiopharmaceutical
precursor. It contains the active
substance copper (
64
Cu) chloride. Copper-64 is a radioactive form of the chemical element
copper,
which emits the radiation needed for certain procedures that may be
carried out on you.
Cuprymina is used for radiolabelling, a technique in which a substance
is tagged (radiolabelled) with a
radioactive compound. Cuprymina is used to label certain medicines
that have been specially
developed and authorised for use with the active substance copper (
64
Cu) chloride. These medicines
act as a carrier to take the radioactivity to where it is needed.
These may be substances that have been
designed to recognise a particular type of cell in the body, including
tumour cells.
The use of Copper-64-labelled medicines involves 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 radiopharmac

Caracteristicilor produsului

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Cuprymina 925 MBq/mL radiopharmaceutical precursor, solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of solution contains 925 MBq of copper (
64
Cu) chloride at calibration time (01h00 a.m.
Central European Time [CET]), corresponding to at least 0.25
micrograms of Copper-64. The
calibration time is set between the end of the synthesis time and the
expiry time.
Each vial contains an activity ranging from 925 MBq to 2,770 MBq (at
calibration time) which
corresponds to an amount of 0.25 to 0.75 micrograms of Copper-64. The
volume varies from 1 to 3 mL.
The minimal specific activity is 3,700 MBq Copper-64/micrograms of
Copper at the expiry date and
time.
Copper-64 has a half-life of 12.7 hours.
Copper-64 decays by an emission of β
+
(17.6 %) with a maximum energy of 0.66 MeV, an emission of
β
-
(38.5 %) with a maximum energy of 0.58 MeV and electronic capture
(43.9 %).
Copper-64 decays in stable Nickel
64
Ni (61 %) by an emission of β
+
(18 %) or by an electronic capture
(43 %). Copper-64 decays also in stable Zinc (
64
Zn) by emission of β
-
(39 %).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Radiopharmaceutical precursor, solution.
Clear, colourless solution, free of particulate matter.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Cuprymina is a radiopharmaceutical precursor. It is not intended for
direct use in patients. This
medicinal product 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
Cuprymina is only to be used by specialists experienced with
_in vitro_
radiolabelling
Posology
The quantity of Cuprymina required for radiolabelling and the quantity
of Copper-64-labelled
medicinal product that is subsequently administered will depend on the
medicinal product
radiolabelled and its intended use.
Refer to the Summary of Product Cha