Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: A.C.O.M. - ADVANCED CENTER ONCOLOGY MACERATA S.R.L., Località Cavallino 39 A/B, 62010 Montecosaro (MC), Italy Tel.: 0039.0733.229739, Fax: 0039.0733.560352, E-mail: amministrazione@acompet.it
Cuprymina 925 MBq/mL radiopharmaceutical precursor, solution.
| Pharmaceutical Form |
|---|
|
Radiopharmaceutical precursor, solution. Clear, colourless solution, free of particulate matter |
Each mL of solution contains 925 MBq of copper (64Cu) 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 64Ni (61%) by an emission of β+ (18%) or by an electronic capture (43%). Copper-64 decays also in stable Zinc (64Zn) by emission of β- (39%).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Copper ⁶⁴Cu chloride |
Copper-64 chloride 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. |
| List of Excipients |
|---|
|
Hydrochloric acid (0.1 N) |
The radiopharmaceutical precursor solution is packaged in a colourless, type I glass 10 mL vial, closed with bromobutyl rubber stopper and aluminium overseal.
The volume of one vial ranges from 1 to 3 mL solution (corresponding to 925 to 2,770 MBq at calibration time).
The vials are packed into a tungsten or lead container for protective shielding.
Each pack contains 1 vial in a tungsten or lead container.
A.C.O.M. - ADVANCED CENTER ONCOLOGY MACERATA – S.R.L., Località Cavallino 39 A/B, 62010 Montecosaro (MC), Italy
Tel.: 0039.0733.229739, Fax: 0039.0733.560352, E-mail: amministrazione@acompet.it
EU/1/12/784/001
Date of first authorisation: 23 august 2012
Date of latest renewal: 19 july 2017
| Drug | Countries | |
|---|---|---|
| CUPRYMINA | Austria, Estonia, Croatia, Ireland, Poland |
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