CUPRYMINA Radiopharmaceutical precursor, solution (2020)
Βιβλιογραφική αναφορά
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Περιεχόμενα
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 (<sup>64</sup>Cu) chloride at calibration time (01h00 a.m. Central European Time [CET]), corresponding to at least 0.25 micrograms of Copper-64. The calibration ...
3. Pharmaceutical form
Radiopharmaceutical precursor, solution. Clear, colourless solution, free of particulate matter
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 ...
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 ...
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Established or suspected pregnancy or when pregnancy has not been excluded (see section 4.6). For information ...
4.4. Special warnings and precautions for use
Individual benefit/risk justification Cuprymina is not to be administered directly to the patient but must be used for the radiolabelling of carrier molecules, such as monoclonal antibodies, peptides or ...
4.5. Interaction with other medicinal products and other forms of interaction
No interactions studies of Copper-64 chloride with other medicinal products have been performed. The possible use of chelating therapies could interfere with the use of Copper-64-labelled medicinal products. ...
4.6. Fertility, pregnancy and lactation
Women of childbearing potential When an administration of radioactive medicinal products to a woman of childbearing potential is intended, it is important to determine whether or not she is pregnant. Any ...
4.7. Effects on ability to drive and use machines
Effects on ability to drive and to use machines following treatment by Copper-64-labelled medicinal products is specified in the Summary of Product Characteristics/package leaflet of the particular medicinal ...
4.8. Undesirable effects
Adverse reactions following the intravenous administration of Copper-64-labelled medicinal products prepared by radiolabelling with Cuprymina, will be dependent on the specific medicinal product being ...
4.9. Overdose
The presence of free copper (<sup>64</sup>Cu) chloride in the body after an inadvertent administration of Cuprymina will lead to increased hepatotoxicity. Therefore, in case of an inadvertent administration ...
5.1. Pharmacodynamic properties
Pharmacotherapeutic group: various diagnostic radiopharmaceuticals ATC code: Not yet assigned The pharmacodynamic properties of Copper-64-labelled medicinal products prepared by radiolabelling with Cuprymina, ...
5.2. Pharmacokinetic properties
The pharmacokinetic properties of Copper-64-labelled medicinal products prepared by radiolabelling with Cuprymina, prior to administration, will be dependent on the nature of the medicinal product to be ...
5.3. Preclinical safety data
The toxicological properties of Copper-64-labelled medicinal products prepared by radiolabelling with Cuprymina prior to administration will be dependent on the nature of the medicinal product to be radiolabelled. ...
6.1. List of excipients
Hydrochloric acid (0.1 N) Water for injections
6.2. Incompatibilities
Radiolabelling of carrier molecules, such as peptides, monoclonal antibodies, or other substrates, with Copper (<sup>64</sup>Cu) chloride is very sensitive to the presence of trace metal impurities. It ...
6.3. Shelf life
48 hours from date and time of End of Synthesis (EOS).
6.4. Special precautions for storage
Store in the original package that provides protection from radiation. Storage of radiopharmaceuticals should be in accordance with national regulation on radioactive materials.
6.5. Nature and contents of container
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 ...
6.6. Special precautions for disposal and other handling
Cuprymina is not intended for direct use in patients. Cuprymina is a sterile solution. General warning Radiopharmaceuticals should be received, used and administered only by authorised persons in designated ...
7. Marketing authorization holder
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
8. Marketing authorization number(s)
EU/1/12/784/001
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 23 august 2012 Date of latest renewal: 19 july 2017
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