Cuprymina - patient leaflet, side effects, dosage

B. PACKAGE LEAFLET

Package leaflet: Information for the patient

Cuprymina 925 MBq/mL radiopharmaceutical precursor, solution Copper (64Cu) 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 medicinal product called a radiopharmaceutical precursor. It contains the active substance copper (64Cu) 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 for use with the active substance copper (64Cu) 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 radiopharmaceutical outweighs the risk from radiation.

Please refer to the package leaflet of the medicine that is to be radiolabelled with Cuprymina.

2. What you need to know before the medicine radiolabelled with Cuprymina is used

The medicine radiolabelled with Cuprymina must not be used:

• – If you are allergic to copper or any of the other ingredients of this medicine listed in section 6.

• – If you are pregnant or believe you may be pregnant.

Warnings and precautions

Talk to your nuclear medicine doctor before using the medicine that is radiolabelled with Cuprymina. Cuprymina should be received, used and administered only by authorised persons in designated clinical settings. Their receipt, storage, use, transfer and disposal are subject to the regulations and/or appropriate licences of the competent official organisation.

Radiopharmace­uticals should be prepared by the user in a manner which satisfies both radiation safety and pharmaceutical quality requirements.

It must be considered that the radiolabelled medicinal product emits high intensity Auger electrons. The condition of negligible radioactivity in the patient is reached, in practice, 4 days after injection.

Children and adolescents

Medicines radiolabelled with Cuprymina should not be used in children and adolescents up to 18 years.

Other medicines and medicines radiolabelled with Cuprymina

Tell your nuclear medicine doctor if you are taking, have recently taken or might take any other medicines since they may interfere with the interpretation of the images.

It is not known whether copper (64Cu) chloride may interact with other medicines as specific studies have not been carried out.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your nuclear medicine doctor for advice before you are given medicines radiolabelled with Cuprymina.

You must inform the nuclear medicine doctor before the administration of medicines radiolabelled with Cuprymina if there is a possibility you might be pregnant, if you have missed your period or if you are breast-feeding.

When in doubt, it is important to consult your nuclear medicine doctor who will supervise the procedure.

If you are pregnant

Medicines radiolabelled with Cuprymina must not be administered if you are pregnant.

If you are breast-feeding

You will be asked to stop breast-feeding if you need to receive a medicine radiolabelled with Cuprymina.

Please ask your nuclear medicine doctor when you can resume breast-feeding.

Driving and using machines

There could be effects on your ability to drive and to use machines due to the medicine used in combination with Cuprymina. Please read the package leaflet of that medicine carefully.

• 3. How the medicine radiolabelled with Cuprymina is used

There are strict laws on the use, handling and disposal of radiopharmaceutical products. Medicines radiolabelled with Cuprymina will only be used in special, controlled areas. This medicinal product will only be handled and given to you by people who are trained and qualified to use it safely. These persons will take special care for the safe use of this medicinal product and will keep you informed of their actions.

The nuclear medicine doctor supervising the procedure will decide on the quantity of medicine radiolabelled with Cuprymina to be used in your case. It will be the smallest quantity necessary to achieve the appropriate outcome, depending on the co-administered medicine and its intended use.

Administration of the medicine radiolabelled with Cuprymina and conduct of the procedure Cuprymina must be used only in combination with another medicine which has been specifically developed and authorised for being combined with Cuprymina, and will be administered subsequently.

Duration of the procedure

Your nuclear medicine doctor will inform you about the usual duration of the procedure before the administration of the medicine radiolabelled with Cuprymina.

After administration of the medicine radiolabelled with Cuprymina has been performed

The nuclear medicine doctor will inform you if you need to take any special precautions after receiving the medicine radiolabelled with Cuprymina. Contact your nuclear medicine doctor if you have any questions.

If you have been given more medicine radiolabelled with Cuprymina than you should

Since the medicine radiolabelled with Cuprymina is handled by a nuclear medicine doctor under strictly controlled conditions, there is only a very small chance of possible overdose. However, in the case of an overdose, you will receive the appropriate treatment.

Should you have any further question on the use of Cuprymina, please ask the nuclear medicine doctor who supervises the procedure.

4. Possible side effects

Like all medicines, the medicine radiolabelled with Cuprymina can cause side effects, although not everybody gets them.

After the medicine radiolabelled with Cuprymina is administered, it will deliver certain amounts of ionising radiation (radioactivity) which can induce a certain risk of cancer and development of hereditary defects. In all cases, the risks of the radiation should be less than from the disease itself.

For more information, refer to the package leaflet of the particular medicine to be radiolabelled.

If you get any side effects, talk to your nuclear medicine doctor. This includes any possible side effects not listed in this leaflet.

Reporting of side effects

If you get any side effects, talk to your nuclear medicine doctor. This includes any possible side effects not listed in this leaflet. Y ou can also report side effects directly via the national reporting system listed in By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Cuprymina

Keep this medicine out of the sight and reach of children.

The following information is intended for the specialist only.

Do not use this medicine after the expiry date and time which are stated on the label after EXP. Cuprymina will be stored in the original package that provides protection from radiation.

You will not have to store this medicinal product. Cuprymina is stored under the responsibility of the specialist in appropriate premises. Storage of radiopharmace­uticals will be in accordance with national regulation on radioactive materials.

6. Contents of the pack and other information

What Cuprymina contains

• – The active substance is copper (64Cu) chloride. Each mL of solution contains 925 MBq at calibration time (01h00 a.m. CET Central European Time), corresponding to at least 0.25 micrograms of copper-64. One vial contains from 925 to 2,770 MBq (corresponding to 0.250.75 micrograms of copper-64). (MBq: mega Becquerel, Becquerel is the unit in which radioactivity is measured)

• – The other ingredients are hydrochloric acid (0.1 N) and water for injections.

What Cuprymina looks like and contents of the pack

Cuprymina is presented as a clear, and colourless solution filled in a 10 mL glass vial.

The volume of one vial ranges from 1 to 3 mL solution (corresponding to 925 to 2,770 MBq at calibration time).

This volume depends on the quantity of medicine combined with Cuprymina required for administration by the nuclear medicine doctor.

Each pack contains 1 vial in a tungsten or lead container.

Marketing Authorisation 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:

Manufacturer

ACOM S.r.l.

Località Cavallino

62010 Montecosaro (MC) – Italy

SPARKLE S.r.l

Contrada Calé, snc

73042 Casarano (LE) – Italy

For any information about this medicine, please contact the Marketing Authorisation Holder.

This leaflet was last revised in MM/YYYY

Detailed information on this medicine is available on the European Medicines Agency web site:

The following information is intended for medical or healthcare professionals only:

The complete Summary of Product Characteristics (SmPC) of Cuprymina is provided as a separate document in the medicinal product pack, with the objective to provide healthcare professionals with other additional scientific and practical information about the use of this medicinal product.

Please refer to the SmPC.

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