Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Fluciclovine (18F)
Blue Earth Diagnostics Ireland Ltd
V09IX12
fluciclovine (18F)
Diagnostic radiopharmaceuticals
Prostatic Neoplasms; Radionuclide Imaging
This medicinal product is for diagnostic use only.Axumin is indicated for Positron Emission Tomography (PET) imaging to detect recurrence of prostate cancer in adult men with a suspected recurrence based on elevated blood prostate specific antigen (PSA) levels after primary curative treatment.
Revision: 16
Authorised
2017-05-21
24 B. PACKAGE LEAFLET 25 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT AXUMIN 1,600 MBQ/ML SOLUTION FOR INJECTION AXUMIN 3,200 MBQ/ML SOLUTION FOR INJECTION fluciclovine ( 18 F) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE 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 Axumin is and what it is used for 2. What you need to know before you use Axumin 3. How to use Axumin 4. Possible side effects 5. How to store Axumin 6. Contents of the pack and other information 1. WHAT AXUMIN IS AND WHAT IT IS USED FOR This medicine is a radiopharmaceutical product for diagnostic use only. Axumin contains the active substance fluciclovine ( 18 F) and is given so that doctors can perform a special type of scan called a positron emission tomography (PET) scan. If you have previously had treatment for prostate cancer and information from other tests (e.g. prostate specific antigen, PSA) indicates that the cancer may have returned, an Axumin PET scan can help your doctor find the locations where the cancer has come back. You should discuss the results of the test with the doctor that requested the scan. The use of Axumin does involve exposure to small amounts of radioactivity. Your doctor and the nuclear medicine doctor have considered that the benefit of this procedure with the radiopharmaceutical outweighs the risk of being exposed to radiation. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE AXUMIN _ _ AXUMIN MUST NOT BE USED - if you are allergic to fluciclovine ( 18 F) or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your nuclear medicine doctor before you are given Axumin if you: - have KIDNEY PROBLEMS - are on a LOW SO Læs hele dokumentet
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Axumin 1,600 MBq/mL solution for injection Axumin 3,200 MBq/mL solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Axumin 1,600 MBq/mL solution for injection Each mL of solution contains 1,600 MBq of fluciclovine ( 18 F) at the date and time of calibration (ToC). The activity per vial ranges from 1,600 MBq to 16,000 MBq at the date and ToC. Axumin 3,200 MBq/mL solution for injection Each mL of solution contains 3,200 MBq of fluciclovine ( 18 F) at the date and ToC. The activity per vial ranges from 3,200 MBq to 32,000 MBq at the date and ToC. Fluorine ( 18 F) decays to stable oxygen ( 18 O) with a half-life of 110 minutes by emitting a positronic radiation of maximum energy of 634 keV, followed by photonic annihilation radiations of 511 keV. Excipients with known effect Each mL of solution contains 7.7 mg of sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. Clear, colourless solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS This medicinal product is for diagnostic use only. Axumin is indicated for positron emission tomography (PET) imaging to detect recurrence of prostate cancer in adult men with a suspected recurrence based on elevated blood prostate specific antigen (PSA) levels after primary curative treatment. For the limitations in the interpretation of a positive scan, see section 4.4 and 5.1. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION A PET scan with fluciclovine ( 18 F) should be administered by appropriately qualified healthcare professionals. 3 Images should only be interpreted by readers trained in the interpretation of PET images with fluciclovine ( 18 F). Posology The recommended activity for an adult is 370 MBq fluciclovine ( 18 F). _ _ _Special populations _ _ _ _Elderly _ No dose adjustment required. _Renal and hepatic impairment _ Axumin has not been studied in patients with renal or hepatic impairment. Careful consideration of the activi Læs hele dokumentet