AXUMIN 1600 MBQ/ML Инъекционный раствор

Содержание инструкции

1. Axumin 1.600 MBq/mL injectable solution, 3.200 MBq/mL injectable solution
   1. What is Axumin and what is it used for?
   2. What you need to know before using Axumin
   3. How to use Axumin
   4. Possible side effects
   5. How to store Axumin
   6. Contents of the pack and other information

Axumin 1.600 MBq/mL injectable solution, 3.200 MBq/mL injectable solution

fluciclovine (F)

Read 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 questions, ask the nuclear medicine doctor who is supervising the procedure.
• If any side effects occur, including those not listed in this leaflet, ask the nuclear medicine doctor. See section 4.

Contents of this leaflet

• 1. What Axumin is and what it is used for
• 2. What you need to know before Axumin is used
• 3. How Axumin is used
• 4. Possible side effects
• 5. How to store Axumin
• 6. Contents of the pack and other information

1. What is Axumin and what is it used for?

This medicine is a radiopharmaceutical for diagnostic use only.
Axumin contains the active substance fluciclovine ( F) and is administered to allow the doctor
to perform a special examination called positron emission tomography (PET) scan. If you
have previously undergone treatment for prostate cancer and the results of other tests (e.g.
prostate-specific antigen, PSA) indicate a possible recurrence of the cancer, a PET scan
with Axumin can help the doctor locate the sites where the cancer has recurred.
You should discuss the results of this examination with the doctor who requested it.
The use of Axumin involves exposure to small amounts of radioactivity. Your doctor and the nuclear medicine physician
have assessed that the benefit of this procedure with the radiopharmaceutical is
greater than the risks associated with exposure to radiation.

2. What you need to know before using Axumin

Axumin must not be used

• if you are allergic to fluciclovine (F) or to 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
• you are following a dietlow in sodium(see section “Axumin contains sodium”)

Before Axumin is administered to you:

• you must avoid strenuous physical activity for at least one day before the Axumin scan
• you must not eat or drink for at least 4 hoursbefore the scan (except for small amounts of water to take medicines)
• you should urinate no later than 60 minutes before the Axumin injection and should avoid urinating until after the scan is completed.

Children and adolescents
Consult your nuclear medicine doctor if you are under 18 years of age. The use of Axumin is not intended
in children and adolescents under 18 years of age.

Other medicines and Axumin
Tell your nuclear medicine doctor if you are taking, have recently taken or might
take any other medicines as they could interfere with the interpretation of the
images.

Pregnancy and breastfeeding
This medicine is not indicated for use in women.

Driving and operating machinery
It is unlikely that Axumin will affect your ability to drive and operate machinery.

Axumin contains sodium
This medicine contains up to 39 mg of sodium (the main component of table salt) in
each dose. This is equivalent to 2% of the maximum recommended daily intake of sodium for
an adult.

3. How to use Axumin

Radiopharmaceuticals are subject to strict laws regulating their use, handling and
disposal.
Axumin will only be used in areas subject to special control. This medicine will be handled and
administered only by trained and qualified personnel to use it without safety risks, who
will pay particular attention to ensure its safe use and will provide you with explanations during use.
The nuclear medicine physician who will supervise the procedure will decide the amount of Axumin to
use in your case. The minimum amount possible will be used to obtain the desired information. The
amount generally recommended for an adult is 370 MBq (the megabecquerel
is the unit used to express radioactivity).

Administration of Axumin and performing the procedure
Axumin is administered intravenously, i.e. by injection into a vein, followed by a
flush with sodium chloride solution to ensure you receive the complete dose.
Generally, a single injection is sufficient to perform the examination requested by the doctor.

Duration of the procedure
The nuclear medicine physician will inform you of the usual duration of the procedure. The scan usually begins
approximately 5 minutes after the injection of Axumin.

After the administration of Axumin you must:

• avoid any closecontactwith small childrenand pregnant womenwithin 12 hours of the injection
• empty your bladderfrequently to eliminate the product from the body.

The nuclear medicine physician will tell you if any further special precautions are necessary after
receiving this medicine. If you have any doubts, please contact the nuclear medicine physician.

If you have been given too much Axumin
It is unlikely that cases of overdose will occur because you will receive only a single dose of
Axumin carefully controlled by the nuclear medicine physician supervising the procedure.
However, in case of overdose, you will receive appropriate treatment. In particular, the physician of
nuclear medicine responsible for the procedure may instruct you on how to empty your bladder and intestines
more frequently to facilitate the elimination of radioactivity from your body.
If you have any doubts about the use of Axumin, please contact the nuclear medicine physician supervising
the procedure.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
In clinical studies, side effects were reported by less than 1 in
100 patients who received the medicine.
The following side effects of Axumin are classified as uncommon(may affect up to
1 in 100 people):

• Alteration of the sense of taste, alteration of the sense of smell, pain or rash at the injection site.

This radiopharmaceutical emits low levels of ionizing radiation associated with a minimal risk of
cancer and hereditary abnormalities.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please contact
your nuclear medicine physician. You can also report side effects directly through the
national reporting system detailed in Annex V. By reporting side effects you can
help to provide more information on the safety of this medicine.

5. How to store Axumin

You must not store this medicine. The medicine is stored under the responsibility of the specialist in appropriate locations. Radiopharmaceuticals must be stored in accordance with national regulations relating to radioactive products.
The following information is intended exclusively for the specialist.
This medicine must not be used after the expiry date that is reported on the label of the protection after Expiry.

6. Contents of the pack and other information

What Axumin contains

• The active substance is fluciclovine ( F). Axumin 1.600 MBq/mL injectable solutionEach mL of solution contains 1,600 MBq of fluciclovine ( F) at the date and time of calibration (ToC, time of calibration). The activity per vial ranges from 1,600 MBq to 16,000 MBq at the date and ToC. Axumin 3.200 MBq/mL injectable solutionEach mL of solution contains 3,200 MBq of fluciclovine ( F) at the date and ToC. The activity per vial ranges from 3,200 MBq to 32,000 MBq at the date and ToC.
• The other ingredients are sodium citrate, concentrated hydrochloric acid, sodium hydroxide and water for injections (see section 2 “Axumin contains sodium”).

Description of the appearance of Axumin and contents of the pack
Axumin is a clear, colourless solution, stored in a 10 mL or 15 mL glass vial.

Axumin 1.600 MBq/mL injectable solution
Each multi-dose vial contains 1–10 mL of solution, corresponding to 1,600–16,000 MBq at the
date and ToC.

Axumin 3.200 MBq/mL injectable solution
Each multi-dose vial contains 1–10 mL of solution, corresponding to 3,200–32,000 MBq at the
date and ToC.
Pack size: 1 vial.

Marketing authorisation holder
Blue Earth Diagnostics Ireland Ltd, 6th Floor, 2 Grand Canal Square, Dublin 2, Ireland

Manufacturer
Seibersdorf Labor GmbH, 2444 Seibersdorf, Austria.
Norsk medisinsk syklotronsenter AS, 0372 Oslo, Norway.
Nucleis SA, 4000 Liège, Belgium
Advanced Accelerator Applications Molecular Imaging Italy S.r.l., 47014, Meldola (FC), Italy
Synektik Pharma Sp. z o.o., 96-320 Mszczonów, Poland
Pharmazac S.A., 351 50, Lamia, Greece

Other sources of information
More detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.
This leaflet is available in all languages of the European Union/European Economic Area on the
European Medicines Agency website.
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The following information is intended exclusively for healthcare professionals:
The full SPC of Axumin is provided as a separate document within the pack of the
medicinal product, with the aim of providing healthcare professionals with further scientific and practical
information on the administration and use of this radiopharmaceutical.
Consult the SPC [the SPC must be inserted in the box].