Polgen

Package leaflet: Information for the

patient
Polgen
8.0- 175 GBq, radionuclide generator
Sodium pertechnetate solution
( Tc)
Please read all of this leaflet carefully before this medicine is used 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 specialist supervising the procedure.
• If you experience any side effects, including those not listed in this leaflet, inform the nuclear medicine specialist. See section 4.

Contents of this leaflet:

1. What Polgen is and what it is used for
2. What you need to know before the sodium pertechnetate ( Tc) solution obtained with Polgen is used
3. How the sodium pertechnetate ( Tc) solution obtained with Polgen is used
4. Possible side effects
5. How Polgen is stored
6. Contents of the pack and other information

1. What Polgen is and what it is used for

This medicine is a radiopharmaceutical for diagnostic use only.
Polgen is a technetium-99m generator, i.e. a device used to obtain an injectable solution of sodium pertechnetate ( Tc). When this radioactive solution is injected, it temporarily accumulates in certain areas of the body. The low level of radioactivity injected can be detected from outside the body using special imaging devices. The nuclear medicine specialist will obtain an image (scan) of the organ in question, providing valuable information about its structure and function.
After injection, the sodium pertechnetate ( Tc) solution is used to image various parts of the body, such as:

• thyroid gland
• salivary glands
• presence of ectopic gastric tissue (Meckel's diverticulum)
• lacrimal ducts of the eyes.

The sodium pertechnetate ( Tc) solution may also be used in combination with another product to prepare a different radiopharmaceutical. In this case, refer to the package leaflet of that specific product.
The nuclear medicine specialist will explain to you what type of examination will be performed with this product.
The use of sodium pertechnetate ( Tc) solution involves exposure to small amounts of radioactivity. Your physician and the nuclear medicine specialist have determined that the clinical benefit you will receive from this radiopharmaceutical procedure outweighs the risk associated with radiation exposure.

2. What you need to know before the sodium pertechnetate ( Tc) solution obtained with Polgen is used
   The sodium pertechnetate ( Tc) solution obtained with Polgen must not be used
   • If you are allergic to sodium pertechnetate ( Tc) or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Inform the nuclear medicine specialist in the following cases:

• If you suffer from allergies, as allergic reactions have been observed after administration of sodium pertechnetate ( Tc) solution
• If you have kidney and/or liver disease
• If you are pregnant or suspect you may be pregnant
• If you are breastfeeding

The nuclear medicine specialist will inform you if you need to take any special precautions after using this medicine. If you have any doubts, consult the nuclear medicine specialist.
Before administration of the sodium pertechnetate ( Tc) solution, you must:

• Drink plenty of water before the examination begins, in order to urinate as frequently as possible during the first few hours after the examination.
• Fast for 3-4 hours before a Meckel's diverticulum scan, to slow down peristalsis in the small intestine.

Children and adolescents
Inform the nuclear medicine specialist if you are under 18 years of age.
Other medicines and the sodium pertechnetate ( Tc) solution
Inform the nuclear medicine specialist if you are taking, have recently taken, or might take any other medicines, as they could interfere with image interpretation; in particular the following medicines:

• Atropine, used for example:
• to reduce spasms in the stomach, intestine, or gallbladder
• to reduce pancreatic secretions
• in ophthalmology
• before administering anesthesia
• to treat slow heart rate, or
• as an antidote
• isoprenaline, a medicine used to treat slow heart rate
• analgesics
• laxatives (should not be taken during this procedure as they irritate the gastrointestinal tract)
• if you have recently undergone imaging with contrast agents (e.g. barium as contrast medium) or an upper gastrointestinal examination (as these should be avoided 48 hours before a Meckel's diverticulum scan)
• antithyroid drugs (e.g. carbimazole or other imidazole derivatives such as propylthiouracil), salicylates, steroids, sodium nitroprusside, sodium sulfobromophthalein, perchlorate) (as these should not be taken during the week before the scan)
• phenylbutazone for treating fever, pain, and inflammation (as this should not be taken within 2 weeks before the scan)
• expectorants (as these should not be taken within 2 weeks before the scan)
• natural or synthetic thyroid preparations (e.g. sodium thyroxine, sodium triiodothyronine, thyroid extract) (as these should not be taken within 2-3 weeks before the scan)
• amiodarone, an antiarrhythmic agent (as this should not be taken within 4 weeks before the scan)
• benzodiazepines, used for example for sedation, anxiolytic, anticonvulsant, or muscle relaxant purposes, or lithium, used as a mood stabilizer in bipolar disorder (as both should not be taken within 4 weeks before the scan)
• intravenous contrast agents for radiological body examinations (as these should not be administered 1-2 months before the scan)

Ask your nuclear medicine specialist for advice before taking any medicine.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult the nuclear medicine specialist before this medicine is administered.
Inform the nuclear medicine specialist before administration of the sodium pertechnetate ( Tc) solution if there is any possibility you may be pregnant, if you have missed a menstrual period, or if you are breastfeeding. If you have any doubts, it is important to consult the nuclear medicine specialist supervising the procedure.
If you are pregnant, the nuclear medicine specialist will administer the medicine during pregnancy only if the expected benefits outweigh the risks.
If you are breastfeeding, inform the nuclear medicine specialist, as they may advise you to interrupt breastfeeding until the radioactivity has been eliminated from your body. This takes approximately 12 hours. The milk produced during this time should be discarded. Resumption of breastfeeding should be done under the guidance of the nuclear medicine specialist supervising the procedure.
Driving and using machines
The sodium pertechnetate ( Tc) solution does not affect your ability to drive or operate machinery.
The sodium pertechnetate solution contains sodium
The sodium pertechnetate solution contains 3.6 mg/ml of sodium. Depending on the injected volume, the administered dose may exceed 1 mmol (23 mg) of sodium per dose. This should be taken into account if you are on a low-sodium diet.

3. How the technetium (99mTc) pertechnetate solution obtained with Polgen is used

There are very strict regulations regarding the use, handling, and disposal of radiopharmaceuticals. Polgen will be used only in designated controlled areas. This product will be handled and administered exclusively by trained and qualified personnel who are experienced in its safe use. These individuals will pay particular attention to the safe handling of this product and will keep you informed about their procedures.

The nuclear medicine specialist supervising the procedure will determine the amount of technetium (99mTc) pertechnetate solution to be used in your case. This will be the minimum quantity necessary to obtain the required diagnostic information.

The recommended dose for an adult varies depending on the type of examination and ranges from 2 to 400 MBq (megabecquerel, the unit used to measure radioactivity).

Use in children and adolescents
In children and adolescents, the administered dose must be adjusted according to the child's body weight.

Administration of the technetium (99mTc) pertechnetate solution and performance of the examination
Depending on the purpose of the examination, the medicinal product will be administered either by intravenous injection into a vein of the arm, or instilled into the eyes as eye drops.

A single administration is sufficient to perform the examination requested by the physician.

Duration of the examination
The nuclear medicine specialist will inform you about the duration of the examination.

Scans may be performed at any time from the moment of injection up to 24 hours after administration, depending on the type of examination.

After receiving the technetium (99mTc) pertechnetate solution, you must:

• Avoid close contact with children and pregnant women for 12 hours after the injection
• Urinate frequently to help eliminate the medicinal product from your body
• After administration, you will be offered fluids to drink and asked to urinate immediately before the examination begins

The nuclear medicine specialist will inform you if you need to take any special precautions after receiving the medicinal product. For any questions, please consult the nuclear medicine specialist.

If you have been given more technetium (99mTc) pertechnetate solution obtained with Polgen than you should have received
Overdose is extremely unlikely, as you will receive a single dose of technetium (99mTc) pertechnetate solution carefully controlled by the nuclear medicine specialist supervising the procedure. However, in the event of an overdose, appropriate treatment will be administered. In particular, the nuclear medicine specialist may recommend that you drink large amounts of fluids to help eliminate residual radioactivity from your body.

If you have any further doubts about the use of this medicinal product, please consult the nuclear medicine specialist supervising the procedure.

4. Possible side effects

Like all medicines, this medicinal product may cause side effects, although not everyone experiences them.
Side effects with unknown frequency (cannot be estimated from the available data):

• allergic reactions, with symptoms such as
• skin rash, itching
• urticaria
• swelling in various parts of the body, for example the face
• shortness of breath
• skin redness
• coma
• circulatory reactions, with symptoms such as
• accelerated or slowed heartbeat
• fainting
• blurred vision
• dizziness
• headache
• flushing
• gastrointestinal disorders, with symptoms such as
• malaise (vomiting)
• feeling unwell (nausea)
• diarrhoea
• reactions at the injection site, with symptoms such as
• skin inflammation
• pain
• swelling
• redness

This radiopharmaceutical will emit low levels of ionizing radiation, which are associated with a very low risk of developing cancer and hereditary abnormalities.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your Nuclear Medicine physician. You may also report side effects directly via the Italian Medicines Agency (Agenzia Italiana del Farmaco) website: http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How Polgen is stored

It is not your responsibility to store this medicinal product. This medicinal product is stored under the responsibility of the specialist in appropriate facilities. Storage of radiopharmaceuticals must comply with national regulations for radioactive materials.
The following information is intended exclusively for the specialist.
This medicinal product must not be used after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.

6. Pack contents and other information

What Polgen contains:
The active substance is sodium pertechnetate (Tc).
The other components are: sodium chloride and water for injections.

Description of the appearance of Polgen and pack contents
The medicine is a solution of sodium pertechnetate (Tc) obtained from a radionuclide generator.
Polgen must be eluted and the resulting solution can be used as such or for radiolabelling
of certain specific kits for radiopharmaceutical preparation.
Examples of packaging:

Marketing Authorization Holder and Manufacturer
National Centre for Nuclear Research
ul. Andrzeja Sołtana 7
05-400 Otwock
Poland
Telephone: +48 22 718 07 00
Fax: +48 22 718 03 50
e-mail: [email protected]

This medicinal product is authorized in the European Economic Area Member States under the following names:
Austria: Poltechnet
Bulgaria: Poltechnet
Czech Republic: Poltechnet
Denmark: Poltechnet
Germany: Poltechnet
Hungary: Poltechnet
Italy: Polgen
Lithuania: Poltechgen 8,0-175 GBq, radionuklidų generatorius
Poland: Poltechnet
Portugal: Poltechnet
Romania: Poltechnet 8.0-175 GBq generator de radionuclizi
Slovakia: Poltechnet
Slovenia: Poltechnet 8-175 GBq, radionuklidni generator
Sweden: Poltechnet

For any information regarding this medicinal product, please contact your physician or the local representative of the Marketing Authorization Holder.

The following information is intended exclusively for healthcare professionals:
The complete Product Information for Polgen is provided as a separate document within the product packaging, intended to provide healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical.
Refer to the Product Information document.