Poltechnet

Package leaflet: Information for the user

Poltechnet
8.0–175 GBq, radionuclide generator
Sodium pertechnetate ( Tc) solution
Please read carefully all of this leaflet before the administration of this medicinal product because it contains
important information for the patient.

• Keep this leaflet as you may need to read it again.
• If you have any questions, please consult the nuclear medicine physician supervising your examination.
• If you experience any adverse reactions, including any not listed in this leaflet, inform the nuclear medicine physician supervising your examination. See section 4.

Table of contents

1. What Poltechnet is and what it is used for
2. Important information before using sodium pertechnetate ( Tc) solution obtained from the Poltechnet generator
3. How to use sodium pertechnetate ( Tc) solution obtained from the Poltechnet generator
4. Possible side effects
5. How to store Poltechnet
6. Contents of the pack and other information

1. What Poltechnet is and what it is used for

This is a medicinal product intended solely for diagnostic use.
Poltechnet is a technetium ( Tc) generator, i.e. a device used to obtain an injectable solution of sodium pertechnetate ( Tc). After injection, the radioactive solution accumulates in certain parts of the body. Small amounts of the injected radioactivity can be detected outside the body using special equipment. The nuclear medicine physician performs the examination by acquiring an image (scan) of a specific organ. The resulting image shows the structure and functional status of that organ.
After injection, the sodium pertechnetate ( Tc) solution is used to obtain images of 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 medicinal product to prepare a radiopharmaceutical. In such a case, please refer to the package leaflet of that medicinal product.
The nuclear medicine physician will inform the patient about the type and method of the examination to be performed.
Administration of sodium pertechnetate ( Tc) solution may result in exposure to a small radiation dose. The patient's attending physician and the nuclear medicine physician have determined that the clinical benefits the patient will gain from the examination using the radiopharmaceutical outweigh the radiation-related risks.

2. Important information before using sodium pertechnetate ( Tc) solution obtained from the Poltechnet generator

When not to use sodium pertechnetate ( Tc) solution obtained from the Poltechnet generator:

• If the patient is allergic to sodium pertechnetate ( Tc) or to any of the other ingredients of this medicinal product (listed in section 6).

Warnings and precautions
Please inform the nuclear medicine specialist if:

• the patient has allergies, as allergic reactions have been observed after administration of sodium pertechnetate ( Tc),
• the patient has renal and/or hepatic impairment,
• the woman is pregnant or suspects she may be pregnant,
• the woman is breastfeeding.

If special precautions are required after the examination, the physician will inform the patient. For additional information, please consult your physician.
Before administration of sodium pertechnetate ( Tc) solution, the patient should:

• drink plenty of water before the examination, in order to void as much urine as possible during the first hours after the examination,
• fast for 3 to 4 hours before a Meckel's diverticulum scintigraphy, to minimize gastrointestinal activity (reduce intestinal peristalsis).

Children and adolescents
Consult the nuclear medicine physician if the patient is under 18 years of age.

Poltechnet, sodium pertechnetate ( Tc) solution and other medicines
Inform your attending physician or the nuclear medicine physician supervising the examination about all medicines currently taken or recently taken, as they may affect the result and interpretation of the examination, particularly the following:

• atropine, used e.g.:
• to reduce contractions of the stomach, intestines or gallbladder,
• to reduce pancreatic secretory function,
• in ophthalmology,
• prior to anesthesia,
• in the treatment of bradycardia (slow heart rate),
• as an antidote,
• isoprenaline, a drug stimulating cardiac activity,
• analgesics,
• laxatives (should not be used during the procedure as they irritate the gastrointestinal tract),
• if the patient has undergone X-ray with contrast medium (e.g. using barium as contrast agent) or upper gastrointestinal tract examination (Meckel's diverticulum scintigraphy should be avoided within 48 hours after these examinations),
• antithyroid drugs (e.g. carbimazole or other imidazole derivatives such as propylthiouracil), salicylates, steroids, sodium sulfobromophthalein, perchlorate (should not be taken within 1 week before scintigraphy),
• phenylbutazone, used in the treatment of pain, fever and inflammatory conditions (should not be taken within 2 weeks before the examination),
• expectorants (should not be taken within 2 weeks before scintigraphy),
• medicines containing natural or synthetic thyroid hormones (e.g. sodium thyroxine, sodium liothyronine, thyroid extract) (should not be administered within 2–3 weeks before scintigraphy),
• amiodarone – an antiarrhythmic drug (should not be taken within 4 weeks before scintigraphy),
• benzodiazepines, used e.g. as sedatives, antidepressants, anticonvulsants, muscle relaxants, or lithium, used as a mood stabilizer in bipolar disorder (should not be administered within 4 weeks before scintigraphy),
• intravenous contrast agents used in radiological examinations (should not be administered 1–2 months before scintigraphy).

Before taking any medicine, consult the nuclear medicine physician who will supervise the examination.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult the nuclear medicine physician before using this medicinal product.
Before administration of sodium pertechnetate ( Tc) solution, the patient must inform the nuclear medicine physician if pregnancy is suspected, if menstruation has not occurred as expected, or if she is breastfeeding. In case of doubt, consultation with the supervising nuclear medicine physician is required.
The nuclear medicine physician will administer this medicinal product to a pregnant patient only if absolutely necessary, when the expected benefits of the examination significantly outweigh the risks associated with the radiopharmaceutical.
In the case of breastfeeding and the simultaneous need to administer a radiopharmaceutical, the physician will ask the patient to interrupt breastfeeding and to express breast milk.
Breastfeeding should be interrupted for 12 hours after injection. Milk expressed during this period should be discarded. The possibility of resuming breastfeeding should be discussed with the nuclear medicine specialist supervising the examination.

Driving and operating machinery
Sodium pertechnetate ( Tc) solution does not affect the ability to drive or operate machinery.

Sodium pertechnetate ( Tc) solution contains sodium
Sodium pertechnetate ( Tc) solution contains 3.6 mg of sodium per millilitre. Depending on the injected volume, the threshold content of 1 mmol (23 mg) of sodium per dose may be exceeded.
This should be taken into account if the patient is on a low-sodium diet.

3. How to use sodium pertechnetate (Tc) solution obtained from the Poltechnet generator

Radiopharmaceuticals may be administered only by authorized personnel.
There are strict legal regulations concerning the use, transfer, and disposal of radiopharmaceuticals. Poltechnet is used exclusively under appropriate clinical conditions and only by appropriately qualified personnel. These individuals take special precautionary measures to ensure safe use of the medicinal product and will continuously report on their actions.
The nuclear medicine specialist supervising the procedure determines the administered dose of sodium pertechnetate (Tc) solution in each individual case. This will be the minimum dose necessary to obtain the required diagnostic information.
The recommended activity dose depends on the patient's age, height, and weight, as well as on the type of examination.
The recommended dose for adults ranges from 2 to 400 MBq (MBq = megabecquerel, a unit of measurement for radioactivity).

Use in children and adolescents
The dose intended for use in children and adolescents is calculated based on the child's body weight.

Administration of sodium pertechnetate (Tc) solution and procedure
Depending on the type of examination, the medicinal product will be administered intravenously (into a vein in the arm) or instilled into the eye as drops.
A single administration is sufficient to perform the examination required by the physician.

Duration of the examination
The physician will inform the patient about the duration of the examination.
Examinations may be performed at any time, provided that no more than 24 hours have passed since injection, depending on the type of examination.

After administration of sodium pertechnetate (Tc) solution, the patient should:

• avoid contact with children and pregnant women for 12 hours after receiving the medicinal product
• urinate frequently to eliminate the medicinal product from the body
• after administration of the medicinal product, the patient will be asked to drink a large amount of water and to urinate frequently before the examination begins.

The nuclear medicine physician performing the examination will inform the patient whether special precautionary measures are necessary after the examination. In case of any questions, the patient should contact the nuclear medicine physician performing the examination.

Administration of a higher than recommended dose of Poltechnet (sodium pertechnetate (Tc) solution)
Overdose is nearly impossible because only a single dose of sodium pertechnetate (Tc) solution will be administered to the patient, and this dose is strictly controlled by the supervising nuclear medicine specialist. However, in the event of an overdose, the nuclear medicine physician may recommend increased fluid intake to help eliminate residual radiopharmaceutical from the body.
In case of any doubts regarding the use of the medicinal product, the patient should contact the supervising nuclear medicine specialist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Frequency unknown – cannot be estimated from the available data:

• Allergic reactions, with symptoms such as:
• rash, itching
• urticaria
• swelling in various parts of the body, for example, face
• shortness of breath
• skin redness
• stupor
• Circulatory reactions, with symptoms such as:
• fast heartbeat, slow heartbeat
• fainting
• blurred vision
• dizziness
• headache
• flushing
• Gastrointestinal disorders, with symptoms such as:
• nausea
• vomiting
• diarrhoea
• Reactions at the injection site, with symptoms such as:
• skin inflammation
• pain
• swelling
• redness

Administration of a radiopharmaceutical results in exposure to a small dose of ionizing radiation, which
is associated with the risk of inducing cancer and heritable genetic defects.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported
directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181c,
02-222 Warsaw,
tel.: +48 22 49 21 301,
fax: +48 22 49 21 309,
website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Poltechnet

The patient will not be required to store this medicinal product.
Radiopharmaceuticals are stored exclusively by authorized personnel under appropriate clinical conditions. Storage of radiopharmaceuticals must comply with local regulations concerning radioactive substances.
The following information is intended solely for medical staff.
Do not use the medicinal product after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.

6. Contents of the packaging and other information

What Poltechnet contains:
The active substance is sodium pertechnetate ( Tc).
The excipients are: sodium chloride, water for injections.

What Poltechnet looks like and contents of the pack
Sodium pertechnetate ( Tc) solution is obtained from a radionuclide generator.
Poltechnet must be eluted. The resulting solution may be used directly or may be used to label special kits intended for the preparation of radiopharmaceutical products.
Example pack sizes:

Other pack sizes in the range of 8.0 – 175 GBq at the date of production are available upon
customer request.
Marketing Authorisation Holder and Manufacturer
National Centre for Nuclear Research
Andrzeja Sołtana 7
05-400 Otwock
Tel: 22 718 07 00
Fax: 22 718 03 50
e-mail: [email protected]
This medicinal product is authorised for sale in the Member States of the European Economic Area under the following names:
Austria: Poltechnet
Bulgaria: Poltechnet
Czech Republic: Poltechnet
Denmark: Poltechnet
Lithuania: Poltechgen 8,0-175 GBq, radionuklidų generatorius
Poland: Poltechnet
Portugal: Poltechnet
Romania: Poltechnet 8.0-175 GBq generator de radionuclizi
Slovenia: Poltechnet 8-175 GBq, radionuklidni generator
Sweden: Poltechnet
For more detailed information, please contact your doctor or the local representative of the Marketing Authorisation Holder.

Information intended exclusively for medical professionals:

The full Product Information Leaflet (SmPC) for Poltechnet is provided as a separate
document within the medicine's packaging, to supply healthcare professionals with additional,
scientific and practical information regarding the administration and use of this radiopharmaceutical.
See Product Information Leaflet.