Polgentec

PACKAGE LEAFLET: INFORMATION FOR THE USER

POLGENTEC
2-120 GBq Tc, radionuclide generator
Sodium pertechnetate ( Tc) injection
Read the entire leaflet before using the medicine,
as it contains important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, consult your nuclear medicine specialist physician.
• If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your nuclear medicine specialist physician. See section 4.

Table of contents of the leaflet:

1. What POLGENTEC is and what it is used for
2. Important information before using POLGENTEC
3. How to use POLGENTEC
4. Possible side effects
5. How to store POLGENTEC
6. Contents of the package and other information

1. WHAT POLGENTEC IS AND WHAT IT IS USED FOR

This medicinal product is intended for diagnostic use only.
POLGENTEC is a radionuclide generator used to obtain an eluate (sodium pertechnetate solution, Na TcO for injection) employed in diagnostic procedures.
Sodium pertechnetate solution (Na TcO ) is used in diagnostic imaging of:

• the thyroid gland,
• salivary glands,
• stomach and intestines,
• brain,
• heart and blood vessels,
• lacrimal ducts.

Use of POLGENTEC results in exposure to a small dose of radiation. Your physician has determined that the benefits of the diagnostic procedure outweigh the potential risks associated with ionizing radiation.

2. IMPORTANT INFORMATION BEFORE USING POLGENTEC

When not to use the eluate from the POLGENTEC generator:
If the patient is allergic to the active substance or to any of the other ingredients of this medicinal product (listed in section 6).

Warnings and precautions
Please inform the nuclear medicine specialist in the following cases:

• if the woman is pregnant or suspects she might be pregnant.
• if the woman is breastfeeding.

Administration of radiopharmaceuticals poses a risk of external ionizing radiation exposure to other individuals, as well as contamination from urine stains, vomit, etc. Therefore, basic hygiene principles in accordance with locally applicable regulations must be observed.
Special caution should be exercised when handling radiopharmaceuticals to prevent unnecessary radiation exposure to staff and patients.
To reduce radiation dose absorbed by the urinary bladder, it is recommended to drink plenty of fluids after injection of the medicinal product to ensure frequent bladder emptying.

POLGENTEC and other medicines
You must inform your attending physician or the nuclear medicine specialist supervising the examination about all medications currently taken or recently used, including those available without a prescription.
The results of the examination may be affected by medications such as atropine (an antispasmodic and pupil-dilating agent), isoprenaline (a drug mainly used in the treatment of bronchial asthma), or analgesics.

POLGENTEC with food and drink
No special diet is required either before or after administration of the medicinal product.

Pregnancy and breastfeeding
Before administration of the medicinal product, the nuclear medicine specialist must be informed if:

• there is suspicion of pregnancy,
• menstruation has not occurred at the expected time,
• the woman is breastfeeding.

In case of uncertainty, consultation with the attending physician or a nuclear medicine specialist supervising the examination is necessary. If the patient is pregnant, it is essential to inform the physician. The use of radiopharmaceuticals during pregnancy should be very carefully considered. The physician will refer for an examination using radiopharmaceuticals during pregnancy only if absolutely necessary.

In the case of breastfeeding and the simultaneous need for administration of a radiopharmaceutical, the physician may request temporary interruption of breastfeeding and expression of milk.
Breastfeeding should be interrupted for 12 hours after injection, and milk expressed during this period must be discarded. Resumption of breastfeeding should be discussed with the nuclear medicine specialist supervising the examination.

Before using any medicinal product, consult your attending physician or the nuclear medicine specialist who will supervise the examination.

Driving and operating machinery
It is unknown whether the eluate from the POLGENTEC generator affects the ability to drive vehicles or operate mechanical equipment.

The eluate from the POLGENTEC generator contains 3.54 mg of sodium per millilitre. This should be taken into account if the patient is on a sodium-restricted diet.

3. HOW TO USE POLGENTEC

Radioactive medicinal products may only be administered by authorized personnel.
There are strict regulations governing the use, transfer, and disposal of
radiopharmaceuticals. POLGENTEC must be used only under appropriate clinical
conditions and only by appropriately qualified individuals. These individuals will take special
precautions to ensure the safe use of the medicine and will keep records of their actions.
The nuclear medicine specialist supervising the procedure decides the dose of the medicine to be
used in each individual case. This will be the minimum dose necessary to obtain the required
diagnostic information. The recommended dose for adults ranges from 40 to 600 MBq
(MBq = megabecquerel, a unit of radioactivity).
The recommended activity dose depends on age, height, weight, and the type of examination.
The doctor administers the eluate from the POLGENTEC generator intravenously or instills it into the eyes.
The doctor will inform the patient about the procedure and safety measures regarding the use of
POLGENTEC.

Use in children
The use of the POLGENTEC generator eluate in children must be carefully evaluated by the
nuclear medicine specialist supervising the examination, taking into account clinical indications and a benefit-risk assessment in this patient group.
The dose depends on the child's body weight and is individually calculated by the physician.

Route of administration and procedure for POLGENTEC
POLGENTEC is used to obtain an eluate, which is then administered intravenously (rarely instilled into the eyes).
After administration of POLGENTEC, the doctor may recommend that the patient drink more fluids and empty the bladder more frequently. This may facilitate elimination of the medicine from the body. Basic hygiene rules must be followed during urination. This is standard practice when using radiopharmaceuticals for diagnostic examinations.

Duration of the examination
The doctor will inform the patient about the duration of the examination.

After receiving POLGENTEC, the patient should:

• avoid contact with children and pregnant women for 24 hours after receiving the medicine,
• urinate frequently to help eliminate the medicine from the body.

The doctor performing the examination will inform the patient whether special care is required after the examination. If there are any questions regarding dosing, the patient should consult the doctor performing the examination.

Administration of a higher than recommended dose of POLGENTEC
Overdose is almost impossible because the dose administered to the patient is strictly controlled by the nuclear medicine specialist supervising the examination. However, in the event of an overdose, the doctor may recommend increased fluid intake to help remove residual radiopharmaceutical from the body.
If there are any doubts regarding the use of the medicine, the patient should consult the doctor or nuclear medicine specialist supervising the examination.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicinal product may cause adverse reactions, although not everyone experiences them.
In the event of profound loss of consciousness (coma), immediate medical attention must be sought.
Other possible adverse reactions after administration of POLGENTEC include:

• Hypersensitivity
• Irregular heartbeat. This may be or become serious. In such a case, contact your doctor.
• Facial swelling.
• Weakness, fainting, low blood pressure due to blood vessel dilation.
• Urticaria (hives),
• Itching.

Administration of a radiopharmaceutical results in exposure to a small dose of ionizing radiation, which is associated with a risk of inducing cancer and hereditary disorders.
If any adverse symptoms occur, including any potential adverse reactions not listed in this leaflet, inform your doctor or the nuclear medicine specialist supervising the examination.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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,
E-mail: [email protected].
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. HOW TO STORE POLGENTEC

The patient will not have to store this medicinal product.
Radiopharmaceuticals are stored exclusively by authorized personnel under appropriate clinical
conditions. Radiopharmaceuticals are stored in compliance with local regulations concerning radioactive substances.
Information intended exclusively for healthcare professionals:
Do not use the medicinal product after the expiry date stated on the packaging.
The expiry date refers to the last day of the stated month.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What POLGENTEC contains
POLGENTEC radionuclide generator contains:

• Active substance: sodium pertechnetate (Tc)
• Excipients: sodium chloride, water for injections.

What POLGENTEC looks like and contents of the pack
POLGENTEC radionuclide generator is packed in a plastic container with a carrying handle.

Marketing Authorisation Holder and Manufacturer
National Centre for Nuclear Research
Andrzeja Sołtana 7
05-400 Otwock
Tel: 22 7180700
Fax: 22 7180350
e-mail: [email protected]

Information intended exclusively for healthcare professionals:

Handling instructions intended for personnel preparing the medicinal product for use:
When handling the generator, strictly adhere to radiation safety regulations regarding exposure to ionizing radiation.
During operation of the generator and dispensing of the sodium ^99m\Tc pertechnetate solution, the use of additional shielding against ionizing radiation (e.g., 50 mm Pb barrier) and syringe shields is recommended.
All work involving the generator and eluate should be performed in an environment ensuring sterility of the obtained eluate.

Procedure:

• Cut the seals on the generator's transport packaging,
• Remove the cover of the generator's transport packaging,
• Remove the inner cover,
• Take out the boxes containing the generator elution kits,
• Remove the generator from its transport packaging and place it on the work station.

The complete Product Information Leaflet (SmPC) for POLGENTEC is included as a separate document within the medicinal product packaging, to provide healthcare professionals with additional scientific and practical information regarding administration and use of this radiopharmaceutical.