Polgentec

LEAFLET INCLUDED IN THE PACKAGE: INFORMATION FOR THE USER

POLGENTEC
2-120 GBq Tc, radionuclide generator
Sodium pertechnetate (Tc) injection

You should read the contents of the leaflet before using the medicine because it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a specialist in nuclear medicine.
• If the patient experiences any adverse reactions, including any possible adverse reactions not listed in the leaflet, they should inform the specialist in nuclear medicine. See section 4

Table of contents of the leaflet:

• 1. What is POLGENTEC and what is it used for.
• 2. Important information before using POLGENTEC.
• 3. How to use POLGENTEC.
• 4. Possible adverse reactions.
• 5. How to store POLGENTEC.
• 6. Package contents and other information.

1. WHAT IS POLGENTEC AND WHAT IS IT USED FOR

Medicinal product intended exclusively for diagnostic purposes.
POLGENTEC is a radionuclide generator used to obtain eluate (a solution of sodium pertechnetate, Na TcO for injections) used in diagnostic tests.
The solution of sodium pertechnetate (Na TcO ) is used in diagnostics, in tests for:

• thyroid,
• salivary glands,
• stomach and intestines,
• brain,
• heart and blood vessels,
• tear ducts.

The use of POLGENTEC results in exposure to a small dose of radiation. The doctor has determined that the benefits of the test 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 any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

You should inform the specialist in nuclear medicine in the following cases:

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

The administration of radiopharmaceuticals poses a risk of exposure to external ionizing radiation or contamination caused by urine stains, vomiting, etc. to other people. Therefore, basic hygiene rules should be followed in accordance with local regulations.
Particular caution should be exercised when using radiopharmaceuticals to avoid unnecessary exposure of personnel and patients.
In order to reduce the radiation dose absorbed by the bladder, it is recommended to drink plenty of fluids after injection to more frequently empty the bladder.

POLGENTEC and other medicines

You should tell the doctor or the specialist in nuclear medicine supervising the test about all medicines currently being taken or recently taken, including those available without a prescription.
The result of the test may be affected by the use of medicines such as atropine (a relaxing and pupil-dilating agent) or isoprenaline (a medicine used mainly in the treatment of bronchial asthma or painkillers.

POLGENTEC with food and drink

No special diet is required before or after taking the medicine.

Pregnancy and breastfeeding

Before taking the medicine, you should inform the specialist in nuclear medicine if:

• the woman suspects she may be pregnant
• the woman has not had her period at the expected time
• the woman is breastfeeding. In case of doubts, consultation with the doctor or specialist in nuclear medicine supervising the test is necessary. If the patient is pregnant, it is essential to inform the doctor. The use of radiopharmaceuticals during pregnancy should be carefully considered. The doctor will only refer for a test using radiopharmaceuticals during pregnancy if absolutely necessary.

In the case of breastfeeding and the need to administer a radiopharmaceutical, the doctor may ask to stop breastfeeding and discard the breast milk.
Breastfeeding should be stopped for 12 hours after injection, and the expressed milk should be discarded. The possibility of returning to breastfeeding should be agreed upon with the specialist in nuclear medicine supervising the test.

Before using any medicine, you should consult the doctor or the specialist in nuclear medicine supervising the test.

Driving and operating machinery

It is not known whether the eluate from the POLGENTEC generator affects the ability to drive vehicles and operate machinery.
The eluate from the POLGENTEC generator contains 3.54 mg of sodium per milliliter. This fact should be taken into account if the patient is on a sodium-controlled diet.

3. HOW TO USE POLGENTEC

Radiopharmaceuticals can only be administered by authorized personnel.
There are strict regulations regarding the use, transfer, and disposal of radiopharmaceutical products. POLGENTEC is used exclusively in appropriate clinical conditions and only by qualified personnel. These personnel take special precautions to ensure safe use of the medicine and will keep you informed about their actions.
The specialist in nuclear medicine supervising the procedure decides on the dose of the medicine to be used in a given case. This will be the minimum dose necessary to obtain the expected diagnostic information. The recommended dose for adults is in the range of 40 to 600 MBq (MBq = megabecquerel, a unit of measurement of radioactivity).
The recommended dose of activity depends on age, height, weight, and the type of test.
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 of using the medicine POLGENTEC.

Use in children

The use of the eluate from the POLGENTEC generator in children must be carefully analyzed by the specialist in nuclear medicine supervising the test, taking into account clinical indications and the assessment of the benefit-to-risk ratio in this group of patients.
The dose depends on the child's weight and is individually calculated by the doctor.

Route of administration and procedure

POLGENTEC is used to obtain eluate, which is then administered intravenously (less frequently instilled into the eyes).
After administering the medicine POLGENTEC, the doctor may recommend that the patient drink plenty of fluids and more frequently empty the bladder. This can help eliminate the medicine from the body. During urination, basic hygiene rules should be followed. This is standard procedure when using radiopharmaceuticals for diagnostic tests.

Duration of the test

The doctor will inform the patient about the duration of the test.

After administering the medicine POLGENTEC, the patient should:

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

The doctor performing the test will inform the patient if any special care is required after the test. In case of any questions regarding dosing, you should consult the doctor performing the test

Use of a higher than recommended dose of POLGENTEC

Overdose is almost impossible because the dose of the medicine administered to the patient is strictly controlled by the specialist in nuclear medicine supervising the test. However, in case of overdose, the doctor may recommend drinking plenty of fluids to remove the radiopharmaceutical from the body.
In case of doubts related to the use of the medicine, you should consult the doctor or the specialist in nuclear medicine supervising the test.

4. POSSIBLE ADVERSE REACTIONS

Like any medicine, this medicine may cause adverse reactions, although not everybody gets them.
In case of deep loss of consciousness (coma), you should immediately contact the doctor.
Other adverse reactions that may occur after administering the medicine POLGENTEC include:

• Hypersensitivity
• Irregular heartbeat. May be or become serious. In such a case, you should contact the doctor.
• Facial swelling.
• Weakness, fainting, low blood pressure due to vasodilation.
• Hives,
• Itching.

Administration of the radiopharmaceutical results in exposure to a small dose of ionizing radiation, which is associated with the risk of causing cancer and genetic disorders.
If any adverse reactions occur, including any possible adverse reactions not listed in the leaflet, you should inform the doctor or the specialist in nuclear medicine supervising the test.

Reporting adverse reactions

If any adverse reactions occur, including any possible adverse reactions not listed in the leaflet, you should tell the doctor. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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,
e-mail: ndl@urpl.gov.pl.
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions can help gather more information on the safety of the medicine.

5. HOW TO STORE POLGENTEC

The patient will not need to store this medicine.
Radiopharmaceutical products are stored exclusively by authorized persons in appropriate clinical conditions. Storage of radiopharmaceuticals is carried out in accordance with local regulations regarding 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 given month.

6. PACKAGE CONTENTS 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 what the package contains

POLGENTEC radionuclide generator is packaged in a plastic container with a handle for carrying.

Marketing authorization holder and manufacturer

National Center for Nuclear Research

ul. Andrzeja Sołtana 7
05-400 Otwock
Tel: 22 7180700
Fax: 22 7180350
e-mail: polatom@polatom.pl

Date of approval of the leaflet: ---------------------------------------------------------------------------------------------------------------------------

Information intended exclusively for healthcare professionals:

Information on handling intended for personnel preparing the medicinal product for use:

When handling the generator, you should strictly follow the safety rules for working in conditions of exposure to ionizing radiation.
During the operation of the generator and the dispensing of the sodium pertechnetate solution, it is recommended to use additional shielding against ionizing radiation (e.g., 50 mm Pb wall) and to use shields on syringes.
All work with the generator and eluate should be carried out in an environment ensuring the sterility of the obtained eluate.
Procedure:

• cut the seals on the transport packaging of the generator,
• remove the cover of the transport packaging of the generator,
• remove the inner cover,
• remove the boxes with the elution sets for the generator,
• remove the generator from the transport packaging and place it on the workstation.

The Full Characteristic of the Medicinal Product (ChPL) POLGENTEC is attached as a separate document to the packaging of the medicinal product, in order to provide healthcare professionals with additional, scientific, and practical information regarding the administration and use of this radiopharmaceutical.