Poltehnet

Package Leaflet: Information for the User

Poltechnet

8.0-175 GBq, Radionuclide Generator

Sodium Pertechnetate (Tc) Solution

Read the package leaflet carefully before using the medicine because it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a nuclear medicine doctor supervising the examination.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, tell the nuclear medicine doctor supervising the examination. See section 4.

Table of Contents of the Leaflet

• 1. What is Poltechnet and what is it 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. Package contents and other information

1. What is Poltechnet and what is it used for

Medicinal product intended for diagnostic use only.
Poltechnet is a technetium (Tc) generator, i.e. a device used to obtain a sodium pertechnetate (Tc) injection solution. After injection, the radioactive solution accumulates in certain parts of the body. Small amounts of injected radioactivity can be detected outside the body using special equipment. The nuclear medicine doctor performs the examination by taking an image (scan) of a given organ. The resulting image shows the structure and functioning 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 stomach tissue in an abnormal location (Meckel's diverticulum),
• tear ducts of the eye. The sodium pertechnetate (Tc) solution may also be used in combination with another medicine to prepare a radiopharmaceutical. In this case, you should read the package leaflet of that medicine.

The nuclear medicine doctor will inform the patient about the type and method of the examination.
The use of sodium pertechnetate (Tc) solution may result in exposure to a small dose of radiation. The doctor treating the patient and the nuclear medicine doctor have determined that the clinical benefits that the patient will gain from the examination using the radiopharmaceutical outweigh the risk associated with radiation.

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

from the Poltechnet generator

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

Poltechnet:

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

Warnings and precautions

The patient should inform the nuclear medicine doctor in the following cases:

• if the patient has allergies, as allergic reactions have been observed after the use of sodium pertechnetate (Tc)
• if the patient has kidney and/or liver failure
• if the patient is pregnant or suspects that she may be pregnant
• if the patient is breastfeeding

In case it is necessary to take special precautions after the examination, the doctor will inform the patient. If additional information is needed, the patient should ask the doctor.
Before administering the sodium pertechnetate (Tc) solution, the patient should:

• drink plenty of water before the examination, so that as much urine as possible can be excreted in the first hours after the examination
• fast for 3 to 4 hours before the scintigraphic examination of Meckel's diverticulum, so that the intestinal peristalsis is as low as possible.

Children and adolescents

Consult a nuclear medicine doctor if the patient is under 18 years old.

Poltechnet, sodium pertechnetate (Tc) solution and other medicines

Tell the treating doctor or the nuclear medicine doctor supervising the examination about all medicines that are currently being taken or have been taken recently, as they may affect the result and interpretation of the examination, and in particular about the following medicines:

• atropine, used for example:
• to reduce stomach, intestine or gallbladder spasms
• to reduce the secretory function of the pancreas
• in ophthalmology
• before anesthesia
• to treat slow heart rate (bradycardia)
• as an antidote
• isoprenaline, a heart-stimulating medicine
• analgesics
• laxatives(should not be used during the procedure, as they irritate the digestive tract)
• if the patient has undergone an X-ray examination with contrast (e.g. using barium as a contrast agent) or an examination of the upper gastrointestinal tract (should avoid scintigraphy of Meckel's diverticulum within 48 hours of these examinations)
• thyroid medicines(e.g. carbimazole or other imidazole derivatives, such as propylthiouracil), salicylates, steroids, sodium nitroprusside, sodium sulfobromophthalein, perchlorate) (should not be taken within 1 week before the scintigraphic examination)
• phenylbutazoneused to treat pain, fever and inflammation in the body (should not be taken within 2 weeks before the examination)
• expectorants(should not be taken for 2 weeks before the scintigraphic examination)
• medicines containing natural or synthetic thyroid hormones(e.g. sodium thyroxine, sodium liotyronine, thyroid extract) (should not be administered for 2-3 weeks before the scintigraphic examination)
• amiodarone- a medicine from the group of antiarrhythmic medicines (should not be taken within 4 weeks before the scintigraphic examination)
• benzodiazepinesused, for example, as sedatives, antidepressants, anticonvulsants, muscle relaxants or lithiumused as a mood stabilizer in manic-depressive illness (should not be administered within 4 weeks before the examination)
• intravenous contrast agentsused for radiological examinations (should not be administered for 1-2 months before the scintigraphic examination).

Before using any medicine, consult a nuclear medicine doctor who will supervise the examination.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects that she may be pregnant or plans to have a child, she should consult a nuclear medicine doctor before using this medicine.
Before administering the sodium pertechnetate (Tc) solution, the patient must inform the nuclear medicine doctor about suspected pregnancy or if the patient has not had a menstrual period at the expected time or if the patient is breastfeeding. In case of doubts, consultation with a nuclear medicine doctor who will supervise the examination is necessary.
The nuclear medicine doctor will administer this medicine to a pregnant patient only if absolutely necessary, when the expected benefits of the examination will significantly outweigh the risk associated with the administration of the radiopharmaceutical.
In the case of breastfeeding and the need to administer a radiopharmaceutical, the doctor will ask the patient to stop breastfeeding and express milk from the breast.
Breastfeeding should be stopped for 12 hours after injection. The food expressed during this time should be discarded. The possibility of returning to breastfeeding should be agreed with the nuclear medicine doctor supervising the examination.

Driving and using machines

The sodium pertechnetate (Tc) solution does not affect the ability to drive and use machines.

The sodium pertechnetate (Tc) solution contains sodium

The sodium pertechnetate (Tc) solution contains 3.6 mg of sodium per milliliter. Depending on the injected volume, this may lead to exceeding the threshold sodium content of 1 mmol (23 mg) per dose.
This fact 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 can only be administered by authorized personnel.
There are strict legal regulations regarding the use, transfer, and disposal of radiopharmaceuticals. Poltechnet is used only in appropriate clinical conditions and only by properly qualified persons. These persons take special precautions to ensure the safe use of the medicine and will keep the patient informed about their actions.
The nuclear medicine doctor supervising the procedure decides on the dose of sodium pertechnetate (Tc) solution used in a specific case. This will be the minimum dose necessary to obtain the expected diagnostic information.
The recommended dose of activity depends on the patient's age, height, and weight, as well as the type of examination. The recommended dose for adults is between 2 and 400 MBq (MBq = megabecquerel, a unit of measurement of 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 medicine will be administered to the patient intravenously (into a vein in the arm) or will be instilled into the eye in the form of drops.
A single administration is sufficient to perform the examination required by the doctor.

Duration of the examination

The doctor will inform the patient about the duration of the examination.
Examinations can be performed at any time, provided that it does not exceed 24 hours from the time of 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 administration of the medicine
• frequently urinate to eliminate the medicine from the body
• after administration of the medicine, the patient will be asked to drink a large amount of water and urinate frequently before the examination begins.

The nuclear medicine doctor performing the examination will inform the patient if special precautions are necessary after the examination. In case of any questions, the patient should consult the nuclear medicine doctor performing the examination.

Use of a higher than recommended dose of Poltechnet (sodium pertechnetate (Tc) solution)

Overdose is almost impossible, because the patient will be administered only one dose of sodium pertechnetate (Tc) solution, which is strictly controlled by the nuclear medicine doctor supervising the examination. However, in case of overdose, the nuclear medicine doctor may recommend drinking more fluids to remove the radiopharmaceutical from the body.
In case of doubts related to the use of the medicine, consult a nuclear medicine doctor supervising the examination.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Frequency not known, cannot be estimated from the available data:

• Allergic reactions, with symptoms such as:
• rash, itching
• hives
• swelling in various places, e.g. face
• shortness of breath
• redness of the skin
• coma
• Circulatory reactions, with symptoms such as:
• rapid heartbeat, slow heartbeat
• fainting
• blurred vision
• dizziness
• headache
• redness
• Gastrointestinal disorders, with symptoms such as:
• nausea
• vomiting
• diarrhea
• Reactions at the injection site, with symptoms such as:
• skin inflammation
• pain
• swelling
• redness

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.

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181c, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Poltechnet

The patient will not need to store this medicine.
Radiopharmaceuticals are stored only by authorized persons in appropriate clinical conditions. The storage of radiopharmaceuticals is carried out in accordance with local regulations regarding radioactive substances.
The following information is intended only for medical personnel.
Do not use the medicine 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 Poltechnet contains:

The active substance of the medicine is sodium pertechnetate (Tc)
The excipients are: sodium chloride, water for injections.

What Poltechnet looks like and what the package contains

The sodium pertechnetate (Tc) solution is obtained from a radionuclide generator.
Poltechnet should be eluted. The resulting solution can be used directly or can be used to label special kits intended for the preparation of radiopharmaceuticals.
Example package sizes:

Other package sizes in the range of 8.0 – 175 GBq on the day of production are available on request.

Marketing authorization holder and manufacturer

National Center for Nuclear Research
ul. Andrzeja Sołtana 7
05-400 Otwock
Phone: 22 718 07 00
Fax: 22 718 03 50
e-mail: [email protected]

This medicinal product is authorized 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, radionuclide generator
Poland:
Poltechnet
Portugal:
Poltechnet
Romania:
Poltechnet 8.0-175 GBq generator de radionuclizi
Slovenia:
Poltechnet 8-175 GBq, radionuclide generator
Sweden:
Poltechnet
To obtain more detailed information, please contact your doctor or local representative of the marketing authorization holder.

Date of last revision of the leaflet: -------------------------------------------------------------------------------------------------------------------------------------

Information intended only for healthcare professionals:
The Full Product Characteristics (SmPC) of Poltechnet is attached as a separate document to the packaging of the medicine, in order to provide healthcare professionals with additional, scientific and practical information on the administration and use of this radiopharmaceutical.
See the Summary of Product Characteristics.