Ultra-tehnekov Fm

B. Patient Information Leaflet

Patient Information Leaflet: Information for the User

Ultra-Technekow FM, 2.15–43.00 GBq, Radionuclide Generator
Sodium Pertechnetate (Tc) Solution

Please read carefully the contents of the leaflet before using the medicine, as it contains important information for the patient.

• Please keep this leaflet, so you can read it again if you need to.
• Please consult a nuclear medicine doctor supervising the examination if you need advice or additional information.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform the nuclear medicine doctor. See section 4.

Table of Contents of the Leaflet

• 1. What is Ultra-Technekow FM and what is it used for.
• 2. Important information before using Sodium Pertechnetate (Tc) solution obtained from the Ultra-Technekow FM generator.
• 3. How to use Sodium Pertechnetate (Tc) solution obtained from the Ultra-Technekow FM generator.
• 4. Possible side effects.
• 5. How to store Ultra-Technekow FM.
• 6. Package contents and other information.

1. What is Ultra-Technekow FM and what is it used for

A medicinal product intended exclusively for diagnostic purposes.
Ultra-Technekow FM is a Technetium (Tc) generator, i.e., a device used to obtain Sodium Pertechnetate (Tc) solution for injections. After injecting the radioactive solution, it 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 doctor performs the examination by creating an image (scan) of a given organ. The resulting image shows the structure and functioning of that organ.
After injecting Sodium Pertechnetate (Tc) solution, it is used to obtain images of various parts of the body, such as:

• thyroid gland;
• salivary glands;
• presence of gastric tissue in an abnormal location (Meckel's diverticulum);
• tear ducts of the eye.

Sodium Pertechnetate (Tc) solution may also be used in combination with another medicine to prepare a radiopharmaceutical. In this case, you should read the leaflet of that medicine.
The nuclear medicine doctor will inform the patient about the type and method of the examination using this medicinal product.
Using Sodium Pertechnetate (Tc) solution involves exposure to a small dose of radiation. The doctor treating the patient and the nuclear medicine doctor have determined that the clinical benefits of performing the examination with the radiopharmaceutical outweigh the risks associated with radiation.

2. Important information before using Sodium Pertechnetate (Tc) solution

obtained from the Ultra-Technekow FM generator

When not to use Sodium Pertechnetate (Tc) solution obtained from the Ultra-Technekow FM generator

• 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

Please inform the nuclear medicine doctor in the following cases:

• if the patient suffers from allergies, as allergic reactions have been observed after using Sodium Pertechnetate (Tc);
• if the patient has kidney failure;
• if the patient is pregnant or suspects she may be pregnant;
• if the patient is breastfeeding.

If special precautions are necessary after the examination with this medicine, the nuclear medicine doctor will inform the patient. In case of questions, please consult the nuclear medicine doctor.
Before administering 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 3-4 hours before the scintigraphic examination of Meckel's diverticulum, so that the intestines can work as slowly as possible (reduce intestinal peristalsis).

Children and adolescents

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

Sodium Pertechnetate (Tc) solution and other medicines

Please tell the nuclear medicine doctor supervising the examination about all medicines currently being taken or recently taken, as they may affect the result and interpretation of the examination. This applies in particular to the following medicines:

• atropine, used for example:
• to reduce stomach, intestine, or gallbladder spasms,
• to reduce pancreatic secretory function,
• in ophthalmology,
• before anesthesia,
• to accelerate heart rate or
• as an antidote;
• isoprenaline, a heart-stimulating medicine;
• analgesics;
• laxatives(should not be used during this 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);
• antithyroid medicines(e.g., carbimazole or other imidazole derivatives, such as propylthiouracil), sodium nitroprusside, sodium sulfobromophthalein, or

sodium 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 scintigraphic examination);
• expectorants(should not be taken for 2 weeks before the scintigraphic examination)
• preparations 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, an antiarrhythmic medicine (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 taken within 4 weeks before the scintigraphic examination);
• intravenous contrast agentsused for radiological examinations (should not be administered within 1-2 months before the scintigraphic examination).

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

Pregnancy and breastfeeding

Please inform the nuclear medicine doctor if the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant.
Before administering Sodium Pertechnetate (Tc) solution, please inform the doctor about suspected pregnancy, in case of missed menstruation, or breastfeeding. In case of doubts, consultation with a nuclear medicine doctor supervising the examination is necessary.
The nuclear medicine doctor will administer this medicine to a pregnant patient only if absolutely necessary, when the benefits outweigh the risks.
In the case of breastfeeding, the nuclear medicine doctor will ask to interrupt it until the radioactivity is eliminated from the body. Breastfeeding should be interrupted for 12 hours after injection. The expressed milk during this time should be discarded. The possibility of returning to breastfeeding should be agreed upon with a nuclear medicine specialist supervising the examination.

Driving and using machines

Sodium Pertechnetate (Tc) solution does not affect the ability to drive vehicles and operate machinery.

Sodium Pertechnetate solution contains sodium

Sodium Pertechnetate solution contains 3.5 mg/ml of sodium. Depending on the injected volume, it may lead to exceeding the limit value of 1 mmol (23 mg) of sodium 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 Ultra-Technekow FM generator

There are strict regulations regarding the use, transfer, and disposal of radiopharmaceuticals.
Ultra-Technekow FM is used exclusively in special, controlled areas.
Only trained and qualified personnel can handle and administer this product to patients. These personnel will take special precautions to ensure safe use and will keep the patient informed about their actions.
The nuclear medicine doctor supervising the examination decides on the administered dose of Sodium Pertechnetate (Tc) solution in a specific case. It will be the minimum dose necessary to obtain the expected diagnostic information.
The recommended dose for adults depends on the type of examination performed and ranges from

• 2–400 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.

Route of 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 instilled into the eye as eye drops.
A single administration is sufficient to perform the examination required by the doctor.

Duration of the examination

The nuclear medicine doctor will inform the patient about the typical duration of the examination.
Examinations can be performed at any time, provided that no more than 24 hours have passed since the injection, depending on the type of examination.

After administering Sodium Pertechnetate (Tc) solution, the patient should:

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

The nuclear medicine doctor will inform the patient if special precautions are necessary after administering this medicine. In case of questions, please consult the nuclear medicine doctor.

Overdose of Sodium Pertechnetate (Tc) solution obtained from the Ultra-Technekow FM generator

Overdose is almost impossible, as the patient will receive a single, strictly controlled dose of Sodium Pertechnetate (Tc) solution by the nuclear medicine doctor supervising the examination. However, in case of overdose, appropriate treatment will be applied. The nuclear medicine doctor may recommend drinking large amounts of fluids to eliminate the radiopharmaceutical from the body.
In case of doubts about using the medicine, please consult the nuclear medicine doctor supervising the examination.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Side effects of unknown frequency (which cannot be determined from the available data):

• Allergic reactions, with symptoms such as:
• rash, itching;
• hives;
• swelling in various locations, such as the face;
• shortness of breath;
• redness of the skin;
• coma.
• Cardiovascular reactions, with symptoms such as:
• rapid heartbeat, slow heartbeat;
• fainting;
• blurred vision;
• dizziness;
• headache;
• redness.
• Gastrointestinal disorders, with symptoms such as:
• vomiting;
• nausea;
• 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 cancer and congenital anomalies.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, please inform your doctor. 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, PL-02 222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, e-mail: ndl@urpl.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ultra-Technekow FM

The patient will not need to store this medicine. This medicine is stored exclusively by medical personnel in appropriate facilities. Storage of radiopharmaceuticals is carried out in accordance with local regulations regarding radioactive substances.
The following information is intended exclusively for medical personnel.
Do not use the medicine after the expiration date stated on the packaging.

6. Package contents and other information

What Ultra-Technekow FM contains

The active substance of the medicine is Sodium Pertechnetate (Tc). The excipients are: sodium chloride and water for injections.

What Ultra-Technekow FM looks like and what the package contains

The product is a Sodium Pertechnetate (Tc) solution obtained from a radionuclide generator.
Ultra-Technekow FM should be eluted. The resulting solution can be used directly or can be used to label special kits intended for the preparation of radiopharmaceuticals.

Marketing authorization holder and manufacturer

Curium Netherlands B.V., Westerduinweg 3, 1755 LE Petten, Netherlands

Date of last revision of the leaflet: 15 May 2019

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Information intended exclusively for healthcare professionals:
The full Summary of Product Characteristics of Ultra-Technekow FM is attached as a separate document to the packaging of the medicine to provide healthcare professionals with additional, scientific, and practical information on the administration and use of this radiopharmaceutical.
See Summary of Product Characteristics.