Ultra-technekow fm

Ultra-Technekow FM, 2.15–43.00 GBq, radionuclide generator
Technetium ( Tc) sodium pertechnetate solution

Please read the entire leaflet carefully before use, as it contains important information for the patient.

• Keep this leaflet for future reference.
• Consult the nuclear medicine physician supervising the examination if you need advice or further information.
• If any adverse reactions occur in the patient, including any adverse reactions not listed in this leaflet, inform the nuclear medicine physician. See section 4.

Table of contents

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

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

This medicinal product is intended for diagnostic use only.
Ultra-Technekow FM is a technetium ( Tc) generator, i.e. a device used to obtain a solution of sodium pertechnetate ( Tc) for injection. After injection, the radioactive solution accumulates in certain parts of the body. Small amounts of the injected radioactivity can be detected externally by special equipment. The nuclear medicine physician performs an 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 body parts, such as:

• thyroid gland;
• salivary glands;
• presence of ectopic gastric tissue (Meckel's diverticulum);
• lacrimal ducts of the eyes.

Sodium pertechnetate ( Tc) solution may also be used in combination with another medicinal product to prepare a radiopharmaceutical. In such cases, the package leaflet of that medicinal product should be consulted.
The nuclear medicine physician will inform the patient about the type and method of the examination using this medicinal product.

Use of sodium pertechnetate ( Tc) solution involves exposure to a small radiation dose. The physician responsible for the patient and the nuclear medicine physician have determined that the clinical benefits the patient will gain from undergoing the examination with the radiopharmaceutical outweigh the risks associated with radiation exposure.

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 medicinal product (listed in section 6).

Warnings and precautions
Please inform the nuclear medicine physician if any of the following apply:

• if the patient suffers from allergies, as allergic reactions have been observed after administration of sodium pertechnetate (Tc);
• if the patient suffers from renal insufficiency;
• if the woman is pregnant or suspects she may be pregnant;
• if the woman is breastfeeding.

If special precautions are required after the examination using this medicinal product, the nuclear medicine physician will inform the patient. For any questions, please consult the nuclear medicine physician.
Before administration of sodium pertechnetate (Tc) solution, the patient should:

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

Children and adolescents
Please consult the nuclear medicine physician if the patient is under 18 years of age.
Sodium pertechnetate ( Tc) solution and other medicines
Inform 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. This particularly includes the following medicines:

• atropine, used e.g.:
• to reduce gastric, intestinal or gallbladder contractions,
• to reduce exocrine pancreatic function,
• in ophthalmology,
• prior to anesthesia,
• to increase heart rate, or
• as an antidote;
• isoprenaline, a drug stimulating cardiac activity;
• analgesics;
• laxatives (should not be used during this procedure, as they irritate the gastrointestinal tract);
• if the patient has undergone X-ray with contrast (e.g. using barium as contrast agent) or upper gastrointestinal tract examination (Meckel's diverticulum scintigraphy should be avoided within 48 hours);
• antithyroid drugs (e.g. carbimazole or other imidazole derivatives such as propylthiouracil), salicylates, steroids, sodium nitroprusside, sodium sulfobromophthalein,
  perchlorates (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 scintigraphy);
• expectorants (should not be taken within 2 weeks before scintigraphy);
• preparations 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 taken within 4 weeks before scintigraphy);
• intravenous contrast agents used in radiological examinations (should not be administered within 1–2 months before scintigraphy).

Before taking any medicine, please consult the nuclear medicine physician supervising the examination.
Pregnancy and breastfeeding
Before administration of the medicinal product, inform the nuclear medicine physician if the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant.
Before administration of sodium pertechnetate (Tc) solution, inform the physician about suspected pregnancy, such as a missed menstrual period, or about breastfeeding. In case of doubt, consultation with the nuclear medicine physician supervising the examination is required.
The nuclear medicine physician will administer this medicinal product to a pregnant patient only if absolutely necessary, when benefits outweigh the risks.
In case of breastfeeding, the nuclear medicine physician will request that breastfeeding be interrupted until radioactivity is eliminated from the body. Breastfeeding should be discontinued for 12 hours after injection. Breast milk expressed during this period should be discarded. Resumption of 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 solution contains sodium
Sodium pertechnetate solution contains 3.5 mg/ml of sodium. Depending on the injected volume, the limit 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 Ultra-Technekow FM generator

Ultra-Technekow FM
There are strict regulations regarding the use, transfer, and disposal of radiopharmaceuticals.
Ultra-Technekow FM is used exclusively in specially designated and controlled areas.
Only trained and qualified personnel may handle and administer this product to patients, and they must take special precautionary measures to ensure the safe use of the medicinal product and will continuously monitor their actions.
The nuclear medicine physician supervising the procedure determines the administered dose of sodium pertechnetate (Tc) in each individual case. This will be the minimum dose necessary to obtain the required diagnostic information.
The recommended dose for adults depends on the type of examination being performed and ranges from 2–400 MBq (megabecquerel, a unit of radioactivity measurement).

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 method of use
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 nuclear medicine physician will inform the patient about the typical duration of the examination.
Examinations may be performed at any time, provided that no more than 24 hours have elapsed since administration, 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;
• drink large amounts of water after administration and urinate shortly before the examination begins, as instructed.

The nuclear medicine physician will inform the patient if any special precautionary measures are necessary after administration of this medicinal product. In case of questions, please consult the nuclear medicine physician.

**Administration of a higher than recommended dose of sodium pertechnetate (Tc) solution obtained from the Ultra-Technekow FM generator
Overdose is almost impossible, as the patient receives a single dose of sodium pertechnetate (Tc), strictly controlled by the supervising nuclear medicine physician. However, in the event of an overdose, appropriate treatment will be administered. The nuclear medicine physician may, in particular, recommend drinking large amounts of fluids to remove residual radiopharmaceutical from the body.
In case of any doubts regarding the use of the medicinal product, please consult the nuclear medicine physician supervising the procedure.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not
occur in everyone. Adverse reactions with unknown frequency (which cannot be
determined from 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:
• rapid heartbeat, slow heartbeat;
• fainting;
• blurred vision;
• dizziness;
• headache;
• flushing.
• Gastrointestinal disturbances, with symptoms such as:
• vomiting;
• nausea;
• diarrhoea.
• 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 developing neoplastic diseases and congenital abnormalities.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet,
you should 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
PL-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 marketing authorization holder.
By reporting adverse reactions, additional information on the safety of using the medicine can be collected.

5. How to store Ultra-Technekow FM

The patient will not have to store this medicine. This medicine is stored exclusively by
medical personnel in appropriate facilities. Radioactive pharmaceuticals are stored
in accordance with local regulations concerning radioactive substances.
The following information is intended solely for medical personnel.
Do not use the medicine after the expiry date stated on the packaging.

6. Contents of the pack and other information

What Ultra-Technekow FM contains
The active substance is sodium pertechnetate (Tc). The excipients are: sodium chloride and water for injections.
What Ultra-Technekow FM looks like and contents of the pack
The product is a solution of sodium pertechnetate (Tc) obtained from a radionuclide generator.
Ultra-Technekow FM must be eluted. The resulting solution may be used directly or may be used to label special kits intended for the preparation of radiopharmaceuticals.
Marketing Authorisation Holder and Manufacturer
Curium Netherlands B.V.
Westerduinweg 3
1755 LE Petten
The Netherlands

Information intended exclusively for medical professionals:

The complete Product Information for Ultra-Technekow FM is attached as
a separate document inside the medicinal product package, providing healthcare professionals
with additional scientific and practical information regarding the administration and use of this
radiopharmaceutical.
Refer to the Product Information.