Tekcis

Package leaflet: Information for the patient

TEKCIS, 2-50 GBq, radionuclide generator
injectable solution of sodium pertechnetate ( Tc) formed by fission
Please read all of this leaflet carefully before receiving the medicine, because it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any further questions, please consult the nuclear medicine physician who will supervise the procedure.
• If you experience any adverse reactions, including any not listed in this leaflet, inform the nuclear medicine physician. See section 4.

Table of contents

1. What TEKCIS is and what it is used for
2. Important information before administration of the sodium pertechnetate ( Tc) solution obtained using TEKCIS
3. How the sodium pertechnetate ( Tc) solution obtained using TEKCIS is administered
4. Possible side effects
5. How to store TEKCIS
6. Contents of the pack and other information

1. What TEKCIS is and what it is used for

TEKCIS is a radiopharmaceutical product used exclusively for diagnostic purposes.
TEKCIS is a technetium ( Tc) generator, which means it is a device used to obtain an injectable solution of sodium pertechnetate ( Tc). When the radioactive solution is injected into the body, it temporarily accumulates in certain parts of the body. The small amount of administered radioactive compound can be detected from outside the body using special cameras. The nuclear medicine physician will then perform an image (scan) of the organ in question, providing valuable information about the structure and function 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
• ectopic gastric tissue (Meckel's diverticulum)
• lacrimal ducts of the eyes

The sodium pertechnetate ( Tc) solution may also be used in combination with another product to prepare a different radiopharmaceutical. In such cases, refer to the respective package leaflet. The nuclear medicine physician will explain to the patient the nature of the examination to be performed using this product. Administration of sodium pertechnetate ( Tc) involves exposure to small amounts of radioactivity. The treating physician and nuclear medicine physician have determined that the clinical benefit the patient will gain from the procedure using this radiopharmaceutical outweighs the radiation risk.

2. Important information before using sodium pertechnetate ( Tc) solution

(obtained using the medicine TEKCIS)

When not to use sodium pertechnetate ( Tc) solution obtained using TEKCIS

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

Warnings and precautions
Inform the nuclear medicine physician if:

• the patient has allergies, as there have been a few reported cases of allergic reactions following administration of sodium pertechnetate ( Tc) solution,
• the patient suffers from kidney disease,
• the patient is pregnant or suspects she may be pregnant,
• the patient is breastfeeding. The nuclear medicine physician will inform the patient whether special precautions are necessary after administration of this medicine. If in doubt, consult the nuclear medicine physician. Before administration of sodium pertechnetate ( Tc) solution, the patient should:
• drink plenty of fluids before the examination begins, to urinate as frequently as possible during the first hours after the examination.
• fast for 3 to 4 hours before Meckel's diverticulum scintigraphy, to maintain as slow a bowel transit as possible.

Children and adolescents
Patients under 18 years of age or parents of such patients should consult with the nuclear medicine physician.

Sodium pertechnetate ( Tc) solution and other medicines

Inform the nuclear medicine physician about all medicines currently taken or recently taken, as well as any medicines the patient plans to take, because they may interfere with image interpretation. This particularly includes the following medicines:

• atropine, used e.g. for:
• reducing stomach, intestinal or gallbladder spasms,
• reducing pancreatic secretion,
• in ophthalmology,
• before administration of anaesthesia,
• in treatment of bradycardia, or
• as an antidote
• isoprenaline, a medicine used in the treatment of bradycardia
• analgesics
• laxatives (should not be used during this procedure, as they irritate the gastrointestinal tract)
• if the patient has undergone contrast examinations (e.g. using barium-containing contrast agents) or upper gastrointestinal tract examinations (these should be avoided within 48 hours before Meckel's diverticulum scintigraphy)
• antithyroid drugs (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 scintigraphy)
• phenylbutazone used in the treatment of fever, pain and inflammatory conditions in the body (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 triiodothyronine, thyroid extract) (should not be taken 2–3 weeks before scintigraphy)
• amiodarone – an antiarrhythmic medicine (should not be taken 4 weeks before scintigraphy)
• benzodiazepines used e.g. for sedation or as anxiolytics, anticonvulsants, or muscle relaxants, or lithium compounds used as mood stabilizers in bipolar disorder (neither should be taken 4 weeks before scintigraphy)
• iodinated contrast agents used in radiological examinations of the body (should not be administered 1–2 months before scintigraphy)

Before taking any medication, consult the nuclear medicine physician.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a nuclear medicine physician before receiving this medicine. The patient must inform the nuclear medicine physician before receiving sodium pertechnetate ( Tc) solution if there is any possibility she is pregnant, if her period is delayed, or if she is breastfeeding. If in doubt, consult the nuclear medicine physician supervising the procedure. If the patient is pregnant, the nuclear medicine physician will administer the medicine during pregnancy only if the expected benefit of the examination clearly outweighs the risk. If the patient is breastfeeding, she should inform the nuclear medicine physician, as he or she will recommend discontinuing breastfeeding until radioactivity has been eliminated from the body. This takes approximately 12 hours. Breast milk expressed during this time 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 has no influence on the ability to drive or operate machinery.

Sodium content of sodium pertechnetate solution
Sodium pertechnetate solution contains 3.6 mg/ml of sodium. Depending on the injected volume, the limit of 1 mmol (23 mg) of sodium per administered dose may be exceeded. This should be taken into account if the patient is on a low-sodium diet.

3. How to use the sodium pertechnetate (Tc) solution obtained using the TEKCIS medicinal product

There are strict regulations regarding the use, handling, and disposal of radiopharmaceuticals. TEKCIS will be used exclusively in specially controlled areas. The product will be prepared and administered to the patient only by personnel who are trained and qualified to do so safely. These individuals will take all necessary precautions to ensure the safe use of the product and to inform the patient about the actions being taken.

The nuclear medicine physician supervising the procedure will determine the amount of sodium pertechnetate (Tc) solution to be administered in each individual case. This will be the smallest dose necessary to obtain the required diagnostic information.

The amount usually recommended for administration to adult patients depends on the type of examination being performed and ranges from 2 to 400 MBq (megabecquerel, the unit used to express radioactivity).

Use in children and adolescents
In children and adolescents, the administered amount will be adjusted according to body weight.

**Administration of sodium pertechnetate (**Tc) solution and performance of the examination
Depending on the purpose of the examination, the product will be administered either as an intravenous injection into the arm vein or instilled into the eye as drops.

For the diagnostic examination required by the physician, only a single administration is needed.

Duration of the procedure
The nuclear medicine physician will inform the patient how long the procedure usually takes. Imaging scans may be performed at any time from the moment of injection up to 24 hours after administration, depending on the type of examination.

**After administration of sodium pertechnetate (**Tc) solution, the patient should:

• avoid close contact with young children and pregnant women for 12 hours after injection,
• urinate frequently to help eliminate the product from the body,
• after administration of the solution, drink plenty of fluids and be asked to empty the bladder immediately before the examination. The nuclear medicine physician will inform the patient whether any special precautionary measures are necessary after receiving this medicinal product. For any questions, please contact the nuclear medicine physician.

**Administration of a higher than recommended dose of sodium pertechnetate (**Tc) solution obtained using the TEKCIS medicinal product:
Overdose is almost impossible, as the patient will receive only a single dose of sodium pertechnetate (Tc) solution, precisely controlled by the nuclear medicine physician supervising the procedure. However, in the event of an overdose, appropriate treatment will be administered. In particular, the nuclear medicine physician responsible for the procedure may recommend drinking large amounts of fluids to help eliminate traces of radioactivity from the body.

For any questions regarding the use of this product, please contact the nuclear medicine physician supervising the procedure.

4. Possible adverse reactions

Like all medicines, this product may cause adverse reactions, although not everyone experiences them.
Adverse reactions of unknown frequency (based on available data, frequency cannot be determined):

• allergic reactions with symptoms such as
• skin rash, itching
• urticaria
• swelling in various parts of the body, including the face
• shortness of breath (short, shallow breathing)
• skin redness
• stupor
• circulatory reactions with symptoms such as:
• rapid heartbeat, slow heartbeat
• fainting
• blurred vision
• dizziness
• headache
• hot flashes with skin redness
• gastrointestinal disturbances with symptoms such as
• vomiting
• nausea
• diarrhoea
• reactions at the injection site with symptoms such as
• skin inflammation
• pain
• swelling (oedema)
• redness.

This radiopharmaceutical product will deliver small amounts of ionizing radiation, which carries a minimal risk of cancer development and occurrence of hereditary abnormalities.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse effects not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to:
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
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder. Reporting adverse reactions helps to provide more information on the safety of using this medicine.

5. How to store TEKCIS

The patient will not store this product. A specialist at the nuclear medicine facility
is responsible for its storage. Storage of radiopharmaceutical products
will be carried out in accordance with national regulations regarding the storage of
radioactive materials.

6. Contents of the package and other information

What TEKCIS contains

• The active substance is sodium pertechnetate (Tc) solution.
• The other components are: sodium chloride, sodium nitrate, and water for injections.

What TEKCIS looks like and contents of the pack
The product is a sodium pertechnetate (Tc) solution obtained from a radionuclide generator.
TEKCIS should be eluted, and the resulting solution may be used directly or for radiolabelling
of certain specific kits for the preparation of radiopharmaceuticals.
Pack sizes:

Marketing Authorisation Holder and Manufacturer
CIS bio international
Route Nationale306
BP 32 SACLAY
F-91192 Gif-sur-Yvette Cedex
France
E-mail: [email protected] , Tel: +33 1.69.85.76.76.
This medicinal product is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Austria, Belgium, Bulgaria, Cyprus, Croatia, Denmark, Estonia, Finland, France, Germany, Greece,
Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden: TEKCIS
Czech Republic: Technecistan-(Tc) sodný CIS bio international
United Kingdom (Northern Ireland): Sodium pertechnetate (Tc) CIS bio international
Other sources of information
Detailed information on this medicinal product is available on the website of the Department of Medicinal Product Registration
( https://rejestrymedyczne.ezdrowie.gov.pl/rpl/search/public )

Information intended for healthcare professionals only:

The complete SmPC of the medicinal product Tekcis is provided as a separate document in the
package to provide healthcare professionals with additional scientific and practical information
on the administration and use of this radiopharmaceutical.
Please consult the SmPC (it should be included in the package).