Tekcis

PATIENT INFORMATION LEAFLET

Leaflet accompanying the packaging: information for the patient

TEKCIS, 2-50 GBq, radionuclide generator

Sodium pertechnetate (Tc) fission-formed injection solution

You should carefully read the contents of this leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a nuclear medicine doctor who will be supervising the procedure.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, they should inform the nuclear medicine doctor. See section 4.

Table of contents of the leaflet

• 1. What is Tekcis and what is it used for
• 2. Important information before using sodium pertechnetate (Tc) solution obtained using Tekcis
• 3. How to use sodium pertechnetate (Tc) solution obtained using Tekcis
• 4. Possible side effects
• 5. How to store Tekcis
• 6. Package contents and other information

1. What is TEKCIS and what is it 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
a sodium pertechnetate (Tc) injection solution. When the radioactive solution is
injected into the body, it temporarily accumulates in certain parts of the body. A small
amount of the administered radioactive compounds can be detected from outside the body using
special cameras. The nuclear medicine doctor will then take an image (scan) of the affected organ,
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
• gastric tissue appearing in an abnormal location (Meckel's diverticulum)
• tear ducts of the eyes. The sodium pertechnetate (Tc) solution may also be used in combination with another product to prepare another radiopharmaceutical. In such a case, refer to the relevant leaflet accompanying the packaging. The nuclear medicine doctor will explain the nature of the examination to be performed using this product. The use of sodium pertechnetate (Tc) solution involves exposure to small amounts of radioactivity. The treating physician and the nuclear medicine doctor have determined that the clinical benefits to the patient from the procedure using the radiopharmaceutical outweigh the risk associated with radiation.

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

obtained using Tekcis

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

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

Warnings and precautions

You should inform the nuclear medicine doctor if:

• the patient has allergies, as a few cases of allergic reactions have been observed after administration of sodium pertechnetate (Tc) solution,
• the patient has kidney disease,
• the patient is pregnant or thinks she may be pregnant,
• the patient is breastfeeding. The nuclear medicine doctor will inform the patient whether it is necessary to take special precautions after using this medicine. In case of doubts, consult the nuclear medicine doctor. Before administering the sodium pertechnetate (Tc) solution, the patient should:
• drink plenty of water before the examination to urinate as often as possible during the first hours after the examination.
• fast for 3 to 4 hours before the Meckel's diverticulum scintigraphy to maintain slow small intestine function.

Children and adolescents

Persons under 18 years of age or their parents should consult a nuclear medicine doctor.

Sodium pertechnetate (Tc) solution and other medicines

You should tell the nuclear medicine doctor about all medicines the patient is taking or has recently taken, as well as any medicines the patient plans to take, as they may interfere with the interpretation of the images. In particular, this applies to the following medicines:

• atropine, used for example for:
• reducing stomach, intestine, or gallbladder spasms,
• reducing pancreatic secretion,
• in ophthalmology,
• before anesthesia administration,
• in the treatment of slow heart rate or
• as an antidote
• isoprenaline, a medicine used to treat slow heart rate
• analgesics
• laxatives(should not be used during this procedure, as they irritate the digestive tract)
• if the patient has undergone contrast agent tests(e.g., using a barium-based contrast agent) or an examination of the upper gastrointestinal tract (as these should be avoided for 48 hours before Meckel's diverticulum scintigraphy)
• antithyroid medicines(e.g., carbimazole or other imidazole derivatives, such as propylthiouracil, salicylates, steroids, sodium nitroprusside, sulfobromophthalein sodium, perchlorate) (should not be taken for 1 week before scintigraphy)
• phenylbutazonein the treatment of fever, pain, and inflammation in the body (should not be taken for 2 weeks before scintigraphy)
• expectorants(should not be taken for 2 weeks before scintigraphy)
• preparations containing natural or synthetic thyroid hormones(e.g., sodium thyroxine, sodium liotyronine, thyroid extract) (should not be taken for 2-3 weeks before scintigraphy)
• amiodarone- an antiarrhythmic medicine (should not be taken for 4 weeks before scintigraphy)
• benzodiazepinesused, for example, in sedation or as anxiolytic, anticonvulsant, or muscle relaxant, or lithiumcompounds used as a mood stabilizer in manic-depressive illness (should not be taken for 4 weeks before scintigraphy)
• iodine-based contrast agentsfor radiological examinations of the body (should not be administered for 1-2 months before scintigraphy) Before taking any medicines, you should consult a nuclear medicine doctor.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult a nuclear medicine doctor before receiving this medicine.
The patient must inform the nuclear medicine doctor before receiving the sodium pertechnetate (Tc) solution if there is a possibility that she is pregnant, if her menstrual period is delayed, or if she is breastfeeding. In case of doubts, consult the nuclear medicine doctor who will be supervising the procedure.
If the patient is pregnant, the nuclear medicine doctor will administer the medicine during pregnancy only if the expected benefit from the examination significantly outweighs the risk.
If the patient is breastfeeding, she should inform the nuclear medicine doctor, as he will recommend stopping breastfeeding until the radioactivity has been eliminated from the body. This takes about 12 hours. The breast milk expressed during this time should be discarded. Resuming breastfeeding should be discussed with the nuclear medicine specialist supervising the examination.

Driving and operating machinery

The sodium pertechnetate (Tc) solution has no effect on the ability to drive vehicles and operate machinery.

The sodium pertechnetate (Tc) solution contains sodium

The sodium pertechnetate (Tc) 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-salt diet.

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

There are strict regulations regarding the use, handling, and disposal of radiopharmaceutical products. Tekcis will be used exclusively in special controlled areas. The product will be prepared and administered to the patient only by persons who are trained and qualified to do so in a safe manner. These persons will make every effort to use the product safely and to inform the patient about the actions being taken.
The nuclear medicine doctor supervising the procedure will decide on the amount of sodium pertechnetate (Tc) solution to be used in a given case. This will be the smallest dose necessary to obtain the expected information.
The usual recommended dose for administration to adults, depending on the type of examination performed, ranges from 2 to 400 MBq (megabecquerel, a unit used to express radioactivity).

Use in children and adolescents

In children and adolescents, the administered dose 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 by injection into a vein in the arm or may be instilled into the eyes in the form of drops.
A single administration is sufficient for the doctor to perform the necessary examination.

Duration of the procedure

The nuclear medicine doctor will inform the patient about how long the procedure usually takes.
Scans can be performed at any time, from the moment of injection and up to 24 hours after administration, depending on the type of examination.

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

• avoid close contact with small children and pregnant women for 12 hours after injection,
• frequently urinate to eliminate the product from the body,
• after administration of the solution, the patient will receive a drink and will be asked to urinate directly before the examination. The nuclear medicine doctor will inform the patient whether it is necessary to take special precautions after receiving this medicine. In case of any questions, consult the nuclear medicine doctor.

Use of a higher than recommended dose of sodium pertechnetate (Tc) solution obtained using Tekcis:

Overdose is almost impossible, as the patient will receive only a single dose of sodium pertechnetate (Tc) solution, which is precisely controlled by the nuclear medicine doctor supervising the procedure. However, in the event of an overdose, the patient will receive appropriate treatment. In particular, the nuclear medicine doctor responsible for the procedure may recommend drinking large amounts of fluids to eliminate the radioactivity from the body.
In case of questions about the use of this product, consult the nuclear medicine doctor supervising the procedure.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects of unknown frequency (based on available data, frequency cannot be estimated):

• allergic reactions with symptoms such as
• skin rash, itching
• hives
• swelling in various locations, including the face
• shortness of breath (short, shallow breathing)
• redness of the skin
• coma
• cardiovascular reactions with symptoms such as:
• rapid heart rate, slow heart rate
• fainting
• blurred vision
• dizziness
• headache
• hot flashes with skin redness
• gastrointestinal disorders with symptoms such as
• vomiting
• nausea (nausea)
• diarrhea
• reactions at the injection site with symptoms such as
• skin inflammation
• pain
• swelling (swelling)
• redness. This radiopharmaceutical product will deliver small amounts of ionizing radiation, which is associated with a minimal risk of cancer and genetic disorders.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should inform your doctor or pharmacist. Side effects can be reported directly to:
Department of Adverse Reaction Monitoring of Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Aleje Jerozolimskie 181C
PL-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. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store TEKCIS

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

6. Package contents and other information

What TEKCIS contains

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

What TEKCIS looks like and what the package contains

The product is a sodium pertechnetate (Tc) solution obtained from a radionuclide generator.
TEKCIS should be eluted, and the resulting solution may be used alone or to radiolabel certain specific kits for the preparation of radiopharmaceuticals.
Package sizes:

Marketing authorization holder and manufacturer

CIS bio international
National Road 306
BP 32 SACLAY
F-91192 Gif-sur-Yvette Cedex
France
Email: drugsafety@curiumpharma.com, Phone: +33 1.69.85.76.76.

This medicine is authorized for marketing 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
Date of last revision of the leaflet:02.08.2024

Other sources of information

Detailed information about this medicine can be found on the website of the Department of Medicinal Product Registration (https://rejestrymedyczne.ezdrowie.gov.pl/rpl/search/public)
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Information intended exclusively for healthcare professionals:
The complete Summary of Product Characteristics (SmPC) of the medicinal product Tekcis is provided as a separate document in the product packaging to provide healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical.
Please refer to the SmPC (which should be included in the packaging).