Tekcis 2-50 gbq generador de radionucleido

Label: information for the user

Tekcis 2-50 GBq radionuclide generator

technetium-99m pertechnetate sodium

Read this label carefully before starting to use this medication, as it contains important information for you.

• Keep this label, as you may need to refer to it again.
• If you have any questions, consult your nuclear medicine specialist who will oversee the procedure.
• If you experience any adverse effects, consult your nuclear medicine specialist, even if they are not listed in this label. See section 4.

This medication is a radiopharmaceutical for diagnostic use only.

Tekcisis a technetium-99m generator, that is, it is a device used to obtain a solution for injection of sodium pertechnetate (99mTc).

When this radioactive solution is injected, it temporarily accumulates in certain areas of the body. The low amount of radioactivity injected can be detected from outside the body with special cameras. The nuclear medicine specialist will obtain an image (scan) of the corresponding organ, which will provide valuable information about its structure.

After injection, the sodium pertechnetate (99mTc) solution is used to obtain images of various body areas, such as:

• the thyroid
• salivary glands
• the presence of stomach tissue in an abnormal location (Meckel's diverticulum)
• tear ducts of the eyes

The sodium pertechnetate (99mTc) solution can also be used in combination with another product to prepare another radiopharmaceutical. In this case, please refer to the corresponding prospectus.

The nuclear medicine specialist will explain which type of examination will be performed with this product.

The use of sodium pertechnetate (99mTc) solution involves exposure to small amounts of radioactivity. Your doctor and the nuclear medicine specialist consider that the benefit you will obtain from this procedure is greater than the risk due to radiation.

Do not usethe pertecnetate (99mTc) sodium solution obtained with Tekcis:

• if you areallergicto sodium pertecnetate or to any of the other components of this medication (which are listed in section 6).

Warnings and precautions

Inform your nuclear medicine specialist in the following cases:

• if you haveallergies, as some cases of allergic reactions have been observed after administration of the pertecnetate (99mTc) sodium solution
• if you have a kidney disease
• if you arepregnantor think you may be
• if you are inlactation.

Your nuclear medicine specialist will inform you if you need to take special precautions after using this medication. If you have any questions, consult your nuclear medicine specialist.

Before the pertecnetate (99mTc) sodium solution is administered, you must:

• drink plenty of waterbefore the start of the examination, to urinate as frequently as possible during the first hours after the study.
• be fasting for 3-4 hours before the Meckel's diverticulum gammagraphy to maintain low intestinal peristalsis.

Children and adolescents

Consult with your nuclear medicine specialist if you or your child are under 18 years old.

Other medications and pertecnetate (99mTc) sodium solution

Inform your doctor or pharmacist if you are taking, have taken recently, or may take other medications, as they may interfere with image interpretation, especially the following medications:

• atropine, which is used, for example

- To reduce gastric or intestinal spasms or gallbladder spasms

- To reduce pancreatic secretions

- In ophthalmology

- Before administering anesthesia

- To treat slow heartbeats or

- As an antidote

• isoprenaline, a medication used to treat slow heartbeats
• pain medications
• • laxatives(should not be taken during this procedure, as they irritate the gastrointestinal tract)
  • if you hadcontrast studies(e.g., with the barium contrast agent) orupper gastrointestinal examinations(as these should be avoided in the 48 hours prior to the Meckel's diverticulum gammagraphy)
• antithyroid medications(e.g., carbimazole or other imidazole derivatives such as propylthiouracil), salicylates, steroids, sodium nitroprusside, sulfobromthalein sodium, or perchlorate (as they should not be taken during 1 week before the gammagraphy)
• phenylbutazoneto treat fever, pain, and inflammation in the body (as it should not be taken during 2 weeks before the gammagraphy)
• expectorants(as they should not be taken during 2 weeks before the gammagraphy)
• natural or synthetic thyroid preparations(e.g., sodium thyroxine, liothyronine sodium, or thyroid extract) (as they should not be taken during 2-3 weeks before the gammagraphy)
• amiodaronea antiarrhythmic (as it should not be taken during 4 weeks before the gammagraphy)
• benzodiazepines,used, for example, for sedation, as anxiolytics, anticonvulsants, or muscle relaxants,or lithium,used as a mood stabilizer in manic-depressive illness (as they should not be taken during 4 weeks before the gammagraphy)
• contrast agents with iodinefor radiological body examinations (as they should not have been administered during 1-2 months before the gammagraphy)

Please consult your nuclear medicine specialist before taking any medication.

Pregnancy and lactation

If you are pregnant or breastfeeding, or think you may be pregnant, or if you plan to become pregnant, consult your nuclear medicine specialist before receiving this medication.

You must inform your nuclear medicine specialist before the pertecnetate (99mTc) sodium solution is administered if you may be pregnant, if you have had a miscarriage, or if you arebreastfeeding.

In case of doubt, it is essential to consult your nuclear medicine specialist who will supervise this procedure.

If you are pregnant,

Your nuclear medicine specialist will administer this medication during pregnancy only when the expected benefit outweighs the risks.

If you are breastfeeding,

Inform your nuclear medicine specialist, who will advise you to stop breastfeeding until you have eliminated all the radioactivity from your body. It will take about 12 hours. You should discard the milk you express. Ask your nuclear medicine specialist when you can resume breastfeeding.

Driving and operating machines

The pertecnetate (99mTc) sodium solution does not affect your ability to drive and operate machines.

The pertecnetate (99mTc) sodium solution contains 3.6 mg/ml of sodium. Depending on the injected volume, you may exceed the limit of 1 mmol (23 mg) of sodium per administered dose. You should take this into account if you follow a low-sodium diet.

The legislation regarding the use, handling, and disposal of radiopharmaceuticals is very strict. Tekciswill only be used in special controlled areas. This product will only be handled and administered by people with the necessary training and qualifications for its safe use. Those people will take special care to use this product safely, and they will keep you informed of their actions.

The nuclear medicine physician overseeing the procedure will decide on the amount of sodium pertechnetate (99mTc) solution to be used in your case. It will be the minimum amount necessary to obtain the desired information.

The recommended dose administered to an adult ranges, depending on the test to be performed, between 2 and 400 MBq (megabecquerel, the unit of measurement used to express radioactivity).

Use in children and adolescents

In children and adolescents,the dose to be administered will be adjusted according to the child's weight.

Administration of the sodium pertechnetate (99mTc) solution and performance of the procedure

Depending on the purpose of the examination,the medicationwill be administered through an injection into a vein in the arm or it may be instilled in the eyes in the form of eye drops.

One administration is sufficient to perform the test that your doctor needs.

Duration of the procedure

Your nuclear medicine specialist will inform you about the usual duration of the procedure.

Nuclear medicine scans can be performed at any time, between the time of injection and up to 24 hours after administration, depending on the type of examination.

After administering the sodium pertechnetate (99mTc) solution, the following should be done:

• Avoid direct contactwith children and pregnant women for 12 hours after injection
• Urinate frequentlyto eliminate the product from your body
• After injection, you will be asked to drink and urinate immediately before the test.

Your nuclear medicine specialist will inform you if you need to take any special precautions after receiving this medication. If you have any questions, consult your nuclear medicine specialist.

If you have received more sodium pertechnetate (99mTc) solution obtained with TEKCIS than you should:

It is almost impossible for you to receive an overdose, as you will only receive a controlled dose of sodium pertechnetate (99mTc) solutionprecisely controlled by the nuclear medicine specialist overseeing the procedure. However, in the event of an overdose, you will be administered the appropriate treatment. Specifically, the nuclear medicine specialist responsible for the procedure may recommend that you drink large quantities of liquids to eliminate the radioactive residues from your body.

If you have any other questions about the use of this product, ask your nuclear medicine specialist or pharmacist.

In the event of an overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 915 620 420, indicating the medication and the amount ingested.

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

Adverse effects of unknown frequency (cannot be estimated from available data):

-Allergic reactions, with symptoms such as

• Skin rash, itching
• Hives
• Swelling in various locations, e.g., on the face
• Difficulty breathing
• Skin redness
• Coma

-Circulatory reactions, with symptoms such as

• Fast or slow heartbeats
• Fainting
• Blurred vision
• Dizziness
• Headache
• Hot flashes

-Digestive problems, with symptoms such as

• Nausea (feeling sick)
• Vomiting
• Diarrhea

-Reactions at the injection site, with symptoms such as

• Skin inflammation
• Pain
• Swelling
• Redness

This radiopharmaceutical will release small amounts of ionizing radiation with a very low risk of causing cancer and genetic defects.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es.

By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

You do not need to conserve this medication. This medication is stored under the responsibility of the specialist in the appropriate facilities. Procedures for conserving radiopharmaceuticals must comply with national regulations on radioactive materials.

Composition of TEKCIS

- The active principle is: pertecnetate (99mTc) of sodium.

- The other components are: sodium chloride and water forinjectable preparations

Appearance of TEKCIS and contents of the packaging

The product is a solution of pertecnetate (99mTc) of sodium obtained from a radionuclide generator.

TEKCIS must be eluted, and the obtained solution can be used as is or for the radiolabeling of some specific reaction equipment for the preparation of radiopharmaceuticals.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Curium Pharma Spain, S.A.

Avda. Doctor Severo Ochoa, 29

28100 Alcobendas. Madrid

Spain

Responsible for manufacturing

CIS BIO INTERNATIONAL

B.P. 32

F-91192 Gif sur Yvette Cedex

This medicine is authorized in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:Austria, Belgium, Bulgaria, Cyprus, Croatia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Norway, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden: Tekcis.

Czech Republic: Technecistan-(99mTc) sodný CIS bio international.

United Kingdom (Northern Ireland): Sodium pertechnetate (99mTc) CIS bio international.

Revision date of this prospectus:06/2024.

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)

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This information is intended solely for healthcare professionals:

The complete technical file of Tekcis is provided as a separate document in the product packaging, with the aim of providing healthcare professionals with additional scientific data and practical information on the administration and use of this radiopharmaceutical.

Consult the technical file (the technical file must be included in the packaging).