TEKCIS 2-50 GBq RADIOPHARMACEUTICAL GENERATOR

Introduction

Package Leaflet: Information for the User

Tekcis 2-50 GBq Radionuclide Generator

Sodium pertechnetate (99mTc)

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your nuclear medicine specialist doctor who will be supervising the procedure.
• If you experience any side effects, talk to your nuclear medicine specialist doctor, even if they are not listed in this leaflet. See section 4.

Contents of the package leaflet

1. What is Tekcis and what is it used for
2. What you need to know before you start using the sodium pertechnetate (99mTc) solution obtained with Tekcis
3. How to use the sodium pertechnetate (99mTc) solution obtained with Tekcis
4. Possible side effects
5. Storage of Tekcis
6. Package contents and further information

1. What is Tekcis and what is it used for

This medicine is a radiopharmaceutical for diagnostic use only.

Tekcis is a technetium (99mTc) generator, i.e., a device used to obtain a solution for injection of sodium pertechnetate (99mTc).

When this radioactive solution is injected, it temporarily accumulates in some areas of the body. The small amount of radioactivity injected can be detected from outside the body with special cameras. The nuclear medicine specialist doctor 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 areas of the body, such as:

• the thyroid
• the 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, consult the corresponding package leaflet.

Your nuclear medicine specialist doctor will explain what type of examination will be performed with this product.

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

2. What you need to know before you start using the sodium pertechnetate (99mTc) solution obtained with Tekcis

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

• if you are allergicto sodium pertechnetate or to any of the other components of this medicine (listed in section 6).

Warnings and precautions

Tell your nuclear medicine specialist doctor in the following cases:

• If you have allergies, as some cases of allergic reactions have been observed after administration of the sodium pertechnetate (99mTc) solution
• If you have kidney disease
• If you are pregnantor think you may be pregnant
• If you are breast-feeding.

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

Before the sodium pertechnetate (99mTc) 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.
• fast for 3-4 hours before the Meckel's diverticulum scintigraphy to keep the small intestine's peristalsis low.

Children and adolescents

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

Other medicines and sodium pertechnetate (99mTc) solution

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, as they may interfere with the interpretation of the images, especially the following medicines:

• atropine, which is used, for example

• To reduce gastric or intestinal spasms or those of the gallbladder
• To reduce pancreatic secretions
• In ophthalmology
• Before administering anesthesia
• To treat slow heartbeats or
• As an antidote
• isoprenaline, a medicine used to treat slow heartbeats
• pain relief medicines
• • laxatives(should not be taken during this procedure, as they irritate the gastrointestinal tract)
  • if you have had contrast studies(e.g., with barium contrast agent) or upper digestive examinations(which should be avoided in the 48 hours prior to the Meckel's diverticulum scintigraphy)
• antithyroid drugs(e.g., carbimazole or other imidazole derivatives such as propylthiouracil), salicylates, steroids, sodium nitroprusside, sodium sulfobromophthalein, or perchlorate (should not be taken during 1 week before scintigraphy)
• phenylbutazoneto treat fever, pain, and inflammation in the body (should not be taken during 2 weeks before scintigraphy)
• expectorant drugs(should not be taken during 2 weeks before scintigraphy)
• natural or synthetic thyroid preparations(e.g., sodium thyroxine, sodium liotironine, or thyroid extract) (should not be taken during 2-3 weeks before scintigraphy)
• amiodarone, an antiarrhythmic (should not be taken during 4 weeks before scintigraphy)
• benzodiazepines, used, for example, for sedation, as anxiolytics, anticonvulsants, or muscle relaxants, or lithium, used as a mood stabilizer in manic-depressive illness (should not be taken during 4 weeks before scintigraphy)
• iodine-based contrast mediafor radiological examinations of the body (should not have been administered during 1-2 months before scintigraphy)

Please consult your nuclear medicine specialist doctor before taking any medicine.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, or think you may be pregnant, or are planning to have a child, ask your nuclear medicine specialist doctor for advice before receiving this medicine.

You must inform your nuclear medicine specialist doctor before you are given the sodium pertechnetate (99mTc) solution if you might be pregnant, if you have missed a period, or if you are breast-feeding.

In case of doubt, it is important that you consult your nuclear medicine specialist doctor who will be supervising this procedure.

If you are pregnant,

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

If you are breast-feeding,

Tell your nuclear medicine specialist doctor, who will advise you to stop breast-feeding until all radioactivity has been eliminated from your body. This will take about 12 hours. You will need to discard the milk you express. Ask your nuclear medicine specialist doctor when you can restart breast-feeding.

Driving and using machines

The sodium pertechnetate (99mTc) solution has no influence on the ability to drive and use machines.

The sodium pertechnetate (99mTc) solutioncontains 3.6 mg/ml of sodium. Depending on the volume injected, the limit of 1 mmol (23 mg) of sodium per administered dose may be exceeded. You should take this into account if you are on a low-sodium diet.

3. How to use the sodium pertechnetate (99mTc) solution obtained with Tekcis

Legislation on the use, handling, and disposal of radiopharmaceuticals is very strict. Tekcis will only be used in special controlled areas. This product will only be handled and administered by persons with training and qualification for safe use. These persons will take special care to use this product safely and will keep you informed of their actions.

The nuclear medicine specialist doctor supervising the procedure will decide 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 amount administered to an adult varies, 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 amount administered will be adapted 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 medicine will be administered by injection into a vein in the arm or can be instilled into the eyes as eye drops.

A single administration is sufficient to perform the test your doctor needs.

Duration of the procedure

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

Scintigraphies 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 administration of the sodium pertechnetate (99mTc) solution, you should:

• Avoid direct contactwith children and pregnant women during the 12 hours following 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 doctor will inform you if you need to take special precautions after being administered this medicine. If you have any questions, ask your nuclear medicine specialist doctor.

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

It is almost impossible for you to be administered an overdose, as you will receive only a precisely controlled dose of sodium pertechnetate (99mTc) solution by the nuclear medicine specialist doctor supervising the procedure. However, in case you receive an overdose, you will be given the appropriate treatment. In particular, the nuclear medicine specialist doctor responsible for the procedure may recommend that you drink large amounts of liquid to eliminate the remains of radioactivity from your body.

If you have any further questions on the use of this product, ask your nuclear medicine specialist doctor or pharmacist.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 915 620 420, indicating the medicine and the amount ingested.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

• allergic reactions, with symptoms such as
• skin rash, itching
• hives
• swelling in different areas, e.g., in the face
• breathing difficulties
• redness of the skin
• coma

• circulatory reactions, with symptoms such as
• fast or slow heartbeats
• fainting
• blurred vision
• dizziness
• headache
• hot flashes

• digestive problems, with symptoms such as
• being sick (vomiting)
• feeling sick (nausea)
• 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 producing cancer and hereditary defects.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Tekcis

You do not need to store this medicine. This medicine is stored under the responsibility of the specialist in suitable facilities. The storage procedures for radiopharmaceuticals must comply with national regulations on radioactive materials.

6. Package contents and further information

Composition of Tekcis

• The active substance is: sodium pertechnetate (99mTc).
• The other components are: sodium chloride and water for injections

Appearance of Tekcis and package contents

The product is a sodium pertechnetate (99mTc) solution obtained using a radionuclide generator.

Tekcis must be eluted, and the obtained solution can be used as is or for the radiolabeling of certain reagent kits for the preparation of radiopharmaceuticals.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

Curium Pharma Spain, S.A.

Avda. Doctor Severo Ochoa, 29

28100 Alcobendas. Madrid

Spain

Manufacturer

CIS BIO INTERNATIONAL

B.P. 32

F-91192 Gif sur Yvette Cedex

This medicine 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, 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.

Date of last revision of this leaflet:06/2024.

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

--------------------------------------------------------------------------------------------------------------------

This information is intended only for healthcare professionals:

The complete technical specifications of Tekcis are 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 specifications (the technical specifications must be included in the packaging).