Label: information for the patient

Montek 10-40 GBq radionuclide generator

Sodium pertecnetate solution (99mTc)

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 physician who will oversee the procedure.
• If you experience any adverse effects, consult your nuclear medicine physician, even if they are not listed in this label. See section 4.

This medication is a radiopharmaceutical for diagnostic use only.

This medication is a technetium-99m generator, that is, a device used to obtain an injectable solution 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 physician will take an image (scan) of the corresponding organ, which will provide useful information about the structure and function of this organ.

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

• thyroid gland
• salivary glands
• appearance 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, see the corresponding package insert.

The nuclear physician will explain what 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 physician have considered that the clinical benefit you will obtain from the procedure with the radiopharmaceutical outweighs the risk due to radiation.

The solution of pertecnetate (99mTc) of sodium obtained with Montek should not be used:

Warnings and precautions

Inform your nuclear physician in the following cases:

Your nuclear physician will inform you if you need to take any special precautions after using this medication. Consult your nuclear physician if you have any questions.

Before administration of the solution of pertecnetate (99mTc) of sodium, you must:

• drink plenty of waterbefore starting 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 physician if you or your child are under 18 years old.

Other medications and the solution of pertecnetate (99mTc) of sodium

Inform your nuclear physician if you are taking, have taken recently, or may need to take any other medication, as they may interfere with the interpretation of the images, especially the following medications:

• atropine, used for example:
• • to reduce stomach, intestine, or gallbladder spasms
  • to reduce pancreatic secretions
  • in ophthalmology
  • before administering anesthesia
  • to treat reduced heart rate or
  • as an antidote
• isoprenaline,a medication to treat reduced heart rate
• analgesics

• laxatives(should not be taken during this procedure, as they irritate the gastrointestinal tract)
• if you havecontrast studies(e.g., with barium contrast agent) orupper gastrointestinal explorations(as they should be avoided in the 48 hours prior to Meckel's diverticulum gammagraphy)

• antithyroid medications(e.g., carbimazole or other imidazole derivatives such as propylthiouracil),salicylates, esteroids, nitroprusside sodium, sulfobromophthalein sodium, perchlorate(as they should not be taken during 1 week before gammagraphy)
• phenylbutazoneto treat fever, pain, and inflammation in the body (as it should not be taken during 2 weeks before gammagraphy)
• expectorants(as they should not be taken during 2 weeks before gammagraphy)
• natural or synthetic thyroid preparations(e.g., sodium thyroxine, lithium sodium or thyroid extract) (as they should not be taken during 2-3 weeks before gammagraphy)
• amiodaronea antiarrhythmic agent (as it should not be taken during 4 weeks before gammagraphy)
• benzodiazepinesused for example for sedation, or as anxiolytics or anticonvulsants or as muscle relaxants orlithiumused as a mood stabilizer in manic-depressive illness (as both should not be taken during 4 weeks before gammagraphy)
• intravenous contrast agentsfor radiological body explorations (as they should not have been administered during 1-2 months before gammagraphy)

Please consult your nuclear physician before taking any medication.

Pregnancy and lactation

If you are pregnant or in lactation, believe you may be pregnant or intend to become pregnant, consult your nuclear physician before this medication is administered.

You must inform your nuclear physician before administration of the solution of pertecnetate (99mTc) of sodium if there is any possibility of pregnancy, if you experience a delay in your period or are in lactation. In case of doubt, it is essential to consult your nuclear medicine physician who will supervise the procedure.

If you are pregnant, your nuclear physician will only administer this medication during pregnancy if it is expected that the benefit will outweigh the risks.

If you are in lactation, inform your nuclear physician, who will advise you to stop until all radiactivity has been eliminated from your body. This will take approximately 12 hours. The expressed milk must be discarded. The resumption of lactation must be agreed with the nuclear medicine specialist who will supervise the procedure.

Driving and using machines

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

The solution of pertecnetate (99mTc) of sodium contains sodium

The solution of pertecnetate (99mTc) of sodium contains3.54 mg/ml of sodium. Depending on the injected volume, the sodium limit of 23 mg (1 mmol) per administered dose may be exceeded. This should be taken into account if you follow a low-sodium diet.

There are strict guidelines for the use, handling, and disposal of radiopharmaceuticals. This medication will only be used in specially controlled areas. This product will only be handled and administered by trained and qualified individuals who will use it safely. Those individuals will take special care in the safe use of this product and will keep you informed of their actions.

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

The generally recommended dose for an adult varies depending on the test to be performed, and ranges from 2 to 400 MBq (megabecquerel, the unit used to express radioactivity).

Use in children and adolescents

The amountthat will be administered will be adapted 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 medication will be administered by injection into a vein in the arm or can be instilled in the eyes in the form of drops.

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

Duration of the procedure

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

Scintigraphy 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 contact with children and pregnant women for 12 hours after the injection
• urinate frequentlyto eliminate the product from your body
• after administration, you will be offered a drink and asked to urinateimmediately before the test.

Your nuclear medicine physician will inform you if you need to take special precautions after this medication is administered. Consult your nuclear medicine physician if you have any doubts.

If you have been administered more sodium pertechnetate (99mTc) solution obtained with Montek than you should

It is almost impossible to have an overdose because you will receive a single, precisely controlled dose of sodium pertechnetate (99mTc) solution by the nuclear medicine physician overseeing the procedure. However, in case of an overdose, you will receive the appropriate treatment. In particular, the nuclear medicine physician in charge of the procedure may recommend that you drink large amounts of liquids to eliminate the remaining radioactivity from your body.

If you have any other questions about the use of this product, ask your nuclear medicine physician who is overseeing the procedure.

Like all medications, this medication may produce adverse effects, although not all people 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 different areas, e.g., on the face
• difficulty breathing
• skin redness
• coma

• circulatory reactions, with symptoms such as

• rapid heart rate, slow heart rate
• syncope
• blurred vision
• dizziness
• headache
• seizures

• gastrointestinal disorders, with symptoms such as

• nausea (vomiting)
• feeling unwell (nausea)
• diarrhea

• reactions at the injection site, with symptoms such as

• skin inflammation
• pain
• swelling
• redness

The administration of this radiopharmaceutical involves receiving a small amount of ionizing radiation with a very low risk of developing cancer and hereditary 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 the Spanish System for Pharmacovigilance of Medicines 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 conserved under the responsibility of the specialist in appropriate facilities. Storage of radiopharmaceuticals will be carried out in accordance with national regulations on radioactive materials.

The following information is intended solely for the specialist.

Do not use this medication after the expiration date that appears on the label.

Keep the generator and eluate, sodium pertecnetate (99mTc) solution, below 25 °C in the original packaging. Do not freeze.

After elution, use within 8 hours.

Composition of Montek 10-40 GBq radionuclide generator:

The active principle is a solution of pertechnetate (99mTc) of sodium.

The other components are:

Aluminum oxide

Molybdenum trioxide

Sodium hydroxide

30% hydrogen peroxide

Sodium hydroxide 1 M (for pH adjustment)

4M hydrochloric acid (for pH adjustment)

1M hydrochloric acid (for pH adjustment)

Sodium chloride 9 mg/ml (0.9%) injectable solution

Water for injectable preparations

Appearance of Montek and contents of the package:

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

Montek 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.

Package size:

The product contains a radioactive generator, 10 vacuum vials, 5 vials with 5 ml of sodium chloride 9 mg/ml (0.9%) injectable solution or 5 vials with 10 ml of sodium chloride 9 mg/ml (0.9%) injectable solution, 10 antiseptic pads.

Holder of the marketing authorization and responsible for manufacturing:

Monrol Europe S.R.L

Str. Gradinarilor, nr.1

077415 Jud. Bucharest

Romania

Phone: +40 21 367 48 01

Fax: +40 21 311 75 84

Email:[email protected]

This medicine is authorized in the member states of the European Economic Area with the following names:

Denmark: MONTEK

Germany: MONTEK

Romania: MONTEK

Bulgaria: MONTEK

Greece: MONTEK

Austria: MONTEK

Belgium: MONROLTEC

France: MONTEK

Hungary: MONTEK

Italy: MONTEK

Netherlands: MONTEK

Poland: MONTEK

Portugal: MONTEK

Spain: MONTEK

Last review date of this leaflet: August 2021

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/)

This information is intended solely for healthcare professionals:

The complete technical file of Montek 10-40 GBq radionuclide generator is included in the product packaging, with the aim of providing healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical.

Consult the technical file.