Montek 10-40 GBq radionuclide generator

Patient Information Leaflet

Introduction

Package leaflet: Information for the patient

Montek 10-40 GBq radionuclide generator

Sodium [99mTc] pertechnetate solution

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your nuclear medicine physician who will supervise the procedure.
• If you experience any adverse reactions, consult your nuclear medicine physician, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of this leaflet

1. What Montek is and what it is used for
2. What you need to know before using the sodium [99mTc] pertechnetate solution obtained with Montek
3. How to use the sodium [99mTc] pertechnetate solution obtained with Montek
4. Possible side effects
5. How to store Montek
6. Contents of the pack and other information

1. What Montek is and what it is used for

This medicine is a radiopharmaceutical for diagnostic use only.

This medicine is a technetium (99mTc) 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 using special cameras. The nuclear medicine physician will take an image (scan) of the relevant organ, providing useful information about the organ's structure and function.

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

• thyroid gland
• salivary glands
• ectopic gastric tissue (Meckel's diverticulum)
• tear ducts of the eyes

The sodium pertechnetate (99mTc) solution can also be used in combination with another product to prepare a different radiopharmaceutical. In such cases, refer to the corresponding package leaflet.

The nuclear medicine physician will explain to you what type of examination will be performed with this product.

The use of sodium pertechnetate (99mTc) solution involves exposure to small amounts of radiation. Your doctor and the nuclear medicine physician have determined that the clinical benefit you will receive from the radiopharmaceutical procedure outweighs the risk associated with radiation exposure.

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

The sodium pertechnetate (99mTc) solution obtained with Montek must not be used:

• if you are allergic to sodium pertechnetate (99mTc) or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Inform your nuclear medicine physician in the following cases:

• if you suffer from allergies, as some cases of allergic reactions have been observed after administration of sodium pertechnetate (99mTc) solution
• if you suffer from kidney disease
• if you are pregnant or think you might be pregnant
• if you are breastfeeding.

Your nuclear medicine physician will inform you whether you need to take any special precautions after using this medicine. Please consult your nuclear medicine physician if you have any questions.

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

• drink plenty of water before starting 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 scan to minimize peristalsis in the small intestine.

Children and adolescents

Please consult your nuclear medicine physician if you or your child are under 18 years of age.

Other medicines and the sodium pertechnetate (99mTc) solution

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

• atropine, used for example:

  • to reduce spasms of the stomach, intestine, or gallbladder
  • to reduce pancreatic secretions
  • in ophthalmology
  • before administering anesthesia
  • to treat slow heart rate or
  • as an antidote

• isoprenaline, a medicine used to treat slow heart rate

• analgesics

• laxatives (should not be taken during this procedure, as they irritate the gastrointestinal tract)

• if you have undergone contrast studies (e.g., with the contrast agent barium) or upper gastrointestinal examinations (which must be avoided within 48 hours prior to the Meckel's diverticulum scan)

• antithyroid drugs (e.g., carbimazole or other imidazole derivatives such as propylthiouracil), salicylates, steroids, sodium nitroprusside, sodium sulfobromophthalein, perchlorate (should not be taken during the week before the scan)

• phenylbutazone for treating fever, pain, and inflammation in the body (should not be taken during the 2 weeks before the scan)

• expectorants (should not be taken during the 2 weeks before the scan)

• natural or synthetic thyroid preparations (e.g., sodium thyroxine, sodium triiodothyronine, or thyroid extract) (should not be taken during the 2–3 weeks before the scan)

• amiodarone, an antiarrhythmic agent (should not be taken during the 4 weeks before the scan)

• benzodiazepines, used for example for sedation, as anxiolytics or anticonvulsants, or as muscle relaxants, or lithium, used as a mood stabilizer in manic-depressive illness (both should not be taken during the 4 weeks before the scan)

• intravenous contrast agents for radiological examinations of the body (should not have been administered within 1–2 months before the scan)

Please consult your nuclear medicine physician before taking any medication.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your nuclear medicine physician before being administered this medicine.

You must inform the nuclear medicine physician before administration of the sodium pertechnetate (99mTc) solution if there is any possibility you might be pregnant, if you have a delayed menstrual period, or if you are breastfeeding. In case of doubt, it is important to consult your nuclear medicine physician who will supervise the procedure.

If you are pregnant, the nuclear medicine physician will only administer this medicine during pregnancy if the expected benefit outweighs the risks.

If you are breastfeeding, inform the nuclear medicine physician, who will advise you to interrupt breastfeeding until all radioactivity has been eliminated from your body. This will take approximately 12 hours. Breast milk expressed during this time must be discarded. Resumption of breastfeeding should be agreed upon with the nuclear medicine specialist supervising the procedure.

Driving and use of machines

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

The sodium pertechnetate (99mTc) solution contains sodium

The sodium pertechnetate (99mTc) solution contains 3.54 mg/ml of sodium. Depending on the volume injected, the limit of 23 mg (1 mmol) of sodium per administered dose may be exceeded. This should be taken into account if you are on a low-salt diet.

3. How to use the sodium pertecnetate (99mTc) solution obtained with Montek

There are strict regulations regarding the use, handling, and disposal of radiopharmaceuticals. This medicine will only be used in special controlled areas. This product will only be handled and administered by trained and qualified personnel who are skilled in its safe use. These individuals will take special care in the safe use of this product and will keep you informed of their actions.

The nuclear medicine physician supervising the procedure will determine the amount of sodium pertecnetate (99mTc) solution to be used in your case. This will be the minimum quantity necessary to obtain the required diagnostic information.

The generally recommended dose for administration in adults varies depending on the test to be performed and ranges between 2 and 400 MBq (megabecquerel, the unit used to express radioactivity).

Use in children and adolescents

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

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

Depending on the purpose of the examination, the medication will be administered either by intravenous injection into a vein of the arm or instilled into the eyes as eye drops.

A single administration is sufficient to perform the test required by your physician.

Duration of the procedure

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

Scintigraphic imaging 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 pertecnetate (99mTc) solution you should:

• avoid direct contact with children and pregnant women during the 12 hours following injection
• urinate frequently to eliminate the product from your body
• after administration, you will be offered a drink and asked to urinate immediately before the test.

The nuclear medicine physician will inform you if you need to take special precautions after receiving this medicine. Consult your nuclear medicine physician if you have any questions.

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

An overdose is highly unlikely, as you will receive a single dose of sodium pertecnetate (99mTc) solution precisely controlled by the nuclear medicine physician supervising the procedure. However, in the event of an overdose, appropriate treatment will be provided. In particular, the physician in charge of the procedure may recommend that you drink large amounts of fluids to help eliminate residual radioactivity from your body.

If you have any further questions about the use of this product, ask your nuclear medicine physician supervising the procedure.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody will experience them.

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

• allergic reactions, with symptoms such as:

• skin rash, itching

• urticaria

• swelling in various areas, e.g., in the face

• breathing difficulty

• skin redness

• coma

• circulatory reactions, with symptoms such as:

• fast heartbeat, slow heartbeat

• fainting

• blurred vision

• dizziness

• headache

• hot flushes

• gastrointestinal disorders, with symptoms such as:

• being sick (vomiting)

• feeling unwell (nausea)

• diarrhoea

• reactions at the injection site, with symptoms such as:

• skin inflammation

• pain

• swelling

• redness

Administration of this radiopharmaceutical involves exposure to a small amount of ionizing radiation, with a very low risk of developing cancer and hereditary defects.

Reporting of 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 leaflet. You may also report them directly via the Spanish System of Pharmacovigilance of Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Montek

You do not have to store this medicine. This medicine is stored under the responsibility of a specialist in appropriate facilities. Storage of radiopharmaceuticals must comply with national regulations concerning radioactive materials.

The following information is intended for specialists only.

Do not use this medicine after the expiry date stated on the label.

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

After elution, use within 8 hours.

6. Contents of the pack and other information

Composition of Montek 10-40 GBq radionuclide generator:

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

The other components are:

Aluminum oxide
Molybdenum trioxide
Sodium hydroxide
Hydrogen peroxide 30%
Sodium hydroxide 1 M (for pH adjustment)
Hydrochloric acid 4 M (for pH adjustment)
Hydrochloric acid 1 M (for pH adjustment)
Sodium chloride 9 mg/ml (0.9%) injectable solution
Water for injections

Appearance of Montek and contents of the pack

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

Montek must be eluted, and the resulting solution may be used directly or for radiolabeling specific reagent kits for the preparation of radiopharmaceuticals.

Pack size:

The product contains one generator with radioactive content, 10 vacuum vials, 5 vials containing 5 ml of sodium chloride 9 mg/ml (0.9%) injectable solution or 5 vials containing 10 ml of sodium chloride 9 mg/ml (0.9%) injectable solution, and 10 antiseptic swabs.

Marketing Authorization Holder and Manufacturer

Curium Romania SRL
Str. Gradinarilor, nr.1
077415 Jud. Bucharest
Romania

This medicinal product is authorized in the European Economic Area member states under 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

Date of the most recent review of this summary: September 2025

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

This information is intended for healthcare professionals only:

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

Refer to the summary of product characteristics.