MONTEK 10-40 GBq RADIOPHARMACEUTICAL GENERATOR

Introduction

Package Leaflet: Information for the Patient

Montek 10-40 GBq Radionuclide Generator

Sodium Pertechnetate (99mTc) Solution

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 doctor who will be supervising the procedure.
• If you experience any side effects, talk to your nuclear medicine doctor, even if they are not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What Montek is and what it is used for
2. What you need to know before you start using the Sodium Pertechnetate (99mTc) Solution obtained with Montek
3. How to use the Sodium Pertechnetate (99mTc) Solution obtained with Montek
4. Possible side effects
5. Storage of 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, i.e., a device used to obtain an injectable Sodium Pertechnetate (99mTc) Solution. When this radioactive solution is injected, it accumulates temporarily 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 doctor 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, consult the corresponding package leaflet.

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

The use of the Sodium Pertechnetate (99mTc) Solution involves exposure to small amounts of radioactivity. Your doctor and the nuclear medicine doctor have considered that the clinical benefit you will obtain from the procedure with the radiopharmaceutical outweighs the risk due to radiation.

2. What you need to know before you start 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 components of this medicine (listed in section 6).

Warnings and precautions

Tell your nuclear medicine doctor in the following cases:

• if you suffer from allergies, as some cases of allergic reactions have been observed after administration of the Sodium Pertechnetate (99mTc) Solution
• if you suffer from kidney disease
• if you are pregnant or think you may be pregnant
• if you are breastfeeding.

Your nuclear medicine doctor will inform you if you need to take any special precautions after using this medicine. Consult your nuclear medicine doctor 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 scintigraphy to keep the small intestine peristalsis low.

Children and adolescents

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

Other medicines and the Sodium Pertechnetate (99mTc) Solution

Tell your nuclear medicine doctor 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, 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 medicine to treat reduced heart rate
• analgesics

• laxatives(should not be taken during this procedure, as they irritate the gastrointestinal tract)
• if you have contrast studies(e.g., with barium contrast agent) or upper gastrointestinal examinations (which should be avoided in the 48 hours prior to Meckel's diverticulum scintigraphy)

• antithyroid medicines(e.g., carbimazole or other imidazole derivatives such as propylthiouracil), salicylates, steroids, sodium nitroprusside, sodium sulfobromophthalein, perchlorate(which should not be taken during 1 week before scintigraphy)
• phenylbutazoneto treat fever, pain, and inflammation in the body (which should not be taken during 2 weeks before scintigraphy)
• expectorants(which should not be taken during 2 weeks before scintigraphy)
• natural or synthetic thyroid preparations(e.g., sodium thyroxine, sodium liotironine, or thyroid extract) (which should not be taken during 2-3 weeks before scintigraphy)
• amiodaronean antiarrhythmic agent (which should not be taken during 4 weeks before scintigraphy)
• benzodiazepinesused for example for sedation, or as anxiolytics or anticonvulsants or as muscle relaxants or lithiumused as a mood stabilizer in manic-depressive illness (which should not be taken during 4 weeks before scintigraphy)
• intravenous contrast agentsfor radiological examinations of the body (which should not have been administered during 1-2 months before scintigraphy)

Please consult your nuclear medicine doctor before taking any medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your nuclear medicine doctor before you are given this medicine.

You must inform the nuclear medicine doctor before administration of the Sodium Pertechnetate (99mTc) Solution if there is any possibility that you may be pregnant, if you have a delayed period, or if you are breastfeeding. In case of doubt, it is important that you consult your nuclear medicine doctor who will be supervising the procedure.

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

If you are breastfeeding, inform the nuclear medicine doctor, who will advise you to stop breastfeeding until all radioactivity has been eliminated from your body. This will take approximately 12 hours. The expressed milk must be discarded. The resumption of breastfeeding should be agreed upon with the nuclear medicine specialist who will be supervising the procedure.

Driving and using machines

The Sodium Pertechnetate (99mTc) Solution does not affect 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 injected volume, 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 Pertechnetate (99mTc) Solution obtained with Montek

There are strict rules for 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 to use it safely. These personnel will take special care in the safe use of this product and will keep you informed of their actions.

The nuclear medicine doctor supervising the procedure will decide the amount of Sodium Pertechnetate (99mTc) Solution to be used in your case. This will be the minimum amount necessary to obtain the desired information.

The generally recommended amount for administration to 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

In children and adolescents, the amount to 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 objective of the examination, the medicine 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 to perform the test that your doctor needs.

Duration of the procedure

Your nuclear medicine 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 must:

• 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 doctor will inform you if you need to take any special precautions after being given this medicine. Consult your nuclear medicine doctor if you have any doubts.

If you have been given more Sodium Pertechnetate (99mTc) Solution obtained with Montek than you should

It is almost impossible to overdose because you will receive a single, precisely controlled dose of Sodium Pertechnetate (99mTc) Solution from the nuclear medicine doctor supervising the procedure. However, in case of overdose, you will receive the appropriate treatment. In particular, the nuclear medicine doctor in charge of the procedure may recommend that you drink large amounts of liquids to eliminate the remains of radioactivity from your body.

If you have any further questions about the use of this product, ask your nuclear medicine doctor who is 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 (cannot be estimated from the available data):

• allergic reactions, with symptoms such as:

• skin rash, itching
• hives
• swelling in different places, e.g., in the face
• difficulty breathing
• redness of the skin
• coma

• circulatory reactions, with symptoms such as

• fast heart rate, slow heart rate
• fainting
• blurred vision
• dizziness
• headache
• flushing

• gastrointestinal disorders, 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

Administration of this radiopharmaceutical involves receiving a small amount of ionizing radiation with a very low risk of developing cancer and genetic 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 Montek

You do not need to store this medicine. This medicine is stored under the responsibility of the specialist in suitable facilities. The storage of radiopharmaceuticals will be carried out in accordance with national regulations on radioactive materials.

The following information is intended only for the specialist.

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

Keep the generator and the eluate, Sodium Pertechnetate (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 Sodium Pertechnetate (99mTc) Solution.

The other components are:

Aluminum oxide

Molybdenum trioxide

Sodium hydroxide

Hydrogen peroxide 30%

Sodium hydroxide 1M (for pH adjustment)

Hydrochloric acid 4M (for pH adjustment)

Hydrochloric acid 1M (for pH adjustment)

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

Water for injectable preparations

Appearance of Montek and contents of the pack

The product is a Sodium Pertechnetate (99mTc) Solution obtained using a radionuclide generator.

Montek 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.

Package size:

The product contains a generator with radioactive content, 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 antisepsis pads.

Marketing Authorization Holder and Manufacturer

Monrol Europe S.R.L

Str. Gradinarilor, nr.1

077415 Jud. Bucharest

Romania

Tel: +40 21 367 48 01

Fax: +40 21 311 75 84

E-mail: [email protected]

This medicine is authorized in the Member States of the European Economic Area 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 last revision of this leaflet: August 2021

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 data sheet for 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 data sheet.