MONTEK

Package leaflet: Information for the patient

MONTEK, 10-40 GBq, radionuclide generator
Sodium pertechnetate ( Tc), solution
Please read carefully the entire leaflet before the administration of the medicinal product, as it contains
important information for the patient.

• Keep this leaflet to be able to read it again if necessary.
• If you have any questions, please consult the nuclear medicine physician supervising the procedure.
• If you experience any adverse reactions, including any not listed in this leaflet, inform the nuclear medicine physician immediately. See section 4.

Table of contents

1. What MONTEK is and what it is used for
2. Important information before administration of sodium pertechnetate ( Tc) solution obtained from the MONTEK generator
3. How to use the sodium pertechnetate ( Tc) solution obtained from the MONTEK generator
4. Possible side effects
5. How to store MONTEK
6. Contents of the package and other information

1. What MONTEK is and what it is used for

This medicinal product is a radiopharmaceutical used exclusively for diagnostic purposes.
MONTEK is a technetium ( Tc) generator, meaning it is a device used to obtain a solution for injection, sodium pertechnetate ( Tc). When this radioactive solution is injected into the body, it temporarily accumulates in specific parts of the body. Small amounts of the administered radioactivity can be detected externally using special equipment. The nuclear medicine physician performs the examination by acquiring an image (scan) of a particular organ, and the resulting image shows both the structure and functional status of that organ.
After injection, the sodium pertechnetate ( Tc) solution is used to obtain images of various parts of the body, such as:

• thyroid gland,
• salivary glands,
• presence of ectopic gastric tissue (Meckel's diverticulum),
• lacrimal ducts of the eyes.

The sodium pertechnetate ( Tc) solution may also be used in combination with another medicinal product to prepare a radiopharmaceutical. In such a case, please refer to the leaflet of that medicinal product.

The nuclear medicine physician will inform the patient about the type of examination to be performed using this medicinal product.
Administration of sodium pertechnetate ( Tc) solution involves exposure to a small radiation dose. The patient's attending physician and the nuclear medicine physician have determined that the clinical benefit the patient will gain from undergoing the radiopharmaceutical examination outweighs the risks associated with radiation exposure.

2. Information before using sodium pertechnetate (Tc) solution

(obtained from the MONTEK generator)

When not to use sodium pertechnetate (Tc) solution (obtained from the MONTEK generator)

• if the patient is allergic to sodium pertechnetate (Tc) or to any of the other components of this medicine (listed in section 6).

Warnings and precautions
Please inform the nuclear medicine physician in the following cases:

• if the patient has allergies, as allergic reactions have been rarely observed after administration of sodium pertechnetate (Tc);
• if the patient has kidney disease;
• if the patient is pregnant or suspects she might be pregnant;
• if the patient is breastfeeding.

The nuclear medicine physician will inform the patient if special precautions are required when using this product. If you have any questions, please consult your nuclear medicine physician.
Before administration of sodium pertechnetate (Tc) solution, the patient should:

• drink plenty of water before starting the examination, in order to void as much urine as possible during the first hours after the examination;
• fast for 3–4 hours before the Meckel's diverticulum scintigraphy examination, to ensure as slow as possible intestinal motility.

Children and adolescents
Please inform the nuclear medicine physician if the patient is under 18 years of age.
Sodium pertechnetate (Tc) solution and other medicines
Please inform the nuclear medicine physician about all medicines currently taken or recently taken by the patient, as they may affect the result and interpretation of the examination. This particularly includes the following medicines:

• atropine, used for example:
  • to reduce stomach, intestinal or gallbladder spasms,
  • to reduce pancreatic secretory function,
  • in ophthalmology,
  • before administration of anaesthesia,
  • to treat bradycardia (slow heart rate), or
  • as an antidote.
• isoprenaline, a drug stimulating cardiac activity;
• analgesics;
• laxatives (should not be used during this procedure, as they irritate the gastrointestinal tract);
• if the patient has undergone X-ray with contrast medium (e.g. using barium as contrast agent) or upper gastrointestinal tract examination (scintigraphy of Meckel's diverticulum should be avoided within 48 hours);
• antithyroid drugs (e.g. carbimazole or other imidazole derivatives such as propylthiouracil), salicylates, steroids, sodium nitroprusside, sodium sulfobromophthalein, perchlorates (should not be taken within 1 week before scintigraphy);
• phenylbutazone, used in the treatment of pain, fever and inflammatory conditions in the body (should not be taken within 2 weeks before scintigraphy);
• expectorants (should not be taken within 2 weeks before scintigraphy);
• preparations containing natural or synthetic thyroid hormones (e.g. sodium thyroxine, sodium liothyronine, thyroid extract) (should not be taken within 2–3 weeks before scintigraphy);
• amiodarone, a drug belonging to the antiarrhythmic class (should not be taken within 4 weeks before scintigraphy);
• benzodiazepines, used e.g. as sedatives, antidepressants, anticonvulsants, muscle relaxants, or lithium, used as a mood stabilizer in bipolar disorder (should not be taken within 4 weeks before scintigraphy);
• intravenous contrast agents (should not be administered within 1–2 months before scintigraphy).

Before using any medicine, please consult the nuclear medicine physician supervising the examination.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to have a child, she should consult her nuclear medicine physician before using this medicine.
Before administration of sodium pertechnetate (Tc) solution, the patient must inform the physician about suspected pregnancy, if menstruation has not occurred at the expected time, or about breastfeeding. In case of doubt, consultation with the nuclear medicine physician supervising the examination is required.
The nuclear medicine physician will administer this medicine to a pregnant patient only if absolutely necessary, when benefits clearly outweigh the risks.
If the patient is breastfeeding, she must inform the nuclear medicine physician, who will advise to interrupt breastfeeding until radioactivity has been eliminated from the body. Breastfeeding must be interrupted for 12 hours after injection. Breast milk expressed during this period should be discarded. Resumption of breastfeeding should be discussed with the nuclear medicine specialist supervising the examination.
Driving and operating machinery
Sodium pertechnetate (Tc) solution does not affect the ability to drive or operate machinery.
Sodium content of sodium pertechnetate (Tc) solution
Sodium pertechnetate (Tc) solution contains 3.45 mg/ml of sodium. Depending on the injected volume, the threshold value of 1 mmol (23 mg) of sodium per dose may be exceeded. This should be taken into account if the patient is on a low-sodium diet.

3. How to use sodium pertechnetate (Tc) solution obtained from the MONTEK generator

There are strict legal regulations regarding the use, transfer, and disposal of radiopharmaceuticals. MONTEK is used exclusively in special, controlled areas. Only trained and qualified personnel may handle this product and administer it to patients. These individuals take special precautionary measures to ensure the safe use of the drug and continuously report on their actions. The nuclear medicine physician supervising the procedure determines the dose of sodium pertechnetate (Tc) solution to be administered to each individual patient. This will be the minimum dose necessary to obtain the required diagnostic information. The recommended dose for adults varies depending on the type of examination and ranges between 2–400 MBq (megabecquerel, a unit of radioactivity measurement).

Use in children and adolescents
The dose intended for use in children and adolescents is calculated based on the child's body weight.

Route of administration of sodium pertechnetate (Tc) solution and method of use
Depending on the type of examination, the medication will be administered intravenously (into a vein in the arm) or instilled into the eye as eye drops. A single administration is sufficient to perform the examination required by the physician.

Duration of the examination
The nuclear medicine physician will inform the patient about the typical duration of the examination. Examinations may be performed at any time, provided that no more than 24 hours have passed since injection, depending on the type of examination.

After administration of sodium pertechnetate (Tc) solution, the patient should:

• avoid close contact with young children and pregnant women for 12 hours after injection;
• urinate frequently to eliminate the drug from the body;
• drink large amounts of water after receiving the medication and be asked to empty the bladder immediately before the examination.

The nuclear medicine physician will inform the patient if any special precautionary measures are necessary after administration of this medication. In case of questions, please consult the nuclear medicine physician.

Administration of a higher than recommended dose of sodium pertechnetate (Tc) solution obtained from the MONTEK generator
Overdose is nearly impossible, as the patient will receive a single dose of sodium pertechnetate (Tc) solution strictly controlled by the nuclear medicine physician supervising the examination. However, in the event of an overdose, appropriate treatment will be administered. The nuclear medicine physician may particularly recommend drinking large amounts of fluids to remove residual radiopharmaceutical from the body.

If there are any doubts regarding the use of the medication, please consult the nuclear medicine physician supervising the examination.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Adverse reactions of unknown frequency (cannot be estimated from the available data):

• allergic reactions with symptoms such as:
• rash, itching;
• urticaria;
• swelling in various parts of the body, e.g. face;
• shortness of breath;
• skin redness;
• coma.
• circulatory reactions with symptoms such as:
• fast heartbeat, slow heartbeat;
• fainting;
• blurred vision;
• dizziness;
• headache;
• flushing.
• gastrointestinal disorders with symptoms such as:
• vomiting;
• nausea;
• diarrhoea.
• reactions at the injection site with symptoms such as:
• skin inflammation;
• pain;
• swelling;
• redness.

Administration of a radiopharmaceutical results in exposure to a small dose of ionizing radiation, which is associated with the risk of developing neoplastic diseases and congenital abnormalities.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181 C, 02-222 Warsaw
Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store MONTEK

The patient will not need to store this medicine. This medicine is stored exclusively by
medical personnel in appropriate facilities. Radioactive pharmaceuticals are stored
in compliance with local regulations concerning radioactive substances.
The following information is intended solely for medical personnel.
Do not use the medicine after the expiry date stated on the packaging.
Store the generator and the eluate, sodium pertechnetate (Tc) solution, below 25°C,
in the original packaging. Do not freeze.
Must be used within 8 hours after elution.

6. Contents of the pack and other information

What MONTEK, 10-40 GBq, radionuclide generator contains
The active substance is sodium pertechnetate (Tc) solution.
The excipients are:
Aluminium 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%), solution for injection
Water for injections

What MONTEK looks like and contents of the pack
The product is a sodium pertechnetate (Tc) solution obtained from a radionuclide generator.
MONTEK must be eluted. The resulting solution may be used directly or may be used to label special kits intended for the preparation of radiopharmaceuticals.

Pack sizes
The product contains one radioactive substance generator, 10 vacuum vials, 5 vials with 5 ml of sodium chloride 9 mg/ml (0.9%) solution for injection or 5 vials with 10 ml of sodium chloride 9 mg/ml (0.9%) solution for injection, and 10 sterile swabs.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Curium Romania SRL
Gradinalrilor Street, No. 1
077145 Pantelimon,
ILFOV
Romania

Manufacturer
Curium Romania SRL
Gradinalrilor Street, No. 1
077145 Pantelimon,
ILFOV
Romania

This medicinal product is authorised in the European Economic Area countries under the following names:
Denmark: MONTEK
Germany: MONTEK
Romania: MONTEK
Bulgaria: MONTEK
Greece: MONTEK
Poland: MONTEK
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Information intended exclusively for medical professionals:

The full Product Information for MONTEK 10-40 GBq, radionuclide generator,
is included in the product packaging to provide additional scientific and practical information
on the administration and use of this radiopharmaceutical.
See Product Information.