Montek

Leaflet accompanying the packaging: patient information

MONTEK, 10-40, GBq, radionuclide generator

Sodium pertechnetate (Tc), solution

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a nuclear medicine doctor supervising the procedure.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, inform the nuclear medicine doctor. See section 4.

Table of contents of the leaflet

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

1. What is MONTEK and what is it used for

This medicine is a radiopharmaceutical product used exclusively for diagnostic purposes.
MONTEK is a technetium (Tc) generator, which means it is a device used to obtain a solution for injection of sodium pertechnetate (Tc). When the radioactive solution is injected into the body, it temporarily accumulates in certain parts of the body. Small amounts of the injected radioactivity can be detected outside the body using special equipment.
The nuclear medicine doctor performs the examination by taking an image (scan) of a given organ, and the resulting image shows the structure and functioning 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 gastric tissue in an abnormal location (Meckel's diverticulum),
• tear ducts of the eye. The sodium pertechnetate (Tc) solution may be used in combination with another medicine to prepare a radiopharmaceutical. In this case, read the leaflet of that medicine.

The nuclear medicine doctor will inform the patient what type of examination will be performed using this medicinal product.
Using the sodium pertechnetate (Tc) solution involves exposure to a small dose of radiation. The patient's doctor and the nuclear medicine doctor have determined that the clinical benefits that the patient will gain from the examination using the radiopharmaceutical outweigh the risks associated with radiation.

2. Important 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 any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Inform the nuclear medicine doctor in the following cases:

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

The nuclear medicine doctor will inform the patient if special precautions are required when using this product. In case of questions, consult the nuclear medicine doctor.
Before administering the sodium pertechnetate (Tc) solution, the patient should:

• drink plenty of water before the examination, so that as much urine as possible can be excreted in the first hours after the examination;
• fast for 3-4 hours before the scintigraphic examination of Meckel's diverticulum, so that the intestines work as slowly as possible.

Children and adolescents

Inform the nuclear medicine doctor if the patient is under 18 years old.

Sodium pertechnetate (Tc) solution and other medicines

Tell the nuclear medicine doctor about all medicines the patient is currently taking or has recently taken, as they may affect the result and interpretation of the examination. This applies in particular to the following medicines:

• atropine,used for example:
• to reduce stomach, intestine or gallbladder spasms,
• to reduce the secretory function of the pancreas,
• in ophthalmology,
• before anesthesia,
• to treat slow heart rate or
• as an antidote.
• isoprenaline,a heart-stimulating medicine;
• analgesics;
• laxatives(should not be used during this procedure, as they irritate the digestive tract);
• if the patient has undergone X-ray examination with contrast(e.g. using barium as a contrast agent) or examination of the upper gastrointestinal tract (should avoid scintigraphy of Meckel's diverticulum within 48 hours);
• antithyroid medicines(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 scintigraphic examination);
• phenylbutazoneused to treat pain, fever and inflammation in the body (should not be taken within 2 weeks before scintigraphic examination);
• expectorants(should not be taken for 2 weeks before scintigraphic examination);
• preparations containing natural or synthetic thyroid hormones(e.g. sodium thyroxine, sodium liotyronine, thyroid extract) (should not be taken for 2-3 weeks before scintigraphic examination);
• amiodarone, a medicine from the group of antiarrhythmic medicines (should not be taken within 4 weeks before scintigraphic examination);
• benzodiazepinesused, for example, as sedatives, antidepressants, anticonvulsants, muscle relaxants or mood stabilizers in manic-depressive illness (should not be taken within 4 weeks before scintigraphic examination);
• intravenous contrast agents(should not be administered within 1-2 months before scintigraphic examination).

Before using any medicine, consult the nuclear medicine doctor who will supervise the examination.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects she may be pregnant or plans to have a child, she should consult the nuclear medicine doctor before using this medicine.
Before administering the sodium pertechnetate (Tc) solution, inform the doctor about suspected pregnancy, in case of missed menstruation, or breastfeeding. In case of doubts, consult the nuclear medicine doctor who will supervise the examination.
The nuclear medicine doctor will administer this medicine to a pregnant patient only if absolutely necessary, when the benefits will significantly outweigh the risk.
If the patient is breastfeeding, she should inform the nuclear medicine doctor, who will ask her to interrupt breastfeeding until the radioactivity has been eliminated from the body. Breastfeeding should be interrupted for 12 hours after injection. The breast milk expressed during this time should be discarded. The possibility of returning to breastfeeding should be agreed with the specialist nuclear medicine doctor supervising the examination.

Driving and operating machinery

The sodium pertechnetate (Tc) solution does not affect the ability to drive and operate machinery.

The sodium pertechnetate (Tc) solution contains sodium

The sodium pertechnetate (Tc) solution contains 3.45 mg/ml of sodium. Depending on the injected volume, the maximum allowed 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 and administer this product to patients. These persons take special precautions to ensure safe use of the medicine and will keep the patient informed about their actions.
The nuclear medicine doctor supervising the examination decides on the dose of sodium pertechnetate (Tc) solution used in individual patients.
This will be the minimum dose necessary to obtain the expected diagnostic information.
The recommended dose for adults depends on the type of examination and ranges from 2 to 400 MBq (megabecquerel, a unit of measurement of radioactivity).

Use in children and adolescents

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

Route of administration of sodium pertechnetate (Tc) solution and procedure

Depending on the type of examination, the medicine will be administered to the patient 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 doctor.

Duration of the examination

The nuclear medicine doctor will inform the patient about the typical duration of the examination.
Examinations can 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 small children and pregnant women for 12 hours after injection;
• frequently urinate to eliminate the medicine from the body;
• after administration of the medicine, the patient will be asked to drink a large amount of water and urinate directly before the examination.

The nuclear medicine doctor will inform the patient if special precautions are required after administration of this medicine. In case of questions, consult the nuclear medicine doctor.

Use of a higher than recommended dose of sodium pertechnetate (Tc) solution obtained from the MONTEK generator

Overdose is almost impossible, as the patient will receive a single dose of sodium pertechnetate (Tc) solution strictly controlled by the nuclear medicine doctor supervising the examination.
However, in case of overdose, appropriate treatment will be used. The nuclear medicine doctor may recommend drinking large amounts of fluids to eliminate the radiopharmaceutical from the body.
In case of doubts related to the use of the medicine, consult the nuclear medicine doctor supervising the examination.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects with unknown frequency (cannot be estimated from the available data):

• allergic reactions with symptoms such as:
• rash, itching;
• hives;
• swelling in various places, e.g. face;
• shortness of breath;
• redness of the skin;
• coma.
• cardiovascular reactions, with symptoms such as:
• rapid heart rate, slow heart rate;
• fainting;
• blurred vision;
• dizziness;
• headache;
• redness.
• gastrointestinal disorders, with symptoms such as:
• vomiting;
• nausea;
• diarrhea.
• reactions at the injection site, with symptoms such as:
• skin inflammation;
• pain;
• swelling;
• redness.

Administration of the radiopharmaceutical results in exposure to a small dose of ionizing radiation, which is associated with the risk of cancer and congenital anomalies.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181 C, 02-222 Warsaw
Phone: +48 22 49 21 301, Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this 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. Storage of radiopharmaceuticals is carried out in accordance with local regulations regarding radioactive substances.
The following information is intended only for medical personnel.
Do not use the medicine after the expiry date stated on the packaging.
Store the generator and eluate, sodium pertechnetate (Tc) solution, at a temperature below 25°C, in the original packaging. Do not freeze.
Use within 8 hours after elution.

6. Package contents and other information

What MONTEK, 10-40 GBq, radionuclide generator contains

The active substance is sodium pertechnetate (Tc) solution.
The excipients are:
Aluminum oxide
Molybdenum trioxide
Sodium hydroxide
Hydrogen peroxide 30%
Sodium hydroxide 1 M (to adjust pH)
Hydrochloric acid 4 M (to adjust pH)
Hydrochloric acid 1 M (to adjust pH)
Sodium chloride 9 mg/ml (0.9%), solution for injection.
Water for injection

What MONTEK looks like and what the package contains

The product is a sodium pertechnetate (Tc) solution obtained from a radionuclide generator.
MONTEK should be eluted. The resulting solution can be used directly or can be used to label special kits intended for the preparation of radiopharmaceuticals.
Package sizes
The product contains a 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, 10 sterile swabs.

Marketing authorization holder and manufacturer

Marketing authorization holder

Monrol Europe S. R. L.
ul. Gradinalrilor, nr. 1
077145 Pantelimon,
ILFOV
Romania
+40 21 367 48 01
fax +40 21 311 75 84
e-mail: [email protected]

Manufacturer

Monrol Europe S. R. L.
ul. Gradinalrilor, nr. 1.
077145 Pantelimon,
ILFOV
Romania

This medicinal product 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
Poland:
MONTEK

Date of last revision of the leaflet:

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Information intended exclusively for healthcare professionals:

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