Montek

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

MONTEK 10-40 GBq radionuclide generator

Sodium pertechnetate ( Tc), solution
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult the nuclear medicine specialist supervising the procedure.
• If you experience any side effects, including those not listed in this leaflet, contact the nuclear medicine specialist. See section 4.

Contents of this leaflet:

1. What MONTEK is and what it is used for
2. What you need to know before the sodium pertechnetate ( Tc) solution obtained with MONTEK is administered to you
3. How the sodium pertechnetate ( Tc) solution obtained with MONTEK is used
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 medicinal product is a radiopharmaceutical for diagnostic use only.
MONTEK is a technetium-99m generator, i.e. a device used to obtain an injectable solution of sodium pertechnetate ( Tc). Once injected, this radioactive solution temporarily accumulates in certain areas of the body. The low level of radioactivity injected can be detected from outside your body using special devices that capture images. The nuclear medicine specialist will use the image (scan) of a specific organ to obtain useful information about the structure and function of that organ.
After injection, the sodium pertechnetate ( Tc) solution is used to visualise images of various parts of the body, for example:

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

The sodium pertechnetate ( Tc) solution may also be used in combination with another product to obtain a different radiopharmaceutical. In this case, please refer to the package leaflet of that product.
The nuclear medicine specialist will provide you with information about the type of examination that will be performed with this medicinal product.
The use of sodium pertechnetate ( Tc) solution involves exposure to small amounts of radioactivity. Your doctor and the nuclear medicine specialist have assessed that the clinical benefit of this examination performed with the radiopharmaceutical outweighs the risk due to radiation exposure.

2. What you should know before being administered the sodium pertechnetate ( Tc) solution obtained with MONTEK

The sodium pertechnetate ( Tc) solution obtained with MONTEK must not be used:

• If you are allergic to sodium pertechnetate ( Tc) or to any of the other ingredients of this medicinal product (listed in section 6).

Warnings and precautions
Inform the nuclear medicine specialist in the following cases:

• if you suffer from allergies, as some cases of allergic reactions have been observed following administration of the sodium pertechnetate ( Tc) solution
• if you have kidney or liver problems
• if you are pregnant or suspect you may be pregnant
• if you are breastfeeding

The nuclear medicine specialist will inform you about the need to take special precautions after using this medicinal product. If you have any doubts, consult the nuclear medicine specialist. Before administration of the sodium pertechnetate ( Tc) solution, you must:

• Drink plenty of water before undergoing the examination, so as to urinate as frequently as possible during the first few hours after the examination.
• Remain fasting for 3 or 4 hours before undergoing a Meckel's diverticulum scan, in order to keep peristalsis of the small intestine low.

Children and adolescents
Inform the nuclear medicine doctor if you are under 18 years of age.
Other medicines and the sodium pertechnetate ( Tc) solution
Inform the nuclear medicine specialist or nurse if you are taking, have recently taken, or might take any other medicine, as they could 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 anaesthesia
• to treat a slow heart rate
• or as an antidote
• Isoprenaline, a medicine used to treat a slow heart rate
• Painkillers
• Laxatives (must not be taken during this procedure, as they irritate the gastrointestinal tract)
• If you have undergone studies with contrast agents (e.g. barium) or examinations of the upper gastrointestinal tract (as these must be avoided for at least 48 hours before Meckel's diverticulum scintigraphy)
• Antithyroid medicines (e.g. carbimazole or other imidazole derivatives such as propylthiouracil), salicylates, steroids, sodium nitroprusside, sodium sulfobromophthalein, perchlorate (must not be taken for 1 week before scintigraphy)
• Phenylbutazone for treating fever, pain and inflammation in the body (must not be taken for 2 weeks before scintigraphy)
• Expectorants (must not be taken for 2 weeks before scintigraphy)
• Natural or synthetic thyroid preparations (e.g. sodium thyroxine, sodium triiodothyronine, thyroid extract) (must not be taken for 2–3 weeks before scintigraphy)
• Amiodarone, an antiarrhythmic agent (must not be taken for 4 weeks before scintigraphy)
• Benzodiazepines, used for example for sedation, as anti-anxiety or anticonvulsant agents, or as muscle relaxants, or lithium, used as a mood stabiliser in manic-depressive illness (both must not be taken for 4 weeks before scintigraphy)
• Intravenous contrast agents used for radiological examinations of the body (must not be administered for 1–2 months before scintigraphy)

Please consult the nuclear medicine specialist before taking any medicine.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, ask your nuclear medicine specialist for advice before this medicinal product is administered to you.
You must inform the nuclear medicine specialist before administration of the sodium pertechnetate ( Tc) solution if there is any possibility that you are pregnant, if you have missed your menstrual period, or if you are breastfeeding.
If in doubt, it is important to consult the nuclear medicine specialist responsible for performing the examination.
During pregnancy, the nuclear medicine specialist will administer this medicinal product only if they consider that the expected benefit outweighs the risks.
If you are breastfeeding, inform the nuclear medicine specialist, who may recommend that you interrupt breastfeeding until the radioactivity has been completely eliminated from your body.
Breastfeeding must be interrupted for at least 12 hours. Breast milk collected during this period must be discarded. Resumption of breastfeeding must be authorised by the nuclear medicine specialist responsible for performing the examination.
Driving and using machines
The sodium pertechnetate ( Tc) solution does not affect the ability to drive or use machines.
The sodium pertechnetate solution contains sodium
The sodium pertechnetate solution contains 3.54 mg/ml of sodium. Depending on the volume injected, the limit of 1 mmol (23 mg) of sodium per administered dose may be exceeded. This should be taken into consideration if you are on a low-sodium diet.

3. How the sodium pertechnetate (Tc) solution obtained with MONTEK is used

There are strict regulations regarding the use, handling, and disposal of radiopharmaceuticals. MONTEK
will be used only in designated controlled areas.
This medicine will be handled and administered exclusively by trained and qualified personnel
who are skilled in its safe use. The staff will ensure that the medicine is used safely and
will inform you about the actions taken.
The nuclear medicine specialist performing the examination will decide the amount of sodium
pertechnetate (Tc) solution to be used in your case.
The smallest amount necessary to obtain the required information will be used.
The usual recommended dose for an adult varies depending on the type of examination and ranges
between 2 and 400 MBq (megabecquerel, the unit of measurement used to express radioactivity).

Use in children and adolescents
In children and adolescents, the administered dose must be adjusted according to body weight.

**Administration of the sodium pertechnetate (Tc) solution and performance of the examination
Depending on the type of examination, the medicine may be administered by intravenous injection into a vein of the arm, or it may be instilled into your eyes in the form of eye drops.
A single administration is sufficient to perform the examination requested by your doctor.

Duration of the examination
The nuclear medicine specialist will inform you about the usual duration of the examination.
Scans may be performed at any time from the moment of injection up to 24 hours after administration, depending on the type of examination to be performed.

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

• avoid close contact with children and pregnant women during the 12 hours following the injection;
• urinate frequently to eliminate the drug from your body;
• after administration, you will be offered fluids to drink and asked to urinate immediately before undergoing the examination.

The nuclear medicine specialist will inform you of any special precautions to be followed after
taking this medicine. If you have any questions, please contact your nuclear medicine physician.

**If you have been administered more sodium pertechnetate (Tc) solution obtained with MONTEK than you should have received
An overdose is extremely unlikely, as you will receive a single dose of sodium pertechnetate (Tc) carefully controlled by the nuclear medicine specialist. However, in the event of an overdose, appropriate treatment will be provided.
In particular, the nuclear medicine specialist performing the examination might recommend that you drink plenty of fluids to help remove traces of radioactivity from your body.

If you have any further doubts about the use of this medicine, please ask the nuclear medicine specialist supervising the procedure.

4. Possible side effects

Like all medicines, this medicinal product can cause side effects, although not everyone will experience
them.
Side effects with unknown frequency (frequency cannot be estimated from the available
data):

• Allergic reactions, whose symptoms may include:
• skin rash, itching
• urticaria
• swelling in various parts of the body, for example facial swelling
• shortness of breath
• facial flushing
• coma (loss of consciousness).
• Circulatory reactions, whose symptoms may include:
• fast heartbeat, slow heartbeat
• fainting
• blurred vision
• dizziness
• headache
• flushing
• Gastrointestinal disorders, whose symptoms may include:
• malaise (vomiting)
• feeling unwell (nausea)
• diarrhoea
• Reactions at the injection site, whose symptoms may include:
• skin inflammation
• pain
• swelling
• redness

This radiopharmaceutical will emit low levels of ionising radiation, which is associated with a minimal
risk of developing tumours and hereditary abnormalities.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact the nuclear medicine specialist or nurse.
You may also report side effects directly via the national reporting system at the website https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How MONTEK is stored

This medicinal product must not be stored. It is stored under the responsibility of a specialist in appropriate premises. Storage of radiopharmaceuticals must comply with national regulations concerning radioactive products.
The following information is intended for specialists only.
This medicinal product must not be used after the expiry date stated on the container.
Do not store the generator and the eluate, the sodium pertechnetate ( Tc) solution, at temperatures above 25°C. 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.
Other ingredients 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 0.9% injectable solution
Water for injections.

Description of the Appearance of MONTEK and Package Contents
The medicine is a sodium pertechnetate ( Tc) solution obtained from a radionuclide generator.
MONTEK must be eluted, and the resulting solution may be used as such or for radiolabelling of certain specific kits for radiopharmaceutical preparation.

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

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Monrol Europe S.R.L.
Pantelimon, Str. Gradinarilor, nr.1
ILFOV
Romania
Tel: +40 21 367 48 01
Fax: +40 21 311 75 84
E-mail: [email protected]

Manufacturer
Monrol Europe S.R.L.
Pantelimon, Str. Gradinarilor, nr.1
ILFOV
Romania

This medicinal product is authorized in the Member States of the
European Economic Area (EEA) under the following names:
Austria: MONTEK
Belgium: MONROLTEC
Bulgaria: MONTEK
Denmark: MONTEK
France: MONTEK
Germany: MONTEK
Greece: MONTEK
Italy: MONTEK
Netherlands: MONTEK
Poland: MONTEK
Portugal: MONTEK
Romania: MONTEK
Spain: MONTEK
Hungary: MONTEK

The following information is intended exclusively for healthcare professionals:
The complete Product Characteristics Summary (SmPC) of MONTEK 10-40 GBq Radionuclide Generator is supplied as a separate document within the product packaging. This provides healthcare professionals with additional scientific and practical information regarding the administration and use of this radiopharmaceutical.
Refer to the SmPC.