Ultra-TechneKow FM 2.15-43.00 GBq radionuclide generator

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET

Ultra-TechneKow FM 2.15–43.00 GBq radionuclide generator

Sodium pertecnetate (99mTc) solution

Read all of this leaflet carefully before you are given this medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your nuclear medicine physician who supervises the procedure.
• If you get any side effects, talk to your nuclear medicine physician, even if it is a side effect not listed in this leaflet. See section 4.

Contents of this leaflet:

1. What Ultra-TechneKow FM is and what it is used for

2. What you need to know before using the sodium pertecnetate (99mTc) solution obtained with Ultra-TechneKow FM

3. How to use the sodium pertecnetate (99mTc) solution obtained with Ultra-TechneKow FM

4. Possible side effects

5. How to store Ultra-TechneKow FM

6. Contents of the pack and other information

1. What Ultra-TechneKow FM is and what it is used for

This medicine is a radiopharmaceutical for diagnostic use only.

Ultra-TechneKow FM is a technetium (99mTc) generator, which means it 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 administered can be detected outside the body using special cameras. The nuclear medicine physician will take an image (scan) of the relevant organ, providing valuable information about its 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 may also be used in combination with another product to prepare a different radiopharmaceutical medicine. In such cases, please refer to the corresponding product leaflet.

The nuclear medicine physician will explain to you which type of scan will be performed using this product.

Administration of the sodium pertechnetate (99mTc) solution involves receiving a small amount of radioactivity. Your doctor and the nuclear medicine physician have determined that the clinical benefit you will obtain from the radiopharmaceutical procedure outweighs the radiation risk.

2. What you need to know before using sodium pertechnetate (99mTc) solution obtained with Ultra-Technekow FM

Sodium pertechnetate (99mTc) solution obtained with Ultra-Technekow FM 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

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)
• 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 special precautions after using this medicine. Consult your nuclear medicine physician if you have any questions.

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

• drink plenty of water before starting the procedure to urinate frequently during the first hours after completion.
• fast for 3 to 4 hours before the Meckel's diverticulum scan to keep small bowel peristalsis low.

Children and adolescents

Inform your nuclear medicine physician if you are under 18 years of age.

Use of sodium pertechnetate (99mTc) solution with other medicines:

Inform your nuclear medicine physician if you are taking, have recently taken, or might need to take any other medicines, as some medicines may interfere with image interpretation:

• atropine, used for example:
  • to reduce spasms of the stomach, intestines, or gallbladder
  • to reduce pancreatic secretions
  • in ophthalmology
  • before administration of 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 had contrast imaging (e.g. with barium as contrast agent) or upper gastrointestinal examination (as these should be avoided within 48 hours before the Meckel's diverticulum scan)
• antithyroid medications (e.g. carbimazole or other imidazole derivatives such as propylthiouracil)
• salicylates, steroids, sodium nitroprusside, sodium sulfobromophthalein, perchlorate (should not be taken within 1 week before the scan)
• phenylbutazone for treating fever, pain, and inflammation in the body (should not be taken within 2 weeks before the scan)
• expectorants (should not be taken within 2 weeks before the scan)
• natural or synthetic thyroid preparations (e.g. sodium thyroxine, sodium liotironine, thyroid extract) (should not be taken within 2–3 weeks before the scan)
• amiodarone, an antiarrhythmic agent (should not be taken within 4 weeks before the scan)
• benzodiazepines, used for example for sedation, as anxiolytics, anticonvulsants, or as muscle relaxants, or lithium, used as a mood stabilizer in manic-depressive illness (both should not be taken within 4 weeks before the scan)
• intravenous contrast agents for radiological body imaging (should not have been administered within 1–2 months before the scan)

Please consult your nuclear medicine physician before taking any medication.

Pregnancy, breastfeeding, and fertility

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

You must inform the nuclear medicine physician before administration of 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 supervises the procedure.

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

If you are breastfeeding, inform your nuclear medicine physician. He/she will advise you to stop breastfeeding until radioactivity has cleared from your body. This takes approximately 12 hours. Breast milk expressed during this time should be discarded. Resumption of breastfeeding should be agreed upon with the nuclear medicine specialist supervising the procedure.

Driving and using machines

Sodium pertechnetate (99mTc) solution has no influence on the ability to drive or use machines.

Sodium content of sodium pertechnetate (99mTc) solution

Sodium pertechnetate solution contains 3.5 mg/ml of sodium. Depending on the injected volume, the limit of 1 mmol (23 mg) 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 Ultra-TechneKow FM

There are strict regulations regarding the use, handling, and disposal of radiopharmaceuticals. Ultra-TechneKow FM will be used only in specially controlled areas. This product will be handled and administered exclusively 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 inform you of their actions.

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

The amount generally recommended for administration to an adult varies depending on the test being performed and ranges between 2 and 400 MBq (MegaBecquerels, the unit used to express radioactivity).

Use in children and adolescents

In children and adolescents, the administered amount will be adjusted according to body weight.

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

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

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

Duration of the procedure

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

Scintigraphic images may be acquired at any time from the moment of injection up to 24 hours after administration, depending on the type of examination.

After administration of the sodium pertechnetate (99mTc) solution, you should:

• avoid direct contact with young 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 something to drink and asked to urinate immediately before the test.

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

If you have been administered more sodium pertechnetate (99mTc) solution obtained with Ultra-TechneKow FM than you should have received

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

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

4. Possible adverse effects

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

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

• allergic reactions, with symptoms such as:

• skin rash, itching

• hives

• swelling in various areas, for example in the 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:

• being sick (vomiting)

• feeling sick (nausea)

• diarrhea

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

• skin swelling

• pain

• swelling

• redness

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

Reporting of adverse effects

If you experience any adverse effects, consult your nuclear medicine physician, even if they are effects not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines:

https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ultra-TechneKow FM

You will not be required to store this medicine. This medicinal product is stored under the responsibility of the 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 medicinal product after the expiry date stated on the container.

6. Contents of the pack and other information

Composition of Ultra-TechneKow FM

• The active substance is sodium pertechnetate (99mTc).
• The other components are: sodium chloride and water for injections.

Appearance of the product and contents of the container

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

Ultra-TechneKow FM must be eluted and the resulting solution may be used directly or for the radiolabelling of certain specific reagent kits for the preparation of radiopharmaceuticals.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Curium Pharma Spain S. A.

Avenida Doctor Severo Ochoa, nº 29, 3º-2

28100, Alcobendas, Madrid, Spain

Manufacturer:

Curium Netherlands B.V.

Westerduinweg 3

1755 LE Petten

The Netherlands

Date of the most recent revision of this summary: April 2017

This information is intended for medical or healthcare professionals only:

The complete summary of product characteristics for Ultra-TechneKow FM is included as a separate document within the product packaging, to provide physicians and healthcare professionals with scientific information as well as practical guidance on the administration and use of this radiopharmaceutical.

Please consult the summary of product characteristics.