ULTRA-TECHNEKOW FM 2.15-43.00 GBq RADIOPHARMACEUTICAL GENERATOR

Introduction

PACKAGE LEAFLET

Ultra-TechneKow FM2,15-43,00 GBq radionuclide generator

Sodium pertechnetate (99mTc) solution

Read all of this leaflet carefully before you are given 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 is 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 Ultra-TechneKow FM is and what it is used for

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

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

4. Possible side effects

5. Storage of Ultra-TechneKow FM

1. Package contents and additional 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 small amount of radioactivity injected can be detected outside the body by special cameras. The nuclear medicine doctor will take an image (scan) of the organ in question, which can provide valuable information about the structure and function of that 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.

Your nuclear medicine doctor will explain to you what type of examination will be performed with this product.

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

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

The sodium pertechnetate (99mTc) solution obtained with Ultra-TechneKow FM must not be used

• If you are allergic to sodium pertechnetate (99mTc) or any of the other components of this medicine (listed in section 6).

Warnings and precautions

Tell your nuclear medicine doctor in the following cases:

Your nuclear medicine doctor will inform you if you need to take 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 should:

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

Children and adolescents

Tell your nuclear medicine doctor if you are under 18 years old.

Using the sodium pertechnetate (99mTc) solution with other medicines:

Tell your nuclear medicine doctor if you are taking, have recently taken, or may need to take any other medicine, as some medicines may interfere with the interpretation of the images:

• atropine, used for example:
• • to reduce stomach, intestine, or gallbladder spasms
  • to reduce pancreatic secretions
  • in ophthalmology
  • before anesthesia administration
  • 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)
contrast examinations(e.g., with barium as a contrast agent) or upper gastrointestinal examination (which should be avoided 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(should not be taken during 1 week before scintigraphy)
• phenylbutazoneto treat fever, pain, and inflammation in the body (should not be taken during 2 weeks before scintigraphy)
• expectorants(should not be taken during 2 weeks before scintigraphy)
• natural or synthetic thyroid preparations(e.g., sodium thyroxine, sodium liotironine, thyroid extract) (should not be taken during 2-3 weeks before scintigraphy)
• amiodaronean antiarrhythmic agent (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 (both should not be taken during 4 weeks before scintigraphy)
• intravenous contrast agentsfor radiological examinations of the body (should not be administered during 1-2 months before scintigraphy)

Please consult your nuclear medicine doctor before taking any medicine.

Pregnancy, breastfeeding, and fertility

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 tell your 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 supervises the procedure.

If you are pregnant, your nuclear medicine doctor will only give you this medicine during pregnancy if the expected benefit outweighs the risk.

If you are breastfeeding, tell your nuclear medicine doctor, he/she will advise you to stop breastfeeding until the radioactivity has left your body. This takes approximately 12 hours. The expressed milk must be discarded. The resumption of breastfeeding should be agreed upon with the nuclear medicine specialist who supervises the procedure.

Driving and using machines

The sodium pertechnetate (99mTc) solution has no influence on the ability to drive and use machines.

The sodium pertechnetate (99mTc) solution contains sodium

The sodium pertechnetate solution contains 3.5 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 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 rules on the use, handling, and disposal of radiopharmaceuticals. Ultra-TechneKow FM 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 people will take special care in the safe use of this product and will inform you 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 adjusted according to their 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 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 procedure 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 should:

• avoid direct contact with small children and pregnant women during the 12 hours after injection
• urinate frequently to eliminate the product from your body
• after administration, you will be offered something to drink and you will be asked to urinate immediately before the test.

Your nuclear medicine doctor will inform you if you need to take special precautions after you are 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 Ultra-TechneKow FM than you should

Overdose is unlikely because you will receive a precisely controlled single dose of sodium pertechnetate (99mTc) solution by 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 plenty of fluids to eliminate the traces of radioactivity from your body.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Side effects with frequency not known (cannot be estimated from the available data):

• allergic reactions, with symptoms such as:

• skin rash, itching
• hives
• inflammation in various areas, for example in the face
• shortness of breath
• 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:

• nausea and vomiting
• feeling unwell (nausea)
• diarrhea

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

• skin inflammation
• pain
• inflammation
• redness

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

Reporting of side effects

If you experience side effects, talk to your nuclear medicine doctor, even if they are not listed in this leaflet. You can also report them directly through

the Spanish Pharmacovigilance System for Human Use Medicines:

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

5. Storage of Ultra-TechneKow FM

You will 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 packaging.

6. Package contents and additional information

Composition of Ultra-TechneKow FM

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

Appearance of the product and package contents

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

Ultra-TechneKow FM must be eluted and the obtained solution can be used as is or for radiolabeling of certain 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

Netherlands

Date of last revision of this leaflet: April 2017

This information is intended only for doctors or healthcare professionals:

The full technical data sheet of Ultra-TechneKow FM is included as a separate document in the product packaging, in order to provide doctors or healthcare professionals with scientific information and practical information on the administration and use of this radiopharmaceutical.

Please consult the technical data sheet.