Ultra-technekow fm 2,15-43,00 gbq generador de radionÚclido

PROSPECTUS

Ultra-TechneKow FM2.15-43.00 GBq radionuclide generator

Solution of sodium pertecnetate (99mTc)

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

2. What you need to know before starting to use 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 adverse effects

5. Storage of Ultra-TechneKow FM

6. Contents of the package and additional information

This medication is a radiopharmaceutical for diagnostic use only.

Ultra-TechneKow FM is a technetium-99m generator, meaning 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 injected radioactivity can be detected outside the body by special cameras. The nuclear physician will take an image (scan) of the organ in question, which can provide valuable information about the structure and function of this organ.

The solution of sodium pertechnetate (99mTc) is used to obtain images of various parts of the body, including:

• 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, please refer to the corresponding package insert.

The nuclear physician will explain to you what type of examination will be performed with this product.

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

The solution of pertecnetate (99mTc) of sodium obtained withUltra-TechneKow FM should not be used

• If you are allergic to pertecnetate (99mTc) of sodium or to any of the other components of this medication (including in section 6).

Warnings and precautions

Inform your nuclear doctor in the following cases:

• If you suffer from allergies, as some cases of allergic reactions have been observed after administration of pertecnetate (99mTc) of sodium
• If you suffer from kidney disease
• If you are pregnant or believe you may be
• If you are breastfeeding

Your nuclear doctor will inform you if you need to take special precautions after using this medication. Consult with your nuclear doctor if you have any questions.

Before administration of the solution of pertecnetate (99mTc) of sodium, you must:

• Drink a lot of water before starting the procedure to urinate very frequently during the first hours after its completion.
• Be fasting for 3 to 4 hours before Meckel's diverticulum gammagraphy to maintain low intestinal peristalsis.

Children and adolescents

Inform your nuclear doctor if you are under 18 years old.

Use of the solution of pertecnetate (99mTc) of sodium with other medications:

Inform your nuclear doctor if you are taking, have taken recently, or may need to take any other medication, as some medications may interfere with image interpretation:

• atropine, used for example:
• • To reduce stomach, intestine, or bile duct spasms
  • To reduce pancreatic secretions
  • In ophthalmology
  • Before anesthesia administration
  • To treat reduced heart rate or
  • As an antidote
• isoprenaline, a medication to treat reduced heart rate
• analgesics
• laxatives(should not be taken during this procedure, as they irritate the gastrointestinal tract)
• If you hadcontrast explorations(e.g. with barium as a contrast agent) or upper gastrointestinal examination (as these should be avoided 48 hours before Meckel's diverticulum gammagraphy)
• antithyroid medications(e.g. carbimazole or other imidazolic derivatives such as propylthiouracil),
• salicylates, steroids, sodium nitroprusside, sulfobromophthalein sodium, perchlorate(as they should not be taken during 1 week before gammagraphy)
• phenylbutazoneto treat fever, pain, and inflammation in the body (as it should not be taken during 2 weeks before gammagraphy)
• expectorants(as they should not be taken during 2 weeks before gammagraphy)
• natural or synthetic thyroid preparations(e.g. sodium thyroxine, lithium triiodothyronine, thyroid extract) (as they should not be taken during 2-3 weeks before gammagraphy)
• amiodaronea antiarrhythmic agent (as it should not be taken during 4 weeks before gammagraphy)
• benzodiazepinesused for example for sedation, or as anxiolytics or anticonvulsants or as muscle relaxants orlithiumused as a mood stabilizer in manic-depressive illness (as both should not be taken during 4 weeks before gammagraphy)
• intravenous contrast agentsfor radiological body explorations (as they should not have been administered during 1-2 months before gammagraphy)

Please consult with your nuclear doctor before taking any medication.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or believe you may be pregnant, or intend to become pregnant, consult with your nuclear doctor before this medication is administered.

You must inform your nuclear doctor before administration of the solution of pertecnetate (99mTc) of sodium if there is any possibility of pregnancy, if you experience a delay in your period, or if you are breastfeeding. In case of doubt, it is essential to consult with your nuclear doctor who will supervise the procedure.

Ifyou are pregnant, your nuclear doctor will only administer this medication during pregnancy if the expected benefit outweighs the risk.

If you arebreastfeeding, inform your nuclear doctor, who will advise you to stop until the radioactivity has left your body, which takes approximately 12 hours. The expressed milk must be discarded. Resumption of breastfeeding must be agreed with the nuclear medicine specialist who will supervise the procedure.

Driving and using machines

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

The solution of pertecnetate (99mTc)ofsodium contains sodium

The solution of pertecnetate of sodium contains 3.5 mg/ml of sodium. Depending on the injected volume, you may exceed the limit of 1 mmol (23 mg) of sodium per administered dose. This should be taken into account if you follow a low-sodium diet.

There are strict guidelines for the use, handling, and disposal of radiopharmaceuticals. Ultra-TechneKow FM will be used only in special controlled areas. This product will only be handled and administeredby trained and qualified personnel to use it safely. Those individuals will take special care in the safe use of this product and will inform you of their actions.

The nuclear medicine physician overseeing the procedure will decide on 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 dose for 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 dose to be administered will be adjusted according to their body weight.

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

Depending on the purpose of the examination, the product will be administered by injection into a vein in the arm or may be instilled in the eyes in the form of drops.

One administration is sufficient to perform the procedure that your nuclear medicine physician needs.

Procedure duration

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

Nuclear medicine scans 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 sodium pertechnetate (99mTc) solution you must:

• 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 asked to urinate immediately before the test.

Your nuclear medicine physician will inform you if you need to take any special precautions after this medication is administered. Consult with 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

It is unlikely to have an overdose because you will receive a controlled and precise dose of sodium pertechnetate (99mTc)solution by the nuclear medicine physician overseeing the procedure. However, in case of an overdose, you will receive the appropriate treatment. In particular, the nuclear medicine physician in charge of the procedure may recommend that you drink a large amount of liquids to eliminate the radioactive traces from your body.

If you have any other doubts about the use of this product, ask the nuclear medicine physician overseeing the procedure.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

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

• allergic reactions, with symptoms such as:

• skin rash, itching
• hives
• inflammation in multiple areas, for example on the face
• shortness of breath
• skin redness
• coma

• circulatory reactions, with symptoms such as:

• rapid heart rate, slow heart rate
• syncope
• blurred vision
• dizziness
• headache
• flushing

• gastrointestinal disturbances, with symptoms such as:

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

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

• skin inflammation
• pain
• inflammation
• redness

The administration of this radiopharmaceutical involves receiving a small amount of ionizing radiation with a very low risk of developing cancer and hereditary defects..

Reporting Adverse Effects

If you experience adverse effects, consult your nuclear physician, even if they are adverse effects not listed in this prospectus. You can also report them directly through

the Spanish System for Pharmacovigilance of Medicines for Human Use:

https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

This medication does not need to be stored. This medication is stored under the responsibility of the specialist in appropriate facilities. Radioactive pharmaceutical storage will be carried out in accordance with national regulations on radioactive materials.

The following information is intended solely for the specialist.

Do not use this medication after the expiration date that appears on the packaging.

Composition of Ultra-TechneKow FM

• The active principle is pertecnetate (99mTc) of sodium.
• The other components are: sodium chloride and water for injection.

Appearance of theproductand contents of the packaging

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

Ultra-TeckneKow FM must be eluted and the obtained solution can be used as is or for radioactive marking of some particular reagent equipment for the preparation of radiopharmaceuticals.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Curium Pharma Spain S. A.

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

28100, Alcobendas, Madrid, Spain

Responsible for manufacturing:

Curium Netherlands B.V.

Westerduinweg 3

1755 LE Petten

Netherlands

Last review date of this leaflet: April 2017

This information is intended solely for doctors or healthcare professionals:

The complete technical data sheet forUltra-TechneKow FMis included as a separate document in the product packaging, in order to facilitate doctors or healthcare professionals with scientific and practical information on the administration and use of this radiopharmaceutical.

Please refer to the technical data sheet.