Label: information for the user

Tetrofosmina ROTOP 0.23 mg kit for radiopharmaceutical preparation EFG

Tetrofosmina as tetrofosmina (bis) tetrafluoroborate

Read this label carefully before this medicine is administered to you, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your nuclear medicine physician who is supervising the procedure
• If you experience any adverse effects, consult your nuclear medicine physician, even if they are not listed in this label. See section 4.

1. What Tetrofosmina ROTOP is and for what it is used

2. What you need to know before starting to use Tetrofosmina ROTOP

3. How to use Tetrofosmina ROTOP

4. Possible adverse effects

5. Storage of Tetrofosmina ROTOP

6. Contents of the package and additional information

This medication is solely for diagnostic use. It is used to help identify diseases.

Tetrofosmina ROTOP belongs to a group of medications called “radiocontrast agents”. It is administered before an examination and, with the help of a special camera, allows for visualization inside a part of the body.

• It contains an active ingredient called “tetrofosmina”. It is mixed with a radioactive component called “technetium-99m” before use.
• Once injected, it can be detected from the outside of the body by a special camera used in the examination.
• The examination may help your nuclear medicine doctor to check the functioning of the heart or to see heart lesions after a myocardial infarction.
• Other people receive this medication before an examination to examine lumps in the breasts.

Your nuclear medicine doctor will explain which part of your body will be examined.

The administration of Tetrofosmina ROTOP involves receiving a small amount of radioactivity. Your doctor and the nuclear medicine doctor have considered that the clinical benefit you will obtain from the procedure with the radiopharmaceutical outweighs the risk of radiation.

Tetrofosmina ROTOP should not be used

• if you are allergic (hypersensitive) to Tetrofosmina ROTOP or to any of the other ingredients of this medicine (listed in section 6).
• if you are pregnant or think you may be pregnant.

Do not use Tetrofosmina ROTOP if you are in any of the above circumstances. If you are unsure, consult your nuclear medicine doctor.

Warnings and precautions

Speak to your nuclear medicine doctor before using Tetrofosmina ROTOP:

• if the person receiving this medicine is a child or adolescent.
• if you are breastfeeding.

Before administration of Tetrofosmina ROTOP

Drink plenty of water before starting the procedure to urinate very frequently during the first hours after its completion.

Children and adolescents

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

Use of Tetrofosmina ROTOP with other medicines

Inform your nuclear medicine doctor, who supervises the procedure, if you are taking or have taken recently or may have to take any other medicine, including those obtained without a prescription, as some medicines may interfere with the interpretation of the images. This includes herbal-based medicines.

If you are to undergo a heart scan, inform your nuclear medicine doctor if you are taking any of the following types of medicines. This is because they may affect the results of the scan:

• Beta-blockers, such as atenolol, bisoprolol or propranolol used for hypertension, coronary artery disease, arrhythmia or heart failure.
• Calcium antagonists, such as nifedipine, diltiazem or felodipine, used for hypertension, coronary artery disease, arrhythmia or heart failure.
• Nitrates, such as glyceryl trinitrate, isosorbide mononitrate or isosorbide dinitrate, used for hypertension, coronary artery disease, arrhythmia or heart failure.
• Any medicine for blood pressure, the heart or heart failure

If you are unsure whether you are in any of the above circumstances, speak to your nuclear medicine doctor before using Tetrofosmina ROTOP.

Use of Tetrofosmina ROTOP with food and drinks

If you are to undergo:

• A heart scan: you may be asked not to eat anything the night before the scan. Or you may be asked to have only a light breakfast on the morning of the scan.
• A breast scan: you can eat and drink normally.

Pregnancy and breastfeeding

You should not receive Tetrofosmina ROTOP if you are pregnant or think you may be pregnant. This is because it may affect your baby.

You should not breastfeed while receiving Tetrofosmina ROTOP. This is because small amounts of radioactivity may pass into breast milk. If you are breastfeeding, your nuclear medicine doctor may wait until you have finished breastfeeding before using Tetrofosmina ROTOP. If this is not possible, your doctor may ask you to:

• stop breastfeeding for 12 hours or more, and
• use formula milk for your baby, and
• express and discard breast milk

Your nuclear medicine doctor will tell you when you can start breastfeeding again.

Driving and operating machinery

It is unlikely that Tetrofosmina ROTOP will affect your ability to drive or use machines. Consult your nuclear medicine doctor if you can drive or use machines after receiving Tetrofosmina ROTOP.

Tetrofosmina ROTOP contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per vial, so it is considered to be essentially “sodium-free”

There are strict guidelines for the use, handling, and disposal of radiopharmaceuticals. Tetrofosmina ROTOP will only be used in specially controlled areas. This product will only be handled and administered by trained and qualified personnel to ensure safe use. 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 Tetrofosmina ROTOP 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 between 250 and 800 MBq (MegaBequerel, the unit used to express radioactivity).

Administration of Tetrofosmina ROTOP and Procedure Performance

Tetrofosmina ROTOP is administered intravenously.

For a cardiac exploration, the usual dose is:

• one injection after resting.
• a second injection (at least one hour after the first), when your heart is working more intensely than normal, such as during or immediately after exercise.

The order of the two injections may be reversed for some patients. Others may only need one injection. In some cases, the nuclear medicine physician may decide to administer the two injections on different days.

For a breast exploration, the usual dose is:

• one single injection.

Procedure Duration

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

After Tetrofosmina ROTOP Administration

• You must urinate frequently to eliminate the product from your body.

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

If You Have Been Administered More Tetrofosmina ROTOP Than Necessary

It is unlikely that an overdose will occur, as you will receive a single, precisely controlled dose of Tetrofosmina ROTOP, supervised by the nuclear medicine physician overseeing the procedure. However, in the event of an overdose, you will receive the necessary treatment.

Like all medications,TetrofosminaROTOPmay cause adverse effects, although not everyone will experience them. These are very rare (affecting fewer than 1 in 10,000 people).

Allergic Reactions

If you experience an allergic reaction while in the hospital or clinic during the examination, inform the nuclear medicine doctor immediately. The signs may include:

• skin rash, itching, or redness
• swelling of the face
• difficulty breathing

In more severe cases, reactions may include:

• loss of consciousness, feeling of instability, or dizziness

If you experience any of the above adverse effects after leaving the hospital or clinic, go directly to the emergency department of the nearest hospital.

Adverse Effects

• unpleasant sensation of heat starting at the site of the injection
• headache
• nausea or vomiting
• alteration of taste, such as a metallic taste
• alteration of smell
• sensation of heat in the mouth
• increase in the number of white blood cells (detected when certain types of blood tests are performed)

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

Reporting Adverse Reactions:

If you experience adverse effects, consult your nuclear medicine doctor, even if they are secondary effects not listed in this prospectus. You can also report adverse reactions directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.By reporting adverse reactions, you can contribute to providing more information on the safety of this medication.

This medication does not need to be stored by you. This medication will be stored under the responsibility of the specialist in appropriate facilities. Storage of radiopharmaceuticals will be carried out in accordance with national regulations on radioactive materials.

This information is intended solely for medical doctors or healthcare professionals.

Do not use this medication after the expiration date appearing on the label.

Composition of Tetrofosmina ROTOP:

• The active ingredient is tetrofosmina. Vial 1 ofTetrofosminaROTOPcontains 0.23 mg of tetrofosmina as tetrofosmina (bis) tetrafluoroborate.
• The other components are stannous chloride dihydrate, sodium sulfosalicylate trihydrate, sodium gluconate, and mannitol.
• Vial 2 contains sodium bicarbonate and water for injection.

Appearance of the product and contents of the packaging

The Tetrofosmina ROTOP reagent kit consists of two different 10 ml glass vialsthat cannot be used separately. Vial 1 contains Tetrofosmina ROTOP powder and vial 2 contains Tetrofosmina ROTOP solution.

Packaging size:2 kits (vial 1 and vial 2)

5 kits (vial 1 and vial 2)

Marketing authorization holder and manufacturer responsible

ROTOP Pharmaka GmbH
Bautzner Landstraße 400
01328 Dresden, Germany
Phone:+49 351 26 31 02 10
Fax:+49 351 26 31 03 13
Email:service@rotop-pharmaka.de

Last review date of this leaflet: February 2018.