TETROFOSMINA ROTOP 0.23 mg KIT FOR RADIOPHARMACEUTICAL PREPARATION

Introduction

Leaflet: Information for the user

Tetrofosmin ROTOP 0.23 mg reagent kit for radiopharmaceutical preparation EFG

Tetrofosmin as tetrofosmin (bis) tetrafluoroborate

Read the entire leaflet carefully before you are given this medicine, as it contains important information for you.

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

Contents of the leaflet

1. What is Tetrofosmin ROTOP and what is it used for
2. What you need to know before starting to use Tetrofosmin ROTOP
3. How to use Tetrofosmin ROTOP
4. Possible side effects
5. Storage of Tetrofosmin ROTOP
6. Package contents and additional information

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

This medicine is for diagnostic use only. It is used to help identify diseases.

Tetrofosmin ROTOP belongs to a group of medicines called "radiopharmaceuticals". It is administered before an examination and, with the help of a special camera, allows visualization of a part of your body.

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

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

Administration of Tetrofosmin ROTOP 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 starting to use Tetrofosmin ROTOP

Tetrofosmin ROTOP must not be used

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

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

Warnings and precautions

Talk to your nuclear medicine doctor before using Tetrofosmin ROTOP:

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

Before administration of Tetrofosmin ROTOP, you must

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

Children and adolescents

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

Use of Tetrofosmin ROTOP with other medicines

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

If you are going to undergo a heart examination, tell 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 examination:

• Betablockers, such as atenolol, bisoprolol, or propranolol, used for hypertension, coronary artery disease, cardiac rhythm disorder, or heart failure.
• Calcium antagonists, such as nifedipine, diltiazem, or felodipine, used for hypertension, coronary artery disease, cardiac rhythm disorder, or heart failure.
• Nitrates, such as glyceryl trinitrate, isosorbide mononitrate, or isosorbide dinitrate, used for hypertension, coronary artery disease, cardiac rhythm disorder, or heart failure.
• Any medicine for blood pressure, heart, or heart failure.

If you are not sure if you are in any of the above circumstances, talk to your nuclear medicine doctor before using Tetrofosmin ROTOP.

Use of Tetrofosmin ROTOP with food and drinks

If you are going to undergo:

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

Pregnancy and breastfeeding

You must not receive Tetrofosmin ROTOP if you are pregnant or think you may be pregnant. This is because it may affect your child.

You must not breastfeed if you are receiving Tetrofosmin 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 Tetrofosmin ROTOP. If it is not possible to wait, the doctor may ask you to:

• interrupt breastfeeding for 12 hours or more, and
• use formula food for your child, and
• express breast milk and discard it.

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

Driving and using machines

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

Tetrofosmin ROTOP contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per vial, so it is considered essentially "sodium-free".

3. How to use Tetrofosmin ROTOP

There are strict rules for the use, handling, and disposal of radiopharmaceuticals. Tetrofosmin ROTOP 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. Those 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 Tetrofosmin ROTOP 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 between 250 and 800 MBq (Megabecquerel, the unit used to express radioactivity).

Administration of Tetrofosmin ROTOP and performance of the procedure

Tetrofosmin ROTOP is administered intravenously.

For a cardiac examination, the usual dose is:

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

The order of the two injections may be the opposite for some patients. Other people only need one injection. In some cases, the nuclear medicine doctor may decide that it is best to administer the two injections on different days.

For a breast examination, the usual dose is:

• a single injection.

Duration of the procedure

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

After administration of Tetrofosmin ROTOP, you must

• urinate frequently to eliminate the product from your body.

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

If you have been given more Tetrofosmin ROTOP than you should

It is unlikely that an overdose will occur because you will receive a single dose of Tetrofosmin ROTOP, precisely controlled by the nuclear medicine doctor supervising the procedure. However, in case of overdose, you will receive the appropriate treatment.

4. Possible side effects

As with all medicines, Tetrofosmin ROTOP can cause side effects, although not everyone gets them. These are very rare (affecting less than 1 in 10,000 people).

Allergic reactions

If you experience an allergic reaction while you are 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 can include:

• fainting (loss of consciousness), feeling of instability, or dizziness.

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

Side effects

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

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

Reporting of side effects:

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

5. Storage of Tetrofosmin ROTOP

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.

This information is intended only for doctors or healthcare professionals.

Do not use this medicine after the expiration date shown on the label.

6. Package contents and additional information

Composition of Tetrofosmin ROTOP:

• The active ingredient is tetrofosmin. Vial 1 of Tetrofosmin ROTOP contains 0.23 mg of tetrofosmin as tetrofosmin (bis) tetrafluoroborate.
• The other components are tin (II) chloride dihydrate, sodium sulfosalicylate trihydrate, sodium gluconate, and mannitol.
• Vial 2 contains sodium bicarbonate and water for injectable preparations.

Appearance of the product and package contents

The Tetrofosmin ROTOP reagent kit consists of two different 10 ml glass vials that cannot be used separately. Vial 1 contains Tetrofosmin ROTOP powder and Vial 2 contains Tetrofosmin ROTOP solution.

Package size: 2 kits (Vial 1 and Vial 2)

5 kits (Vial 1 and Vial 2)

Marketing authorization holder and manufacturer

ROTOP Pharmaka GmbH, Bautzner Landstraße 400, 01328 Dresden, Germany. Phone: +49 351 26 31 02 10, Fax: +49 351 26 31 03 13, Email: [email protected]

Date of the last revision of this leaflet: February 2018.