Tetrofosmina Rotop 0,23 mg radiopharmaceutical preparation kit EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Tetrofosmina ROTOP 0.23 mg kit for radiopharmaceutical preparation EFG

Tetrofosmina as tetrofosmina (bis) tetrafluoroborate

Read the entire leaflet carefully before you are administered 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, consult your nuclear medicine physician who supervises the procedure.
• If you experience any adverse reactions, consult your nuclear medicine physician, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

1. What Tetrofosmina ROTOP is and what it is used for
2. What you need to know before using Tetrofosmina ROTOP
3. How to use Tetrofosmina ROTOP
4. Possible side effects
5. How to store Tetrofosmina ROTOP
6. Contents of the pack and other information

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

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

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

• It contains an active substance called "tetrofosmina". Before use, it is mixed with a radioactive component called "technetium-99m".
• Once injected, it can be detected from outside the body by a special camera used during the scan.
• The scan can help your nuclear medicine physician assess heart function or detect cardiac damage after a myocardial infarction.
• Other patients receive this medicine before a scan to examine breast lumps.

Your nuclear medicine physician will explain which part of your body will be scanned.

Administration of Tetrofosmina ROTOP 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 Tetrofosmina ROTOP

Tetrofosmina ROTOP must not be used

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

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

Warnings and precautions

Talk to your nuclear medicine physician before using Tetrofosmina ROTOP:

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

Before administration of Tetrofosmina ROTOP you should

Drink plenty of water before starting the procedure to ensure frequent urination during the first hours after completion.

Children and adolescents

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

Use of Tetrofosmina ROTOP with other medicines

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

If you are undergoing a cardiac scan, inform your nuclear medicine physician if you are taking any of the following types of medicines. This is because they may affect the scan results:

• Beta-blockers, such as atenolol, bisoprolol, or propranolol, used for hypertension, coronary artery disease, cardiac rhythm disorders, or heart failure.
• Calcium channel antagonists, such as nifedipine, diltiazem, or felodipine, used for hypertension, coronary artery disease, cardiac rhythm disorders, or heart failure.
• Nitrates, such as glyceryl trinitrate, isosorbide mononitrate, or isosorbide dinitrate, used for hypertension, coronary artery disease, cardiac rhythm disorders, or heart failure.
• Any medication for blood pressure, heart conditions, or heart failure.

If you are unsure whether you are in any of the above situations, speak with your nuclear medicine physician before using Tetrofosmina ROTOP.

Use of Tetrofosmina ROTOP with food and drink

If you are undergoing:

• A cardiac scan: You may be asked not to eat anything the night before the scan. Alternatively, you may be allowed only a light breakfast on the morning of the scan.
• A breast scan: You may eat and drink liquids normally.

Pregnancy and breastfeeding

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

You must 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 physician may wait until you have finished breastfeeding before administering Tetrofosmina ROTOP. If waiting is not possible, your physician may ask you to:

• interrupt breastfeeding for 12 hours or longer,
• use formula feeding for your child, and
• express and discard breast milk.

Your nuclear medicine physician will inform you when you can resume breastfeeding.

Driving and use of machines

It is considered unlikely that Tetrofosmina ROTOP will affect your ability to drive or operate machinery. Consult your nuclear medicine physician to determine whether 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 and is therefore considered essentially "sodium-free".

3. How to use Tetrofosmina ROTOP

There are strict regulations regarding the use, handling, and disposal of radiopharmaceuticals. Tetrofosmina ROTOP will be used only in specially controlled areas. This product will be handled and administered only by trained and qualified personnel who are skilled in its safe use. These individuals will take special care in the safe handling of this product and will inform you of their actions.

The nuclear medicine physician supervising the procedure will determine the amount of Tetrofosmina ROTOP to be used in your case. This amount will be the minimum necessary to obtain the required diagnostic information.

The dose generally recommended for administration in adults ranges between 250 and 800 MBq (MegaBecquerel, the unit used to express radioactivity).

Administration of Tetrofosmina ROTOP and performance of the procedure

Tetrofosmina ROTOP is administered intravenously.

For a cardiac scan, the usual dosing regimen is:

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

The order of these injections may be reversed for some patients. Other patients may require only one injection. In some cases, the nuclear medicine physician may decide it is best to administer the two injections on separate days.

For a breast scan, the usual dose is:

• a single injection.

Duration of the procedure

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

After administration of Tetrofosmina ROTOP you should

• urinate frequently to help eliminate the product from your body.

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

If you have been given more Tetrofosmina ROTOP than you should have received

An overdose is unlikely to occur, as you will receive a single, precisely controlled dose of Tetrofosmina ROTOP, administered under the supervision of the nuclear medicine physician. However, in the event of an overdose, appropriate treatment will be provided.

4. Possible adverse effects

Like all medicines, Tetrofosmina ROTOP may cause adverse effects, although not everyone experiences them. These are very rare (affecting less than 1 in 10,000 people).

Allergic reactions

If you experience an allergic reaction while at the hospital or clinic during the examination, inform the nuclear medicine physician immediately. Signs may include:

• skin rash, itching, or redness
• facial swelling
• difficulty breathing

In more severe cases, reactions may include:

• fainting (loss of consciousness), feeling unsteady, or dizziness

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

Adverse effects

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

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

Reporting of adverse reactions:

If you experience any adverse effects, consult your nuclear medicine physician, even if they are side effects not listed in this leaflet. You can also report adverse reactions directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Tetrofosmina ROTOP

You will not be required to store this medicine. This medicinal product is stored under the responsibility of a specialist in suitable facilities. Storage of radiopharmaceuticals must comply with national regulations concerning radioactive materials.

This information is intended exclusively for physicians or healthcare professionals.

Do not use this medicine after the expiry date stated on the label.

6. Contents of the pack and other information

Composition of Tetrofosmina ROTOP:

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

Appearance of the product and contents of the pack

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

Pack sizes: 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
Telephone: +49 351 26 31 02 10
Fax: +49 351 26 31 03 13
Email: [email protected]

Date of the most recent revision of this leaflet: February 2018.