Tetrofosmin Rotop

Package leaflet: Information for the user

Tetrofosmina ROTOP 0.23 mg

Radiopharmaceutical preparation kit
Active substance: tetrofosmin as (bis)tetrafluoroborate of tetrofosmin
Read this leaflet carefully before you are given Tetrofosmina ROTOP because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask the nuclear medicine physician who will supervise the procedure.
• If you experience any side effects, including those not listed in this leaflet, contact the nuclear medicine physician. See section 4.

Contents of this leaflet

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

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

This medicinal product is for diagnostic use only. It is used to help identify a disease.
Tetrofosmina ROTOP is a "radiopharmaceutical". It is administered before a scan and helps a special camera to see inside a part of the body.

• It contains an active substance called "tetrofosmina", which is mixed with a radioactive ingredient called "technetium-99m" prior to use.
• Once injected, it can be detected from outside the body by a special camera used during the scan.
• The scan can help the nuclear medicine physician to assess how the heart is functioning or to detect heart damage after a heart attack.
• This medicinal product may also be administered before a breast nodule scan. The nuclear medicine physician will explain which part of your body will be examined.

Use of Tetrofosmina ROTOP involves exposure to low levels of radioactivity. Your doctor and the nuclear medicine physician have determined that the benefits you will receive from the radiopharmaceutical procedure outweigh the risks associated with radiation exposure.

2. What you need to know before Tetrofosmina ROTOP is used

Tetrofosmina ROTOP must not be used:

• if you are allergic (hypersensitive) to the active substance or to any of the other ingredients of this medicine (listed in section 6)
• if you are pregnant or think you might be pregnant

If any of the above situations apply to you, or if you are unsure, speak to your
physician.
Warnings and precautions
Speak to the nuclear medicine physician before using Tetrofosmina ROTOP

• if the person to be administered the medicine is a child or adolescent
• if you are breastfeeding Before administration of Tetrofosmina ROTOP you must: Drink plenty of water before the examination begins, so that you urinate as frequently as possible during the first few hours after the procedure. Children and adolescents Talk to the nuclear medicine physician if you are under 18 years of age. Other medicines and Tetrofosmina ROTOP Inform the nuclear medicine physician supervising the procedure if you are taking, have recently taken, or might take any other medicines, including medicines without a prescription, as they could interfere with the interpretation of the images. Herbal medicines are included. If you are undergoing a heart examination, inform the nuclear medicine physician if you are taking any of the following medicines, as they might affect the examination results:
• beta-blockers such as atenolol, bisoprolol or propranolol, e.g. for high blood pressure, coronary artery disease, cardiac arrhythmias or heart failure
• calcium antagonists such as nifedipine, diltiazem or felodipine, e.g. for high blood pressure, coronary artery disease, cardiac arrhythmias or heart failure
• nitrates such as glyceryl trinitrate, isosorbide mononitrate or isosorbide dinitrate, e.g. for high blood pressure, coronary artery disease, cardiac arrhythmias or heart failure
• any medicine for blood pressure, heart conditions or heart failure If you are unsure whether any of the above situations apply to you, speak to the nuclear medicine physician before using Tetrofosmina ROTOP.

Tetrofosmina ROTOP with food and drink
If you are undergoing

• a heart examination: You may be asked not to eat from the evening before. Alternatively, you may be asked to have only a light breakfast on the morning of the examination.
• a breast examination: You may eat and drink fluids normally. Pregnancy and breastfeeding Tetrofosmina ROTOP must not be administered to you if you are pregnant or think you might be pregnant, as it could affect the unborn child.

Do not breastfeed if you are administered Tetrofosmina ROTOP, because small amounts of
"radioactivity" may pass into breast milk. If you are breastfeeding, the nuclear medicine
physician might wait until you have finished breastfeeding before using Tetrofosmina ROTOP.
If waiting is not possible, the nuclear medicine physician might ask you to:

• stop breastfeeding for 12 hours or more, and
• use infant formula for your child, and
• express (remove) your milk and discard it. The nuclear medicine physician will inform you when you can breastfeed again. Driving and using machines Tetrofosmina ROTOP is considered unlikely to affect your ability to drive or operate machinery. Ask the nuclear medicine physician whether you may drive or use machinery after receiving Tetrofosmina ROTOP. Tetrofosmina ROTOP contains sodium This medicine contains less than 1 mmol of sodium (23 mg) per vial, i.e. it is essentially "sodium-free".

3. How Tetrofosmina ROTOP is used

There are strict regulations regarding the use, handling, and disposal of radiopharmaceuticals.
Tetrofosmina ROTOP may only be used in specially controlled areas. The product may be
handled and administered solely by trained and qualified personnel competent to use it safely.
These individuals will pay particular attention to the safe use of the product and will keep you
informed of their actions.
The nuclear medicine physician supervising the procedure will determine the amount of
Tetrofosmina ROTOP to be used in your case. This will be the lowest quantity necessary to
obtain the required information.
The usually recommended administered activity for 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 heart examination, the usual dose is:

• one injection after resting
• a second injection (at least one hour later) when your heart is working harder than normal, such as during or immediately after physical exercise. The order of the two injections may be reversed for some patients. Some patients may require only one injection. In some cases, the nuclear medicine physician may decide it is preferable to perform the two injections on separate days.
  For a breast examination, the usual dose is:
• a single injection.

Duration of the procedure
Your nuclear medicine physician will inform you about the usual 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 special precautions after receiving the medicine. If you have any doubts, consult your nuclear medicine physician.

If you have been administered more Tetrofosmina ROTOP than you should have
Overdose is unlikely, as you will receive only a single dose of Tetrofosmina ROTOP precisely controlled by the nuclear medicine physician supervising the procedure. However, in the event of an overdose, appropriate treatment will be provided.

4. Possible side effects

Like all medicines, Tetrofosmina ROTOP can cause side effects, although not everyone experiences them. They are very rare (affecting fewer than 1 in 10,000 people).
Allergic reactions
If you have an allergic reaction while at the hospital or clinic for your examination, inform the nuclear medicine physician immediately. Signs may include:

• skin rash or itching or flushing
• swelling of the face
• difficulty breathing In more severe cases, reactions may include:
• fainting (loss of consciousness), dizziness or lightheadedness If any of the above-mentioned side effects occur after you have left the hospital or clinic, go immediately to the nearest hospital emergency department.

Adverse reactions

• unpleasant sensation of warmth starting at the injection site
• headache
• nausea or vomiting
• taste disturbances, such as a metallic taste
• changes in smell
• sensation of warmth in the mouth
• increase in white blood cell count (observed in certain types of blood tests) This radiopharmaceutical emits low levels of ionizing radiation, associated with a minimal risk of cancer and hereditary abnormalities. Reporting of side effects If you experience any side effect, including those not listed in this leaflet, consult the nuclear medicine physician. You may also report side effects directly via the national reporting system at http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa . Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Tetrofosmina ROTOP

This medicinal product must not be stored by the user. The medicine is stored under the responsibility of a specialist in appropriate locations. Storage of radiopharmaceuticals must comply with national regulations concerning radioactive materials.
The following information is intended exclusively for healthcare professionals or physicians.
Tetrofosmina ROTOP must not be used after the expiry date stated on the label.

6. Package contents and other information

What Tetrofosmina ROTOP contains:

• The active substance is tetrofosmina. Vial 1 of Tetrofosmina ROTOP contains 0.23 mg of tetrofosmina as (bis)tetrafluoroborate of tetrofosmina.
• The other components are tin dichloride dihydrate, disodium sulfosalicylate trihydrate, sodium gluconate, mannitol.
• Vial 2 contains sodium hydrogen carbonate and water for injections as a solution.

Description of the appearance of Tetrofosmina ROTOP and contents of the pack

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

Pack: 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
E-mail: [email protected]