Myoview 230 micrograms radiopharmaceutical preparation kit

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

MYOVIEW 230 micrograms radiopharmaceutical preparation kit

Tetrofosmin

Read the entire leaflet carefully before you are given 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 Myoview is and what it is used for
2. What you need to know before being given Myoview
3. How Myoview is used
4. Possible side effects
5. How to store Myoview
6. Contents of the pack and other information

1. What Myoview is and what it is used for

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

Myoview belongs to a group of medicines called "radiopharmaceuticals". It is given before a scan and helps a special camera to see inside a part of the body.

• It contains the active substance 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 during the scan.
• The scan can help your nuclear medicine physician to assess heart function or to identify heart damage after a myocardial infarction.
• Other patients receive this medicine before a scan to examine lumps in the breasts.

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

Administration of Myoview involves receiving a small amount of radioactivity. Your physician and the nuclear medicine physician have determined that the clinical benefit you will obtain from the radiopharmaceutical procedure outweighs the risk from radiation exposure.

2. What you need to know before using Myoview

Myoview must not be used:

• If you are allergic (hypersensitive) to Myoview or to any of the other components of Myoview (listed in section 6).
• If you are pregnant or think you might be pregnant.

Do not use Myoview if any of the above apply to you. If you are unsure, speak with your nuclear medicine physician.

Warnings and precautions

Take special care with Myoview

Talk to your nuclear medicine physician before using Myoview if:

• The person to receive this medicine is a child or adolescent.
• You have a delayed menstrual period. This could indicate that you are pregnant and therefore should not receive Myoview (see section “Pregnancy and breastfeeding”).
• You are on a low-sodium diet.
• You are breastfeeding.

Before administration of Myoview you should:

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

Children and adolescents

The safety and efficacy in patients under 18 years of age have not been established. Inform your nuclear medicine physician if you are under 18 years of age.

Use of Myoview with other medicines

Inform your nuclear medicine physician if you are taking, have recently taken, or might need to take any other medicines, as some medicines may interfere with the interpretation of images.

If you are undergoing a heart scan, inform your nuclear medicine physician if you are taking any of the following types of medicines, as they may affect the scan results:

• Beta-blockers, such as atenolol, bisoprolol, or propranolol.
• Calcium channel blockers, such as nifedipine, diltiazem, or felodipine.
• Nitrates, such as glyceryl trinitrate, isosorbide mononitrate, or isosorbide dinitrate.
• Any medicine for blood pressure, heart conditions, or heart failure.

If you are unsure whether any of the above apply to you, speak with your nuclear medicine physician before using Myoview.

Use of Myoview with food and drink

If you are undergoing:

• A heart 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 inform the nuclear medicine physician before administration of Myoview if there is any possibility you might be pregnant, if you have a delayed menstrual period, or if you are breastfeeding.

If in doubt, it is important to consult your nuclear medicine physician who supervises the procedure.

If you are pregnant

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

Your nuclear medicine physician will only administer this medicine during pregnancy if the expected benefit outweighs the potential risk.

If you are breastfeeding

Do not breastfeed if you receive Myoview. This is because small amounts of radioactivity could pass into breast milk. If you are breastfeeding, your nuclear medicine physician may wait until you have finished breastfeeding before using Myoview. If waiting is not possible, your physician may ask you to:

• Interrupt breastfeeding for 3 to 6 hours
• Use formula feeding for your child
• Express and discard breast milk

Please consult your nuclear medicine physician about when you can resume breastfeeding.

Driving and use of machines

It is considered unlikely that Myoview will affect your ability to drive or operate machinery. Consult your physician to determine whether you may drive or use machines after receiving Myoview.

Myoview contains sodium

This medicine contains 15 – 29 mg of sodium (the main component of table/cooking salt) per reconstituted vial. This corresponds to 0.7 – 1.4% of the maximum daily sodium intake recommended for an adult.

The use of Myoview involves exposure to "radioactivity."

• Your nuclear medicine physician will always consider the potential risks and benefits before administering the medicine.

Ask your nuclear medicine physician if you have any questions.

3. How to use Myoview

There are strict regulations regarding the use, handling, and disposal of radiopharmaceuticals. Myoview will only be used in specially controlled areas. This product will only be handled and administered 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 Myoview to be used in your case. This will be the minimum quantity necessary to obtain the required information.

Administration of Myoview and performance of the procedure

The usual dose for a heart scan is:

• One injection after you have rested.
• A second injection (after at least one hour) under conditions of cardiac stress, for example, during or immediately after exercise.

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

The usual dose for a breast scan is:

• A single injection.

Duration of the procedure

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

After administration of Myoview, you should:

Urinate frequently to eliminate the product from your body.

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

If you have been given more Myoview than you should

Myoview is administered in a hospital or clinic by qualified personnel with specific training. An overdose is unlikely. However, in the event of an overdose, you will receive appropriate treatment.

If you have any further questions about the use of Myoview, ask the nuclear medicine physician supervising the procedure.

4. Possible adverse effects

Like all medicines, Myoview can cause adverse effects, although not everyone will experience them.

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

Serious adverse effects

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

Uncommon (may affect up to 1 in 100 people)

• Skin redness (rubefaction)

Rare (may affect up to 1 in 1,000 people)

• Skin rash

Frequency not known (frequency cannot be estimated from available data)

• Itching, redness, or hives
• Swelling of the face, local swelling
• Difficulty breathing, wheezing, throat tightness, cough

In more severe cases (serious allergic reactions or anaphylaxis), reactions may include:

• Fainting (loss of consciousness), feeling unstable or dizziness.

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

Other adverse effects include

Uncommon (may affect up to 1 in 100 people)

• Altered sense of taste, such as a metallic taste
• Unpleasant sensation of heat starting at the injection site
• Vomiting

Rare (may affect up to 1 in 1,000 people)

• Altered sense of smell
• Visual disturbances
• Abdominal pain, discomfort (nausea), burning sensation in the mouth

Frequency not known (frequency cannot be estimated from available data)

• Headache, dizziness
• Palpitations, chest pain
• Fever
• Increased number of leukocytes (in certain types of blood tests)

Reporting of adverse effects:

If you experience any adverse effect, consult your doctor, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Myoview

You will not be responsible for storing this medicine. This medicine is stored by the specialist under appropriate conditions. Radioactive pharmaceuticals must be stored in accordance with national regulations regarding radioactive materials.

Hospital staff will ensure that the product is stored and dispensed correctly. Do not use Myoview after the expiry date stated on the label.

The following information is intended for specialists only.

Keep Myoview out of the reach and sight of children.

Do not use Myoview after the expiry date stated on the label, after EXP. Store the product in the refrigerator at 2–8 °C. Keep in the original packaging to protect from light.

Chemical and physical in-use stability of the reconstituted injectable solution has been demonstrated for 12 hours at 2–25 °C. Store the reconstituted product below 25 °C. Do not freeze.

6. Contents of the pack and other information

The following information is intended exclusively for medical or healthcare professionals.

Composition of Myoview

• The active substance is tetrofosmin. Each Myoview vial contains 230 micrograms of tetrofosmin.
• The other components are stannous chloride dihydrate, disodium sulfosalicylate, sodium D-gluconate and sodium bicarbonate.

Appearance of the product and contents of the container

Myoview is a kit for radiopharmaceutical preparation supplied in a clear glass vial containing a powder for injectable solution. Packs are available in sizes of 2 or 5 vials; not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder

GE HEALTHCARE BIO-SCIENCES, S.A.U.

C/ Gobelas, 35-37, La Florida

28023 Madrid, Spain

Manufacturer

GE Healthcare AS

Nycoveien, 1

NO-0485 Oslo

Norway

Date of the most recent revision of this summary: 06/2023

Other sources of information

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/

Myoview is a trademark of GE Healthcare.

GE and the GE monogram are trademarks of General Electric Company.

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This information is intended solely for physicians or healthcare professionals:

The complete Summary of Product Characteristics (SmPC) for Myoview is included within the product packaging as a separate section of this patient leaflet, providing healthcare professionals with scientific and practical information on the administration and use of this radiopharmaceutical.