Patient Information Leaflet

MYOVIEW 230 micrograms kit for radiopharmaceutical preparation

Tetrofosmina

Read this leaflet carefully beforeyou receive 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 doctor who is supervising the procedure.
• If you experience any side effects, consult your nuclear medicine doctor, even if they are not listed in this leaflet. See section 4.

Contents of theleaflet:

1. What Myoview is and how it is used

2. What you need to know before using Myoview

3. How to use Myoview

4. Possible side effects

5. Storage of Myoview

6. Contents of the package and additional information

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

Myoview belongs to a group of medications called “radioactive pharmaceuticals.” It is administered before an examination and helps a special camera to see inside a part of the body.

• It contains the active ingredient called “tetrofosmin”. 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 or nurse will explain which part of your body will be examined.

The administration of Myoview involves receiving a small amount of radioactivity. Your doctor and the nuclear medicine doctor have considered the clinical benefit you will obtain from the procedure with the radioactive pharmaceutical to outweigh the risk of radiation.

Myoview should not be used:

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

Do not use Myoview if you are in any of the above circumstances. If you are unsure, speak with your nuclear medicine doctor.

Warnings and precautions

Be especially careful with Myoview

Speak with your nuclear medicine doctor before using Myoview:

• The person to whom this medication will be administered is a child or adolescent.
• You have a delayed menstrual period. This may indicate that you are pregnant and, therefore, should not receive Myoview (see the section “Pregnancy and breastfeeding”).
• You are following a low-sodium diet.
• You are breastfeeding.

Before Myoview administration, you must:

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

Children and adolescents

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

Use of Myoview with other medications

Inform your nuclear medicine doctor if you are taking or have taken recently or may need to take any other medication, as some medications may interfere with image interpretation.

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

• Beta blockers, such as atenolol, bisoprolol, or propranolol.
• Calcium antagonists, such as nifedipine, diltiazem, or felodipine.
• Nitrates, such as glyceryl trinitrate, isosorbide mononitrate, or isosorbide dinitrate.
• Any medication for high blood pressure, the heart, or heart failure.

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

Use of Myoview with food and beverages

If you are 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 day of the examination.
• A breast examination: you may eat and drink normally.

Pregnancy and breastfeeding

You must inform your nuclear medicine doctor before Myoview administration if there is any possibility that you may be pregnant, if you have a delayed menstrual period, or if you are breastfeeding.

It is essential to consult with your nuclear medicine doctor who will oversee the procedure in case of doubt.

If you are pregnant

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

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

If you are breastfeeding

Do not breastfeed if you receive Myoview. This is because small amounts of radioactivity may pass to the mother's milk. If you are breastfeeding, your nuclear medicine doctor may wait until you have finished breastfeeding before using Myoview. If this is not possible, your nuclear medicine doctor may ask you to:

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

Please consult with your nuclear medicine doctor when you can resume breastfeeding.

Driving and operating machinery

It is considered unlikely that Myoview will affect your ability to drive or operate machinery.Consult your doctor if you can drive or operate machinery after receiving Myoview.

Myoview contains sodium

This medication contains 15 – 29 mg of sodium (main component of table salt/for cooking) per reconstituted vial. This is equivalent 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 doctor will always consider the possible risks and benefits before administering the medication.

Ask your nuclear medicine doctor if you have any doubts.

There are strict guidelines for the use, handling, and disposal of radiopharmaceuticals. Myoview will be used only in specially controlled areas. This product will only be handled and administered by trained and qualified personnel to use it safely. 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 Myoview to be used in your case. This will be the minimum amount necessary to obtain the desired information.

Administration of Myoview and procedure performance

The usual dose for a heart scan is:

• One injection after resting.
• A second injection (at least one hour after the first) in a situation of cardiac stress, for example, during or immediately after exercise.

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

The usual dose for a breast scan is:

• One single injection.

Procedure duration

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

After Myoview 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 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 the appropriate treatment.

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

Like all medicines, Myoview may cause side effects, although not everyone will experience them.

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

Severe side effects

If you experience an allergic reaction while in the hospital or clinic undergoing the examination, inform the nuclear physician immediately. The signs and symptoms may be:

Rare (may affect up to 1 in 100 people)

• Redness of the skin (erythema)

Very rare (may affect up to 1 in 1,000 people)

• Skin rash

Frequency unknown (the frequency cannot be estimated from the available data)

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

In more severe cases (severe allergic reactions or anaphylaxis), the reactions may consist of:

• Loss of consciousness, feeling of instability or dizziness.

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

Other side effects are

Rare (may affect up to 1 in 100 people)

• Alteration of taste, such as a metallic taste
• Unpleasant sensation of heat that begins at the site of injection
• Vomiting

Very rare (may affect up to 1 in 1,000 people)

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

Frequency unknown (the frequency cannot be estimated from the available data)

• Headache, dizziness
• Palpitations, chest pain
• Fever
• Increased white blood cell count (in some types of blood tests)

Reporting of side effects:

If you experience any type of side effect, consult your doctor, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information about the safety of this medication.

This medication does not need to be stored by the patient. This medication is 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.

The hospital staff will ensure that the product is stored and dispensed correctly. Do not use Myoview after the expiration date that appears on the label.

The following information is intended solely for the specialist.

Keep Myoview out of the reach and sight of children.

Do not use Myoview after the expiration date that appears on the label, after CAD. Store the product in the refrigerator at 2-8 °C. Keep in the original packaging to protect it from light.

The chemical and physical stability of the use 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.

The following information is exclusively directed to medical or healthcare professionals.

Composition of Myoview

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

Appearance of the product and contents of the packaging

Myoview is a radiopharmaceutical preparation kit supplied in an colourless glass vial containing an injectable solution powder. The packaging is presented in sizes of 2 or 5 vials; not all packaging sizes may be commercially available.

Marketing authorization holder and manufacturer responsible:

Marketing authorization holder

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

C/ Gobelas, 35-37, La Florida

28023 Madrid, Spain

Manufacturer responsible

GE Healthcare AS

Nycoveien, 1

NO-0485 Oslo

Norway

Last review date of this prospectus: 06/2023

Other sources of information

The detailed information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.es/

Myoview is a commercial brand of GE Healthcare.

GE and the GE monogram are commercial brands of General Electric Company.

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This information is intended solely for doctors or healthcare professionals:

The complete technical data sheet of Myoview is included in the product packaging, as a separate section of this prospectus, in order to provide healthcare professionals with scientific and practical information on the administration and use of this radiopharmaceutical.