MYOVIEW 230 micrograms KIT FOR RADIOPHARMACEUTICAL PREPARATION

Introduction

Package Leaflet: Information for the Patient

MYOVIEW 230 micrograms radiopharmaceutical preparation kit

Tetrofosmin

Read all of this leaflet carefully before this medicine is administered to you because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your nuclear medicine doctor who is supervising the procedure.
• If you experience 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 what it is used for
2. What you need to know before using Myoview
3. How to use Myoview
4. Possible side effects
5. Storage of Myoview
6. Package contents and further information

1. What Myoview is and what it is used for

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

diseases.

Myoview belongs to a group of medicines called “radiopharmaceuticals”. 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 outside the body by a special camera used in the examination.
• The examination can help your nuclear medicine doctor to check the functioning of the heart or to see heart lesions after a heart attack.
• Other people receive this medicine 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.

Administration of Myoview 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 Myoview

Myoview must 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 pregnant.

Do not use Myoview if you are in any of the above circumstances. If you are not sure, talk to your nuclear medicine doctor.

Warnings and precautions

Be especially careful with Myoview

Talk to your nuclear medicine doctor before using Myoview:

• The person to whom this medicine is administered 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 the section “Pregnancy and breastfeeding”).
• You are on a low-sodium diet.
• You are breastfeeding.

Before administration of Myoview you must:

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

Children and adolescents

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

Use of Myoview with other medicines

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

If you are going to undergo a heart examination, inform 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.
• Calcium antagonists, such as nifedipine, diltiazem or felodipine.
• Nitrates, such as glyceryl trinitrate, isosorbide mononitrate or isosorbide dinitrate.
• 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 Myoview.

Use of Myoview 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 normally.

Pregnancy and breastfeeding

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

In case of doubt, it is important that you consult your nuclear medicine doctor who supervises the procedure.

If you are pregnant

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

The nuclear medicine doctor will only administer this medicine during pregnancy if the benefit is expected to outweigh the risk.

If you are breastfeeding

You must not breastfeed if you receive Myoview. This is because small amounts of radioactivity may pass into breast milk. If you are breastfeeding, the nuclear medicine doctor may wait until you finish breastfeeding before using Myoview. If it is not possible to wait, the doctor may ask you to:

• interrupt breastfeeding for 3 to 6 hours
• use formula feed for your child
• express breast milk and discard it

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

Driving and using machines

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

Myoview contains sodium

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

Ask your nuclear medicine doctor if you have any questions.

3. How to use Myoview

There are strict rules about the use, handling, and disposal of radiopharmaceuticals. Myoview 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. These 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 Myoview to be used in your case. This will be the minimum amount necessary to obtain the desired information.

Administration of Myoview and performance of the procedure

The usual dose for a heart examination is:

• A single injection after you have rested.
• A second injection (at least one hour later) in a situation of cardiac stress, for example, during or immediately after exercise.

The order of the two injections may be reversed for some people. Other people only need a single injection. In some cases, the nuclear medicine doctor may decide that it is better to administer the two injections on different days.

The usual dose for a breast examination 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 Myoview, 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 this medicine is administered. Consult your nuclear medicine doctor if you have any questions.

If you have been administered more Myoview than you should

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

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

4. Possible side effects

Like all medicines, Myoview can cause side effects, although not everybody gets them.

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

Serious side effects

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

Uncommon (may affect up to 1 in 100 people)

• Redness of the skin (flushing)

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

• Rash

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

• itching, redness or hives
• swelling of the face, local swelling
• difficulty breathing, wheezing, throat tightness, cough

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

• 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.

Other side effects are

Uncommon (may affect up to 1 in 100 people)

• alteration of taste, such as metallic taste
• unpleasant feeling of heat that starts at the injection site
• vomiting

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

• alteration of smell
• visual disturbance
• abdominal pain, discomfort (nausea), burning sensation in the mouth

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

• headache, dizziness
• palpitations, chest pain
• fever
• increase in white blood cell count (in some types of blood tests)

Reporting of side effects:

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

5. Storage of Myoview

You will not have 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.

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 only for specialists.

Keep Myoview out of the reach and sight of children.

Do not use Myoview after the expiry date stated on the label, after CAD. Store the product in the refrigerator at 2-8 ºC. Keep in the original package to protect from light.

The chemical and physical stability of the reconstituted injectable solution has been demonstrated for 12 hours at 2-25 ºC. Store the reconstituted product below 25 ºC. Do not freeze.

6. Package contents and further information

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

Composition of Myoview

• The active ingredient is tetrofosmin. Each vial of Myoview contains 230 micrograms of tetrofosmin.
• The other components are tin(II) chloride dihydrate, sodium sulfoisophthalate, sodium D-gluconate, and sodium bicarbonate.

Appearance of the product and package contents

Myoview is a radiopharmaceutical preparation kit that is supplied in a colorless glass vial containing a powder for injectable solution. The packages are available in sizes of 2 or 5 vials; not all package 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 last revision of this leaflet: 06/2023

Other sources of information

Detailed information on this medicine 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 only for doctors or healthcare professionals:

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