THALLIUM CHLORIDE (201 Tl) CIS BIO INTERNATIONAL 37 MBq/mL INJECTABLE SOLUTION

Introduction

Leaflet: information for the patient

Thallous chloride (201Tl) CIS bio international 37 MBq/ml injectable solution

Thallous chloride (201Tl)

Read this leaflet carefully before you are given this medicine 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 will be supervising the procedure
• If you experience any side effects, talk to your nuclear medicine doctor, even if they are not listed in this leaflet. See section 4

Contents of the leaflet:

1. What Thallous chloride (201Tl) CIS bio international is and what it is used for
2. What you need to know before using Thallous chloride (201Tl) CIS bio international
3. How to use Thallous chloride (201Tl) CIS bio international
4. Possible side effects
5. Storage of Thallous chloride (201Tl) CIS bio international
6. Package contents and further information

1. What Thallous chloride (201Tl) CIS bio international is and what it is used for

This medicine is a radiopharmaceutical for diagnostic use only.

When injected, certain organs in the body absorb it quickly. Since the product contains a small amount of radioactivity, it can be made visible from outside the body using special cameras, and a picture can be taken (this is called scintigraphy). This scintigraphy shows how the radioactivity has spread in the organ, which can give the doctor valuable information about the shape of the organ and its function.

Thallous chloride (201Tl) CIS bio international is used to obtain an image that examines:

• the heart. These tests provide information about heart perfusion, cell quality, and cardiac muscle function
• leg muscles, to examine blood flow in the muscles in a particular disease where the arteries of the limbs are narrowed (peripheral vascular disorder)
• parathyroid glands
• or certain tumors that are known to capture thallium, such as brain and thyroid tumors and metastases

Administration of Thallous chloride (201Tl) CIS bio international involves receiving a small amount of radioactivity. Your doctor and nuclear medicine doctor have considered that the clinical benefit you will get from the procedure with the radiopharmaceutical outweighs the risk of radiation.

2. What you need to know before using Thallous chloride (201Tl) CIS bio international

Thallous chloride (201Tl) CIS bio international must not be used:

• If you are allergic to Thallous chloride (201Tl) or any of the other components of this medicine (listed in section 6)
• If you are pregnant
• If you are breastfeeding
• If you are under 18 years old
• With some cardiac tests, you have to do exercises that make your heart work harder. The nuclear medicine specialist will only consider this type of test if they are sure that the exercise is not dangerous for you

Warnings and precautions

Talk to your nuclear medicine doctor before you are given Thallous chloride (201Tl) CIS bio international if you have reduced kidney or liver function

Before administration of Thallous chloride (201Tl) CIS bio international you must:

• drink plenty of water before starting the procedure to urinate frequently during the first hours after its completion
• fast for at least 4 hours in case your heart is examined

Using Thallous chloride (201Tl) CIS bio international with other medicines

Tell your nuclear medicine doctor if you are taking or have recently taken any other medicines, as some medicines may interfere with the test or with the interpretation of the images. Your nuclear medicine doctor will tell you if you need to stop taking certain medicines before the procedure and for how long

Some examples are:

• products containing xanthinessuch as certain medicines for treating migraines and theophylline(medicine for treating asthma and other respiratory diseases)
• dipyridamole: medicine for reducing blood clotting
• medicines known as beta-blockers. These are used to treat high blood pressure, heart disease, or other diseases, and have active substance names that end in “olol”
• medicines known as nitrates, for treating chest pain due to narrowing of the heart's blood vessels, irregular heartbeats, or high blood pressure
• medicines known as calcium channel blockers, for treating high blood pressure and certain heart conditions
• medicines containing digitalis, such as digoxin, for treating heart failure

Thallous chloride (201Tl) CIS bio international with drinks

Depending on the type of test, it may be necessary to avoid caffeinated drinks for at least 12 hours before the procedure. Your doctor will indicate if this is necessary in your case

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, talk to your nuclear medicine doctor before you are given this medicine

You must inform the nuclear medicine specialist before administration of Thallous chloride (201Tl) CIS bio international if there is any possibility that you may be pregnant, if you have a delayed or missed period, or if you are breastfeeding. In case of doubt, it is important to consult the nuclear medicine specialist who will be supervising the procedure

• If you are pregnant:

The nuclear medicine doctor will notgive you this medicine during pregnancy, as it could harm the fetus

• If you are breastfeeding:

Tell your doctor if you are breastfeeding your child, as you may need to delay the procedureuntil breastfeeding has stopped. If the procedure cannot be postponed, you will need to interrupt breastfeeding for 2 daysand discard this milk, until the radioactivity is no longer in your body

Please ask your nuclear medicine doctor when you can resume breastfeeding

Driving and using machines

It is considered unlikely that Thallous chloride (201Tl) CIS bio international will affect your ability to drive or use machines

Thallous chloride (201Tl) contains sodium

This medicine contains 3.3 mg of sodium (main component of table/cooking salt) per mL

This is equivalent to 0.17% of the maximum recommended daily sodium intake for an adult

3. How to use Thallous chloride (201Tl) CIS bio international

There are strict rules on the use, handling, and disposal of radiopharmaceuticals. Thallous chloride (201Tl) CIS bio international 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 Thallous chloride (201Tl) CIS bio international to be used in your case. This will be the minimum amount necessary to obtain the desired information

The generally recommended amount to administer to an adult is 50 to 110 MBq (MBq: megabecquerel, unit used to express radioactivity)

Administration of Thallous chloride (201Tl) CIS bio international and performance of the procedure

Thallous chloride (201Tl) CIS bio international will be administered by intravenous injection

Normally, one injection is sufficient to provide the information your nuclear medicine doctor needs, although sometimes a second injection may be necessary

The injection can be administered at rest or during physical exercise. You may also be given a medicine that makes your heart work harder

Duration of the procedure

Your nuclear medicine doctor will inform you of the usual duration

After administration of Thallous chloride (201Tl) CIS bio international you must

• urinate frequentlyto eliminate the product from the body

The nuclear medicine doctor supervising the procedure will inform you if you need to take any special precautions after receiving this medicine. Contact the nuclear medicine doctor supervising the procedure if you have any doubts

If you are given more Thallous chloride (201Tl) CIS bio international than you should

An overdose is unlikely because Thallous chloride (201Tl) CIS bio international is administered by a doctor under strictly controlled conditions. However, in case of overdose, you will receive the appropriate treatment. The nuclear medicine doctor may recommend that you drink plenty of water and urinate frequently to eliminate the radioactivity from your body

If you have any further questions about the use of Thallous chloride (201Tl) CIS bio international, ask the nuclear medicine doctor supervising the procedure

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them

The following side effects have been reported as a result of the administration of Thallous chloride (201Tl) CIS bio international (frequency not known (cannot be estimated from the available data)):

• Allergic reactions with symptoms such as

• Laryngeal spasm
• Pharyngeal inflammation
• Swelling in various places, such as the face, larynx, tongue
• Difficulty breathing
• Redness of the skin, rash, pustules, itching, urticaria, skin pain
• Hypersensitivity
• Facial pain
• Eye inflammation, causing itching, tearing, or redness of the eye
• Alteration of tear flow
• Redness
• Increased sweating
• Cough

• Fainting or experiencing symptoms such as

• Dizziness
• Slow heartbeat
• Low blood pressure
• Tremors
• Headache
• Pallor

• Reaction at the injection site such as local swelling, pain, redness, or other reactions at the injection site
• Local tissue damage (necrosis) has been reported in cases where the injection was not administered into a vein

Thallous chloride (201Tl) is often used in combination with a cardiac stress test. The cardiac stress test can cause certain cardiac symptoms, such as palpitations, anomalies in the cardiac tracing (ECG), irregular heartbeats, chest pain, difficulty breathing, and ultimately, a heart attack. Other symptoms related to induced stress are high or low blood pressure, chills, taste disorders, nausea, vomiting, and fatigue or general malaise

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

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, 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 Thallous chloride (201Tl) CIS bio international

You will not need 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

6. Package contents and further information

Composition of Thallous chloride (201Tl) CIS bio international

• The active substance is thallous chloride (201Tl)

Each mL contains 37 MBq of thallous chloride (201Tl) at the date and time of calibration

• The other components are sodium chloride and water for injectable preparations

Appearance of the product and package contents

Thallous chloride (201Tl) CIS bio international is presented as an injectable solution

Package size: 1 multidose vial

Marketing authorization holder and manufacturer:

CIS bio international

BP 32 - 91192 Gif sur Yvette Cedex

France

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Curium Pharma Spain, S.A.

Avda. Dr. Severo Ochoa, 29

28100-Alcobendas

Phone: 91 4841989

Date of last revision of this leaflet: March 2024

This information is intended only for healthcare professionals:

The complete technical data sheet of Thallous chloride (201Tl) CIS bio international is included as a separate document in the product packaging, in order to provide healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical

Please consult the technical data sheet [the technical data sheet must be included in the box]