Exametazime Radiopharmacy 500 micrograms radiopharmaceutical preparation kit EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Exametazima-Radiopharmacy 500 micrograms reagent kit for radiopharmaceutical preparation EFG

Exametazima

Read all of this 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 effects, consult your nuclear medicine physician, even if they are effects not listed in this leaflet.

Contents of this leaflet:

1. What Exametazima-Radiopharmacy is and what it is used for
2. What you need to know before being given Exametazima-Radiopharmacy
3. How Exametazima-Radiopharmacy is used
4. Possible side effects
5. How to store Exametazima-Radiopharmacy
6. Contents of the pack and other information

1. What Exametazima-Radiopharmacy is and what it is used for

This medicine is a radiopharmaceutical for diagnostic use only.

Exametazima-Radiopharmacy 500 micrograms, kit for radiopharmaceutical preparation, is a medicine known as a "radiopharmaceutical". It is administered before a radiological scan and helps visualize the inside of the body using a special camera.

• It contains an active substance called "exametazima", which is mixed with another ingredient called "technetium" before use.
• Once injected, your body can be visualized using a special camera used in scanning.
• This technique allows the doctor to observe blood flow in the brain, and may be important following a stroke, to determine whether you have seizures or epilepsy, Alzheimer's disease, or a similar type of dementia. It may also be used in people with migraine (headaches).
• This technique can also help the doctor investigate fever when its cause is unknown.
• It may also help your doctor investigate sites of infection such as in the abdomen (the area around the stomach).
• Some people receive this medicine to assess intestinal inflammation.

The nuclear medicine physician will explain which part of your body will be scanned.

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

2. What you need to know before using Exametazima-Radiopharmacy

Exametazima-Radiopharmacy must not be used

if you are allergic to the active substance or to any of the other components of this medicine (listed in section 6).

Warnings and precautions

Take special care with Exametazima-Radiopharmacy

• if you are pregnant or think you might be pregnant
• if you are breastfeeding
• if you have any liver or kidney disease.

The handling of human cells (leukocyte labelling) carries a risk of transmission of infections (HBV, HIV, etc.).

The nuclear medicine physician will inform you whether you need to take special precautions after using this medicine. If you have any doubts, consult your nuclear medicine physician.

Before administration of Exametazima-Radiopharmacy you should:

• drink plenty of water before starting the procedure in order to urinate frequently during the first hours after completion.

Children

Inform your nuclear medicine physician if you are under 18 years of age.

Use of Exametazima-Radiopharmacy with other medicines

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

Exametazima-Radiopharmacy with food, beverages and alcohol

Before the test, avoid excessive consumption of stimulants (caffeine, cola and energy drinks), alcohol, tobacco, and medications with a known effect on cerebral blood flow.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your nuclear medicine physician before this medicine is administered to you.

You must inform the nuclear medicine physician before administration of Exametazima-Radiopharmacy if there is any possibility you might be pregnant, if you have missed a period, or if you are breastfeeding.

If in doubt, it is important that you consult your nuclear medicine physician supervising the procedure.

If you are pregnant

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

If you are breastfeeding

Inform your nuclear medicine physician, as they may advise you to stop breastfeeding until the radioactivity has cleared from your body, which takes approximately 12 hours. Breast milk produced during this period should be discarded.

Please consult your nuclear medicine physician regarding when you may resume breastfeeding.

Driving and use of machines

Exametazima-Radiopharmacy is considered unlikely to affect your ability to drive or operate machinery.

Important information about some components of Exametazima-Radiopharmacy

Exametazima-Radiopharmacy contains sodium chloride.

Depending on the timing of the patient's conditioning injection, the sodium content may exceed 1 mmol, which should be taken into account if the patient is on a low-sodium diet.

3. How to use Exametazima-Radiopharmacy

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

The generally recommended dose for administration in adults varies depending on the type of test being performed and ranges from 200 to 350 MBq (megabecquerels, the unit used to express radioactivity).

Use in children and adolescents

In children and adolescents, the administered dose will be adjusted according to body weight.

Administration of Exametazima-Radiopharmacy and performance of the procedure

Exametazima-Radiopharmacy is administered intravenously.

A single injection is sufficient to perform the procedure required by your physician.

After the injection, you will be offered a drink and asked to urinate immediately before starting the procedure.

Duration of the procedure

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

The ready-to-use solution will be injected into a vein prior to the scintigraphy. Depending on the type of test, imaging will be performed between 30 minutes and 24 hours after injection.

After administration of Exametazima-Radiopharmacy, you should:

• avoid direct contact with young children and pregnant women for 12 hours after the injection.
• urinate frequently to help 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 Exametazima-Radiopharmacy than you should have received

An overdose is unlikely because you will receive a single, precisely controlled dose of 99mTc exametazime, administered under the supervision of the nuclear medicine physician. However, in the event of an overdose, appropriate treatment will be provided.

Specifically, the nuclear medicine physician in charge of the procedure may recommend that you drink plenty of water to facilitate the elimination of 99mTc exametazime from your body.

If you have any further questions about the use of Exametazima-Radiopharmacy, please consult the nuclear medicine physician supervising the procedure.

4. Possible adverse effects

Like all medicines, this medicinal product may cause adverse effects, although not everyone will experience them.

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

If you experience any adverse effects, consult your nuclear medicine physician, even if they are adverse effects not listed in this leaflet.

The frequency of adverse reactions is defined as follows:

Very common: affects more than 1 in 10 people
Common: affects 1 to 10 in 100 people
Uncommon: affects 1 to 10 in 1,000 people
Rare: affects 1 to 10 in 10,000 people
Very rare: affects less than 1 in 10,000 people
Frequency not known: cannot be estimated from available data.

Frequency not known

Allergic reactions:

If you experience an allergic reaction while at the hospital or clinic undergoing the test, inform the doctor or nurse immediately. Signs may include:

• skin rash, itching, or flushing
• swelling of the face
• difficulty breathing.

In more severe cases, reactions may include:

• fainting (loss of consciousness), dizziness, or lightheadedness.

Other adverse effects include:

Frequency not known

• itchy rash (hives)
• headache
• dizziness
• flushing
• nausea
• vomiting
• general malaise, weakness, or fatigue
• unusual sensations of numbness, tingling, prickling, or burning.

This radiopharmaceutical emits a small amount of ionizing radiation, with a very low risk of cancer and hereditary abnormalities.

If you experience any adverse effects, consult your nuclear medicine physician, even if they are adverse effects not listed in this leaflet.

Reporting of adverse effects:

If you experience any adverse effects, speak to your doctor or nurse, even if they are possible adverse effects not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Exametazime-Radiopharmacy

You will not be required to store this medicinal product. This medicine is stored under the responsibility of a specialist in appropriate facilities. Storage of radiopharmaceuticals must comply with national regulations concerning radioactive materials.

The following information is intended for specialists only.

Do not use this medicinal product after the expiry date stated on the container (after EXP).

Do not use this medicinal product if there are any visible signs of deterioration.

Unlabelled product:

Store between 2°C and 8°C. Do not freeze.

Keep in the original packaging to protect from light.

After radiolabelling:

Do not store above 25°C after radiolabelling.

Do not refrigerate or freeze.

6. Contents of the pack and other information

Composition of Exametazima-Radiopharmacy

• The active substance is exametazima. Each vial contains 500 micrograms of

exametazima.

• The other components are: tin(II) chloride dihydrate, tetrasodium pyrophosphate decahydrate and nitrogen.

Appearance of the product and contents of the pack

This product is a reagent kit for a radiopharmaceutical preparation.

Exametazima-Radiopharmacy is a white lyophilized powder. The injection is prepared from the vial immediately before administration.

Exametazima-Radiopharmacy consists of exametazima, which must be dissolved in a solution and combined with radioactive technetium prior to use as an injection. Once the radioactive substance, sodium pertechnetate (99mTc), is added to the vial, technetium (99mTc) exametazima is formed. This solution is then ready for use.

Each pack contains 3 or 6 multidose vials.

Sample pack: 1 multidose vial

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder:

RADIOPHARMACY LABORATORY Ltd

2040 Budaörs, Gyár st. 2 Hungary

(Budaörs Industrial and Technology Park

Gutenberg st. 125)

Telephone: +36-23-886-950, 886-951

Fax: +36-23-886-955

Email: [email protected]

Manufacturer:

MEDI-RADIOPHARMA LTD

H-2030 Érd Szamos u. 10-12

Hungary

Telephone: +36-23-521-261

Fax: +36-23-521-260

Email: [email protected]

This medicinal product is authorized in the Member States of the European Economic Area

under the following names:

You can request further information about this medicinal product by contacting the local representative of the

Marketing Authorization Holder:

Date of the latest review of this leaflet: May 2017

Other sources of information

Detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu

This leaflet is available on the European Medicines Agency website in all languages of the European Union/European Economic Area.

This information is intended for healthcare professionals only:

The full Summary of Product Characteristics for Exametazima-Radiopharmacy is included in a separate document within the product packaging, providing healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical.