EXAMETAZIMA RADIOPHARMACY 500 MICROGRAMS RADIOPHARMACEUTICAL PREPARATION KIT

Introduction

Package Leaflet: Information for the Patient

Exametazima-Radiopharmacy 500 micrograms kit for radiopharmaceutical preparation

radiofarmaceutical EFG

Exametazima

Read all of 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 is supervising the procedure.
• If you experience side effects, ask your nuclear medicine doctor, even if you think they are not related to this medicine.

Contents of the package leaflet:

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

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

This medicine is a radiopharmaceutical for diagnostic use only.

Exametazima-Radiopharmacy 500 micrograms kit for radiopharmaceutical preparation is a medicine called a "radiopharmaceutical". It is given before a radiological examination and helps to observe the inside of the body using a special camera.

• It contains an active ingredient 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 the scanner.
• This technique allows the doctor to observe the amount of blood flowing through the brain, and may be important after a stroke, to determine if you have seizure disorders or epilepsy, Alzheimer's disease or a similar type of dementia. It can also be used in people with migraine (headaches).
• This technique can also help the doctor investigate fever when the cause is unknown.
• It can also help your doctor investigate infection sites such as the abdomen (the area around the stomach).
• Some people receive this medicine to see intestinal inflammation.

Your nuclear medicine doctor will explain which part of your body will be scanned.

Administration of Exametazima-Radiopharmacy 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 you are given Exametazima-Radiopharmacy

Exametazima-Radiopharmacy must not be used

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

Warnings and precautions

Be particularly careful with Exametazima-Radiopharmacy

• if you are pregnant or think you may be pregnant
• if you are breast-feeding.
• if you have any liver or kidney disease.

Handling human cells (leukocyte labeling) carries a risk of infection transmission (HBV, HIV, etc.).

Your nuclear medicine doctor will inform you if you need to take special precautions after using this medicine. If you have any doubts, ask your nuclear medicine doctor.

Before administration of Exametazima-Radiopharmacy you should:

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

Children

Tell your nuclear medicine doctor if you are under 18 years old.

Using Exametazima-Radiopharmacy with other medicines

Tell your nuclear medicine doctor 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, drinks, and alcohol

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

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or plan to become pregnant, consult your nuclear medicine doctor before you are given this medicine.

You must inform your nuclear medicine doctor before administration of Exametazima-Radiopharmacy if there is any possibility that you may be pregnant, if you have a delayed period, or if you are breast-feeding.

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

If you are pregnant

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

If you are breast-feeding

Tell your nuclear medicine doctor, as you may be advised to stop breast-feeding until you no longer have radioactivity in your body, which should be about 12 hours. Breast milk produced during this period should be discarded.

Please consult your nuclear medicine doctor when you can resume breast-feeding.

Driving and using machines

It is considered unlikely that Exametazima-Radiopharmacy will affect your ability to drive or use machines.

Important information about some components of Exametazima-Radiopharmacy

Exametazima-Radiopharmacy contains sodium chloride.

Depending on the time of injection preparation for the patient, the sodium content may be higher than 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 rules about the use, handling, and disposal of radiopharmaceuticals. Exametazima-Radiopharmacy will only be used in specially 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 Exametazima-Radiopharmacy 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 varies depending on the test to be 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 amount to be administered will be adjusted according to their 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 that your doctor needs.

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 doctor will inform you about the usual duration of the procedure.

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

After administration of Exametazima-Radiopharmacy, you should:

• avoid direct contact with small children and pregnant women during the 12 hours after the injection.
• urinate frequently to eliminate the product from your body.

Your nuclear medicine doctor will inform you if you need to take special precautions after you are given this medicine. Consult your nuclear medicine doctor if you have any doubts.

If you have been given more Exametazima-Radiopharmacy than you should

Overdose is unlikely because you will receive a single dose of 99mTc exametazima precisely controlled by the nuclear medicine doctor supervising the procedure. However, in case of overdose, you will receive appropriate treatment.

In particular, the nuclear medicine doctor in charge of the procedure may recommend that you drink plenty of water to facilitate the elimination of 99mTc exametazima from your body.

If you have any further questions about the use of Exametazima-Radiopharmacy, ask your nuclear medicine doctor.

4. Possible side effects

Like all medicines, this medicine 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 abnormalities.

If you experience side effects, ask your nuclear medicine doctor, even if you think they are not related to this medicine.

The frequency of adverse reactions is defined as follows:

Very common: affects more than 1 in 10 people

Common: affects between 1 and 10 in 100 people

Uncommon: affects between 1 and 10 in 1,000 people

Rare: affects between 1 and 10 in 10,000 people

Very rare: affects less than 1 in 10,000 people

Frequency not known: cannot be estimated from the available data.

Frequency not known

Allergic reactions:

If you experience an allergic reaction while you are in the hospital or clinic having the test, tell the doctor or nurse immediately. The signs may be:

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

In more severe cases, the reactions can be:

• fainting (loss of consciousness), feeling dizzy or lightheaded.

Other side effects are:

Frequency not known

• hives with itching
• headache
• feeling dizzy
• flushing
• nausea
• vomiting
• general feeling of discomfort, weakness or fatigue
• unusual sensations of numbness, tingling, prickling or burning.

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

If you experience side effects, ask your nuclear medicine doctor, even if you think they are not related to this medicine.

Reporting of side effects:

If you experience any side effects, tell your doctor or nurse, even if you think they are not related to this medicine. You can also report side effects 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 Exametazima-Radiopharmacy

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.

The following information is intended only for the specialist.

Do not use this medicine after the expiry date stated on the packaging (after EXP).

Do not use this medicine if you notice visible signs of deterioration.

Unmarked product:

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

Store in the original packaging to protect from light.

After radiolabeling:

Do not store above 25°C after radiolabeling.

Do not refrigerate or freeze.

6. Contents of the pack and other information

Composition of Exametazima-Radiopharmacy

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

exametazima.

• The other ingredients are: tin(II) chloride dihydrate, sodium pyrophosphate

decahydrate and nitrogen.

Appearance and packaging of the product

This product is a kit for radiopharmaceutical preparation.

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

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

Each pack contains 3 or 6 multidose vials.

Sample packaging: 1 multidose vial

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer:

Marketing authorisation holder:

RADIOPHARMACY LABORATORY Ltd

2040 Budaörs, Gyár st. 2 Hungary

(Budaörs Industrial and Technology Park

Gutenberg st. 125)

Phone: +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

Phone: +36-23-521-261

Fax: +36-23-521-260

Email: [email protected]

This medicine is authorised in the Member States of the European Economic Area under the following names:

You can ask for more information about this medicine from the local representative of the marketing authorisation holder:

Date of last revision of this leaflet:May 2017

Other sources of information

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

The leaflet for this medicine can be found on the European Medicines Agency website in all languages of the European Union/European Economic Area.

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This information is intended only for healthcare professionals:

The complete technical leaflet for Exametazima-Radiopharmacy is included in 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.