Patient Information Leaflet

Exametazima-Radiopharmacy 500 micrograms kit for preparation of radiopharmaceutical EFG

Exametazima

Read this leaflet carefully before you 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, ask your nuclear medicine doctor who is supervising the procedure.

- If you experience any side effects, ask your nuclear medicine doctor, even if they are not listed in this leaflet.

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

2. What you need to know before starting to use Exametazima-Radiopharmacy

3. How to use Exametazima-Radiopharmacy

4. Possible side effects

5. Storage of Exametazima-Radiopharmacy

6. Contents of the pack and additional information

This medication is a radiopharmaceutical for diagnostic use only.

Exametazima-Radiopharmacy 500 micrograms kit for radiopharmaceutical preparation is a medication called "radiopharmaceutical". It is administered before a radiological examination and helps to observe the interior 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, the 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 know if you suffer from seizures or epilepsy, Alzheimer's disease or a similar type of dementia. It can also be used in people with migraines (headaches).
• This technique can also help the doctor to investigate the cause of fever when unknown.
• It can also help your doctor to investigate foci of infection such as the abdomen (the area around the stomach).
• Some people receive this medication to see intestinal inflammation.

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

The administration of Exametazima-Radiopharmacy involves receiving a small amount of radioactivity. Your doctor and the nuclear medicine doctor have considered that the clinical benefit you will obtain from the procedure with the radiopharmaceutical outweighs the risk of radiation.

Exametazima-Radiopharmacy should not be used

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

Warnings and precautions

Be especially careful with Exametazima-Radiopharmacy

- if you are pregnant or think you may be

- if you are breastfeeding.

- if you have any liver or kidney disease.

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

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

Before the administration of Exametazima-Radiopharmacy you must:

- drink a lot of water before starting the procedure to urinate very frequently during the first hours after its completion.

Children

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

Use of Exametazima-Radiopharmacy with other medications

Inform your nuclear medicine doctor if you are taking or have recently taken other medications, 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 energy drinks), alcohol, tobacco, and medications with a known effect on cerebral blood flow.

Pregnancy and lactation

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

You must inform your nuclear medicine doctor before the administration of Exametazima-Radiopharmacy if there is any possibility of pregnancy, if you experience a delay in your period, or if you are breastfeeding.

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

If you are pregnant

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

If you are breastfeeding

Inform your nuclear medicine doctor, as they may recommend that you stop breastfeeding until the radioactive material is no longer present in your body, which should take approximately 12 hours. The milk produced during this period should be discarded.

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

Driving and operating machinery

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

Important information about some components of Exametazima-Radiopharmacy

Exametazima-Radiopharmacy contains sodium chloride.

Depending on the time of injection of the conditioning solution for the patient, it is possible that the sodium content may be higher than 1 mmol, which should be taken into account if the patient follows a low-sodium diet.

There are strict guidelines for 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. 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 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 dose for an adult varies depending on the test to be performed, and ranges from 200 to 350 MBq (megabequerelios, the unit used to express radioactivity).

Use in children and adolescents

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

Administration of Exametazima-Radiopharmacy and procedure performance

Exametazima-Radiopharmacy is administered intravenously.

One injection is sufficient to perform the procedure your doctor needs.

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

Procedure duration

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

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

After the administration of Exametazima-Radiopharmacy, you must:

- 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 physician will inform you if you need to take special precautions after this medication is administered. Consult with your nuclear medicine physician if you have any doubts.

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

It is unlikely to have an overdose because you will receive a single dose of uncontrolled 99mTc exametazima with precision by the nuclear medicine physician overseeing the procedure. However, in case of an overdose, you will receive the appropriate treatment.

Specifically, it is possible that the nuclear medicine physician in charge of the procedure will recommend that you drink plenty of water to facilitate the elimination of exametazima 99mTc from your body.

If you have any other doubts about the use of Exametazima-Radiopharmacy, ask the nuclear medicine physician overseeing the procedure.

nuclear medicine physician who oversees the procedure.

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

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

If you experience side effects, consult your nuclear medicine doctor, even if they are side effects that do not appear in this prospectus.

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

Unknown frequency: cannot be estimated from available data.

Unknown frequency

Allergic reactions:

If you experience an allergic reaction while in the hospital or clinic during the test, inform the doctor or nurse immediately. The signs may be the following:

• skin rash, itching or redness

• facial swelling

• difficulty breathing.

In more severe cases, reactions may be the following:

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

Other side effects are as follows:

Unknown frequency

• itchy rash

• headache

• dizziness

• redness

• nausea

• vomiting

• general feeling of discomfort, weakness or fatigue

• unusual sensations of numbness, tingling, prickling or burning.

This radioactive drug releases a small amount of ionizing radiation with a very low risk of cancer and genetic anomalies.

If you experience side effects, consult the nuclear medicine doctor, even if they are side effects that do not appear in this prospectus.

Reporting of side effects:

If you experience any type of side effect, consult your doctor or nurse, 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 on the safety of this medicine.

This medication does not need to be stored by you. This medication is stored under the responsibility of the specialist in suitable facilities. Radioactive material storage will be carried out in accordance with national regulations.

The following information is intended solely for the specialist.

Do not use this medication after the expiration date appearing on the packaging (after CAD).

Do not use this medication if you observe visible signs of deterioration.

Unmarked product:

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

Store in the original packaging to protect it from light.

After radiolabeling:

Do not store at a temperature above 25°C after radiolabeling.

Do not refrigerate or freeze.

Composition of Exametazima-Radiopharmacy

- The active principle is exametazima. Each vial contains 500 micrograms of

exametazima.

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

Aspect of the product and content of the packaging

This product is a kit of reagents for a radiopharmaceutical preparation.

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

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

Each package contains 3 or 6 multi-dose vials.

Sample package: 1 multi-dose vial

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing:

Holder of the marketing authorization:

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]

Responsible for manufacturing:

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 authorized in the member states of the European Economic Area with the following names:

Denmark

Medi-Exametazim

Radiopharmacy Laboratory Ltd

Gyár st. 2.

H-2040, Budaörs

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

Email: [email protected]

Germany

Medi-Exametazim 500 Mikrogramm

Radiopharmacy Laboratory Ltd

Gyár st. 2.

H-2040, Budaörs

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

Email: [email protected]

Austria

Medi-Exametazim 500 Mikrogramm

Radiopharmacy Laboratory Ltd

Gyár st. 2.

H-2040, Budaörs

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

Email: [email protected]

Spain

Exametazima-Radiopharmacy 500 microgramos

Radiopharmacy Laboratory Ltd

Gyár st. 2.

H-2040, Budaörs

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

Email: [email protected]

Portugal

Medi-Exametazime,

Radiopharmacy Laboratory Ltd

Gyár st. 2.

H-2040, Budaörs

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

Email: [email protected]

Italy

Esametazima Radiopharmacy

Radiopharmacy Laboratory Ltd

Gyár st. 2.

H-2040, Budaörs

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

Email:[email protected]

United Kingdom

Medi-Exametazime 500 microgram

Radiopharmacy Laboratory Ltd

Gyár st. 2.

H-2040, Budaörs

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

Email: [email protected]