Exametascand

Package leaflet: Information for the user

ExametaScan 500 micrograms

radiopharmaceutical preparation kit
Hexamethylenepropylene amine oxime
Please 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 questions, ask the nuclear medicine physician who will perform your procedure.
• If you experience any side effects, contact the nuclear medicine physician. This includes any side effects not listed in this leaflet.

Contents of this leaflet

1. What ExametaScan is and what it is used for
2. Before you are given ExametaScan
3. How ExametaScan is used
4. Possible side effects
5. How to store ExametaScan
6. Contents of the pack and other information

1. What ExametaScan is and what it is used for

This medicinal product is a radiopharmaceutical for diagnostic use only.
ExametaScan 500 micrograms kit for radiopharmaceutical preparation is a radiopharmaceutical product. It is administered prior to an imaging procedure and helps a special camera to visualize the inside of your body.

• It contains an active substance called “exametazime”. Before use, this is mixed with another compound called “technetium”. Once injected, ExametaScan can be detected from outside your body using a special camera employed during the imaging procedure.
• The scan can help the doctor assess blood flow in your brain. This may be important in determining, after a stroke, whether you have seizures or epilepsy, Alzheimer's disease, or a similar type of dementia. It may also be used in individuals suffering from migraine (headache).
• The scan can help the doctor evaluate fever when the cause of the fever is unknown.
• The scan may also assist the doctor in identifying sites of infection, such as in your abdomen (the area around the stomach).
• This medicine is administered to many patients to visualize intestinal inflammation (inflammatory swelling). The nuclear medicine physician will specify which part of your body will be examined. Use of ExametaScan involves exposure to small amounts of radioactivity. Your doctor and the nuclear medicine physician have determined that the clinical benefit obtained from the radiopharmaceutical procedure outweighs the radiation risk.

2. What you need to know before using ExametaScan

Do not use ExametaScan

• if you are allergic to exametazime or to any of the excipients of this medicine (listed in section 6) Warnings and precautions Take special care with ExametaScan
• if you are pregnant or think you might be
• if you are breastfeeding
• if you have liver or kidney disease The handling of human cells (leukocyte labelling) carries a potential risk of transmission of infections (HBV, HIV, etc.) The nuclear medicine physician will inform you if any special precautions are necessary after using this medicine. Speak with the nuclear medicine physician if you have any questions. Before administration of ExametaScan you must: Drink plenty of water before starting the procedure to urinate as frequently as possible during the first few hours after the examination Children If you are under 18 years of age, speak with the nuclear medicine physician. Use of ExametaScan with other medicines Inform the nuclear medicine physician if you are taking or have recently taken any other medicines, as they might interfere with the interpretation of the images. Use of ExametaScan with food, drinks and alcohol Avoid excessive stimulants (such as caffeine, cola and energy drinks), alcohol, smoking, and any medicines known to affect cerebral blood flow prior to imaging. Pregnancy and breastfeeding If you are breastfeeding or pregnant, think you might be, or are planning to have a child, consult the nuclear medicine physician for advice before taking this medicine. If there is any possibility that you are pregnant, if you have missed a menstrual period or if you are breastfeeding, you must inform the nuclear medicine physician before administration of ExametaScan. In case of doubt, it is important to consult the nuclear medicine physician who will supervise your procedure.

If you are pregnant
The nuclear medicine physician will administer the medicine during pregnancy only if the expected benefit outweighs the potential risks.
If you are breastfeeding
Consult the nuclear medicine physician, as they will advise you to stop breastfeeding until radioactivity has cleared from your body. This takes approximately 12 hours. Breast milk produced during this time must be discarded.
Ask the nuclear medicine physician when it is safe to resume breastfeeding.
Driving and use of machines
It is considered unlikely that ExametaScan will affect your ability to drive or operate machinery.
Important information about some excipients in ExametaScan
ExametaScan contains Sodium Chloride
Depending on timing, the amount of sodium administered to the patient with the injection may exceed 1 mmol in some cases. This should be taken into account in patients on a low-sodium diet.

3. How to use ExametaScan

There are strict regulations regarding the use, handling, and disposal of radiopharmaceuticals.
ExametaScan will be used exclusively in designated controlled areas. This product must be
handled and administered by trained and qualified personnel who are experienced in its safe use. These
individuals will take particular care in the safe handling of this medicinal product and will keep you
informed about their actions.
The nuclear medicine physician overseeing the procedure will determine the amount of ExametaScan
to be used in your case, which will be the minimum quantity necessary to achieve the desired diagnostic result.
The generally recommended administered activity in adults varies depending on the type of test to be performed,
and ranges between 200 and 350 MBq (Megabecquerel – a unit of radioactivity measurement).

Use in children and adolescents
In children and adolescents, the administered amount will be adjusted according to the child's body weight.

Administration of ExametaScan and procedure conduct
ExametaScan is administered intravenously.
A single injection is sufficient to perform the test required by the physician.
After the injection, you will be offered a drink and will be asked to urinate immediately before the scan.
The ready-to-use solution will be injected into a vein prior to the start of the scintigraphy.
The examination may take place within 30 minutes or up to 24 hours after the injection, depending on the type of test.

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

After administration of ExametaScan, you should

• avoid close contact with children and pregnant women during the first 12 hours after injection;
• urinate frequently to help eliminate the medicinal product from your body.

The nuclear medicine physician will inform you if any special precautions are necessary after receiving the medicinal product.
Please consult your nuclear medicine physician if you have any questions.

If you have received more ExametaScan than you should
An overdose is extremely unlikely, as you will receive only a single, precisely controlled dose of Tc-exametazime, administered under the supervision of the nuclear medicine physician overseeing the procedure. In the event of an overdose, appropriate treatment will be provided.

In particular, the nuclear medicine physician in charge of the procedure may advise you to drink plenty of fluids to facilitate the elimination of Tc-exametazime from your body.
If you have any further questions about the use of ExametaScan, please consult the nuclear medicine physician who will supervise the procedure.

4. Possible side effects

Like all medicines, this medicinal product can cause side effects, although not everyone experiences them.
The frequencies of side effects are 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 fewer than 1 in 10,000 people,
Not known: frequency cannot be estimated from the available data.

Frequency not known
Allergic reactions:
If you experience an allergic reaction while in hospital or clinic undergoing the examination, inform the doctor or nurse immediately. Symptoms may include:

• skin rash, itching or hot flushes
• swelling of the face
• breathing difficulties; in more severe cases, reactions may include:
• fainting (loss of consciousness), dizziness or lightheadedness.

Other side effects include:
Frequency not known

• itchy, lumpy skin rash
• headache
• dizziness
• hot flushes
• feeling unwell (nausea)
• feeling unwell (vomiting)
• general feeling of malaise, fatigue, weakness
• unusual sensations of numbness, tingling, burning sensations or chills on the skin

This radiopharmaceutical delivers low amounts of ionizing radiation, with a very low risk of cancer and hereditary abnormalities. If you experience any side effect, contact the nuclear medicine physician. This includes also possible side effects not listed in this leaflet.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your nuclear medicine physician. You can also report side effects directly via the reporting system at the website https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store ExametaScan

You will not have to store this medicinal product. This medicinal product will be 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 exclusively for the specialist.
ExametaScan must not be used after the expiry date stated on the carton (Expiry date).
ExametaScan must not be used if any visible signs of deterioration are observed.
Unlabelled product
Store at 2-8°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. Package contents and other information

What ExametaScan contains
The active substance is exametazime. Each vial contains 500 micrograms of exametazime.
The excipients are: tin (II) chloride dihydrate, tetrasodium pyrophosphate decahydrate, nitrogen

Description of the appearance of ExametaScan and contents of the pack
The product is a kit for radiopharmaceutical preparation.
ExametaScan is a white, lyophilized powder. The injection is prepared from the vial immediately before administration.
ExametaScan consists of exametazime which must be dissolved in a solution and combined with radioactive technetium prior to use as an injection. Once the radioactive substance sodium pertechnetate ( Tc) is added to the vial, technetium ( Tc) exametazime is formed. This solution is then ready for use.
Each pack contains 3 or 6 multidose vials.
Sample pack: 1 multidose vial
Multiple pack: 2 packs containing 6 multidose vials each
Multiple pack: 4 packs containing 6 multidose vials each
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder:
RADIOPHARMACY LABORATORY Ltd
2040 Budaörs, Gyàr st. 2, Hungary
(Budaörs Industrial and Technology Park, Gutemberg st. 125)
Tel: +36-23-886-950, 886-981
Fax: +36-23-886-955
e-mail: [email protected]

Manufacturer:
Medi-Radiopharma Ltd
H-2030 Érd, Szamos u. 10-12.
Hungary
Tel: +36-23-521-261
Fax: +36-23-521-260
e-mail: [email protected]

This medicinal product is authorized in EEA member states under the following names:
Austria - Medi-Exametazim 500 mikrogramm, Kit für ein radioaktives Arzneimittel
Denmark – Medi-Exametazime, Kit for a radiopharmaceutical preparation
Germany - Medi-Exametazim, Kit für ein radioaktives Arzneimittel
Portugal - Medi-Exametazime, Pó para solução injectável
United Kingdom – Medi-Exametazime 500 mcg
Spain - Exametazima-Radiopharmacy 0,5 mg equipo de reactivos para preparacion farmaceutica

This Patient Information Leaflet was last approved on

Other information
The following information is intended exclusively for the specialist.
The full product characteristics summary of ExametaScan is provided as a separate document within the pack, intended to provide the specialist with additional practical-scientific information on the administration and use of this radiopharmaceutical.