ADREVIEW 74 MBQ/ML Roztwór do wstrzykiwań

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1. AdreView 74 MBq/ml injectable solution
   1. What is AdreView and what is it used for
   2. What you need to know before you are given AdreView
   3. How AdreView is used
   4. Possible side effects
   5. How AdreView is stored
   6. Contents of the pack and other information

AdreView 74 MBq/ml injectable solution

Iobenguane (I)

Read this leaflet carefully before using this medicine as it contains important information for you

• Keep this leaflet. You may need to read it again.
• If you want more information, ask the specialist doctor in nuclear medicine, who supervises the procedure.
• If any undesirable effects occur, contact the nuclear medicine doctor. This applies

Contents of this leaflet:

• 1. What AdreView is and what it is used for
• 2. What you need to know before AdreView is administered to you
• 3. How AdreView is used
• 4. Possible side effects
• 5. How AdreView is stored
• 6. Contents of the pack and other information

1. What is AdreView and what is it used for

This medicine is a radiopharmaceutical used only for diagnostic purposes.
It is only used to help identify any presence of diseases.
AdreView is a ‘radiopharmaceutical’ medicine. It is administered before a scan and helps a
special device to visualize the inside of a part of your body.

• Contains an active substance called ‘iobenguano’.
• Once injected, it can be seen from outside your body through the device that acquires the images, used for the diagnostic examination.
• The diagnostic examination can help your doctor detect some types of tumors in the adrenal glands or the thyroid and see how a tumor responds to treatment.
• This medicine is also used in some people before a diagnostic examination to see the functionality of the heart. The use of AdreView involves exposure to small amounts of radioactivity. Your doctor or the nuclear medicine doctor will need to assess that the clinical benefit you will obtain from the diagnostic procedure with the radiopharmaceutical outweighs the risk due to radiation. Your doctor or nurse will explain which part of your body will undergo the examination

2. What you need to know before you are given AdreView

AdreView must not be used:

• If you are allergic (hypersensitive) to the active substance or to any of the excipients of this medicine (listed in section 6). Do not take AdreView if the above cases apply to you. If you are unsure, talk to your doctor or nurse.

AdreView must not be administered to premature and newborn infants. (See section
“Important information on some ingredients of Adreview”).

Warnings and precautions
Tell the nuclear medicine doctor before you are given Adreview if:

• you have kidney problems - you are pregnant or think you may be pregnant

Before receiving AdreView you must:
Drink plenty of fluids before undergoing the examination, so as to urinate as often as possible in the
first few hours after the examination.

Children and adolescents
Tell the nuclear medicine doctor if you are under 18 years of age.

Other medicines and AdreView
Tell the nuclear medicine doctor if you are taking, have recently taken or might
take any other medicines, including over-the-counter medicines, including
herbal medicines.
This is because some medicines can interfere with AdreView.
Before undergoing the investigation, tell your nuclear medicine doctor if you are taking
any of the types of medicines listed below. This is because these medicines can
interfere with the results of your examination:

• Calcium channel blockers, such as: diltiazem, nifedipine or verapamil.
• Antidepressants, such as amitriptyline or imipramine.
• ‘”Sympathomimetic agents” (used as decongestants for coughs or colds) such as phenylephrine, ephedrine, pseudoephedrine or phenpropanolamine.
• Reserpine (used to treat mental problems or high blood pressure).
• Labetalol (used to treat high blood pressure).
• Phenothiazines (used to treat mental problems).
• Cocaine. If you are not sure whether any of the above cases apply to you, tell your nuclear medicine doctor before taking AdreView.

Pregnancy and breastfeeding
Tell the nuclear medicine doctor before the administration of AdreView if you are
pregnant or if you suspect you may be pregnant, if you have missed a menstrual period or if you are breastfeeding.
If in doubt, it is important to consult the nuclear medicine doctor who supervises
the procedure.

In case of pregnancy
Your doctor will only administer this medicine if they assess that the expected benefit outweighs the
risk.
AdreView contains benzyl alcohol, which can pass through the placenta. Therefore, potential toxicity in premature infants should be considered if the administration of
Adreview occurred shortly before or during delivery, even if by caesarean section.

In case of breastfeeding
Do not breastfeed if you have been given AdreView.
This is because small amounts of radioactivity can pass into breast milk.
If you are breastfeeding, your nuclear medicine doctor should wait until the end
of breastfeeding, before using AdreView.
If it is not possible to wait, your nuclear medicine doctor will ask you to:

• stop breastfeeding for 3 days, and
• use formula for your baby, and
• collect (express) breast milk and throw it away. Your doctor will tell you when you can resume breastfeeding.

Driving and operating machinery
Ask your doctor if you can drive vehicles or operate machinery after you have been
given AdreView.

Important information on some excipients of AdreView

• AdreView contains benzyl alcohol. Benzyl alcohol can cause toxic and allergic reactions in infants and children up to 3 years of age.
• 0.18 mmol (4.23 mg) of sodium per ml. This medicine contains less than 1 mmol (23 mg) of sodium per dose, therefore it is essentially sodium-free.

Important information on AdreView
When AdreView is used, you are exposed to radioactivity.

• Your doctor will always assess the possible risks and benefits before giving you the medicine. Ask your doctor if you have any questions.

3. How AdreView is used

There are strict regulations regarding the use, handling and disposal of radiopharmaceuticals.
AdreView will only be used in a hospital setting.
This product will be handled and administered by specially
trained and qualified personnel.
The staff will ensure that the product is used safely and will inform you about the measures
taken.

• Your doctor will tell you to take another medicine at least one hour before you are administered AdreView. The medicine will serve to block the accumulation of radioactivity in the thyroid. The nuclear medicine physician supervising the procedure will decide the amount of AdreView to use in your case. The minimum dose necessary to obtain the desired information will be used. The usual amount to administer to an adult is between 80 and 400 MBq. The megabecquerel (MBq) is the unit of measure for radioactivity.

Use in children and adolescents
The amount to be administered to a child or adolescent depends on body weight.

Administration of AdreView and performing the procedure:
The usual dose is:

• A single injection given for a few minutes. You will usually undergo the examination on the same day or the day after the drug injection and the administration may be repeated.

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

If you have been given too much AdreView:
It is unlikely that cases of overdose will occur, due to the nature of the radioactive
isotope and the amount of Iobenguano present.
However, in case of overdose, you will receive appropriate treatment.
If you have questions about the use of AdreView, ask the nuclear medicine physician supervising the
procedure.

4. Possible side effects

Like all medicines, AdreView can cause side effects, although not everybody gets them.

Allergic reactions
If you experience an allergic reaction while in hospital or a clinic during the investigation, tell the doctor or nurse.
Symptoms may include:

• skin rash, itching or flushing
• swelling of the face
• difficulty breathing. In more severe cases, reactions may include:
• fainting (loss of consciousness), feeling dizzy or lightheaded
• nausea (feeling sick)
• cold chills. If any of the side effects described above occur after you have left hospital or clinic, go directly to the emergency room of the nearest hospital.

Other side effects include
If AdreView is injected too quickly, the following may occur:

• fast or irregular heartbeat
• difficulty breathing
• feeling unusually warm
• stomach cramps
• high blood pressure. Symptoms of this side effect may be headache and changes in vision (visual disturbances).

With AdreView you will receive a small amount of ionising radiation, with a low risk
of developing cancer or hereditary abnormalities.
Your doctor has assessed that the clinical benefit you will obtain from the procedure with the radiopharmaceutical
outweighs the risk due to the radiation.
If any of the side effects occur, if any of the side effects
worsen, or if you notice any side effect not listed in this
leaflet, tell your doctor or the nuclear medicine physician supervising the procedure.

Reporting of side effects
If you get any side effects, even if not listed in this leaflet,
contact your nuclear medicine physician. Side effects can also be
reported directly through the national reporting system at
www.agenziafarmaco.gov.it/it/responsabili”. Reporting side effects
helps to provide more information on the safety of this medicine.

5. How AdreView is stored

You must not store this medicine. This medicine is stored under the responsibility
of a specialist in appropriate premises. Storage will occur in accordance with the regulations
in force regarding radioactive material.
AdreView must not be used after the expiry date stated on the packaging.
The following information is intended for the specialist only.
It can be used up to 36 hours from the calibration time indicated on the label.
After opening, store in a refrigerator (2°C – 8°C) and use within 8 hours.
The medicine must be stored at a temperature not exceeding 25°C. Do not freeze.
Store protected from light.
Store in the original lead container or in an equivalent container.
Keep AdreView out of the sight and reach of children.
The product label includes the correct storage conditions and the expiry date of the
batch.
Hospital staff will ensure that the product is stored and disposed of correctly
and that it is not used after the expiry date stated on the label.

6. Contents of the pack and other information

What AdreView contains

• The active substance is iobenguane (I). Each ml of AdreView contains 74 MBq of iobenguane at the date and time of calibration.
• The other components are benzyl alcohol, 3-iodobenzylguanidine, disodium phosphate monobasic dihydrate, disodium phosphate dibasic dihydrate and water for injections.

Description of the appearance of AdreView and contents of the pack
AdreView is supplied in a single multi-dose glass vial containing a variable amount
of injectable solution between 0.5 mL and 10 mL.

Marketing Authorisation Holder
GE Healthcare S.r.L.
Via Galeno 36,
20126 Milano
Italy

Manufacturer
GE Healthcare B.V.
Den Dolech 2
5612 AZ Eindhoven
Netherlands
The following information is intended exclusively for the doctor or healthcare professional:
The complete Summary of Product Characteristics (SmPC) of AdreView is provided as a separate document inside the pack,
with the aim of providing medical personnel with further scientific information and practical information
on the administration and use of the radiopharmaceutical.
Please refer to the SmPC (the SmPC must be included in the pack)