Technescan Mag 3 DRN 4334

Package leaflet: Information for the user

Technescan MAG3 - DRN 4334

1 mg kit for radiopharmaceutical preparation
mercaptoacetyltriglycine
Please read this leaflet carefully before using this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult the nuclear medicine specialist supervising the procedure.
• If you experience any side effects, including those not listed in this leaflet, contact the nuclear medicine specialist. See section 4.

Contents of this leaflet

1. What Technescan MAG3 - DRN 4334 is and what it is used for
2. What you need to know before using Technescan MAG3 - DRN 4334
3. How to use Technescan MAG3 - DRN 4334
4. Possible side effects
5. How to store Technescan MAG3 - DRN 4334
6. Contents of the pack and other information

1. What Technescan MAG3 - DRN 4334 is and what it is used for

Radiopharmaceutical for diagnostic use only.
Technescan MAG3 - DRN 4334 is used during a scan to evaluate nephrological (kidney diseases) and urological (urinary tract) conditions, particularly for studying morphology, renal perfusion, kidney function, and characterization of urinary outflow. The medicine is a powder, which, once mixed by qualified personnel with a solution containing the radioactive substance sodium pertechnetate ( Tc), forms technetium [ Tc] mertiatide. This compound, when injected into the body, accumulates in certain organs such as the kidneys.
The radioactive substance can be detected from outside the body using special imaging equipment that produces an image known as a scan. This scan shows the distribution of radioactivity within the organ and body, providing the physician with valuable information about their structure and function.
The use of Technescan MAG3 - DRN 4334 in combination with sodium pertechnetate [ Tc] involves exposure to small amounts of radioactivity. Your treating physician and the nuclear medicine specialist have determined that the clinical benefit you will receive from this radiopharmaceutical procedure outweighs the risk associated with radiation exposure.

2. What you need to know before using Technescan MAG3 - DRN 4334

Technescan MAG3 - DRN 4334 must not be used:

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

Warnings and precautions
Inform the nuclear medicine physician before receiving Technescan MAG3

• if you are pregnant or think you might be pregnant
• if you are breastfeeding

Before administration of Technescan MAG3 - DRN 4334 you must:

• Drink plenty of water before the start of the examination, in order to urinate as frequently as possible during the first hours following the study;
• Consult the nuclear medicine specialist if you have kidney problems.

Children and adolescents
Consult the nuclear medicine specialist if you are under 18 years of age.
Other medicines and Technescan MAG3 - DRN 4334
Inform the nuclear medicine specialist if you are taking, have recently taken, or
might take any other medicines, as they could interfere with
the interpretation of the images.
Inform your doctor if you have used a contrast agent for a diagnostic examination and if you are
receiving treatment with any of the following medicines:

• acetylsalicylic acid, a medicine used for fever, pain, inflammation and as an antiplatelet agent (which prevents blood clot formation and platelet aggregation contributing to thrombus formation);
• probenecid (a medicine used to treat gout);
• hydrochlorothiazide, captopril and other medicines used to reduce blood pressure;
• anti-inflammatory and pain-relieving medicines such as diclofenac;
• sulfonamides (antibiotics used for bacterial infections);
• contrast agents (substances used in medical imaging to better visualize certain body structures);
• anti-inflammatory and pain-relieving medicines such as diclofenac;
• calcium antagonists (medicines used to reduce blood pressure and to treat heart disorders).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding
with breast milk, consult the nuclear medicine specialist before using this
medicine.
Women of childbearing potential
Inform the nuclear medicine specialist before administration of Technescan MAG3 - DRN 4334

• if you suspect pregnancy, if you have missed a menstrual period, have a very irregular menstrual cycle, or are breastfeeding with breast milk. If you have any doubts, it is important to consult the nuclear medicine specialist supervising the procedure.

Pregnancy
The nuclear medicine specialist will administer the medicine during pregnancy only if absolutely necessary, when the expected benefits outweigh the risks.
Breastfeeding
The doctor might postpone the examination until after breastfeeding has ended. If this is not
possible, breastfeeding must be interrupted for at least four hours and breast milk expressed
during this time must be discarded.
During this period, it is not necessary to limit close contact with infants.
Driving and using machines
Technescan MAG3 - DRN 4334 does not affect or affects negligibly the ability to drive
vehicles and use machinery.
Technescan MAG3 - DRN 4334 contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per vial, i.e.
essentially “sodium-free”.

3. How to use Technescan MAG3 - DRN 4334

There are very strict regulations regarding the use, handling, and disposal of
radiopharmaceutical products. Technescan MAG3 - DRN 4334 will be used only in special, controlled areas. This medicine will be handled and administered exclusively by trained and qualified personnel who are experienced in its safe use. These individuals will take particular care in the safe use of this medicine and will keep you informed about their actions.
The nuclear medicine specialist supervising the procedure will determine the amount of
Technescan MAG3 - DRN 4334 and sodium pertechnetate ( Tc) to be used in your case. This will be the minimum amount necessary to obtain the required diagnostic information.
The recommended dose of sodium pertechnetate ( Tc) usually administered to adults ranges from 40 to 200 MBq (megabecquerels are the units used to measure radioactivity).
Use in children and adolescents
The administered dose will be adjusted according to body weight.
Administration of Technescan MAG3 - DRN 4334 and procedure performance
Technescan MAG3 - DRN 4334 is administered by intravenous injection.
A single injection of Technescan MAG3 - DRN 4334 is sufficient to perform the test requested by the physician.
Duration of the procedure
The nuclear medicine specialist will inform you about the duration of the procedure.
After administration
After completion of the examination, you should drink plenty of water to urinate frequently and eliminate the medicine from your body.
The nuclear medicine specialist will inform you if it is necessary to take any special precautions after receiving the medicine. For any questions, please consult the nuclear medicine specialist.
If you are given more Technescan MAG3 - DRN 4334 than you should
An overdose is unlikely, as the nuclear medicine specialist supervising the procedure will administer a precisely controlled single dose of Technescan MAG3 - DRN 4334. However, in the event of an overdose, your doctor will provide appropriate treatment. In particular, the nuclear medicine specialist performing the procedure will recommend that you drink large amounts of water and urinate frequently to remove traces of radioactivity from your body.
If you have any questions about the use of Technescan MAG3 - DRN 4334, please consult the nuclear medicine specialist supervising the procedure.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects with unknown frequency (frequency cannot be estimated from the available data):
Severe allergic reactions presenting as:

• urticarial rash (skin irritation),
• eyelid swelling,
• cough,
• nausea,
• vomiting. Vasovagal reactions presenting as:
• seizures (involuntary, sudden and uncontrollable muscle movements),
• dyspnea (difficulty breathing),
• flushing,
• headache,
• facial edema (swollen face),
• pain,
• abnormal sensation,
• dizziness (sensation of movement or spinning),
• hypotension (low blood pressure),
• tachycardia (increased heart rate). Reactions at the injection site presenting as:
• skin rash (skin irritation),
• pain,
• swelling. This radiopharmaceutical emits low amounts of ionizing radiation, which entails a low risk of cancer and hereditary abnormalities.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your nuclear medicine specialist. You may also report side effects directly via the national reporting system at the following address:
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 Technescan MAG3 - DRN 4334

It is not your responsibility to store this medicine. This medicine is stored by the specialist under appropriate conditions.
Storage of radiopharmaceuticals must comply with national regulations concerning radioactive materials.
The following information is intended exclusively for the specialist:
Do not use Technescan MAG3 - DRN 4334 after the expiry date stated on the label after "EXP".
Do not use Technescan MAG3 - DRN 4334 if you notice any visible signs of deterioration.

6. Package contents and other information

What Technescan MAG3 - DRN 4334 contains

• The active substance is betiatide. One vial contains 1 mg of betiatide.
• The other components are: sodium acid tartrate dihydrate, stannous chloride dihydrate, hydrochloric acid.

Description of the appearance of Technescan MAG3 - DRN 4334 and package contents
Powder in a 10 mL glass vial with a rubber stopper and sealed with an aluminium crimp cap.
Pack size: 5 vials.

Marketing Authorisation Holder and Manufacturer
Curium Netherlands B.V.
Westerduinweg 3
1755 LE Petten
The Netherlands
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The following information is intended exclusively for healthcare professionals:
The product characteristics summary (SmPC) of Technescan MAG3 - DRN 4334 is provided as a separate document within the package, aimed at providing healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical.