Poltehmbrida

Package Leaflet: Information for the User

PoltechMBrIDA, 20 mg, Kit for the Preparation of a Radiopharmaceutical

Sodium N-[3-bromo-2,4,6-trimethyl-acetanilido]-iminodiacetate

Read the Leaflet Carefully Before Using the Medicinal Product

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or nuclear medicine specialist who is supervising your examination.
• If you experience any side effects, including any not listed in this leaflet, tell your nuclear medicine specialist. See section 4.

Table of Contents of the Leaflet:

• 1. What is PoltechMBrIDA and what is it used for.
• 2. Important information before using PoltechMBrIDA.
• 3. How to use PoltechMBrIDA.
• 4. Possible side effects.
• 5. How to store PoltechMBrIDA.
• 6. Contents of the pack and other information.

1. What is PoltechMBrIDA and what is it used for

PoltechMBrIDA is a radiopharmaceutical preparation intended exclusively for diagnostic purposes.
The medicinal product (radiopharmaceutical) PoltechMBrIDA, after labeling (i.e., combination with) the radioactive isotope technetium (Tc), is used for imaging (scintigraphic) diagnosis of the liver and bile ducts.
Due to the combination with the radioactive isotope technetium Tc, the use of PoltechMBrIDA is associated with exposure to a small dose of radiation. The doctor has determined that the benefits of the examination outweigh the potential risk associated with ionizing radiation.

2. Important information before using PoltechMBrIDA

When not to use PoltechMBrIDA

PoltechMBrIDA must not be used if the patient is allergic to the active substance or any of the other ingredients of this medicinal product (listed in section 6).

Warnings and precautions

Tell your nuclear medicine specialist if:
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a woman is pregnant or thinks she may be pregnant,
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a woman is breastfeeding.
The administration of radiopharmaceuticals poses a risk of exposure to external ionizing radiation or contamination caused by urine, vomit, etc. to other people. Therefore, basic personal hygiene rules should be followed and urine and vomit residues should be removed as directed by the doctor.
Particular caution should be exercised when using radiopharmaceuticals to avoid unnecessary exposure of personnel and patients.
The bile ducts may not be properly visualized in the following situations:
 parenteral nutrition,
 prolonged fasting (over 24 hours),
 after a meal (the patient's examination should be performed at least 2 hours, and preferably 6 hours after the last meal),
 severe liver damage.

Children and adolescents

Tell your nuclear medicine specialist if the patient is under 18 years of age.
The administration of the medicinal product to children should be carefully considered, taking into account the clinical indications and the assessment of the benefit-risk ratio in this patient group.

PoltechMBrIDA and other medicinal products

Tell your doctor about all medicinal products you are currently taking or have recently taken, as well as any medicinal products you plan to take during the examination.
Certain narcotic analgesics may affect the flow of the radiopharmaceutical in the extrahepatic bile ducts. Morphine sulfate is commonly used in scintigraphic examinations of the bile ducts.
Cholecystokinin and its analogs cause contraction of the gallbladder and may change the flow of the radiopharmaceutical in the bile ducts. Similar changes may be caused by fatty meals and some dietary supplements.
In patients receiving parenteral nutrition or fasting for more than 24-48 hours, the pressure in the gallbladder may increase, making it difficult for the radiopharmaceutical to flow properly.
Phenobarbital and ursodeoxycholic acid increase the excretion of the radiopharmaceutical through the bile ducts.
Other medicinal products and substances that affect the gallbladder, bile ducts, or change the distribution of Tc-labeled iminodiacetates in the body are listed in the table below.
Atropine
Benzodiazepines
Erythromycin
Estrogens
Ethanol
Glyceryl trinitrate
Glucagon
Naloxone
Nicotine
Nifedipine
Nicardipine
Nitric oxide
Pancreatic enzymes
Pirenzepine
Progesterone
Prostigmine
Somatostatin analogs
Theophylline
In patients treated with chemotherapeutic agents (anticancer drugs) administered through a hepatic artery injection, there may be a risk of gallbladder inflammation, which may cause it to not be visualized during scintigraphy performed using Tc-MBrIDA.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicinal product.
Before administering the medicinal product, tell your nuclear medicine specialist if:

• there is a suspicion of pregnancy,
• menstruation has not occurred at the expected time,
• you are breastfeeding. In case of doubt, consultation with the attending physician or nuclear medicine specialist who will supervise the examination is necessary.

If you are pregnant, it is essential to inform your doctor. The use of radiopharmaceuticals during pregnancy should be carefully considered. Your doctor will only refer you for an examination using radiopharmaceuticals during pregnancy if it is absolutely necessary.
If you are breastfeeding and need to receive a radiopharmaceutical, your doctor may ask you to stop breastfeeding and discard breast milk. You should stop breastfeeding for at least 4 hours after the injection of the radiopharmaceutical and discard the breast milk expressed during this time. The possibility of resuming breastfeeding should be discussed with the nuclear medicine specialist supervising the examination.

Driving and using machines

The effect of the medicinal product on the ability to drive and use machines has not been studied.

PoltechMBrIDA contains sodium ions.

Tell your nuclear medicine specialist if you are on a low-sodium diet.

3. How to use PoltechMBrIDA

Radiopharmaceuticals can only be administered by authorized personnel.
There are strict regulations regarding the use, transfer, and disposal of radiopharmaceutical preparations. PoltechMBrIDA is used exclusively in appropriate clinical conditions and only by qualified personnel. These personnel take special precautions to ensure the safe use of the radiopharmaceutical and will keep you informed about their actions.
The radiopharmaceutical is intended for intravenous administration.
The nuclear medicine specialist supervising the procedure decides on the dose of the medicinal product to be used in a given case. This will be the minimum dose necessary to obtain the expected diagnostic information. The recommended dose ranges from 111 to 185 MBq (MBq = megabecquerel, a unit of measurement of radioactivity). However, in cases of elevated bilirubin levels in the blood, the administration of higher doses may be considered.

Use in children and adolescents

In children and adolescents, the amount of medicinal product to be administered is determined based on the patient's body weight.

Administration of the medicinal product and performance of the examination

The ready-to-use solution for injection will be administered intravenously before the examination.
The radiopharmaceutical preparation Tc-MBrIDA is intended for intravenous administration under the strict supervision of qualified personnel.
During the preparation of the medicinal product, the rules of safe work in conditions of exposure to ionizing radiation must be strictly followed.
It is recommended to fast for 6-24 hours before the start of the examination (this time may vary depending on the indications) and to avoid taking products that may affect the result of the examination.

Duration of the procedure

Your doctor will inform you about the standard duration of the procedure.

After administration of PoltechMBrIDA

Your doctor will inform you about the need to take special precautions after administration of the radiopharmaceutical.
In case of doubt, consult your attending physician or nuclear medicine specialist.

Overdose of PoltechMBrIDA

Overdose is practically impossible, as the dose of the radiopharmaceutical administered to the patient is strictly controlled by the nuclear medicine specialist supervising the examination. However, in case of overdose, the doctor may recommend laxatives and/or increased fluid intake to remove the radiopharmaceutical residues from the body.
In case of doubts related to the use of the medicinal product, consult your doctor or nuclear medicine specialist supervising the examination.

4. Possible side effects

Like all medicinal products, PoltechMBrIDA can cause side effects, although not everybody gets them.
Serious side effects
Side effects of unknown frequency:

• Allergic reactions: If an allergic reaction occurs during the performance of imaging examinations in a hospital or outpatient setting, tell your doctor or nurse immediately. Symptoms may include: skin rash, itching or redness of the skin, swelling of the face, breathing difficulties. If any of the above side effects occur after leaving the hospital or outpatient setting, go directly to the emergency department of the nearest hospital.

Administration of the radiopharmaceutical causes exposure to a small dose of ionizing radiation, which is associated with a risk of inducing cancer and genetic disorders. Current evidence suggests a low probability of such side effects in the case of diagnostic examinations in nuclear medicine.

Reporting of side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or nurse.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Aleje Jerozolimskie 181 C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting of side effects allows for the collection of more information on the safety of the medicinal product.

5. How to store PoltechMBrIDA

The patient will not need to store this medicinal product.
Radiopharmaceutical preparations are stored exclusively by authorized personnel in appropriate clinical conditions. The storage of radiopharmaceuticals is carried out in accordance with local regulations regarding radioactive substances.
The following information is intended exclusively for medical personnel.
Do not use the medicinal product after the expiry date stated on the packaging.

6. Contents of the pack and other information

What PoltechMBrIDA contains

• The active substance of the medicinal product is sodium N-[3-bromo-2,4,6-trimethyl-acetanilido]-iminodiacetate
• The other ingredients of the medicinal product are: tin(II) chloride dihydrate, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment)

What PoltechMBrIDA looks like and what the pack contains

Kit for the preparation of a radiopharmaceutical.
White powder.
The kit is supplied in 10 ml glass vials with a rubber stopper and an aluminum cap, in a cardboard box.
The pack contains:
3 vials or 6 vials.
Each vial contains a lyophilisate for the preparation of a solution for injection.

Marketing authorization holder and manufacturer

National Centre for Nuclear Research
ul. Andrzeja Sołtana 7
05-400 Otwock
Phone: 22 7180700
Fax: 22 7180350
e-mail: [email protected]
For more detailed information, consult your doctor or the representative of the marketing authorization holder.

Date of last revision of the leaflet:

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The Full Prescribing Information (FPI) of PoltechMBrIDA is attached as a separate document to the packaging of the product, in order to provide healthcare professionals with additional, scientific, and practical information regarding the administration and use of this radiopharmaceutical.