Poltehdmsa

Package Leaflet: Information for the User

PoltechDMSA, 1 mg, Kit for the Preparation of a Radiopharmaceutical

Mesozoic-2,3-dimercaptosuccinic acid (DMSA)

Read the Package Leaflet Carefully Before Using the Medicinal Product

• Keep this package leaflet. You may need to read it again.
• In case of any doubts, consult your doctor or a specialist in nuclear medicine who supervises the examination.
• If the patient experiences any adverse reactions, including those not listed in this package leaflet, inform the specialist in nuclear medicine. See section 4.

Table of Contents of the Package Leaflet

• 1. What is PoltechDMSA and what is it used for
• 2. Important Information Before Using PoltechDMSA
• 3. How to Use PoltechDMSA
• 4. Possible Adverse Reactions
• 5. How to Store PoltechDMSA
• 6. Package Contents and Other Information

1. What is PoltechDMSA and What is it Used For

PoltechDMSA is a radiopharmaceutical preparation intended exclusively for diagnostic purposes.
The radiopharmaceutical (radiofarmaceutical) PoltechDMSA, after labeling (i.e., combination with)
the radioactive technetium isotope (Tc), is used in diagnostic imaging (scintigraphic) of the kidneys, in particular: static kidney imaging, kidney localization, determination of functional kidney mass, morphological examinations of the kidney cortex, and single kidney function tests.
Due to the combination with the radioactive technetium isotope (Tc), the use of PoltechDMSA involves exposure to a small dose of radiation. The treating physician and the specialist in nuclear medicine have determined that the benefits of the examination outweigh the potential risks associated with ionizing radiation.

2. Important Information Before Using PoltechDMSA

When Not to Use PoltechDMSA

PoltechDMSA must not be administered 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

Inform the specialist in nuclear medicine in the following cases:

• if the patient has kidney function disorders,
• if the woman is pregnant or suspects she may be pregnant,
• if the woman is breastfeeding.

The administration of radiopharmaceuticals poses a risk of exposure to external ionizing radiation or contamination caused by urine stains, etc. Therefore, basic personal hygiene rules should be observed, and urine residues, etc. should be removed for a period of time recommended by the doctor.
Particular caution should be exercised when using radiopharmaceuticals to avoid unnecessary exposure of personnel and patients.
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Before Administering PoltechDMSA:

drink plenty of water and ensure good hydration before the examination to urinate as frequently as possible during the first few hours after the examination.

Children and Adolescents

Inform the specialist in nuclear medicine if the patient is under 18 years of age.

PoltechDMSA and Other Medicinal Products

Inform the treating physician or the specialist in nuclear medicine supervising the examination about all medicinal products currently being taken or recently taken, including those available without a prescription, as well as any planned treatments.
The use of medicinal products that alter the acid-base balance, such as ammonium chloride and sodium bicarbonate, the use of mannitol, ACE inhibitors may affect the functions of the examined organ. Medicinal products used in chemotherapy (methotrexate, cyclophosphamide, vincristine) may cause changes in the biodistribution of the medicinal product.

PoltechDMSA with Food and Drink

No special precautions are recommended.

Pregnancy and Breastfeeding

Before administering the medicinal product, inform the specialist in nuclear medicine if:

• the woman suspects she may be pregnant,
• the woman has not had her menstrual period at the expected time,
• the woman is breastfeeding. In case of doubts, consultation with the treating physician or the specialist in nuclear medicine who will supervise the examination is necessary.

If the patient is pregnant, it is essential to inform the doctor. The use of radiopharmaceuticals during pregnancy should be carefully considered. The doctor will only refer for an examination using radiopharmaceuticals during pregnancy if absolutely necessary.
In the case of breastfeeding and the need to administer a radiopharmaceutical, the doctor may recommend interrupting breastfeeding for 4 hours and expressing milk from the breast during this time. The possibility of returning to breastfeeding should be agreed upon with the specialist in nuclear medicine who supervises the examination.

Driving and Operating Machinery

It is considered unlikely that PoltechDMSA will affect the ability to drive and operate machinery.

PoltechDMSA Contains Sodium

This medicinal product contains less than 1 mmol of sodium (23 mg) per vial, which means that the medicinal product can be considered 'sodium-free'.

3. How to Use PoltechDMSA

Radiopharmaceuticals can only be administered by authorized personnel.
There are strict regulations regarding the use, transfer, and disposal of radiopharmaceutical preparations. The PoltechDMSA medicinal product is used exclusively in appropriate clinical conditions and only by qualified personnel. These personnel take special precautions to ensure the safe use of the medicinal product and will keep you informed about their actions.
The medicinal product is intended for intravenous administration.
The specialist in nuclear medicine 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. Depending on the type of examination, the recommended dose ranges from 75 to 150 MBq (megabecquerel, a unit of measurement of radioactivity), but other doses may also be used.

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 examination, depending on its type, may take place after a few or several hours after the injection.
The radiopharmaceutical Tc-DMSA preparation is intended for intravenous administration under the strict supervision of qualified personnel.
During the preparation of the medicinal product, the rules of safe working practices in conditions of exposure to ionizing radiation must be strictly observed.

Duration of the Procedure

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

After Administering PoltechDMSA:

• avoid close contact with small children and pregnant women for up to 24 hours after the injection,
• frequently urinate to remove the medicinal product from the body.

The doctor will inform you about the need to take special precautions after administering the medicinal product.
In case of doubts, consult the treating physician or the specialist in nuclear medicine.

Overdose of PoltechDMSA

Overdose is practically impossible because the dose of the medicinal product administered to the patient is strictly controlled by the specialist in nuclear medicine supervising the examination. However, in case of overdose, the doctor may recommend drinking more fluids to remove the radiopharmaceutical residues from the body.
In case of doubts related to the use of the medicinal product, consult the doctor or the specialist in nuclear medicine supervising the examination.

4. Possible Adverse Reactions

Like all medicinal products, PoltechDMSA can cause adverse reactions, although not everybody gets them.
Possible adverse reactions after using PoltechDMSA include: rash, itching, urticaria, erythema, excessive sweating, swelling around the eyes, conjunctivitis, laryngeal edema, cough, dyspnea, abdominal pain, vomiting, nausea, excessive salivation, tongue swelling, hypotension, flushing, syncope, headache, dizziness, pallor, weakness, fatigue, reaction at the injection site.
These symptoms usually have a mild course, and their exact frequency is impossible to estimate based on available data.
The administration of radiopharmaceuticals results in exposure to a small dose of ionizing radiation, which is associated with the risk of causing cancer and congenital anomalies.
Current evidence suggests a low probability of such adverse reactions in the case of diagnostic examinations in nuclear medicine.

Reporting Adverse Reactions

If any adverse reactions occur, including those not listed in this package leaflet, inform the doctor or the specialist in nuclear medicine. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181 C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: ndl@urpl.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to gather more information on the safety of the medicinal product.

5. How to Store PoltechDMSA

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 only for medical personnel.
Do not use the medicinal product after the expiry date stated on the packaging.

6. Package Contents and Other Information

What PoltechDMSA Contains

• The active substance of the medicinal product is meso-2,3-dimercaptosuccinic acid.
• The other ingredients are: tin(II) chloride dihydrate, ascorbic acid, D-mannitol, nitrogen.

What PoltechDMSA Looks Like and What the Package 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 package 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 Center for Nuclear Research
ul. Andrzeja Sołtana 7
05-400 Otwock
Phone: 22 7180700
Fax: 22 7180350
e-mail: polatom@polatom.pl
To obtain more detailed information, consult your doctor or a representative of the marketing authorization holder.

Date of the Last Update of the Package Leaflet:

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The Full Characteristic of the Medicinal Product (ChPL) PoltechDMSA is attached as a separate document to the product packaging to provide healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical.
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