Poltehdtpa

Leaflet included in the packaging: information for the user

PoltechDTPA, 13.25 mg, kit for the preparation of a radiopharmaceutical

Sodium diethylenetriamine pentaacetate monohydrate (DTPA)
You should carefully read the contents of the leaflet before using the medicine, as it contains
important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, you should consult your doctor or a specialist in nuclear medicine who supervises the examination.
• If the patient experiences any undesirable symptoms, including any undesirable symptoms not listed in this leaflet, they should inform their doctor or a specialist in nuclear medicine.

Table of contents of the leaflet

• 1. What is PoltechDTPA and what is it used for
• 2. Important information before using PoltechDTPA
• 3. How to use PoltechDTPA
• 4. Possible side effects
• 5. How to store PoltechDTPA
• 6. Package contents and other information

1. What is PoltechDTPA and what is it used for

PoltechDTPA is a radiopharmaceutical intended exclusively for diagnostic purposes.
The radiopharmaceutical (radiofarmaceutic) PoltechDTPA, after labeling (i.e., after combining with)
the radioactive technetium isotope (Tc), is used in imaging diagnostics (scintigraphic) of the kidneys (in dynamic scintigraphy to assess the value of the glomerular filtration rate - GFR for each kidney and to assess disturbances in urine outflow), blood sample testing, and for angioscintigraphy and brain scintigraphy.
Due to the combination with the radioactive technetium isotope (Tc), the use of PoltechDTPA involves exposure to a small dose of radiation. The attending 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 PoltechDTPA

When not to use PoltechDTPA

PoltechDTPA should not be administered if the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

You should inform your doctor or a specialist in nuclear medicine in the following cases:

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

Administering radiopharmaceuticals poses a risk of external ionizing radiation exposure or contamination to others. Therefore, you should follow basic personal hygiene rules and remove any urine residue, etc., for the period of time recommended by your doctor.
You should exercise particular caution when using radiopharmaceuticals to avoid unnecessary exposure of staff and patients.

Before administering PoltechDTPA:

• you should drink plenty of water and ensure good hydration before the examination, in order to urinate as frequently as possible during the first hours after the examination.

Children and adolescents

You should inform your doctor or a specialist in nuclear medicine if the patient is under 18 years old.

PoltechDTPA and other medicines

You should tell your doctor or a specialist in nuclear medicine about all medicines you are currently taking or have recently taken, including those available without a prescription, as well as any medicines you plan to take.
Diagnostic use of captopril, furosemide, and certain psychotropic drugs may affect the functions of the examined organ.

PoltechDTPA with food and drink

No special precautions are recommended.

Pregnancy and breastfeeding

Before administering the medicine, you should inform your doctor or a specialist in nuclear medicine if:

• a woman suspects she may be pregnant,
• a woman has not had her menstrual period at the expected time,
• a woman is breastfeeding. In case of doubt, consultation with the attending physician or a specialist in nuclear medicine who supervises 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 it is absolutely necessary.
In the case of breastfeeding and the need to administer a radiopharmaceutical, the doctor may recommend stopping breastfeeding for 4 hours and removing 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 the Tc-DTPA medicine will affect the ability to drive vehicles and operate machinery.

PoltechDTPA contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per vial, so it can be considered "sodium-free".

3. How to use PoltechDTPA

Radiopharmaceuticals can only be administered by authorized personnel.
There are strict regulations regarding the use, transfer, and disposal of radiopharmaceuticals. PoltechDTPA is used exclusively in appropriate clinical conditions and only by qualified personnel. These personnel take special precautions to ensure safe use of the medicine and will inform you about their actions.
The medicine is intended for intravenous administration.
The specialist in nuclear medicine who supervises the procedure decides on the dose of the medicine 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 74 to 555 MBq (MBq = megabecquerel, a unit of measurement of radioactivity), but other doses may also be used, e.g., for a kidney function test, 1.8-3.7 MBq.

Use in children and adolescents

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

Administration of the medicine 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 within 1 or several hours after injection.
The radiopharmaceutical Tc-DTPA is intended for intravenous administration under the strict supervision of qualified personnel.
During the preparation and administration of the medicine, you should strictly follow the regulations regarding safety at work in conditions of exposure to ionizing radiation.

Duration of the procedure

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

After administering PoltechDTPA:

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

Your doctor will inform you about the need to take special precautions after administering the medicine. In case of doubt, you should consult your doctor or a specialist in nuclear medicine.

Use of a higher than recommended dose of PoltechDTPA

Overdose is practically impossible, as the dose of the medicine administered to the patient is strictly controlled by the specialist in nuclear medicine who supervises the examination. However, in the event of an overdose, the doctor may recommend drinking more fluids to remove the radiopharmaceutical residue from the body.
In case of doubts related to the use of the medicine, you should consult your doctor or a specialist in nuclear medicine who supervises the examination.

4. Possible side effects

Like all medicines, PoltechDTPA can cause side effects, although not everybody gets them.
Possible side effects after using PoltechDTPA include: dizziness, low blood pressure, shortness of breath, redness, hives, rash, itching.
These symptoms occur very rarely and are usually mild.
Administration of the radiopharmaceutical results in exposure to a small dose of ionizing radiation, which is associated with the risk of causing cancer and genetic disorders.
Current evidence suggests a low probability of such side effects occurring in the case of diagnostic tests in nuclear medicine.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should inform your doctor or a specialist in nuclear medicine. Side effects can be reported directly to the Department for Monitoring of Adverse Reactions of 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.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects helps to gather more information on the safety of the medicine.

5. How to store PoltechDTPA

The patient will not need to store this medicine.
Radiopharmaceuticals are stored exclusively by authorized persons 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 professionals.
Do not use the medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the given month.

6. Package contents and other information

What PoltechDTPA contains

• The active substance of the medicine is sodium diethylenetriamine pentaacetate monohydrate
• The other ingredients are: tin(II) chloride dihydrate, sodium chloride, nitrogen.

What PoltechDTPA 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 Centre 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, you should consult your doctor or a representative of the marketing authorization holder.
Date of the last update of the leaflet:
-------------------------------------------------------------------------------------------------------------------------------
The Full Characteristic of the Medicinal Product (ChPL) of PoltechDTPA is attached as a separate document to the packaging of the medicinal product, in order to provide medical professionals with additional, scientific, and practical information regarding the administration and use of this radiopharmaceutical.