Poltehmdp

Leaflet included in the packaging: information for the user

PoltechMDP, 5 mg, kit for the preparation of a radiopharmaceutical

Methylene diphosphonic acid
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 necessary.
• In case of any doubts, you should consult the doctor in charge or the specialist in nuclear medicine who supervises the examination.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, they should inform the specialist in nuclear medicine.

Table of contents of the leaflet:

• 1. What is the PoltechMDP kit and what is it used for
• 2. Important information before using the PoltechMDP kit
• 3. How to use the PoltechMDP kit
• 4. Possible adverse reactions
• 5. How to store the PoltechMDP kit
• 6. Package contents and other information

1. What is the PoltechMDP kit and what is it used for

PoltechMDP is a radiopharmaceutical preparation intended exclusively for diagnostic purposes.
The medicine (radiopharmaceutical) PoltechMDP, after labeling (i.e., combination with) the radioactive technetium isotope (Tc), is used for imaging (scintigraphic) diagnostics of the skeletal system.
Due to the combination with the radioactive technetium isotope Tc, the use of PoltechMDP is associated with exposure to a small dose of radiation. The doctor has determined that the benefits of the examination outweigh the potential risks associated with ionizing radiation.

2. Important information before using the PoltechMDP kit

When not to use the PoltechMDP kit

PoltechMDP should not be used 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 the specialist in nuclear medicine in the following cases:

• if the woman is pregnant or suspects she may be pregnant,
• if the woman is breastfeeding.

Administering radiopharmaceuticals creates a risk of exposure to external ionizing radiation or contamination caused by urine, vomit, etc. for other people. Therefore, you should follow basic personal hygiene rules and remove any urine, vomit, etc. for the period of time recommended by the doctor.
You should exercise particular caution when using radiopharmaceuticals to avoid unnecessary exposure of personnel and patients.

Children and adolescents

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

PoltechMDP and other medicines

You should tell the doctor in charge or the specialist in nuclear medicine supervising the examination about all medicines currently being taken or recently taken, including those available without a prescription, as well as any medicines the patient plans to take.
Concomitant administration of products containing iron or aluminum, certain immunosuppressive and cytostatic agents, alkalizing agents, radiological contrast agents, antibiotics, anti-inflammatory agents, calcium gluconate, calcium heparin salt, γ-aminocaproic acid, bisphosphonates may contribute to the accumulation of the radiopharmaceutical outside bone tissue.

PoltechMDP with food and drink

No special precautions are recommended.

Pregnancy and breastfeeding

Before administering the medicine, you should 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 doubt, consultation with the doctor in charge or the specialist in nuclear medicine supervising 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 stopping 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 supervising the examination.

Driving and operating machinery

The effect of the medicine on the ability to drive and operate machinery has not been studied.

PoltechMDP 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 the PoltechMDP kit

Radiopharmaceuticals can only be administered by authorized personnel.
There are strict regulations regarding the use, transfer, and disposal of radiopharmaceutical preparations. PoltechMDP 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 about their actions.
The medicine is intended for intravenous administration.
The specialist in nuclear medicine supervising 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. The recommended dose ranges from 370 to 740 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 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 be performed 2 or several hours after injection.
The radiopharmaceutical preparation Tc-MDP 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

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

After administration of PoltechMDP

• 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 the body.

The doctor will inform about the need to take special precautions after administration of the medicine. In case of doubt, you should consult the doctor in charge or the specialist in nuclear medicine.

Use of a higher dose of PoltechMDP than recommended

Overdose is practically impossible, as the dose of the medicine 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 from the body.
In case of doubts related to the use of the medicine, you should consult the doctor or the specialist in nuclear medicine supervising the examination.

4. Possible adverse reactions

Like all medicines, PoltechMDP can cause adverse reactions, although not everybody gets them.
Possible adverse reactions after using PoltechMDP include: headache, joint pain, nausea, vomiting, low blood pressure, redness or rash, itching, skin irritation, swelling of the arms and legs, general malaise, and very rarely, symptoms of anaphylaxis.
These symptoms usually have a mild course, and their exact frequency is impossible to estimate based on available data.
Administration of the radiopharmaceutical causes exposure to a small dose of ionizing radiation, which is associated with the risk of inducing cancer and genetic disorders.
Current evidence suggests a low probability of such adverse reactions occurring in the case of diagnostic examinations in nuclear medicine.

Reporting adverse reactions

If any adverse reactions occur, including any adverse reactions not listed in this leaflet, you should inform the doctor or the specialist in nuclear medicine. Adverse reactions can be reported directly to the Department of Adverse Reaction Monitoring 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 medicine.

5. How to store the PoltechMDP kit

The patient will not need to store this medicine.
Radiopharmaceutical preparations are stored exclusively by authorized personnel in appropriate clinical conditions. Storage of radiopharmaceuticals is carried out in accordance with local regulations regarding radioactive substances.
The following information is intended exclusively for medical professionals.
The medicine should not be used 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 does the PoltechMDP kit contain

• The active substance of the medicine is methylene diphosphonic acid
• The other ingredients are: tin(II) chloride dihydrate, ascorbic acid, nitrogen

What does the PoltechMDP kit look like and what does the packaging contain

Kit for the preparation of a radiopharmaceutical.
White or off-white powder.
The kit is supplied in 10 ml glass vials with a rubber stopper and an aluminum cap, in a cardboard box.
The packaging 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 a doctor or a representative of the marketing authorization holder.

Date of the last update of the leaflet:

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The Full Characteristic of the Medicinal Product (ChPL) PoltechMDP 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.