Package leaflet: Information for the user

PoltechMDP, 5 mg, kit for the preparation of a radiopharmaceutical preparation
Methylenediphosphonic acid
Please read carefully the entire leaflet before use, as it contains important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any doubts, please consult your treating physician or the nuclear medicine specialist supervising the examination.
If the patient experiences any adverse reactions, including those not listed in this leaflet, they should inform the nuclear medicine specialist.

Leaflet contents:

What is PoltechMDP kit and for what purpose is it used
Important information before using PoltechMDP kit
How to use PoltechMDP kit
Possible adverse effects
How to store PoltechMDP kit
Contents of the package and other information

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

PoltechMDP is a radiopharmaceutical agent intended exclusively for diagnostic use.
The medicinal product (radiopharmaceutical) PoltechMDP, after radiolabelling (i.e. binding with) the radioactive isotope
technetium (Tc), is used in imaging diagnostics (scintigraphy) of the skeletal system.
Due to its binding with the radioactive isotope technetium Tc, the use of PoltechMDP involves
exposure to a small dose of radiation. The physician has determined that the benefits obtained
from performing the examination outweigh the potential risks associated with ionizing radiation.

2. Important information before using PoltechMDP kit

When not to use PoltechMDP kit
PoltechMDP must not be used if the patient is allergic to the active substance or to any of the other
components of this medicine (listed in section 6).

Warnings and precautions
You should inform the nuclear medicine specialist physician in the following cases:

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

Administration of radiopharmaceuticals poses a risk of exposure to ionizing radiation for other individuals or contamination due to urine stains, vomit, etc. For this reason, basic personal hygiene principles should be maintained, and residues of urine or vomit should be cleaned up promptly for the time period recommended by the physician.
Special care should be taken when handling radiopharmaceuticals to avoid unnecessary exposure of staff and patients.

Children and adolescents
You should inform the nuclear medicine specialist physician if the patient is under 18 years of age.

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

PoltechMDP with food and drink
No special precautions are recommended.

Pregnancy and breastfeeding
Before administering the medicine, inform the nuclear medicine specialist physician if:

there is suspicion of pregnancy,
menstruation has not occurred at the expected time,
the woman is breastfeeding. In case of doubt, consultation with the treating physician or a nuclear medicine specialist supervising the examination is necessary.

If the patient is pregnant, it is important to inform the physician. The use of radiopharmaceuticals during pregnancy should be carefully considered. The physician will refer the patient for examination with radiopharmaceuticals during pregnancy only if absolutely necessary.

In case of breastfeeding and the simultaneous need to administer a radiopharmaceutical, the physician may recommend interrupting breastfeeding for 4 hours and expressing milk during this time. The possibility of resuming breastfeeding should be discussed with the nuclear medicine specialist supervising the examination.

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

PoltechMDP contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per vial; at this level, the medicine can be considered "sodium-free".

3. How to use PoltechMDP kit

Radiopharmaceuticals may be administered only by authorized personnel.
There are strict regulations regarding the use, transfer, and disposal of radiopharmaceuticals.
The PoltechMDP medicinal product is used exclusively under appropriate clinical conditions and only by appropriately qualified individuals. These individuals take special precautionary measures to ensure safe use of the medicinal product and will continuously report on their actions.
The medicinal product is intended for intravenous administration.
The nuclear medicine specialist supervising the procedure determines the dose of the medicinal product to be used in a given case. This will be the minimum dose necessary to obtain the required diagnostic information. The recommended dose ranges between 370 and 740 MBq (megabecquerel, a unit of radioactivity measurement), although 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-for-use injection solution will be administered intravenously before the examination. Depending on the type of examination, imaging may be performed within 2 hours or several hours after injection.
The radioactive preparation Tc-MDP is intended for intravenous administration under strict supervision by qualified personnel.
During preparation and administration of the medicinal product, regulations concerning radiation protection and safety at work involving ionizing radiation must be strictly observed.

Duration of the procedure
The physician will inform you about the standard duration of the procedure.

After administration of PoltechMDP you should

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

The physician will inform you about the need to take special precautionary measures after administration of the medicinal product. In case of doubts, consult the attending physician or the nuclear medicine specialist supervising the examination.

Administration of a higher than recommended dose of PoltechMDP
Overdose is practically unlikely, as the dose administered to the patient is strictly controlled by the nuclear medicine specialist supervising the examination. However, in the event of an overdose, the physician may recommend increased fluid intake to help eliminate the radiopharmaceutical from the body.

In case of any doubts related to the use of the medicinal product, consult the physician or the nuclear medicine specialist supervising the examination.

4. Possible adverse reactions

Like any medicinal product, PoltechMDP may cause adverse reactions, although not everyone experiences them.
Possible adverse reactions after administration of PoltechMDP include: headache, joint pain, nausea, vomiting, hypotension, redness or rash, itching, skin irritation, swelling of the hands and feet, general malaise, and very rarely, symptoms of anaphylaxis.
These symptoms are usually mild in nature, and their exact frequency cannot be estimated based on available data.
Administration of a radiopharmaceutical results in exposure to a small dose of ionizing radiation, which is associated with the risk of inducing cancer and heritable genetic defects.
Current evidence indicates a low probability of such adverse reactions occurring in diagnostic procedures in nuclear medicine.
Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your physician or a specialist in nuclear medicine. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions 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: [email protected]
Adverse reactions may also be reported to the marketing authorization holder.
Reporting of adverse reactions helps to provide more information on the safety of the medicinal product.

5. How to store PoltechMDP kit

The patient does not need to store this medicinal product.
Radiopharmaceuticals are stored exclusively by authorised personnel under appropriate clinical conditions. Storage of radiopharmaceuticals is carried out in compliance with local regulations concerning radioactive substances.
The following information is intended solely for healthcare professionals.
Do not use the medicinal product after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.

6. Contents of the package and other information

What the PoltechMDP kit contains

The active substance is methylene diphosphonic acid
Other components are: tin(II) chloride dihydrate, ascorbic acid, nitrogen

What the PoltechMDP kit looks like and contents of the pack
Kit for the preparation of a radiopharmaceutical preparation.
White or almost white powder.
The kit is supplied in 10 ml glass vials, each closed with a rubber stopper and aluminium crimp cap, packed in a cardboard box.
Pack contents:
3 vials or 6 vials.
Each vial contains a lyophilisate for preparation of an injection solution.

Marketing Authorisation Holder and Manufacturer
National Centre for Nuclear Research
7 Andrzej Soltan Street
05-400 Otwock
Tel: +48 22 7180700
Fax: +48 22 7180350
e-mail: [email protected]

For further information, please contact your doctor or a representative of the Marketing Authorisation Holder.

The full Summary of Product Characteristics (SmPC) for PoltechMDP is provided as a separate document inside the medicinal product packaging, intended to supply healthcare professionals with additional scientific and practical information regarding the administration and use of this radiopharmaceutical.