Poltechrbc

PoltechRBC, 13.40 mg, lyophilisate for the preparation of radiopharmaceutical solution for injection
Stannous pyrophosphate and technetium (Tc) injectable solution
Please read the entire package leaflet before using this medicinal product.

• Keep this leaflet for future reference.
• If you have any further questions, consult your physician or the nuclear medicine specialist supervising your examination.
• If any of the adverse reactions worsen, or if you experience any adverse reactions not listed in this leaflet, inform your physician or the nuclear medicine specialist supervising your examination.

Table of contents:

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

1. WHAT PoltechRBC IS AND WHAT IT IS USED FOR

A radiopharmaceutical product intended solely for diagnostic use.
Indications for use:
Blood pool scintigraphy using labeled red blood cells, enabling:

• Assessment of cardiac ejection fraction,
• Evaluation of global and regional myocardial wall motion,
• Organ perfusion imaging and detection of vascular abnormalities,
• Diagnosis and localization of gastrointestinal bleeding,
• Blood volume measurement,
• Splenic scintigraphy.

Use of PoltechRBC results in exposure to a small radiation dose. Your physician has determined that the benefits derived from the diagnostic procedure outweigh the potential risks associated with ionizing radiation.

2. IMPORTANT INFORMATION BEFORE USING PoltechRBC

When not to use PoltechRBC
Do not administer this medicinal product if the patient is allergic (hypersensitive) to the active substance or
to any of the other components of the medicine (listed in section 6).

Warnings and precautions
Please inform the nuclear medicine specialist in the following cases:

• if the woman is pregnant or pregnancy is suspected,
• if the woman is breastfeeding,
• if the patient is under 18 years of age.

Administration of radiopharmaceuticals poses a risk of external ionizing radiation exposure and contamination from urine, vomit, etc., to other individuals. Therefore, basic hygiene principles must be followed in accordance with locally applicable regulations.
Special caution must be exercised when handling radiopharmaceuticals to avoid unnecessary radiation exposure to medical staff and patients.
To reduce the absorbed radiation dose to the urinary bladder, it is recommended to drink plenty of fluids after injection to ensure frequent bladder emptying.

Interaction of PoltechRBC with other medicinal products
Inform your treating physician or the supervising nuclear medicine specialist about all medications currently or recently taken, including those available without a prescription.

PoltechRBC with food and drink
No special precautions are required.

Pregnancy and breastfeeding
Before administration of the medicinal product, inform the nuclear medicine specialist if:

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

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

In case of breastfeeding and when administration of a radiopharmaceutical is required, the physician may instruct to interrupt breastfeeding and to express milk. Breastfeeding should be interrupted for 12 hours after injection, and any milk expressed during this period must be discarded. Resumption of breastfeeding should be discussed with the nuclear medicine specialist supervising the procedure.

Driving and operating machinery
No data available.

3. HOW TO USE PoltechRBC

Radiopharmaceuticals may only be administered by authorized personnel.
There are strict regulations regarding the use, transfer, and disposal of
radiopharmaceuticals. PoltechRBC 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 keep the patient informed about their actions.

The medicinal product is intended for intravenous administration.
Before administration, PoltechRBC must be dissolved in a physiological saline solution. The nuclear medicine specialist supervising the procedure determines the dose of the medicinal product to be used in each individual case. This will be the minimum dose necessary to obtain the required diagnostic information.

Depending on the type of examination, the recommended dose of the medicinal product will fall within the following range:

• blood pool scintigraphy: 500 - 1050 MBq (average 800 MBq),
• blood volume measurement: 1 - 5 MBq (average 3 MBq),
• spleen scintigraphy: 20 - 70 MBq (average 50 MBq).
  (MBq = megabecquerel, a unit of measurement of radioactivity.)

Use in children
The use of PoltechRBC in children must be carefully evaluated by the nuclear medicine specialist supervising the examination, who will consider clinical indications and assess the benefit-risk ratio in this patient group. In children, the dose of the medicinal product will be adjusted according to body weight or body surface area.

Administration of the medicinal product and performance of the examination
The ready-to-use injection solution will be administered intravenously prior to scintigraphy. In some cases, blood sampling may be necessary before or at the end of the examination. Depending on the method of blood cell labeling, two injections may be required. The examination may begin anywhere from a few minutes to about half an hour after injection, depending on its type.

The radioactive technetium Tc product is intended for intravenous administration only under strict supervision of specialized personnel. During preparation and administration of the radiopharmaceutical, regulations concerning radiation protection and safety when working with ionizing radiation must be strictly observed.

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

Administration of a higher than recommended dose of the medicinal product
Overdose is almost impossible because 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 residual radiopharmaceutical from the body.

If you have any further questions concerning the use of this medicinal product, please consult your physician or the nuclear medicine specialist supervising the examination.

4. POSSIBLE ADVERSE REACTIONS

Like all medicinal products, PoltechRBC may cause adverse reactions, although not everyone experiences them.
Adverse reactions following intravenous administration of both Tc-labeled and unlabeled complexes have been reported in isolated cases (1 – 5 per 100,000 administrations; exact frequency cannot be estimated based on available data). These reactions are usually transient and range from mild to moderate in severity, although severe adverse reactions have also been reported. Possible adverse reactions include cardiac arrhythmias, headache, dizziness, fainting, nausea, vomiting, skin rashes, hypotension, flushing, facial swelling, local reactions at the injection site, and allergic symptoms.
Administration of a radiopharmaceutical results in exposure to a small dose of ionizing radiation, which is associated with a risk of inducing cancer and hereditary disorders.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or a specialist in nuclear medicine.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: [email protected]
Reporting adverse reactions helps to provide more information on the safety of the medicinal product.

5. HOW TO STORE PoltechRBC

The patient will not be required to store this medicinal product.
Radiopharmaceuticals are stored exclusively by authorized personnel under appropriate clinical conditions. Storage of radiopharmaceuticals must comply with local regulations concerning radioactive substances.
The following information is intended solely for medical staff.
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. PACK CONTENTS AND OTHER INFORMATION

What PoltechRBC contains
The active substance is sodium pyrophosphate decahydrate (13.40 mg/vial).
The medicine also contains:

• zinc chloride dihydrate
• nitrogen

What PoltechRBC looks like and contents of the pack
Lyophilisate for the preparation of an injection solution.
White powder.
The medicine is supplied in 10 ml glass vials.
Each vial is sealed with a rubber stopper and an aluminium cap.
Vials are packed in cardboard boxes.
Sets are available in packages containing 3 or 6 vials.
Each vial contains a powder for the preparation of an injection solution.

Marketing Authorisation Holder and Manufacturer:
National Centre for Nuclear Research
Andrzej Soltan Street 7
05-400 Otwock
Tel.: 22 718 07 00
Fax: 22 718 03 50
e-mail: [email protected]

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

The complete Product Information (SmPC) for PoltechRBC is included as a separate document within the product packaging, providing healthcare professionals with additional scientific and practical information regarding the administration and use of this radiopharmaceutical.