Poltehrbc

PATIENT LEAFLET: INFORMATION FOR THE USER

PoltechRBC, 13.40 mg, lyophilisate for solution for injection

Stannous pyrophosphate and technetium (Tc) injection solution

Read the leaflet carefully before using the medicine.

• Keep this leaflet, you may need to read it again.
• In case of any further questions, consult your doctor or a specialist in nuclear medicine who supervises the examination.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or a specialist in nuclear medicine who supervises the examination.

Table of contents of the leaflet:

• 1. What is PoltechRBC and what is it 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 IS PoltechRBC AND WHAT IS IT USED FOR

A radiopharmaceutical product intended exclusively for diagnostic purposes.
Indications for use are:
Red blood cell scintigraphy using labeled erythrocytes used for :
scintigraphy allowing for:

• study of the ejection fraction of the heart chambers,
• study of total and segmental mobility of the heart muscle walls, imaging of organ perfusion and vascular abnormalities, diagnosis and localization of gastrointestinal bleeding. Blood volume study. Spleen scintigraphy.

The use of PoltechRBC results in 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 PoltechRBC

When not to use PoltechRBC

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

Warnings and precautions

Inform the specialist in nuclear medicine in the following cases:

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

Administration of radiopharmaceuticals creates a risk of exposure to external ionizing radiation or contamination caused by urine stains, vomiting, etc. for other people. Therefore, basic hygiene rules should be followed in accordance with local regulations.
Particular caution should be exercised when using radiopharmaceuticals to avoid unnecessary exposure of personnel and patients.
In order to reduce the radiation dose absorbed by the bladder, it is recommended to drink plenty of fluids after injection to more frequently empty the bladder.

PoltechRBC and other medicines

Tell your doctor or a specialist in nuclear medicine supervising the examination about all medicines that are currently being taken or have been taken recently, including those that are available without a prescription.

PoltechRBC with food and drink

No special precautions are recommended.

Pregnancy and breastfeeding

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

• there is a suspicion of pregnancy in a woman,
• menstruation has not occurred at the expected time,
• the woman is breastfeeding. In case of doubt, consultation with the doctor or a specialist in nuclear medicine who will supervise the examination is necessary.

If the patient is pregnant, it is important to inform the doctor. The use of radiopharmaceuticals during pregnancy should be carefully considered. The doctor will refer for an examination using radiopharmaceuticals during pregnancy only in case of absolute necessity.
In the case of breastfeeding and the need to administer a radiopharmaceutical, the doctor may ask to stop breastfeeding and discard breast milk. Breastfeeding should be stopped for 12 hours after injection and the expressed breast milk should be discarded. The possibility of returning to breastfeeding should be agreed with the specialist in nuclear medicine who supervises the examination.

Driving and using machines

No data available.

3. HOW TO USE PoltechRBC

Radiopharmaceuticals can only be administered by authorized personnel.
There are strict regulations regarding the use, transfer, and disposal of radiopharmaceuticals. PoltechRBC is used exclusively in appropriate clinical conditions and only by properly qualified personnel. These persons take special precautions to ensure safe use of the medicine and will keep the patient informed about their actions.
The medicine is intended for intravenous administration.
PoltechRBC should be dissolved in a physiological saline solution before 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.
Depending on the type of examination, the recommended dose of the medicine will be in the range:

• red blood cell scintigraphy: 500 - 1050 MBq (average 800 MBq),
• blood volume study: 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 analyzed by the specialist in nuclear medicine supervising the examination, who will consider the clinical indications and the assessment of the benefit-to-risk ratio in this patient group. In the case of children, the dose of the medicine will be adjusted to the child's weight or body surface area .

Administration of the medicine and performance of the examination

The ready-to-use solution for injection will be administered intravenously before performing the scintigraphy. In some cases, it may be necessary to take a blood sample before or after the examination. Depending on the method of labeling the blood cells, two injections may be necessary. The examination, depending on its type, may start within a few minutes to about half an hour after injection.
The technetium Tc radiopharmaceutical product is intended for intravenous administration only under the strict supervision of specialized personnel. When preparing and administering the radiopharmaceutical, the regulations regarding safety at work in conditions of exposure to ionizing radiation must be strictly followed.

Duration of the procedure

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

Use of a higher than recommended dose of the medicine

Overdose is almost impossible, because 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 remnants of the radiopharmaceutical from the body.
In case of any further doubts related to the use of the medicine, consult the doctor or a specialist in nuclear medicine supervising the examination.

4. POSSIBLE SIDE EFFECTS

Like all medicines, PoltechRBC can cause side effects, although not everybody gets them.
Side effects after intravenous administration of both labeled and unlabeled complexes with Tc have been reported in individual cases (1 – 5 per 100,000 administrations, the exact frequency is not possible to estimate based on available data). These symptoms are usually short-term and mild to moderate, although serious side effects have also been reported. Possible side effects include cardiac arrhythmias, headaches, dizziness, fainting, nausea, vomiting, skin rashes, blood pressure drops, flushing, facial swelling, local reactions at the injection site, allergic reactions.
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.

Reporting of side effects

If you experience any side effects, including those not listed in this leaflet, please tell your doctor or a specialist in nuclear medicine.
Side effects 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 181C
02-222 Warsaw
Phone: + 48 22 49 21 301
Fax: + 48 22 49 21 309
e-mail: ndl@urpl.gov.pl
By reporting side effects, you can help provide more information on the safety of the medicine.

5. HOW TO STORE PoltechRBC

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

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What PoltechRBC contains

The active substance is disodium pyrophosphate decahydrate (13.40mg/vial).
The medicine also contains:
tin (II) chloride dihydrate
nitrogen

What PoltechRBC looks like and contents of the pack

Lyophilisate for solution for injection.
White powder.
The medicine is supplied in 10 ml glass vials.
The vial is closed with a rubber stopper and an aluminum cap.
The vials are packed in cardboard boxes.
Sets are offered in packages containing 3 or 6 vials.
Each vial contains powder for solution for injection.

Marketing authorization holder and manufacturer:

National Centre for Nuclear Research
ul. Andrzeja Sołtana 7
05-400 Otwock
Phone: 22 718 07 00
Fax: 22 718 03 50
e-mail: polatom@polatom.pl
To obtain more detailed information, please contact your doctor or a representative of the marketing authorization holder.

Date of last revision of the leaflet:

The full Summary of Product Characteristics (SmPC) of PoltechRBC is attached as a separate document to the product packaging, in order to provide healthcare professionals with additional, scientific and practical information on the administration and use of this radiopharmaceutical.