Poltechcolloid

Package leaflet: Information for the user

PoltechColloid, 0.17 mg, kit for the preparation of a radiopharmaceutical preparation
Stannous chloride dihydrate
Please read carefully the entire text of this leaflet before using the medicinal product, 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 any adverse reactions occur in the patient, including any adverse reactions not listed in this leaflet, inform the nuclear medicine specialist immediately.

Table of contents of the leaflet:

1. What is PoltechColloid kit and for what purpose is it used
2. Important information before use of PoltechColloid kit
3. How to use PoltechColloid kit
4. Possible adverse reactions
5. How to store PoltechColloid kit
6. Contents of the package and other information

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

This product is intended exclusively for diagnostic use.
After labelling (binding) with radioactive technetium isotope (Tc), PoltechColloid is used in the diagnosis of liver and spleen.
Due to its combination with the radioactive technetium isotope Tc, the use of PoltechColloid involves exposure to a small radiation dose. The physician has determined that the benefits derived from the examination outweigh the potential risks associated with ionizing radiation.

2. Important information before using PoltechColloid kit

When not to use PoltechColloid kit

• if the patient has hypersensitivity to the active substance or to any of the other components of this medicinal product (listed in section 6).

Warnings and precautions
You must 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, as well as contamination from bodily fluids such as urine or vomit. For this reason, basic hygiene principles must be observed.
Special care must be taken when handling radiopharmaceuticals to avoid unnecessary exposure of medical personnel and patients.

Children and adolescents
You must inform the nuclear medicine specialist physician if the patient is under 18 years of age.
Administration of the product in children should be carefully considered, taking into account clinical indications and risk-benefit assessment in this patient group.

PoltechColloid kit and other medicines
You must tell your doctor about all medicines currently used or recently used, as well as any medicines the patient plans to use.

Pregnancy and breastfeeding

During pregnancy, breastfeeding, when there is suspicion of pregnancy, or when pregnancy is planned, medical advice must be sought before using this medicinal product.
Before administration of the product, the nuclear medicine specialist physician must be informed 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 attending physician or a nuclear medicine specialist supervising the examination is required.

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

In case of breastfeeding and when administration of a radiopharmaceutical is medically necessary, the physician may request temporary discontinuation of breastfeeding and regular expression and disposal of breast milk. Breastfeeding must be interrupted for at least 12 hours after injection of the preparation, and milk expressed during this period must be discarded. Resumption of breastfeeding should be discussed with the nuclear medicine specialist supervising the examination.

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

PoltechColloid kit contains sodium ions
You must inform the nuclear medicine specialist physician if the patient is on a low-sodium diet.

3. How to use PoltechColloid kit

Radiopharmaceuticals may be administered only by authorized personnel.
There are strict regulations concerning the use, transfer, and disposal of radiopharmaceutical products. The PoltechColloid kit 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 product and will continuously report on their actions.
The preparation is intended for intravenous administration.
Dosage and method of administration
Before administration, the PoltechColloid kit must be dissolved in sodium pertechnetate (Tc). The nuclear medicine specialist supervising the procedure determines the dose of product to be used in each individual case. This will be the minimum dose necessary to obtain the required diagnostic information. The recommended dose ranges between 150 and 200 MBq (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 medication to be administered is determined based on the patient's body weight.
Administration of a higher than recommended dose of PoltechColloid
Overdose is practically impossible, 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 residual radiopharmaceutical from the body.
In case of any doubts regarding the use of the medicinal product, consult the physician or the nuclear medicine specialist supervising the procedure.

4. Possible adverse reactions

Like all medicines, this medicinal product may cause adverse reactions, although not everyone experiences them.
Possible adverse reactions after administration of PoltechColloid include: lowering of blood pressure,
slowing of heart rate, vascular motor disturbances, shallow breathing, bronchospasm, allergic
skin reactions, malaise, chest or back pain.
These symptoms are usually mild in nature, and their exact frequency cannot be estimated based on the available data.
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 defects. Current evidence
suggests a low probability of such adverse effects occurring in the context of diagnostic procedures in nuclear medicine.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or a nuclear medicine specialist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
{current address, telephone and fax number of the above-mentioned Department}
e-mail: [email protected].
By reporting adverse reactions, more information on the safety of this medicinal product can be collected.

5. How to store PoltechColloid kit

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 exclusively for medical personnel.
Store in a refrigerator (2°C – 8°C).
During transport (up to 7 days), temperatures below 35°C are permitted.
The expiry date is indicated on the packaging.
After reconstitution and labelling with sodium pertechnetate ( Tc) solution: 4 hours at a temperature below 25°C, shielded with radiation-absorbing material.
Do not use the product after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.

6. Contents of the package and other information

What the PoltechColloid kit contains

• The active substance is tin(II) chloride dihydrate
• Other ingredients: sodium fluoride, povidone, nitrogen.

What the PoltechColloid kit looks like and contents of the pack
The PoltechColloid kit is supplied in 10 ml glass vials with a rubber stopper and an aluminum seal, packed in a cardboard box.
The pack contains:
3 vials or 6 vials.
Each vial contains a lyophilisate for the preparation of a solution for injection.

Marketing Authorisation Holder and Manufacturer
National Centre for Nuclear Research
ul. Andrzeja Sołtana 7
05-400 Otwock
Tel: 22 7180700
Fax: 22 7180350
e-mail: [email protected]

The complete Product Information (SmPC) for PoltechColloid 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.