Poltehcolloid

Package Leaflet: Information for the User

PoltechColloid, 0.17 mg, Kit for the Preparation of a Radiopharmaceutical

Copper(II) chloride dihydrate
You should carefully read the contents of this 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 you need to.
• If you have any doubts, you should consult your doctor or a specialist in nuclear medicine who is supervising the examination.
• If the patient experiences any undesirable effects, including any undesirable effects not mentioned in this leaflet, they should inform their doctor or a specialist in nuclear medicine.

Table of Contents of the Leaflet:

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

1. What is PoltechColloid and what is it used for

This product is intended exclusively for diagnostic purposes.
The PoltechColloid preparation, after labeling (combination with) the radioactive technetium isotope (Tc),
is used for the diagnosis of the spleen and liver.
Due to the combination with the radioactive technetium isotope Tc, the use of PoltechColloid
involves 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 PoltechColloid

When not to use PoltechColloid

• 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 your doctor or a specialist in nuclear medicine in the following cases:

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

The administration of radiopharmaceuticals poses a risk of external ionizing radiation exposure or contamination caused by urine, vomit, etc. to other people. For this reason, basic hygiene rules should be observed.
Particular caution should be exercised when using radiopharmaceuticals to avoid unnecessary exposure of personnel and patients.

Children and adolescents

You should inform your doctor or a specialist in nuclear medicine if the patient is under 18 years of age.
The administration of the product to children should be carefully considered, taking into account the clinical indications and the assessment of the risk-benefit ratio in this patient group.

PoltechColloid and other medicines

You should tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

Pregnancy and breastfeeding

In pregnancy and during breastfeeding, or if there is a suspicion that the woman is pregnant, or if she plans to become pregnant, you should consult your doctor before using this medicine.
Before administering the product, you should inform your doctor or a specialist in nuclear medicine if:

• the woman suspects she may be pregnant;
• she has not had her menstrual period at the expected time;
• the woman is breastfeeding. In case of doubt, consultation with the attending physician or a specialist in nuclear medicine who will supervise 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 it is absolutely necessary.
In the case of breastfeeding and the need to administer a radiopharmaceutical, the doctor may ask to stop breastfeeding and discard the milk. Breastfeeding should be stopped for at least 12 hours after the injection of the preparation, and the milk expressed during this time should be discarded.
The possibility of returning to breastfeeding should be agreed upon with the specialist in nuclear medicine who supervises the examination.

Driving and using machines

The effect of the product on the ability to drive and use machines has not been studied.

PoltechColloid contains sodium ions

You should inform your doctor or a specialist in nuclear medicine if the patient is on a low-sodium diet.

3. How to use PoltechColloid

Radiopharmaceuticals can only be administered by authorized personnel.
There are strict regulations regarding the use, transfer, and disposal of radiopharmaceutical products. The PoltechColloid kit is used exclusively in appropriate clinical conditions and only by qualified personnel. These personnel take special precautions to ensure the safe use of the product and will inform about their actions.
The preparation is intended for intravenous administration.

Dosage and administration

The PoltechColloid kit should be dissolved in sodium pertechnetate (Tc) before administration. The doctor or a specialist in nuclear medicine supervising the procedure decides on the dose of the product 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 150 to 200 MBq (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 weight.

Use of a higher than recommended dose of PoltechColloid

Overdose is practically impossible, as the dose of the product administered to the patient is strictly controlled by the doctor or a specialist in nuclear medicine supervising the examination. However, in the event of an overdose, the doctor may recommend drinking more fluids to remove the radiopharmaceutical residues from the body.
In case of doubts related to the use of the medicine, you should consult your doctor or a specialist in nuclear medicine who supervises the examination.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Possible side effects after using PoltechColloid include: low blood pressure, slow heart rate, vascular spasms, shallow breathing, bronchospasm, allergic skin reactions, malaise, chest or back pain.
These symptoms usually have a mild course, and their exact frequency is impossible to estimate based on available data.
The administration of radiopharmaceuticals results in exposure to a small dose of ionizing radiation, which is associated with the risk of causing cancer and genetic disorders. Current evidence suggests a low probability of such side effects occurring in the case of diagnostic tests in nuclear medicine.

Reporting side effects

If any side effects occur, including any side effects not mentioned in this leaflet, you should inform your doctor or a specialist in nuclear medicine. Side effects can be reported directly to the Department of Post-Marketing Surveillance of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
{current address, phone number, and fax of the above Department}
e-mail: adr@urpl.gov.pl.
Thanks to the reporting of side effects, more information can be gathered on the safety of the use of the medicine.

5. How to store PoltechColloid

The patient will not need to store this medicinal product.
Radiopharmaceutical products are stored exclusively by authorized personnel in appropriate clinical conditions. The storage of radiopharmaceuticals is carried out in accordance with local regulations regarding 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), a temperature below 35°C is allowed.
The expiration date is stated on the packaging.
After dissolution and labeling in sodium pertechnetate (Tc) solution: 4 hours at a temperature below 25°C, in a shielded container.
Do not use the product after the expiration date stated on the packaging. The expiration date means the last day of the given month.

6. Contents of the pack and other information

What PoltechColloid contains

• The active substance of the medicine is copper(II) chloride dihydrate
• The other ingredients are: sodium fluoride, povidone, nitrogen.

What PoltechColloid looks like and what the pack contains

PoltechColloid 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

Date of the last update of the leaflet:

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The Full Prescribing Information (FPI) for PoltechColloid is attached as a separate document to the product packaging, in order to provide healthcare professionals with additional, scientific, and practical information regarding the administration and use of this radiopharmaceutical.