Iodek sodu Na 131 I Polatom, kapsuvki do diagnostiki

PATIENT LEAFLET: INFORMATION FOR THE USER

SODIUM IODIDE Na I POLATOM, capsules for diagnostic use

1-37 MBq, hard capsules

Active substance: sodium iodide

Read the leaflet carefully before taking the medicine, as it contains

important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a specialist doctor in nuclear medicine supervising the examination,
• If the patient experiences any adverse reactions, including any adverse reactions not listed in the leaflet, inform the specialist doctor in nuclear medicine supervising the examination.

Table of contents of the leaflet:

• What Sodium Iodide Na I POLATOM, capsules for diagnostic use are and what they are used for
• Important information before taking Sodium Iodide Na I POLATOM, capsules for diagnostic use
• How to take Sodium Iodide Na I POLATOM, capsules for diagnostic use
• Possible side effects.
• How to store Sodium Iodide Na I POLATOM, capsules for diagnostic use
• Contents of the pack and other information.

1. What Sodium Iodide Na I POLATOM, capsules for diagnostic use are and what they are used for

Sodium Iodide Na I POLATOM, capsules for diagnostic use are a medicinal product (radio-pharmaceutical), intended exclusively for diagnostic purposes. The capsules are administered orally and are used for the diagnosis of thyroid diseases.
Sodium Iodide Na I POLATOM, capsules for diagnostic use are intended for performing isotope tests in thyroid diseases. They are used to assess thyroid function disorders (hyperthyroidism and hypothyroidism), to localize the thyroid gland, to assess its size and shape, and to assess the function of changes in the thyroid gland: "cold" nodules (not accumulating iodine), "warm" (accumulating iodine to a similar extent as normal thyroid tissue), "hot" (accumulating iodine to a greater extent than normal thyroid tissue).
Sodium Iodide Na I POLATOM, capsules for diagnostic use may be used to study the behavior of radioiodine in the thyroid gland. The assessment of thyroid iodine uptake and its half-life in the thyroid gland can be used for dosimetric calculations of the therapeutic dose of radioiodine.
Sodium Iodide Na I POLATOM, capsules for diagnostic use are used in patients treated for differentiated thyroid cancer to identify thyroid remnants and to diagnose metastases.
Due to the content of the radioactive isotope of iodine - 131, the use of this medicine is associated with exposure to ionizing radiation. The doctor has determined that the benefits of the performed test outweigh the potential risk associated with ionizing radiation.

2. Important information before taking Sodium Iodide Na I POLATOM, capsules for diagnostic use

When not to take Sodium Iodide Na I POLATOM, capsules for diagnostic use

• If the patient is allergic (hypersensitive) to the active substance or any of the other ingredients of the medicine (listed in section 6).
• In women with confirmed or suspected pregnancy (or when pregnancy has not been ruled out),
• In breastfeeding women,
• In the diagnosis of children under 10 years of age,
• In scintigraphic examination of the thyroid gland, except in cases of thyroid cancer or if iodine-123 or technetium-99m are not available,

Warnings and precautions

Great caution should be exercised when using Sodium Iodide Na I POLATOM, capsules for diagnostic use in patients with swallowing disorders or gastrointestinal diseases causing regurgitation of food or vomiting (due to the risk of improper administration of the medicine and radioactive contamination, it is recommended to consider the possibility of administering iodine-131 in a different pharmaceutical form or by a different route than oral).
Administering medicines containing radioactive isotopes creates a risk of exposure to external ionizing radiation or contamination caused by spots of urine, vomit, sweat, etc. in relation to other people. Therefore, basic hygiene rules should be observed.
To reduce the dose of radiation absorbed by the bladder, it is recommended to drink a slightly larger amount of fluids than usual and to empty the bladder frequently after taking the medicine.

Before taking Sodium Iodide Na I POLATOM, capsules for diagnostic use, the doctor may recommend:

• a low-iodine diet (especially limiting the consumption of seafood),
• avoiding medicines containing iodine (e.g. vitamins with iodine, some disinfectants, some eye drops, some expectorants, amiodarone preparations, some contrast agents used in radiological examinations),
• temporarily discontinuing natural or synthetic thyroid hormones to increase iodine uptake by the thyroid tissue
• temporarily discontinuing antithyroid medicines, e.g. containing thiamazole or propylthiouracil

Sodium Iodide Na I POLATOM, capsules for diagnostic use and other medicines

Inform the specialist doctor in nuclear medicine about all medicines currently being taken or recently taken, including those available without a prescription, as well as any medicines that the patient plans to take.
Many substances interact with iodides. They affect the mechanisms of iodide binding to proteins and their behavior in the body. This means that the doctor should be aware of all medicines taken by the patient and decide whether to discontinue some of them before administering Sodium Iodide Na I POLATOM, capsules for diagnostic use.

Sodium Iodide Na I POLATOM, capsules for diagnostic use with food and drink

Before taking Sodium Iodide Na I POLATOM, capsules for diagnostic use, the doctor may recommend a low-iodine diet, which increases its uptake by the thyroid tissue. It is recommended that the patient fasts for about 2 hours before and after swallowing the capsule containing Sodium Iodide Na I POLATOM, capsules for diagnostic use to enable good absorption of the medicine.

Pregnancy and breastfeeding

Sodium Iodide Na I POLATOM, capsules for diagnostic use must not be used in pregnant or breastfeeding women.
Before taking the medicine, inform the specialist doctor in nuclear medicine if:

• there is a suspicion of pregnancy in a woman,
• menstruation has not occurred at the expected time,
• a woman is breastfeeding. In case of doubts, it is necessary to consult a specialist doctor in nuclear medicine supervising the examination. If the patient is pregnant, inform the doctor before taking the capsule. If it is necessary to use Sodium Iodide Na I POLATOM, capsules for diagnostic use in a breastfeeding woman, breastfeeding should be discontinued.

Driving and using machines

No data available.

Sodium Iodide Na I POLATOM, capsules for diagnostic use contain sodium

The medicine contains up to 96 mg of sodium in one capsule. This should be taken into account in patients on a low-sodium diet.

3. How to take Sodium Iodide Na I POLATOM, capsules for diagnostic use

There are strict regulations regarding the use, transfer, and disposal of radio-pharmaceuticals. Sodium Iodide Na I POLATOM, capsules for diagnostic use are administered only under appropriate conditions and only by qualified personnel. These personnel take special precautions to ensure safe use of the medicine and will keep you informed about their actions.
Sodium Iodide Na I POLATOM, capsules for diagnostic use are a medicine for oral administration in doses of different radioactivity.
The activity (dose) of the medicine is determined by a specialist doctor in nuclear medicine. It will be the minimum dose necessary to obtain the expected diagnostic information.
Depending on the type of examination, the recommended radioactivity of the capsules ranges from:

• in isotope tests performed in patients with benign thyroid diseases, it is recommended to administer 0.15 - 4 MBq of Sodium Iodide Na I POLATOM, capsules for diagnostic use.
• in examinations in patients treated for differentiated thyroid cancer, it is recommended to administer 37 - 240 MBq (usually 37 - 74 MBq) of Sodium Iodide Na I POLATOM, capsules for diagnostic use.

(MBq = megabecquerel - a unit of measurement of radioactivity)

Use in children

The use of Sodium Iodide Na I POLATOM, capsules for diagnostic use in children must be carefully analyzed by a specialist doctor in nuclear medicine, taking into account clinical indications and the assessment of the benefit-to-risk ratio in this group of patients. It should be remembered that remote potential adverse reactions associated with the administration of iodine (I) in children (especially under 10 years of age) and adolescents are more likely than in adults.
The diagnostic activity for children should be part of the adult dose and can be calculated by modifying the adult activity, taking into account the child's weight and/or body surface area.

After taking Sodium Iodide Na I POLATOM, capsules for diagnostic use, you should:

• to reduce the dose of radiation absorbed by the bladder, drink more fluids (about 1 - 1.5 liters more) than usual,

and frequently urinate to remove the remnants of the radio-pharmaceutical from the body. Administering medicines containing radioactive isotopes creates a risk of exposure to external ionizing radiation or contamination caused by spots of urine, vomit, sweat, etc. in relation to other people. Therefore:

Overdose

Overdose is almost impossible, as the dose of the medicine administered to the patient is strictly controlled by a specialist doctor in nuclear medicine.
The medicine is supplied in capsules with a known activity, which makes it easier for the doctor to control the dose to be administered to the patient.
In case of overdose, the doctor may administer medicines that block the accumulation of iodine-131 by the thyroid gland or induce vomiting and recommend drinking more fluids and frequent urination to remove the remnants of the radio-pharmaceutical from the body.
In case of doubts related to the use of the medicine, consult a specialist doctor in nuclear medicine.

4. Possible side effects

Like all medicines, Sodium Iodide Na I POLATOM, capsules for diagnostic use can cause side effects, although not everybody gets them.
Side effects after taking Sodium Iodide Na I POLATOM, capsules for diagnostic use have been reported in individual cases (the exact frequency is impossible to estimate based on available data).
Possible side effects include allergic reactions, nausea, and vomiting.
Exposure to ionizing radiation may lead to an increased incidence of cancer or genetic disorders. However, current evidence suggests that the risk of such side effects is low in the case of diagnostic tests in nuclear medicine.
If you experience any side effects, including any side effects not listed in the leaflet, inform the specialist doctor in nuclear medicine supervising the examination.

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, inform the doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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: ndl@urpl.gov.pl
Reporting side effects can help gather more information on the safety of the medicine.

5. How to store Sodium Iodide Na I POLATOM, capsules for diagnostic use

The patient will not need to store this medicine.
Radio-pharmaceuticals are stored only by authorized personnel, under appropriate conditions, in accordance with regulations regarding radioactive substances.
The following information is intended only for medical personnel.
Do not use the medicinal product after the expiry date stated on the packaging.

6. Contents of the pack and other information

What Sodium Iodide Na I POLATOM, capsules for diagnostic use contain

The active substance is sodium iodide (I).
One capsule contains from 1 to 37 MBq of sodium iodide (I).
The other ingredients are:
sodium carbonate
sodium bicarbonate
disodium phosphate dihydrate
sodium thiosulfate pentahydrate
water for injections
The composition of the gelatin capsule shell:
indigotine (E 132)
titanium dioxide (E 171)
gelatin

What Sodium Iodide Na I POLATOM, capsules for diagnostic use look like and what the pack contains

A polypropylene vial closed with a polyethylene plug and placed in a lead shielding container. One vial can contain up to 10 capsules of the same activity. A certificate of the radio-pharmaceutical is attached to each package.

Marketing authorization holder and manufacturer

National Center for Nuclear Research
ul. Andrzeja Sołtana 7
05-400 Otwock
Phone: 22 7180700
Fax: 22 7180350
e-mail: polatom@polatom.pl
To obtain more detailed information, consult a doctor or a representative of the marketing authorization holder.

Date of last revision of the leaflet:

Information intended only for healthcare professionals

The radio-pharmaceutical is supplied in the form of capsules with an activity consistent with the order (activity is determined at 12:00 on the day of calibration).
When handling and administering the medicinal product, strictly follow the safety rules for working with ionizing radiation.
How to open the packaging with the radioactive product:
• Check the radioactivity and calibration date on the outer packaging.
• Remove the metal can from the cardboard box and tear off its top cover
• Remove the top part of the styrofoam insert.
• Remove the shielding container with the capsule.
• Remove the top cover of the lead shielding container.
• Remove the plastic cap from the polypropylene vial placed inside the lead container.
• Remove the capsules from the vial one by one using tweezers.
Any unused remnants of the medicinal product or its waste should be disposed of in accordance with local regulations.