Iodek sodu Na 131i, roztvur do vstzhikivani

LEAFLET INCLUDED IN THE PACKAGE: INFORMATION FOR THE USER

Sodium Iodide I-131, Solution for Injection

Solution for Injection, 37-740 MBq/ml

Active substance: sodium iodide [I-131]

Read the leaflet carefully before using 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 nuclear medicine specialist.
• If the patient experiences any side effects, including those not listed in the leaflet, inform the nuclear medicine specialist.

Table of Contents of the Leaflet:

• 1. What is Sodium Iodide I-131, Solution for Injection and what is it used for
• 2. Important information before using Sodium Iodide I-131, Solution for Injection
• 3. How to use Sodium Iodide I-131, Solution for Injection
• 4. Possible side effects
• 5. How to store Sodium Iodide I-131, Solution for Injection
• 6. Contents of the package and other information

1. What is Sodium Iodide I-131, Solution for Injection and what is it used for

Sodium Iodide I-131, Solution for Injection is a medicinal product (radiopharmaceutical) intended for both diagnostic and therapeutic use.
Sodium Iodide I-131, Solution for Injection is administered intravenously and is used for the diagnosis and treatment of thyroid diseases. The product is intended for direct administration to patients in doses of varying radioactivity, depending on the indications.
Sodium Iodide I-131, Solution for Injection is intended for performing isotope tests in thyroid diseases. It is 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 higher extent than normal thyroid tissue).
Sodium Iodide I-131, Solution for Injection may be administered as a test dose to study the behavior of radioiodine in the thyroid gland. The assessment of thyroid iodine uptake and its half-life in the thyroid gland may be used to calculate the therapeutic activity of radioiodine.
Sodium Iodide I-131, Solution for Injection is used in patients treated for differentiated thyroid cancer to identify thyroid remnants after surgery and to diagnose metastases.
Sodium Iodide I-131 is used to treat benign thyroid diseases: nodular goiter without thyroid function disorders, hyperthyroidism in the course of Graves' disease and Basedow's disease, single nodule and multinodular goiter. It is also used to treat differentiated thyroid cancer: after surgical treatment to destroy residual thyroid tissue, to destroy residual cancer foci, and to treat iodine-accumulating metastases of thyroid cancer.
Due to the content of the radioactive isotope iodine-131, the use of this medicinal product is associated with exposure to ionizing radiation. The doctor has determined that the benefits of the performed examination or therapy outweigh the potential risk associated with ionizing radiation.

2. Important information before using Sodium Iodide I-131, Solution for Injection

When not to use Sodium Iodide I-131, Solution for Injection

Sodium Iodide I-131, Solution for Injection must not be used:

• if the patient is hypersensitive (allergic) to the active substance or any of the other ingredients of the medicinal product.
• in pregnant or breastfeeding women,

Sodium Iodide I-131, Solution for Injection should not be used:

• for diagnostic purposes in children under 10 years of age,
• for 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

Due to the risk of radiation contamination, caution should be exercised when treating patients with radioactive iodine, especially:

• those who may not follow the recommendations of medical personnel,
• those with urinary incontinence.

Some patients receiving large activities of iodine-131 may need to be hospitalized due to the need to comply with radiation protection regulations.
The administration of medicinal products containing radioactive isotopes poses a risk of exposure to external ionizing radiation or contamination caused by isotopes present in urine, vomit, sweat, etc. Therefore, after administration of Sodium Iodide I-131, it is recommended to:

• drink a slightly larger amount of fluids (about 1-1.5 liters more per day) and
• urinate frequently to remove the radioactive medicinal product from the body as quickly as possible.

Observations have shown a small concentration of sodium in the blood in elderly patients after thyroidectomy. The occurrence of this phenomenon is most likely in women and patients taking diuretics (such as hydrochlorothiazide). If the patient belongs to one of these groups, the doctor may recommend regular blood tests to determine the electrolyte concentration (e.g. sodium) in the blood.

Before administering Sodium Iodide I-131, Solution for Injection, the doctor may recommend:

• a low-iodine diet (especially limiting the consumption of seafood),
• avoiding medicinal products containing iodine (e.g. vitamins with iodine, some disinfectants, some eye drops, some expectorants, medicinal products containing amiodarone, 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 medicinal products, e.g. containing thiamazole or propylthiouracil.

Sodium Iodide I-131, Solution for Injection and other medicinal products

Inform the nuclear medicine specialist about all medicinal products currently being taken, including those available without a prescription, as well as those planned to be taken.
Many substances interact with iodides, affecting their binding to proteins, their behavior in the body, or modifying the effects of radioactive iodine. This means that the doctor should be aware of all medicinal products taken by the patient and decide on the possible discontinuation of some medicinal products before administering Sodium Iodide I-131.

Sodium Iodide I-131, Solution for Injection with food and drink

Before administering Sodium Iodide I-131, the doctor may recommend a low-iodine diet, which increases its uptake by the thyroid tissue.

Pregnancy and breastfeeding

Sodium Iodide I-131, Solution for Injection must not be used in pregnant or breastfeeding women.
Before taking the medicinal product, inform the nuclear medicine specialist if:

• pregnancy is suspected or confirmed,
• menstruation has not occurred at the expected time,
• the woman is breastfeeding. In case of doubts, consultation with a nuclear medicine specialist supervising the examination is necessary. If the patient is pregnant, it is essential to inform the doctor.

For both sexes, it is recommended to use contraception for at least 4 months after treatment with Sodium Iodide I-131. The doctor may also consider recommending contraception for a similar period after administration of higher activities of Sodium Iodide I-131 for diagnostic purposes in patients with differentiated thyroid cancer.
In the event of the need to administer Sodium Iodide I-131 to a breastfeeding woman, breastfeeding should be discontinued.

Driving and using machines

No data available.

Sodium Iodide I-131, Solution for Injection contains sodium

The medicinal product contains from 1.2 to 1.3 mg of sodium per milliliter. This should be taken into account in patients on a low-sodium diet.

3. How to use Sodium Iodide I-131, Solution for Injection

There are strict regulations regarding the use, transfer, and disposal of radiopharmaceuticals. Sodium Iodide I-131, Solution for Injection is administered only under appropriate clinical conditions and only by qualified personnel. These persons take special precautions to ensure safe use of the medicinal product and will keep the patient informed about their actions.
Sodium Iodide I-131, Solution for Injection is a medicinal product for intravenous administration, in doses of varying radioactivity.
The activity (dose) of the medicinal product is determined by the nuclear medicine specialist. This activity should be determined individually for each patient and will be the minimum dose necessary to achieve the expected therapeutic effect or diagnostic information.
Activities used in diagnostics.

• In isotope tests performed in patients with benign thyroid diseases, it is recommended to administer 0.15-4 MBq of Sodium Iodide I-131.
• In tests performed in patients treated for differentiated thyroid cancer, it is recommended to administer 37-240 MBq (usually 37-74 MBq) of Sodium Iodide I-131.

Activities used in therapy.

• Treatment of hyperthyroidism and simple goiter: 200-800 MBq
• Destruction of thyroid tissue after surgery for thyroid cancer: 1850-3700 MBq Treatment of thyroid cancer metastases: 3700-11,100 MBq (MBq = megabecquerel - a unit of measurement of radioactivity)

Use in children

The use of Sodium Iodide I-131, Solution for Injection in children must be carefully analyzed by the nuclear medicine specialist, taking into account clinical indications and the assessment of the benefit-to-risk ratio in this patient group. The dose of the medicinal product is calculated in a similar way to that used in adults, but it may be considered to be reduced depending on the age and weight of the child.
It should be remembered that remote potential side effects associated with the administration of iodine (I-131) in children (especially under 10 years of age) and adolescents are more likely than in adults.

After administration of Sodium Iodide I-131, Solution for Injection:

• to reduce the radiation dose absorbed by the bladder, drink a slightly larger amount of fluids (about 1-1.5 liters more) and
• urinate frequently to remove the radioactive medicinal product from the body as quickly as possible,
• use contraception for at least 4 months after treatment.

The administration of medicinal products containing radioactive isotopes poses a risk of exposure to external ionizing radiation or contamination caused by isotopes present in urine, vomit, sweat, etc. Therefore, after administration of Sodium Iodide I-131, it is recommended to:

• avoid close contact with other people, especially small children and pregnant women, for a period of time recommended by the doctor,
• carefully remove any residues of urine, feces, sweat, etc. for a period of time recommended by the doctor.

Use of a higher than recommended dose of the medicinal product

Overdose is almost impossible, as the dose of the medicinal product administered to the patient is strictly controlled by the nuclear medicine specialist.
The medicinal product is supplied in the form of a solution with a known activity, which makes it easier for the doctor to control the dose to be administered to the patient.
In the event of an overdose, the doctor may administer medicinal products that block the accumulation of iodine-131 by the thyroid gland or induce vomiting and recommend drinking a larger amount of fluids and frequent urination to remove the radioactive medicinal product from the body.
In case of any further doubts related to the use of this medicinal product, consult the nuclear medicine specialist.

• 4.

Possible side effects

Like all medicinal products, Sodium Iodide I-131, Solution for Injection can cause side effects, although not everybody gets them.
Side effects after diagnostic use of Sodium Iodide I-131 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 risk of cancer or genetic disorders. Currently available data indicate a low risk of such side effects in the case of diagnostic tests in nuclear medicine.
Side effects after therapeutic doses:

Early consequences
The early side effects that occur very frequently (observed in more than 1 in 10 patients) in the first hours or days after administration of the medicinal product (especially in high doses) include: radiation-induced thyroiditis (manifested by discomfort, rarely severe pain in the neck; swelling of the neck), radiation-induced sialadenitis (manifested by swelling, discomfort, rarely severe pain in the salivary glands), dry mouth, nausea, rarely vomiting, tracheal stenosis.
In patients treated for thyroid cancer metastases to the lungs (usually with multiple, high activities of iodine-131), radiation-induced pneumonia or pulmonary fibrosis may occur.
It is necessary to consider the possibility of local brain edema and (or) exacerbation of existing brain edema in patients with thyroid cancer metastases to the central nervous system.
Late consequences
A very common (observed in more than 1 in 10 patients) late consequence of treatment with Sodium Iodide I-131 for benign thyroid diseases is hypothyroidism, which requires compensation with thyroid hormones.
All the following side effects occur with an unknown frequency, which cannot be estimated based on available data.
In some patients, after administration of radioactive iodine, there is an increase in thyroid hormone levels in the blood (usually 7-10 days after treatment). In patients with poorly controlled thyroid function, this may lead to symptoms of hyperthyroidism (similar to those at the beginning of thyroid disease), and in extreme cases, a life-threatening thyroid crisis may occur. In a small percentage of patients with nodular goiter, administration of iodine-131 may cause symptoms of Graves' disease and Basedow's disease.
A late consequence is also the occurrence of reversible or, in very rare cases (in persons treated with high doses of iodine-131), irreversible impairment of bone marrow function, manifested by a decrease in platelet count and (or) white blood cell count, rarely red blood cell count.
A rare consequence of treatment with iodine-131 in patients with Graves' disease and Basedow's disease (especially smokers) may be worsening or occurrence of exophthalmos (thyroid ophthalmopathy). Similarly, rare in patients treated with iodine-131 for thyroid nodules, thyroiditis of immunological origin may occur, usually transient, but may manifest as hyperthyroidism requiring treatment.
Treatment of thyroid cancer with Sodium Iodide I-131 may cause temporary (rarely permanent) impairment of fertility in women and men.
As a result of administration of Sodium Iodide I-131, permanent damage to the salivary glands with dry mouth, taste disorders, and smell disorders (more frequent after multiple administrations of iodine-131) may occur, rarely permanent impairment of tear secretion (dry eye syndrome) or their outflow from the eye (due to narrowing of the tear ducts).
In a small number of patients after treatment with iodine-131, disorders of parathyroid function - hyperparathyroidism or hypoparathyroidism - have occurred.
Exposure to ionizing radiation may lead to an increased risk of cancer (in the case of high activities of radioactive isotopes) or genetic disorders. Epidemiological data indicate an increased frequency of stomach cancer, bladder cancer, breast cancer, and leukemia in persons treated with high activities of Sodium Iodide I-131.
Reporting of side effects
If any side effects occur, including those not listed in the leaflet, inform the doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, e-mail: ndl@urpl.gov.pl.
Side effects can also be reported to the marketing authorization holder.
Reporting of side effects will help to gather more information on the safety of the medicinal product.

5. How to store Sodium Iodide I-131, Solution for Injection

The patient will not need to store this medicinal product.
Radiopharmaceuticals are stored only by authorized persons, 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 package and other information

What Sodium Iodide I-131, Solution for Injection contains

• The active substance of the medicinal product is sodium iodide I-131, with an activity of [37-740 MBq/ml]
• The other ingredients are: sodium carbonate, sodium bicarbonate, sodium thiosulfate pentahydrate, sodium chloride, water for injections

What Sodium Iodide I-131, Solution for Injection looks like and what the package contains

The medicinal product is supplied in the form of a solution in a vial.
The vial is made of type I glass with a capacity of 10 ml, closed with a rubber stopper and an aluminum cap, placed in a lead shielding container

Marketing authorization holder and manufacturer

National Centre for Nuclear Research
ul. Andrzeja Sołtana 7
05-400 Otwock
Tel: 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:08.02.2018

Information intended only for healthcare professionals:

The radiopharmaceutical is supplied in a ready-to-use form.
Radiopharmaceuticals should be prepared by the user in a way that ensures appropriate radiation safety and pharmaceutical quality. It is necessary to take appropriate precautions to ensure the sterility of the medicinal product.
The vial must not be opened before disinfecting the stopper, and the solution should be drawn up through the stopper using a single-use syringe with a suitable shield and a single-use needle or using an automated injection system. The medicinal product should not be used if the vial is damaged.
Any unused remnants of the medicinal product or its waste should be disposed of in accordance with local regulations.