Sodium iodide na 131 i for injection

INSTRUCTION for medical use of the medicinal product Sodium iodide Na131I for injection (Sodium iodide Na131I for injection)

Composition:

Active substance
: sodium iodide-131;

1 ml contains sodium iodide-131 with an activity of 37–740 MBq;

Excipients:
anhydrous sodium carbonate, sodium hydrocarbonate, sodium thiosulfate, sodium chloride, water for injections.

Pharmaceutical form.
Solution for injection.

Main physicochemical properties:
clear, colourless solution.

Pharmacotherapeutic group.

Diagnostic radiopharmaceuticals. Various radiopharmaceuticals for thyroid gland investigation. Sodium iodide (131I).
ATC code V09FX03.

Therapeutic radiopharmaceuticals. Other therapeutic radiopharmaceuticals. Sodium iodide (131I).
ATC code V10XA01.

Pharmacological properties.

Pharmacodynamics.

Sodium iodide Na131I for injection, at doses used for diagnostic and therapeutic purposes, exhibits no pharmacological effect.

Pharmacokinetics.

After administration, approximately 20% of iodine is absorbed into the blood and accumulates during each passage through the thyroid gland.

Maximum iodine uptake by the thyroid gland occurs within 24–48 hours after administration (about 50% of iodine is absorbed already within 5 hours). This iodine kinetics is a necessary condition for performing diagnostic tests at 24 and 72 hours after administration.

Sodium iodide Na131I for injection accumulates in small amounts in the salivary glands, gastric mucosa, choroid plexuses of the brain, as well as in the placenta and is secreted into human breast milk. The effective half-life of radioactive iodine from blood plasma is approximately 12 hours, whereas for iodine accumulated in the thyroid gland, it is about 6 days. Thus, after administration of Sodium iodide Na131I for injection, the effective half-life of about 40% of the activity is 0.4 days, and the remaining 60% is 8 days. Approximately 37–75% of the activity is excreted in urine, about 10% in feces, and a small amount is also eliminated from the body in sweat.

Sodium iodide Na131I for injection accumulates in the thyroid gland via active transport across the gland's cell membrane. In the thyroid gland, iodide is oxidized to iodine, followed by incorporation of iodine into tyrosine amino acid residues and subsequent binding to thyroglobulin. Under normal conditions, approximately 2% of circulating radioactive iodine is taken up by the thyroid gland each hour.

Clinical characteristics.

Indications.

The medicinal product is used for diagnosis and therapy.

It is used for the diagnosis of thyroid dysfunction (hyperthyroidism and hypothyroidism), for assessing thyroid function (including ectopy), its size, shape, and functional characteristics of focal lesions: "cold" nodules (without iodine uptake), "warm" nodules (iodine uptake similar to normal thyroid parenchyma), and "hot" nodules (increased iodine uptake compared to normal thyroid parenchyma).

It is used to study the kinetics of radioactive iodine in the thyroid gland. Assessment of iodine uptake by the thyroid gland and the effective half-life of iodine in the thyroid can be used to calculate the therapeutic activity of radioactive iodine.

It is used to detect residual thyroid tissue after surgical interventions and for the diagnosis of metastases in differentiated thyroid tumors.

For the treatment of nontoxic nodular goiter, hyperthyroidism in Graves' disease, solitary nodules, and toxic multinodular goiter. It is used for ablation of residual thyroid tissue after surgery in differentiated thyroid cancers and for the treatment of iodine-accumulating metastases.

Contraindications.

Sodium iodide Na131I for injection should not be used:

• in women with confirmed or suspected pregnancy (or when pregnancy has not been excluded);
• in breastfeeding women;
• in patients with hypersensitivity to the active substance or to any of the excipients;
• for diagnostic procedures in children under 10 years of age;
• for thyroid scintigraphy, except in cases of thyroid cancer or when iodine-123 or technetium-99m are unavailable.

Special safety precautions.

When handling the medicinal product Sodium iodide Na131I for injection, as with other radioactive medicinal products, caution must be exercised and appropriate safety measures taken to minimize radiation exposure to clinical staff and patients to the lowest possible level.

Only personnel with appropriate authorization may handle radiopharmaceuticals (RPs). Storage, administration, transportation, and disposal of RP waste must comply with national licensing regulations.

Dosimetry

The half-life of the Sodium iodide Na131I for injection preparation is 8.02 days, the maximum beta radiation energy is 606 keV, and the gamma radiation energy is 365 keV.

The radiation dose received by the patient depends on iodine uptake by the thyroid gland.

With 55% uptake of iodine-131 by the thyroid, circulation and recirculation of iodide result in increased radiation dose to other internal organs, particularly the gastrointestinal tract and urinary bladder.

Radiation doses absorbed by other organs depend on the pathophysiological changes caused by thyroid disease.

As part of the risk/benefit assessment, it is recommended to evaluate the effective dose for treatment of individual organs. Thus, therapy intensity can be adjusted according to thyroid mass, biological half-life, and amount of iodine uptake, which depend on the patient's physiological state (including iodine deficiency) and disease-related changes.

Absorbed doses following administration of Sodium iodide Na131I for injection are provided according to recommendations of the International Commission on Radiological Protection.

Table 1

Organ	Absorbed dose per unit of activity, administered to patient [mGy/MBq] (with blocked thyroid, uptake 0 %)
	Adults	15 years	10 years	5 years	1 year
Adrenal glands	0.037	0.042	0.067	0.110	0.200
Wall of urinary bladder	0.610	0.750	1.100	1.800	3.400
Bone surface	0.032	0.038	0.061	0.097	0.190
Breast tissue	0.033	0.033	0.052	0.085	0.170
Gastrointestinal tract: Stomach wall Small intestine Colon – upper segment Colon – lower segment	0.034 0.038 0.037 0.043	0.040 0.047 0.045 0.052	0.064 0.075 0.070 0.082	0.100 0.120 0.120 0.130	0.190 0.220 0.210 0.230
Kidneys	0.065	0.080	0.120	0.170	0.310
Liver	0.033	0.040	0.065	0.100	0.200
Lungs	0.031	0.038	0.060	0.096	0.190
Ovaries	0.042	0.054	0.084	0.130	0.240
Pancreas	0.035	0.043	0.069	0.110	0.210
Bone marrow	0.035	0.042	0.065	0.100	0.190
Spleen	0.034	0.040	0.065	0.100	0.200
Testes	0.037	0.045	0.075	0.120	0.230
Thyroid gland	0.029	0.038	0.063	0.100	0.200
Uterus	0.054	0.067	0.110	0.170	0.300
Other organs	0.032	0.039	0.062	0.100	0.190
Effective dose, mSv/MBq	0.072	0.088	0.140	0.210	0.400
Contribution from the urinary bladder wall accounts for up to 50.8 % of the effective dose. Partial blocking: Effective dose (mSv/MBq) with minor thyroid iodine uptake
uptake: 0.5 %	0.300	0.450	0.690	1.500	2.800
uptake: 1.0 %	0.520	0.810	1.200	2.700	5.300
uptake: 2.0 %	0.970	1.500	2.400	5.300	10.00

Table 2

Organ	Absorbed dose per unit of activity, administered to patient [mGy/MBq] (with blocked thyroid, 15% uptake)
	Adults	15 years	10 years	5 years	1 year
Adrenal glands	0.036	0.043	0.071	0.110	0.220
Wall of urinary bladder	0.520	0.640	0.980	1.500	2.900
Bone surface	0.047	0.067	0.094	0.140	0.240
Breast tissue	0.043	0.043	0.081	0.130	0.250
Gastrointestinal tract: Stomach wall Small intestine Colon – upper segment Colon – lower segment	0.460 0.280 0.059 0.042	0.580 0.350 0.065 0.053	0.840 0.620 0.100 0.082	1.500 1.000 0.160 0.130	2.900 2.000 0.280 0.230
Kidneys	0.060	0.075	0.110	0.170	0.290
Liver	0.032	0.041	0.068	0.110	0.220
Lungs	0.053	0.071	0.120	0.090	0.330
Ovaries	0.043	0.059	0.092	0.140	0.260
Pancreas	0.052	0.062	0.100	0.150	0.270
Bone marrow	0.054	0.074	0.099	0.140	0.240
Spleen	0.042	0.051	0.081	0.120	0.230
Testes	0.028	0.035	0.058	0.094	0.180
Thyroid gland	210.0	340.0	510.0	1100.0	2000.0
Uterus	0.054	0.068	0.110	0.170	0.310
Other organs	0.065	0.089	0.140	0.220	0.400
Effective dose, mSv/MBq	6.600	10.00	15.00	34.00	62.00

Table 3

Organ	Absorbed dose per unit activity administered to the patient [mGy/MBq] (with blocked thyroid, uptake 35 %)
	Adults	15 years	10 years	5 years	1 year
Adrenal glands	0.042	0.050	0.087	0.140	0.280
Bladder wall	0.400	0.500	0.760	1.200	2.300
Bone surface	0.076	0.120	0.160	0.230	0.350
Breast	0.067	0.066	0.130	0.220	0.400
Gastrointestinal tract: Stomach wall Small intestine Colon – upper region Colon – lower region	0.460 0.280 0.058 0.040	0.590 0.350 0.065 0.051	0.850 0.620 0.100 0.080	1.500 1.000 0.170 0.130	3.000 2.000 0.300 0.240
Kidneys	0.056	0.072	0.110	0.170	0.290
Liver	0.037	0.049	0.082	0.140	0.270
Lungs	0.090	0.120	0.210	0.330	0.560
Ovaries	0.042	0.057	0.090	0.140	0.270
Pancreas	0.054	0.069	0.110	0.180	0.320
Red bone marrow	0.086	0.120	0.160	0.220	0.350
Spleen	0.046	0.059	0.096	0.150	0.280
Testes	0.026	0.032	0.054	0.089	0.180
Thyroid gland	500.0	790.0	1200.0	2600.0	4700.0
Uterus	0.050	0.063	0.100	0.160	0.300
Other organs	0.110	0.160	0.140	0.410	0.710
Effective dose, mSv/MBq	15.00	24.00	36.00	78.00	140.00

Table 4

Organ	Absorbed dose per unit of activity administered to patient [mGy/MBq] (with blocked thyroid gland, uptake 55 %)
	Adults	15 years	10 years	5 years	1 year
Adrenal glands	0.049	0.058	0.110	0.170	0.340
Wall of urinary bladder	0.290	0.360	0.540	1.850	1.600
Bone surface	0.110	0.170	0.220	0.320	0.480
Breast	0.091	0.089	0.190	0.310	0.560
Gastrointestinal tract: stomach wall small intestine colon – upper segment colon – lower segment	0.460 0.280 0.058 0.039	0.590 0.350 0.067 0.049	0.860 0.620 0.110 0.078	1.500 1.000 0.180 0.130	3.000 2.000 0.320 0.240
Kidneys	0.051	0.068	0.100	0.170	0.290
Liver	0.043	0.058	0.097	0.170	0.330
Lungs	0.130	0.180	0.300	0.480	0.800
Ovaries	0.041	0.056	0.090	0.150	0.270
Pancreas	0.058	0.076	0.130	0.210	0.380
Bone marrow	0.120	0.180	0.220	0.290	0.460
Spleen	0.051	0.068	0.110	0.170	0.330
Testes	0.026	0.031	0.052	0.087	0.170
Thyroid gland	790.0	1200.0	1900.0	4100.0	7400.0
Uterus	0.046	0.060	0.099	0.160	0.300
Other organs	0.160	0.240	0.370	0.590	1.000
Effective dose, mSv/MBq	24.00	37.00	56.00	120.00	220.00

Interaction with other medicinal products and other forms of interaction.

Many substances affect the mechanisms of iodide binding to proteins, the pharmacokinetics of the drug, or alter the effects of radioactive iodine. This highlights the necessity of reviewing all medications being used by the patient and making a decision regarding the possible discontinuation of other drugs prior to the administration of Sodium Iodide I-131 for injection.

Table 5 lists the duration for which administration of certain medicinal products must be discontinued.

Table 5

Active substance	Period during which administration of the specified substances must be discontinued prior to administration of sodium iodide (131I)
Medicinal products that block thyroid function, e.g., carbimazole, metamizole, propylthiouracil, perchlorates	2–5 days before the start of examination/treatment
Salicylates (high doses), glucocorticosteroids, sodium nitroprusside, nitrates, sulfobromophthalein, oral anticoagulants, antihistamines, antiparasitic agents, penicillin, sulfonamides, tolbutamide, thiocyanate, thiopental	1 week
Phenylbutazone	1–2 weeks
Expectorant medicinal products and iodine-containing vitamins	4 weeks
Triiodothyronine	2 weeks
Liothyronine	4 weeks
Amiodarone	3–6 months
Topical medicinal products containing iodine compounds	1–9 months
Water-soluble contrast medicinal agents	1–2 months
Water-insoluble contrast medicinal agents	3–6 months

Special precautions for use.

When determining doses, the individual benefit/risk ratio should be taken into account.

The lowest effective dose sufficient to achieve the desired result (diagnostic or therapeutic) should be used.

The risk of hypersensitivity reactions (including anaphylactic and anaphylactoid reactions) following administration of Sodium Iodide Na131I for injection is very low. However, this possibility should be considered, and immediate emergency treatment should be readily available.

Administration of this agent results in high radiation exposure in most patients. However, there are no reports of increased incidence of cancer, leukemia, or mutations in individuals who received iodine-131 for benign thyroid diseases. In patients treated with iodine-131 for thyroid cancer, the risk of developing secondary tumors is slightly increased compared to patients with thyroid cancer who did not receive iodine-131.

There are no data indicating increased incidence of cancer, leukemia, or mutations in individuals who received Sodium Iodide Na131I for injection for diagnostic purposes.

Administration of high activities of iodine-131 may cause sialadenitis (inflammation of the salivary glands). There is no convincing evidence that stimulation of salivary secretion prevents this adverse effect. In patients with active ophthalmopathy (especially smokers), administration of iodine-131 may worsen ophthalmopathy. In such cases, consideration should be given to prescribing steroids during therapy with Sodium Iodide Na131I for injection or using alternative treatment methods for hyperthyroidism.

Due to the risk of environmental radioactive contamination, caution should be exercised when treating patients with radioactive iodine who do not comply with medical staff instructions, as well as patients with urinary incontinence.

Renal impairment

Particular attention is required in patients with impaired renal function. In these patients, the appropriate iodine-131 activity dose must be selected, taking into account limited elimination capacity.

Children

When treating children, greater tissue sensitivity to ionizing radiation and longer life expectancy should be considered. These factors, along with other therapeutic options, should be taken into account when selecting treatment methods.

Patient preparation

Prior to treatment with Sodium Iodide Na131I for injection, the patient should follow a low-iodine diet, which may enhance iodine uptake by the thyroid gland.

Before initiating treatment of thyroid cancer with Sodium Iodide Na131I for injection, thyroid hormone therapy may be temporarily discontinued to increase uptake of Sodium Iodide Na131I for injection by cancer cells. Recombinant human TSH (rhTSH) may also be administered for this purpose.

During treatment of hyperthyroidism with Sodium Iodide Na131I for injection, antithyroid drugs should be discontinued.

After administration

Some patients receiving therapeutic doses of Sodium Iodide Na131I for injection may require hospitalization to comply with radiation protection principles. The need for hospitalization is determined by established treatment protocols.

When high doses of the drug are administered, for example, for treatment of thyroid cancer, radiation exposure to the urinary bladder can be reduced by having the patient drink large amounts of fluids, resulting in frequent bladder emptying.

Contraception is recommended for at least 4 months after treatment with Sodium Iodide Na131I for injection.

After administration of Sodium Iodide Na131I for injection, contact with other individuals, especially children and pregnant women, should be avoided for the period specified in approved treatment protocols.

Special warnings

The product contains 1.2 to 1.3 mg of sodium per 1 mL; this should be considered in patients on a low-sodium diet.

Use during pregnancy or breastfeeding.

Women of reproductive potential

Before administering the drug to women of reproductive age, pregnancy must be ruled out. Any woman with menstrual delay should be considered pregnant until proven otherwise. In cases of suspected pregnancy (e.g., menstrual delay or irregular cycles), alternative diagnostic/therapeutic methods not involving ionizing radiation should be considered, if available.

Contraception is recommended for at least 4 months after treatment with Sodium Iodide Na131I for injection. Contraception may also be advised for a similar period after diagnostic administration of Sodium Iodide Na131I for injection in patients with differentiated thyroid cancer.

Pregnancy

Administration of Sodium Iodide Na131I for injection is contraindicated during confirmed pregnancy or when pregnancy cannot be excluded (the absorbed radiation dose to the uterus ranges from 11 to 511 mGy, and the fetal thyroid actively accumulates iodine during the second and third trimesters of pregnancy).

If differentiated thyroid cancer is diagnosed during pregnancy, treatment with Sodium Iodide Na131I for injection should be postponed until after delivery.

Breastfeeding

Before administering a radiopharmaceutical, a woman who is breastfeeding should consider delaying administration until she has stopped breastfeeding.

If administration of Sodium Iodide Na131I for injection is necessary in a breastfeeding woman, breastfeeding must be discontinued.

Fertility

Treatment of thyroid cancer with radioactive iodine may impair fertility in both men and women.

Ability to affect reaction speed when driving or operating machinery.

No data available.

Administration and Dosage

Sodium iodide Na131I for injection is a solution for intravenous administration. The product is intended for direct administration to patients in doses of varying radioactivity depending on the indication. The activity dose for the patient is determined by a specialist in radiological medicine.

Diagnostic activity dose

For thyroid scintigraphy to diagnose benign thyroid disorders and to study the kinetics of radioactive iodine in the thyroid gland, a dose of 0.15–4 MBq of Sodium iodide Na131I for injection is recommended, administered within 24 hours prior to the test. Assessment of thyroid iodine uptake is performed according to indications at 4–6 hours or within the first few days after administration of Sodium iodide Na131I for injection.

For patients with differentiated thyroid cancer, a dose of
37–240 MBq (usually 37–74 MBq) of sodium iodide (131I) is recommended. Whole-body scintigraphy is usually performed 72 hours (or later) after administration of Sodium iodide Na131I for injection.

In accordance with European Directive 97/43/Euratom and current European practice, these recommendations should be considered only as general guidance. It should be noted that in each country, the nuclear medicine specialist establishes diagnostic reference levels (Diagnostic Reference Levels, DRL) according to approved standards. Administration of doses exceeding locally established DRLs must be justified.

Therapeutic activity dose Adults

• Treatment of hyperthyroidism and goiter.

Sodium iodide Na131I for injection with an activity of 200–800 MBq can usually be administered repeatedly. The therapeutic activity of iodine depends on the disease, the rate of change or the size of the thyroid gland, iodine uptake by the thyroid, and the effective half-life of Sodium iodide Na131I for injection in the thyroid. Prior to administration of the drug, clinical signs of hyperthyroidism should be reduced by appropriate pharmacological treatment.

• Ablation of thyroid tissue, treatment of metastatic thyroid cancer.

After thyroidectomy, to complete removal of residual thyroid tissue, a dose of Sodium iodide Na131I for injection activity of usually
1850–3700 MBq is administered. This dose may vary depending on the amount of tissue remaining after surgery and the rate of iodine uptake. If radioisotope therapy is indicated for metastases, a dose of 3700–11100 MBq of sodium iodide-131 activity is usually administered.

Children

The use of radioactive iodine in children is possible only after careful consideration of clinical indications and evaluation of the risk-benefit ratio for this patient group. Therapeutic activity is calculated as in adults, but dose adjustment based on body weight and/or age of the child may be considered.

It should be noted that late potential adverse reactions associated with administration of Sodium iodide Na131I for injection to children (especially under 10 years of age) occur more frequently than in adults.

Instructions for Radiopharmaceutical Preparation

The radiopharmaceutical is supplied ready for use.

Radiopharmaceutical equipment and reagents must be prepared to ensure appropriate radiation safety conditions regarding ionizing radiation exposure. Appropriate precautions must be taken to ensure sterility of the preparation.

Do not open the vial before disinfecting the stopper. The solution should be drawn through the stopper using a disposable syringe equipped with an appropriate shield and a disposable needle, or by using an automated injection system. Do not use the product if the vial is damaged.

Any unused portions of the medicinal product or waste materials must be disposed of in accordance with local regulations.

Children

Diagnostic use of the drug in children under 10 years of age is contraindicated (see section "Contraindications"). It is used for treatment of children with highly differentiated thyroid cancer.

Overdose

The medicinal product is supplied as a solution of known activity, allowing the physician to control the dose to be administered to the patient.

In case of administration of an excessive amount of radioactive substance, the effects of high radiation doses can be minimized by blocking the uptake of radioactive substances into thyroid tissue using agents such as potassium perchlorate, or by inducing vomiting and enhancing diuresis.

Adverse reactions.

The impact of ionizing radiation for each patient should be justified by the expected benefit from the use of the radiopharmaceutical.

The frequency of adverse reactions following administration of the drug, as presented in Table 6, is defined as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (frequency cannot be determined from available data).

Table 6

Adverse reactions when used for diagnostic purposes

Immune system disorders
Not known	Hypersensitivity reactions
Gastrointestinal disorders:
Not known	Nausea, vomiting
Congenital abnormalities, familial and genetic disorders
Not known	Congenital thyroid dysfunction

The effect of ionizing radiation is associated with the risk of cancer and congenital defects. Current data indicate a low probability of such adverse reactions when the drug is used for diagnostic tests in nuclear medicine.

Table 7

Adverse reactions with therapeutic doses

Disorders of blood and lymphatic system
Unknown	Bone marrow suppression, including significant thrombocytopenia, erythrocytopenia and/or leukopenia
Eye disorders
Uncommon	Dry eye syndrome, acquired tear duct strictures
Unknown	Thyroid ophthalmopathy
Gastrointestinal disorders
Very common	Transient or persistent inflammation of salivary glands, including dryness of the oral cavity, nausea
Rare	Vomiting
Endocrine disorders
Very common	Hypothyroidism
Unknown	Exacerbation of thyrotoxicosis, Graves' disease, hypoparathyroidism, hyperparathyroidism
Benign, malignant and unspecified neoplasms (including cysts and polyps)
Uncommon	Leukemia
Unknown	Stomach, bladder and breast cancer
Immune system disorders
Unknown	Hypersensitivity
Reproductive system and breast disorders
Unknown	Impaired reproductive function in men and women
Congenital, familial and genetic disorders
Unknown	Congenital thyroid dysfunction
Injuries, poisonings and procedural complications
Very common	Radiation-induced tissue damage, including radiation thyroiditis; pain caused by irradiation
Rare	Tracheal stenosis

Early effects

Radiation pneumonitis and pulmonary fibrosis have been reported in patients with lung metastases.

Local brain edema and/or exacerbation of pre-existing cerebral edema should be considered in patients with central nervous system metastases from thyroid cancer.

Late effects

Hypothyroidism may occur following treatment of thyrotoxicosis with Sodium Iodide Na131I for injection. It may manifest weeks or even years after treatment, requiring appropriate monitoring of thyroid function and possibly hormone replacement therapy. Hypothyroidism typically does not occur until 6–12 weeks after treatment.

Salivary and/or lacrimal duct dysfunction, with associated dryness syndrome, may occur months to up to 2 years after radioactive iodine therapy. Impaired lacrimal duct patency may also lead to excessive tearing, usually within 3–16 months after radioactive iodine treatment. Cases of salivary gland carcinoma have been described as a result of radiation-induced sialadenitis.

Late effects also include reversible, and in very rare cases irreversible, bone marrow suppression with isolated thrombocytopenia or erythrocytopenia. These complications are more likely after a single administered activity exceeding 5000 MBq or repeated doses administered at intervals of less than 6 months and may result in fatal outcomes.

Radioactive iodine treatment for thyroid cancer may impair reproductive function in both men and women. Reversible impairment of spermatogenesis occurs at activities above 1850 MBq. Clinically significant adverse reactions, including oligospermia and azoospermia, as well as increased plasma FSH concentration, are caused by administration of more than 3700 MBq of iodine-131.

Ionizing radiation doses received during therapy with Sodium Iodide Na131I for injection may increase the risk of developing tumors and mutations. In all cases, it is essential to ensure that risks associated with radiation exposure are outweighed by the risks associated with the disease itself.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after marketing authorization is of great importance. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals and patients or their legal representatives should report all suspected adverse reactions and lack of efficacy through the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua/.

Shelf life.

28 days from the date of manufacture stated in the special certificate.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C.

Incompatibilities.

Do not mix with other medicinal products in the same container. Compatibility studies have not been conducted.

Packaging.

Portions of 1000 MBq, 2000 MBq, 4000 MBq, 5000 MBq, 7000 MBq in 10 ml vials.

Sealed vials are transported in lead containers.

Prescription status.

By prescription only.

Administered only in hospital settings. Supplied exclusively to specialized medical facilities authorized to handle radiopharmaceuticals. A special certificate is provided for each batch of radiopharmaceutical product.

Manufacturer.

National Centre for Nuclear Research / Narodowe Centrum Badan Jądrowych.

Manufacturer's address and location of operations.

Andrzeja Soltana 7, Otwock, 05-400, Poland / ul. Andrzeja Soltana 7, Otwock, 05-400, Poland.