Fludeoxiglucose (18f) Biont

CHARACTERISTICS OF THE MEDICINAL PRODUCT

LABELING OF PACKAGING AND PATIENT INFORMATION LEAFLET

CHARACTERISTICS OF THE MEDICINAL PRODUCT

1. NAME OF THE MEDICINAL PRODUCT

Fludeoxyglucose (18F) Biont, 200-2200 MBq/ml, solution for injection

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

1 ml of Fludeoxyglucose (18F) Biont contains Fluorodeoxyglucose (F) with a radioactivity of 200 to 2200 MBq at the time of calibration (t + 4 hours). The radioactivity of the solution in each vial is between 40 MBq and 22000 MBq at the time of calibration (t + 4 hours), i.e., 182 MBq to 100095 MBq at the end of synthesis (t). The fluorine isotope (F) decays into stable oxygen (O) with a half-life of 110 minutes. This decay is accompanied by the emission of positron radiation with a maximum energy of 634 keV. The positron annihilates upon contact with an electron, resulting in the emission of two photons with an energy of 511 keV. Excipient with known effect: Sodium chloride 9 mg/ml. Ethanol 0.2% v/v. For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Solution for injection. Clear, colorless or slightly yellow solution. pH: 4.5 – 8.5. Osmolality: 300 ± 50 mOsm/kg

4. CLINICAL PARTICULARS

1. INDICATIONS FOR USE

The medicinal product is intended for diagnostic use only. Fluorodeoxyglucose (F) is indicated for use in studies using positron emission tomography (PET).

Oncology

The medicinal product Fludeoxyglucose (18F) Biont is intended for use in patients undergoing imaging studies in oncology, allowing for the visualization of changes resulting from functional disorders or the presence of diseases in which there is increased glucose accumulation in specific organs or tissues and the occurrence of a contrast enhancement effect. The following indications are well-documented (see also section 4.4): Diagnosis:

• Differential diagnosis of single focal lesions located in the lungs;
• Detection of tumors of unknown origin, associated with lymph node changes in the neck (cervical adenopathy), metastases to the liver or bones
• Characterization of a mass in the pancreas.

Staging:

• Head and neck tumors, including supportive use in determining the site of biopsy;
• Primary lung cancer;
• Locally advanced breast cancer;
• Esophageal cancer;
• Pancreatic cancer;
• Colorectal cancer, particularly when re-establishing the stage of advancement in the case of tumor recurrence;
• Malignant lymphoma;
• Malignant melanoma, > 1.5 mm in Breslow scale or metastases to lymph nodes at diagnosis.

Monitoring response to treatment in the case of:

• Malignant lymphoma;
• Head and neck tumors.

Detection of changes in the case of suspected recurrence of a malignant disease such as:

• High-grade glioma (III or IV);
• Head and neck tumors;
• Thyroid cancer (non-medullary): in patients with elevated thyroglobulin levels in serum and negative whole-body scan results using radioactive iodine;
• Primary lung cancer (see also section 4.4);
• Breast cancer;
• Pancreatic cancer;
• Colorectal and rectal cancer
• Ovarian cancer;
• Malignant lymphoma;
• Malignant melanoma.

Cardiology

In cardiological indications, the diagnostic point of glucose uptake is the living tissue of the heart muscle, which consumes glucose but is characterized by reduced perfusion. Perfusion should be assessed beforehand using appropriate imaging techniques that allow for the determination of blood flow.

• Evaluation of myocardial viability in patients with severe left ventricular dysfunction who are candidates for revascularization, when traditionally used imaging techniques do not provide clear results.

Neurology

In neurological indications, the goal of diagnosis is to visualize and determine the location of areas with interictal hypometabolism of glucose.

• Localization of epileptogenic foci in pre-surgical evaluation of patients with temporal lobe epilepsy.

2. DOSAGE AND ADMINISTRATION

Dosage The recommended dose of radioactivity for an adult weighing 70 kg is between 100 and 400 MBq (the activity value should be individually adjusted based on the patient's body weight, the type of PET device used, and the method and mode of acquisition) and is administered as an intravenous injection. Children and adolescents The use of Fludeoxyglucose (18F) Biont in children and adolescents should be carefully considered, based on the diagnostic usefulness and the assessment of the benefit-risk ratio of the medicinal product in this patient population. The recommended activity used in children and adolescents can be calculated according to the recommendations of the pediatric group of the EANM regarding the Dosage Card. The activity dose administered to children and adolescents can be calculated by multiplying the base activity (for calculations) by the body mass-dependent factor according to the table below. A [MBq] Administered = Base activity x factor Base activity for 2D imaging is 25.9 MBq, and for 3D imaging, it is 14.0 MBq (recommendations for children).

Special populations Patients with renal impairment No detailed studies have been conducted on the dosage range and dose adjustment for this medicinal product in healthy populations and in special patient populations. The pharmacokinetics of fluorodeoxyglucose (F) have not been described in patients with renal impairment. Method of administration Preparation of the patient, see section 4.4. The activity of fluorodeoxyglucose (F) should be measured with an activity meter immediately before injection. Fluorodeoxyglucose (F) must be administered intravenously to avoid radiation exposure, local irritation caused by extravasation, and to avoid the formation of image artifacts during the examination. Precautions to be taken before using or administering the medicinal product Do not administer more than 10 ml. Instructions for diluting the medicinal product before administration, see section 12. Image acquisition Positron emission tomography (PET) usually begins 45 to 60 minutes after intravenous injection of fluorodeoxyglucose (F). Provided that sufficient activity is maintained for statistical counting, the PET examination with fluorodeoxyglucose (F) can also be performed up to two or three hours after administration, thereby reducing background radioactivity. If necessary, the PET examination with fluorodeoxyglucose (F) can be repeated after a short time.

3. CONTRAINDICATIONS

• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

4. SPECIAL WARNINGS AND PRECAUTIONS FOR USE

Possible hypersensitivity or anaphylactic reaction In the event of hypersensitivity or anaphylactic reaction, administration of the medicinal product should be discontinued immediately and appropriate symptomatic intravenous treatment should be initiated if necessary. To enable immediate action in emergency situations, the necessary medicinal products and equipment, such as an intubation tube and respirator, should be readily available. Individual assessment of the benefit-risk ratio For each patient, the expected diagnostic benefit must justify exposure to ionizing radiation. The administered activity should be as low as reasonably achievable, but still sufficient to obtain the required diagnostic information. Renal and hepatic impairment Due to the high renal excretion of fluorodeoxyglucose (F), careful consideration of the benefit-risk ratio is required in patients with renal impairment, as increased radiation exposure is possible. The radioactivity dose should be adjusted if necessary. Children and adolescents Children and adolescents, see section 4.2 or 5.1. The indication should be carefully considered, as the effective dose in MBq is higher in the pediatric population than in adults (see section 11). Patient preparation The medicinal product Fludeoxyglucose (18F) Biont should be administered to patients with sufficient hydration, after at least 4 hours have elapsed since the last meal, to obtain maximum activity in the target tissues, as glucose uptake in cells is limited ("saturation kinetics"). Fluid intake should not be restricted (it is necessary to avoid glucose-containing beverages). To obtain images of the highest quality and to reduce radiation exposure to the urinary bladder, patients should be encouraged to drink appropriate amounts of fluids and to empty their bladder before and after the PET examination.

• - Oncology and neurologyTo avoid excessive uptake of the tracer by muscles, it is recommended that patients avoid any strenuous physical activity before the examination and remain at rest between tracer injection and imaging, as well as during image acquisition (patients should lie comfortably, without reading or talking). Brain glucose metabolism is dependent on brain activity. Therefore, neurological studies should be performed after a period of rest in a darkened and quiet room. Before administering the medicinal product, a blood glucose test should be performed, as hyperglycemia can reduce the sensitivity of the study with the medicinal product Fludeoxyglucose (18F) Biont, especially if the blood glucose level is higher than 8 mmol/l. Similarly, it is recommended to avoid performing a PET study with fluorodeoxyglucose (F) in patients with uncontrolled diabetes.
• - CardiologySince glucose uptake by the heart muscle is insulin-dependent, it is recommended to administer 50 g of glucose about 1 hour before administering the medicinal product Fludeoxyglucose (18F) Biont. Alternatively, especially in diabetic patients, blood glucose levels can be corrected by combined infusion of insulin and glucose (glucose clamp), if necessary. Interpretation of PET study results with fluorodeoxyglucose (F)

Infectious or inflammatory diseases and post-surgical healing processes may result in significant uptake of fluorodeoxyglucose (F) by the affected tissues, leading to false-positive results in cases where the purpose of the PET study with fluorodeoxyglucose (F) is not to search for infectious or inflammatory changes. In cases where fluorodeoxyglucose (F) accumulation may be caused by both tumor and infection or inflammation, additional diagnostic techniques may be necessary to determine the nature of the pathological changes that caused the accumulation, to complement the information obtained from the PET study with fluorodeoxyglucose (F). In some circumstances, such as determining the stage of multiple myeloma, both malignant and infectious foci are sought, which can be distinguished with high accuracy based on topographic criteria, such as uptake in areas outside the bone marrow and (or) bones and joint changes, which would be atypical for multiple myeloma and would indicate infection. Currently, there are no other criteria that allow for differentiation between infection and inflammation based on imaging with fluorodeoxyglucose (F). Due to the high physiological uptake of fluorodeoxyglucose (F) by the brain, heart, and kidneys, the PET-CT study with fluorodeoxyglucose (F) has not been evaluated for the detection of septic metastatic foci in these organs in patients referred for examination due to bacteremia or endocarditis. It is not possible to rule out the possibility of false-positive or false-negative results of the PET study with fluorodeoxyglucose (F) during the first 2-4 months after radiotherapy. If clinical indications require earlier diagnosis using PET with fluorodeoxyglucose (F), the reason for early PET study with fluorodeoxyglucose (F) should be properly documented. An optimal interval of at least 4-6 weeks after the last cycle of chemotherapy is recommended, especially to avoid false-negative results. In cases where clinical indications require earlier diagnosis using PET with fluorodeoxyglucose (F), the reason for early PET study should be properly documented. In the case of chemotherapy cycles shorter than 4 weeks, the PET study with fluorodeoxyglucose (F) should be performed immediately before starting a new cycle. In the case of low-grade lymphomas, esophageal cancer, and suspected ovarian cancer recurrence, only positive predictive factors should be considered, due to the limited sensitivity of the PET study with fluorodeoxyglucose (F). The study with fluorodeoxyglucose (F) is not effective in detecting brain metastases. The accuracy of imaging with fluorodeoxyglucose (F) is better with a PET-CT device than with a PET scanner. When using a hybrid PET-CT device with or without contrast agent administration for computed tomography, artifacts may occur on PET images obtained with attenuation correction. After the procedure Within the first 12 hours after injection, close contact with small children and pregnant women should be limited. Special warnings In some cases, the sodium content may be higher than 1 mmol (23 mg) depending on the time of injection. This should be taken into account in patients controlling their sodium intake.

5. INTERACTIONS WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION

All medicinal products that affect blood glucose levels may affect the sensitivity of the study (e.g., corticosteroids, valproic acid, carbamazepine, phenytoin, phenobarbital, and catecholamines). After administration of colony-stimulating factors (CSFs) for several days, there is increased uptake of fluorodeoxyglucose (F) in the bone marrow and spleen. This should be considered when interpreting images obtained with PET. This effect can be reduced by a minimum of 5-day interval between CSF treatment and PET imaging. Administration of glucose and insulin affects the uptake of fluorodeoxyglucose (F) by cells. In the case of high blood glucose levels and low insulin activity in the serum, the uptake of fluorodeoxyglucose (F) by organs and tumors is reduced. No studies have been conducted on the interaction between fluorodeoxyglucose (F) and any contrast agent used in computed tomography.

6. EFFECTS ON FERTILITY, PREGNANCY, AND LACTATION

Women of childbearing age If it is intended to administer a radiopharmaceutical to a woman of childbearing age, it is essential to determine whether the woman is not pregnant. Any woman with a delayed menstrual period must be considered pregnant until this possibility is ruled out. In case of doubt about possible pregnancy (if the expected menstrual period has not occurred, if the period is very irregular, etc.), the patient should be offered alternative techniques that do not use ionizing radiation (if such techniques exist). Pregnancy Studies related to the use of radionuclides in pregnant women are associated with exposure of the fetus to ionizing radiation. During pregnancy, only necessary examinations should be performed when the expected benefits significantly outweigh the risk to the mother and fetus. Breastfeeding Before administering radiopharmaceuticals to a breastfeeding woman, it is always necessary to consider the possibility of delaying the examination until the end of breastfeeding and to choose the most suitable radiopharmaceutical, taking into account the penetration of radioactive isotopes into human milk. If administration of the radiopharmaceutical during lactation is necessary, breastfeeding should be interrupted for at least 12 hours, and the expressed milk should be discarded. It is recommended to avoid close contact between the mother and the infant during the first 12 hours after administration of the medicinal product. Fertility No fertility studies have been conducted.

7. EFFECTS ON ABILITY TO DRIVE AND USE MACHINES

Not applicable.

8. UNDESIRABLE EFFECTS

To date, no undesirable effects have been observed after administration of fluorodeoxyglucose (F). Exposure to ionizing radiation is associated with the possibility of inducing cancer or genetic damage. Since the effective dose resulting from the administration of the maximum recommended activity of fluorodeoxyglucose (F) 400 MBq is approximately 7.6 mSv, the likelihood of these effects is low. Reporting of suspected adverse reactions After the medicinal product has been authorized, it is essential to report any suspected adverse reactions. This allows for the continuous monitoring of the benefit-risk ratio of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Department of Adverse Reaction Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, e-mail: ndl@urpl.gov.pl.

9. OVERDOSE

In the event of administration of an excessive dose of radiation due to overdose of fluorodeoxyglucose (F), the dose of radiation absorbed by the patient's body should be reduced as much as possible by increasing the elimination of the radionuclide through forced diuresis and frequent urination. Estimating the administered effective dose may be helpful.

5. PHARMACOLOGICAL PROPERTIES

1. PHARMACODYNAMIC PROPERTIES

Therapeutic group: diagnostic radiopharmaceuticals; other radiopharmaceuticals used in cancer diagnosis. ATC code: V09IX04. No pharmacodynamic activity has been observed at concentrations used for diagnostic studies.

2. PHARMACOKINETIC PROPERTIES

Distribution Fluorodeoxyglucose (F) is an analog of glucose, accumulated in all cells that use glucose as the primary source of energy. Fluorodeoxyglucose (F) accumulates in cancer cells characterized by high glucose metabolism. After intravenous administration, the pharmacokinetic profile of fluorodeoxyglucose (F) in the vascular compartment is biphasic. The distribution time is 1 minute, and the elimination time is approximately 12 minutes. In healthy individuals, fluorodeoxyglucose (F) is distributed throughout the body, particularly in the brain and heart, and to a lesser extent in the lungs and liver. Organ uptake The cellular uptake of fluorodeoxyglucose (F) occurs through specific tissue carrier systems, which are partially insulin-dependent and may be affected by diet, nutritional status, and diabetes. In patients with diabetes, there is reduced uptake of fluorodeoxyglucose (F) into the cell due to changes in tissue distribution and glucose metabolism. Fluorodeoxyglucose (F) is transported across the cell membrane in a similar way to glucose but undergoes only the first stage of glycolysis, leading to the formation of fluorodeoxyglucose-(F)-6-phosphate, which is trapped in the cancer cell and not further metabolized. Since the subsequent dephosphorylation by intracellular phosphatases occurs slowly, fluorodeoxyglucose-(F)-6-phosphate remains in the tissue for several hours (trap mechanism). Fluorodeoxyglucose (F) crosses the blood-brain barrier. Approximately 7% of the injected dose accumulates in the brain within 80-100 minutes after administration. Epileptogenic foci show reduced glucose metabolism during interictal phases. Approximately 3% of the administered activity is taken up by cardiac muscle cells within 40 minutes. The distribution of fluorodeoxyglucose (F) in healthy cardiac cells is mainly uniform, but local differences of up to 15% have been described in the case of the interventricular septum. During and after reversible cardiac ischemia, there is increased glucose uptake in cardiac muscle cells. In the pancreas and lungs, 0.3% and 0.9-2.4% of the administered activity accumulate, respectively. Fluorodeoxyglucose (F) is also bound to a lesser extent in the extraocular muscles, throat, and intestine. Muscle binding may occur after recent exercise and when performing muscle work during the examination. Elimination The elimination of fluorodeoxyglucose (F) occurs mainly through the kidneys, and 20% of the activity is excreted in the urine within 2 hours after administration. The binding to kidney tissue is weak, but due to the elimination of fluorodeoxyglucose (F) through the kidneys, the entire urinary system, especially the bladder, shows significant radioactivity.

3. PRECLINICAL SAFETY DATA

In toxicity studies, doses 50 times higher than those used in humans, administered to dogs, and 1000 times higher than those used in humans, administered to mice, did not result in fatalities. This medicinal product is not intended for systematic or continuous administration. No studies have been conducted on the mutagenic potential or toxic effects on reproduction and potential carcinogenic effects.

6. PHARMACEUTICAL PARTICULARS

1. LIST OF EXCIPIENTS

Sodium chloride Water for injections Sodium hydroxycitrate sesquihydrate Sodium citrate Sodium chloride 0.9% Anhydrous ethanol

2. INCOMPATIBILITIES

This medicinal product must not be mixed with other medicinal products, except those mentioned in section 12.

3. SHELF LIFE

The medicinal product Fludeoxyglucose (18F) Biont can be used within 13 hours from the date and time of the end of synthesis, stated on the outer packaging and on the vial of the medicinal product. After the first puncture, store below 25°C and use within 12 hours, without exceeding the shelf life.

4. SPECIAL PRECAUTIONS FOR STORAGE

Store below 25°C in the original packaging. This medicinal product should be stored in accordance with national regulations regarding radioactive products to protect against radiation. Storage conditions for the medicinal product after the first puncture – see section 6.3.

5. NATURE AND CONTENTS OF CONTAINER

Multi-dose vial with a capacity of up to 19 ml, colorless, made of neutral glass type I according to the European Pharmacopoeia, closed with a chlorobutyl rubber stopper and an aluminum cap. One vial contains 0.2 to 10 ml of solution, corresponding to 200 - 2200 MBq/ml at the time of calibration (t + 4 hours).

6. SPECIAL PRECAUTIONS FOR DISPOSAL AND PREPARATION OF THE MEDICINAL PRODUCT

for useThe container should be checked before use, and the activity should be measured using an activity meter. The medicinal product can be diluted with a sodium chloride solution for injection 9 mg/ml (0.9%). The medicinal product should be withdrawn from the vial under aseptic conditions. The vial must not be opened; after disinfecting the stopper, the solution should be withdrawn through the stopper using a single-dose syringe with appropriate protective shields and a single-use, sterile needle or using an authorized system for automatic drug administration. If the vial is damaged, the medicinal product must not be used. Quality control The solution should be inspected visually before use. Only clear solutions without visible particles can be used. The administration of radiopharmaceuticals poses a risk to others, related to external radiation or contamination associated with the presence of spilled urine, vomit, etc. Radiological protection measures should be taken in accordance with national regulations. Unused medicinal product and radioactive waste should be disposed of in accordance with relevant national regulations.

7. MARKETING AUTHORIZATION HOLDER

RESPONSIBLE FOR MARKETING AUTHORIZATION

BIONT, a.s. Karloveská 63 842 29 Bratislava Slovakia Phone: +421 2 206 70 749 Fax: +421 2 206 70 748 Email: biont@biont.sk

8. MARKETING AUTHORIZATION NUMBER

20277

9. DATE OF FIRST MARKETING AUTHORIZATION

/DATE OF RENEWAL OF MARKETING AUTHORIZATION

• 06.06.2012 / 27.01.2015

10. DATE OF REVISION OF THE TEXT

OF THE SUMMARY OF PRODUCT CHARACTERISTICS

09/2015

11. DOSIMETRY

The following table shows the dosimetry calculated in accordance with ICRP Publication 106.

Absorbed dose per unit of administered activity (mGy/MBq)

Organ Adult 15-year-old 10-year-old 5-year-old

child1-year-oldAdrenal glands 0.012 0.016 0.024 0.039 0.071 Urinary bladder wall 0.130 0.160 0.250 0.340 0.470 Bone surfaces 0.011 0.014 0.022 0.034 0.064 Brain 0.038 0.039 0.041 0.046 0.063 Breasts 0.009 0.011 0.018 0.029 0.056 Gallbladder 0.013 0.016 0.024 0.037 0.070 Gastrointestinal tract: 0.011 0.014 0.022 0.035 0.067 Small intestine 0.012 0.016 0.025 0.040 0.073 Large intestine 0.013 0.016 0.025 0.039 0.070 Upper large intestine 0.012 0.015 0.024 0.038 0.070 Lower large intestine 0.014 0.017 0.027 0.041 0.070 Heart 0.067 0.087 0.130 0.210 0.380 Kidneys 0.017 0.021 0.029 0.045 0.078 Liver 0.021 0.028 0.042 0.063 0.120 Lungs 0.020 0.029 0.041 0.062 0.120 Muscles 0.010 0.013 0.020 0.033 0.062 Esophagus 0.012 0.015 0.022 0.035 0.066 Ovaries 0.014 0.018 0.027 0.043 0.076 Pancreas 0.013 0.016 0.026 0.040 0.076 Bone marrow 0.011 0.014 0.021 0.032 0.059 Skin 0.008 0.010 0.015 0.026 0.050 Spleen 0.011 0.014 0.021 0.035 0.066 Testes 0.011 0.014 0.024 0.037 0.066 Thymus 0.012 0.015 0.022 0.035 0.066 Thyroid 0.010 0.013 0.021 0.034 0.065 Uterus 0.018 0.022 0.036 0.054 0.090 Other organs 0.012 0.015 0.024 0.038 0.064

Effective dose (mSv/MBq)

0.019 0.024 0.037 0.056 0.095

For the medicinal product Fludeoxyglucose (18F) Biont, the effective dose resulting from the administration of approximately 400 MBq to an adult is approximately 7.6 mSv. For this activity of 400 MBq, the radiation doses delivered to the most important organs, the bladder, heart, and brain, are approximately: 52 mGy, 27 mGy, and 15 mGy, respectively.

12. INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS

Before use, the packaging should be checked, and the activity should be measured using an activity meter. The medicinal product can be diluted with a sodium chloride solution for injection 9 mg/ml (0.9%). The medicinal product should be withdrawn from the vial under aseptic conditions. The vial must not be opened; after disinfecting the stopper, the solution should be withdrawn through the stopper using a single-dose syringe with appropriate protective shields and a single-use, sterile needle or using an authorized system for automatic drug administration. If the vial is damaged, the medicinal product must not be used. Quality control The solution should be inspected visually before use. Only clear solutions without visible particles can be used.

LABELING OF PACKAGING

Fludeoxyglucose (18F) Biont, 200-2200 MBq/ml, solution for injection Fluorodeoxyglucose (F) 1 ml contains from 200 to 2200 MBq of fluorodeoxyglucose (F) at the time of calibration. The activity contained in one vial may be from 40 MBq to 22000 MBq at the time of calibration (t + 4 hours), i.e., 182 MBq to 100095 MBq at the end of synthesis (t). Sodium chloride, water for injections, sodium hydroxycitrate sesquihydrate, sodium citrate, sodium chloride 0.9%, anhydrous ethanol Solution for injection. Activity: 182 – 100095 MBq Volume: 0.2 to 10 ml Time of activity measurement: HH:DD Client: XXXXX_N Date of production: DD.MM.YYYY Intravenous administration. Intended for diagnostic use only. Read the patient information leaflet before using the medicinal product. Keep the medicinal product out of the sight and reach of children. Warning: radioactive material

Date of production: DD.MM.YYYY Expiration date: DD.MM.YYYY, time HH:DD Store below 25°C in the original packaging. This product should be stored in accordance with national regulations regarding radioactive materials. Radioactive waste should be disposed of in accordance with relevant national and international regulations. BIONT a.s. Karloveská 63 842 29 Bratislava Slovakia 20277 Batch Product intended for use in hospital settings only – Lz. Maximum recommended dose: 10 ml Not applicable Fludeoxyglucose (18F) Biont, 200-2200 MBq/ml, solution for injection Fluorodeoxyglucose (F) iv. Not applicable Batch Client: XXXXX_N Not applicable Warning: radioactive material

PATIENT INFORMATION LEAFLET

Patient information leaflet: information for the patient

Fludeoxyglucose (18F) Biont, 200-2200 MBq/ml, solution for injection Fluorodeoxyglucose (F)

You should read this leaflet carefully before you are given this medicine, as it contains important information for you.

Keep this leaflet, you may need to read it again. If you have any further questions, ask your doctor or the nuclear medicine specialist who will be supervising your examination.

Contents of the leaflet:

• 1. What Fludeoxyglucose (18F) Biont is and what it is used for
• 2. Important information before you are given Fludeoxyglucose (18F) Biont
• 3. How Fludeoxyglucose (18F) Biont is given
• 4. Possible side effects
• 5. How to store Fludeoxyglucose (18F) Biont
• 6. Contents of the pack and other information

1. What Fludeoxyglucose (18F) Biont is and what it is used for

This is a radiopharmaceutical intended for diagnostic use only. The active substance contained in Fludeoxyglucose (18F) Biont is intended for radiological imaging of certain parts of the body. After a small amount of Fludeoxyglucose (18F) Biont is injected into a vein, a suitable device will allow your doctor to take images and determine the location or extent of the disease.

2. Important information before you are given Fludeoxyglucose (18F) Biont

When not to use Fludeoxyglucose (18F) Biont

• if you are allergic to Fluorodeoxyglucose (F) or any of the other ingredients of Fludeoxyglucose (18F) Biont (listed in section 6).

Warnings and precautions

You should be particularly careful:

• if you have uncontrolled diabetes;
• if you have an infection or inflammatory disease;
• if you have kidney problems.

Tell your doctor who is supervising the examination if:

• you are pregnant or think you may be pregnant;
• you are breastfeeding;
• you are under 18 years old.

Fludeoxyglucose (18F) Biont with other medicines

Tell your doctor or nuclear medicine specialist who will be supervising the examination about all the medicines you are taking now or have taken recently, including those obtained without a prescription, as they may interfere with the interpretation of the results of the examination:

• any medicines that may affect blood glucose levels (such as corticosteroids, valproic acid, carbamazepine, phenytoin, phenobarbital, and catecholamines);
• glucose;
• insulin;
• colony-stimulating factors.

Fludeoxyglucose (18F) Biont with food and drink

This medicine can only be given to patients who have not eaten for at least 4 hours. Before administration, your blood glucose level will be measured; high blood glucose levels (hyperglycemia) may make it difficult for your doctor to interpret the results of the examination.

Pregnancy and breastfeeding

You must inform the nuclear medicine specialist before Fludeoxyglucose (18F) Biont is injected if you think you may be pregnant, have not had a menstrual period, or are breastfeeding. In case of doubt, talk to your doctor or nuclear medicine specialist who will be supervising the examination. If you are pregnant Your doctor will only consider performing this examination during pregnancy if it is absolutely necessary. If you are breastfeeding You should stop breastfeeding for 12 hours after injection, and the expressed milk should be discarded. To determine when you can start breastfeeding again, consult your doctor. Before taking any medicines, ask your doctor or nuclear medicine specialist who will be supervising the examination.

Before Fludeoxyglucose (18F) Biont is given

• avoid strenuous physical activity;
• drink plenty of water in the 4 hours before the examination;
• fast for at least 4 hours.

After Fludeoxyglucose (18F) Biont is given

• avoid close contact with small children for up to 12 hours after injection;
• urinate frequently to help eliminate the medicine from your body.

There are strict regulations regarding the use and disposal of radiopharmaceuticals and their handling. Fludeoxyglucose (18F) Biont is only used in hospitals. It can only be administered by trained and qualified personnel who will take care to ensure the safe use of this medicine and will inform you of what they are doing.

Driving and using machines

It is unlikely that Fludeoxyglucose (18F) Biont will affect your ability to drive or use machines.

Important information about some of the ingredients of Fludeoxyglucose (18F) Biont

Depending on the time of injection, the sodium content may sometimes be higher than 1 mmol (23 mg). This should be taken into account in patients controlling their sodium intake.

3. How Fludeoxyglucose (18F) Biont is given

The nuclear medicine specialist supervising the examination will decide on the amount of Fludeoxyglucose (18F) Biont to be used in your case. This will be the smallest amount necessary to obtain the required information. For an adult, the recommended activity is usually between 100 and 600 MBq (depending on the patient's weight and the type of PET device used and the method of image acquisition). Megabecquerel (MBq) is a unit of measurement of radioactivity in the metric system.

Use in children

When used in children, the amount of Fludeoxyglucose (18F) Biont given will be adjusted according to the child's weight.

Administration of Fludeoxyglucose (18F) Biont

Fluorodeoxyglucose (18F)

4. Possible side effects

Like any medicine, Fludeoxyglucose (18F) Biont for injection can cause side effects, although they do not occur in everyone.
After administration, this radiopharmaceutical will emit a small dose of ionizing radiation, which is associated with a very low risk of developing cancer and (or) birth defects.
The doctor ordering such an examination has considered that the therapeutic benefits for the patient obtained through the examination using the radiopharmaceutical outweigh the risk associated with radiation exposure.
If you notice any side effects, or side effects not mentioned in this leaflet, you should inform your doctor or the specialist doctor in nuclear medicine who supervises the examination.

Reporting side effects

If any undesirable symptoms occur, including any side effects not mentioned in the leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the 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. By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Fludeoxyglucose (18F) Biont for injection

Store in a temperature below 25°C in the original packaging.
Storage of radionuclides should be carried out in accordance with national regulations regarding radioactive products.

6. Package contents and other information

What Fludeoxyglucose (18F) Biont for injection contains

The active substance of the medicine is Fluorodeoxyglucose (F).

• 1 ml contains 200 - 2200 MBq of fluorodeoxyglucose (F) on the day and hour of calibration (t + 4 hours), i.e. 182 MBq to 100095 MBq at the end of synthesis (t).

Other ingredients (excipients) are:
Sodium chloride,
Water for injections,
Sodium hydroxycitrate sesquihydrate,
Sodium citrate,
Sodium chloride 0.9%
Anhydrous ethanol 0.2%

What Fludeoxyglucose (18F) Biont for injection looks like and what the pack contains

The radioactivity contained in 1 vial is from 40 MBq to 22000 MBq on the day and hour of calibration.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:
BIONT a.s.
Karloveská 63
842 29 Bratislava
Slovakia
tel: +421 2 206 70 749
fax: +421 2 206 70 748
e-mail: biont@biont.sk
Manufacturers:
BIONT a.s.
Monrol Europe S.R.L.
Karloveská 63
Gradinarilor, No. 1
842 29 Bratislava
Pantelimon, Jud. Ilfov
077 145
Slovakia
Romania
tel: +421 2 206 70 749
tel.: +40 213 674 801
fax: +421 2 206 70 748
fax: +40 213 117 584
e-mail: biont@biont.sk
e-mail: monrol@monrol.com
Monrol Poland Ltd .
Monrol Bulgaria Ltd.
Keramzytowa 16
Bansko shose 128
96-320 Mszczonów
1331 Sofia
Poland
Bulgaria
tel.: +48 46 857 1425
tel.:
fax: +48 46 857 1428
fax:
e-mail: monrol@monrol.com
e-mail: monrol@monrol.com

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Austria - [18F] Fludeoxyglucose Biont 200-2200 MBq/ml Injektionslösung
Bulgaria - флудеоксиглюкоза (18Ф) 200 – 2200 MBq/ml инжекционен разтвор
Czech Republic - Fludeoxyglucose (18F) Biont 200-2200 MBq/ml injekční roztok
Poland - Fludeoxyglucose (18F) Biont
Romania - Fludeoxyglucose Biont 200-2200 MBq/ml soluţie injectabilă
Slovakia - biontFDG

Date of last revision of the leaflet: -----------------------------------------------------------------------------------------------------------------

Information intended for healthcare professionals only:
The full Summary of Product Characteristics of Fludeoxyglucose (18F) Biont for injection is available as a separate document, which aims to provide healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical.
You should consult the Summary of Product Characteristics (SPC is included in the package).