Hipuran - 131^i do vstzhikivani

PATIENT INFORMATION LEAFLET: USER INFORMATION

Hipuran- I for injections

Sodium iodohippurate (I) injectable solution

Read the leaflet carefully before using the medicine.

• Keep this leaflet, you may need to read it again.
• Ask your doctor if you need advice or more information.
• This medicine has been prescribed for you only. Do not pass it on to others, as it may harm them, even if their symptoms are the same as yours.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

Table of contents of the leaflet:

• 1. What is Hipuran- I for injections and what is it used for?
• 2. Important information before using the radiopharmaceutical Hipuran- I for injections.
• 3. How to use the medicine Hipuran- I for injections.
• 4. Possible side effects.
• 5. How to store the medicine Hipuran- I for injections.
• 6. Other information.

1. WHAT IS HIPURAN- I FOR INJECTIONS AND WHAT IS IT USED FOR?

Hipuran- I for injections is a radiopharmaceutical that contains the active substance, the radioactive isotope iodine-131. Iodine-131, during nuclear transformation, emits radiation (beta minus with a maximum energy of 606 keV and gamma radiation quanta with energies of 248 keV, 364 keV, 637 keV, and 723 keV), which can be recorded. The half-life of iodine-131 is very short, approximately 8.04 days, which significantly affects the safety of its use. Hipuran- I for injections (ortho-iodohippurate-I sodium) is a radiopharmaceutical intended for the diagnosis of kidney function, renal blood flow, urinary tract obstruction, assessment of glomerular filtration, and effective plasma flow in the kidneys. After intravenous administration, Hipuran- I for injections accumulates in the kidneys, from where it is then excreted.

2. IMPORTANT INFORMATION BEFORE USING THE RADIOFARMACEUTICAL HIPURAN- I FOR INJECTIONS

WHEN NOT TO USE THE MEDICINE HIPURAN- I FOR INJECTIONS

The main contraindication for the use of the preparation in humans is the period of pregnancy and breastfeeding in women. Other therapeutic methods that do not use ionizing radiation should be considered at that time.

WHEN TO EXERCISE SPECIAL CAUTION WHEN USING HIPURAN- I FOR INJECTIONS

In patients with urinary incontinence, a catheter should be inserted into the bladder immediately before administering the radiopharmaceutical. The urine produced at that time is radioactive, so all hygiene procedures, especially emptying the urine container, should be performed with special caution, wearing rubber gloves, to limit the possibility of contamination.

USING THE MEDICINE HIPURAN- I FOR INJECTIONS WITH OTHER MEDICINES

Tell your doctor about all the medicines you have taken recently, including those available without a prescription. Furosemide, a diuretic, affects the excretion of Hipuran- I for injections. Do not take any diuretics before the examination.

USING THE MEDICINE HIPURAN- I FOR INJECTIONS WITH FOOD AND DRINK

No special precautions are recommended.

PREGNANCY AND BREASTFEEDING

The preparation is not recommended for administration to pregnant or breastfeeding women. Other diagnostic methods that do not use ionizing radiation should be considered at that time. If it is necessary to administer the radiopharmaceutical to women of childbearing age, it should be ensured that the woman is not pregnant. In women with menstrual disorders, pregnancy should be ruled out. If a woman has not menstruated at the expected time, it should be assumed that she is pregnant until pregnancy is ruled out. Examinations in women of childbearing age should be performed in the first ten days after menstruation. Breastfeeding should be discontinued after administration of the radiopharmaceutical and may be resumed when the radiation dose that the child could receive during breastfeeding and contact with the mother is within the legally established norms.

DRIVING AND USING MACHINERY

Hipuran- I for injections does not affect the ability to drive vehicles or operate machinery.

3. HOW TO USE THE MEDICINE HIPURAN- I FOR INJECTIONS

DOSAGE AND ADMINISTRATION

Hipuran- I is administered to an adult patient (70 kg) in a single intravenous injection, in a dose corresponding to an activity of 0.185-1.295 MBq. Depending on the diagnostic purpose, an intravenous infusion or a single intravenous injection is used. After intravenous administration, Hipuran- I accumulates in the kidneys within 2-5 minutes, where it is concentrated and excreted. The rate of elimination of this radiopharmaceutical from the plasma depends on the rate of its flow. Under normal conditions, the half-life of elimination is approximately 20 minutes.

OVERDOSAGE OF THE MEDICINE HIPURAN- I FOR INJECTIONS

The activity of the dose of the radiopharmaceutical administered to patients should always be considered in relation to its diagnostic and therapeutic values. There are no known cases of overdosing of Hipuran- I, understood as the administration of an excessive amount of radioactive substance. In case of overdosing, diuretics should be administered to accelerate excretion and reduce the radiation dose for the patient.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Hipuran- I can cause side effects, although not everybody gets them. There are no known serious side effects after administration of Hipuran- I. However, according to literature data, in rare cases, patients may experience nausea, vomiting, rash, itching, urticaria, and decreased blood pressure. Reporting side effects If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or a specialist in nuclear medicine. Side effects can be reported directly to the Department for Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products Al. Jerozolimskie 181 C 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. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE THE MEDICINE HIPURAN- I FOR INJECTIONS

Storage conditions and shelf life are stated on the packaging. Do not use the medicine after the expiry date stated on the label. Trained personnel of a specialized facility will ensure proper storage conditions for the medicine Hipuran- I for injections.

6. OTHER INFORMATION

WHAT THE MEDICINE HIPURAN- I FOR INJECTIONS CONTAINS

• The active substance of the medicine is sodium 2-[I]jodohippurate [3.7 - 74 MBq/ml]
• Other ingredients of the medicine are: benzyl alcohol, sodium chloride, water for injections

WHAT THE MEDICINE HIPURAN- I FOR INJECTIONS LOOKS LIKE AND WHAT THE PACKAGING CONTAINS

The immediate packaging is a 10 ml glass vial closed with a rubber stopper and an aluminum cap, placed in a lead shielding container. The vial contains a volume of solution corresponding to the activity specified on the calibration date.

INFORMATION FOR MEDICAL PERSONNEL

The radiopharmaceutical is supplied in a ready-to-use form. Radioactive waste (residual radiopharmaceutical solution) and solid waste (vials, stoppers, needles, syringes, gauze, cotton, and other materials) should be placed in separate, tightly closed containers in a ventilated room. After filling a given container, it should be handed over to the Radioactive Waste Disposal Facility or left in a separate, ventilated room until the radioactive isotope has decayed.

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

DATE OF APPROVAL OF THE LEAFLET: APRIL 2016