Hipuran - 131^i for injections
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Hipuran - 131^I for injection
Sodium iodohippurate ( I) solution for injection
Read the entire leaflet carefully before using this medicine.
- Keep this leaflet for future reference.
- Consult your doctor if you need advice or additional information.
- This medicine has been prescribed for a specific individual only and must not be passed on to others, as it may harm them even if their symptoms are similar.
- If any of the adverse effects worsen or if any adverse effects not listed in this leaflet occur, inform your doctor immediately.
Table of contents:
- What is Hipuran-131^I for injection and what is it used for?
- Important information before using Hipuran-131^I for injection.
- How to use Hipuran-131^I for injection.
- Possible side effects.
- How to store Hipuran-131^I for injection.
- Further information.
1. WHAT IS HIPURAN-131^I FOR INJECTION AND WHAT IS IT USED FOR?
Hipuran-131^I for injection is a radiopharmaceutical agent containing the active substance, radioactive isotope iodine-131. During nuclear decay, iodine-131 emits radiation (beta particles with a maximum energy of 606 keV and gamma photons with energies of 248 keV, 364 keV, 637 keV, and 723 keV), which can be detected externally. The half-life of iodine-131 is relatively short, approximately 8.04 days, which significantly contributes to its safety profile.
Hipuran-131^I for injection (sodium ortho-iodohippurate labeled with iodine-131) is a radiopharmaceutical intended for diagnostic evaluation of kidney function, renal blood flow, urinary tract obstructions, glomerular filtration, and effective renal plasma flow.
After intravenous administration, Hipuran-131^I accumulates in the kidneys and is subsequently excreted.
2. IMPORTANT INFORMATION BEFORE USING HIPURAN-131^I FOR INJECTION
When not to use Hipuran-131^I for injection
The main contraindication for using this preparation in humans is pregnancy and breastfeeding in women. Alternative diagnostic methods not involving ionizing radiation should be considered in such cases.
Special precautions to take when using Hipuran-131^I for injection
In patients with urinary incontinence, a urinary catheter should be inserted into the bladder prior to administration of the radiopharmaceutical. The urine produced during this time is radioactive; therefore, all hygiene procedures, especially emptying of urine collection containers, must be performed with particular care and while wearing rubber gloves to minimize the risk of contamination.
Use of Hipuran-131^I for injection with other medicines
Inform your doctor about all medications you are currently taking, including those available without a prescription.
Furosemide, a diuretic, affects the excretion of Hipuran-131^I. Diuretics should not be taken prior to the examination.
Use of Hipuran-131^I for injection with food and drink
No special precautions are required.
Pregnancy and breastfeeding
This product is not recommended for administration to pregnant or breastfeeding women. Alternative diagnostic methods not involving ionizing radiation should be considered.
If administration of a radiopharmaceutical is necessary in women of childbearing age, it is essential to confirm that the woman is not pregnant. In women with menstrual irregularities, pregnancy must be ruled out. A missed menstrual period should be considered as possible pregnancy until proven otherwise. Diagnostic procedures in women of childbearing age should ideally be scheduled within the first 10 days following the onset of menstruation.
Breastfeeding must be interrupted after administration of a radiopharmaceutical and may be resumed only when the radiation dose potentially received by the infant during breastfeeding and contact with the mother falls within legally permitted limits.
Driving and operating machinery
Hipuran-131^I for injection has no effect on the ability to drive motor vehicles or operate mechanical equipment.
3. HOW TO USE THE MEDICINAL PRODUCT HIPURAN- I FOR INJECTION
Dosage and method of administration
Hipuran- I is administered to an adult patient (70 kg) as a single intravenous injection
at 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 may be used.
After intravenous administration, Hipuran- I accumulates in the kidneys within 2–5 minutes,
where it is concentrated and excreted. The rate of disappearance of this radiopharmaceutical from plasma depends on the rate of plasma flow. Under normal conditions, the half-life of disappearance is approximately 20 minutes.
Overdose of Hipuran- I for injection
The dose activity of a radiopharmaceutical administered to patients should always be considered in relation to its diagnostic and therapeutic value.
For Hipuran- I, there are no known cases of overdose defined as administration of an excessive amount of radioactive substance.
In the event of an overdose, diuretic agents should be administered to accelerate excretion and reduce radiation dose to the patient.
4. POSSIBLE ADVERSE REACTIONS
Like all medicines, Hipuran - 131^I do wstrzykiwań may have side effects, although not everybody experiences them.
No serious adverse effects are known after administration of Hipuran - 131^I, however, according to the literature data, in rare cases nausea, vomiting, rash, itching, urticaria, and low blood pressure may be observed in patients.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or a nuclear medicine specialist.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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: [email protected]
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.
5. HOW TO STORE HIPURAN- I INJECTION
Storage conditions and expiry date are stated on the packaging. Do not use the medicinal product after the expiry date indicated on the label.
Trained personnel at the specialist facility will ensure appropriate storage conditions for Hipuran- I injection.
6. OTHER INFORMATION
What Hipuran-^131^I for injection contains
- The active substance is sodium 2-[131^I]iodohippurate [3.7 - 74 MBq/ml]
- Other components of the medicinal product are: benzyl alcohol, sodium chloride, water for injections
What Hipuran-^131^I for injection looks like and contents of the pack
The immediate packaging consists of a 10 ml glass vial closed with a rubber stopper and sealed with an aluminium cap, placed inside a lead shielding container. The vial contains a volume of solution corresponding to the activity calibrated for the reference date.
Information for medical personnel
The radiopharmaceutical is supplied ready for use.
Radioactive waste – liquid (residual radiopharmaceutical solution) and solid (vials, stoppers, needles, syringes, gauze, cotton wool, etc.) – must be placed in separate tightly sealed containers kept in a ventilated room. Once a container is full, it should be transferred to a Radioactive Waste Disposal Facility or stored separately in a ventilated room until the radioactive isotope has completely decayed.
Marketing Authorisation Holder and Manufacturer
National Centre for Nuclear Research
Andrzej Soltan Street 7
05-400 Otwock
Phone: +48 22 7180700
Fax: +48 22 7180350
e-mail: [email protected]