Ortofosforan sodu, Na2h32po4, do vstzhikivani

PATIENT INFORMATION LEAFLET: USER INFORMATION

Sodium Orthophosphate Na 2 H 32 PO 4, for injections

Sodium phosphate (P) 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 and you should not pass it on to others. 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 Sodium Orthophosphate Na H PO for injections and what is it used for?
• 2. Important information before using Sodium Orthophosphate Na H PO for injections
• 3. How to use the medicine Sodium Orthophosphate Na H PO for injections.
• 4. Possible side effects.
• 5. How to store the medicine Sodium Orthophosphate Na H PO for injections.
• 6. Other information.

1. WHAT IS SODIUM ORTHOPHOSPHATE Na H PO FOR INJECTIONS AND WHAT IS IT USED FOR

WHAT IS IT USED FOR

Sodium Orthophosphate Na H PO for injections is a radiopharmaceutical that contains the active substance, the radioactive isotope phosphorus-32. This isotope has a short half-life of 14.29 days, emits beta particles (E 1.71 MeV), which produce bremsstrahlung radiation when passing through matter. This preparation is intended for the treatment of polycythemia vera and primary thrombocythemia, if other treatment methods are ineffective. It can also be used to treat leukemia and other hematological disorders. Sodium Orthophosphate Na H PO for injections can be used as a pain-relieving agent for bone metastases, but its toxicity to the bone marrow must be considered.

2. IMPORTANT INFORMATION BEFORE USING THE MEDICINE SODIUM ORTHOPHOSPHATE Na H PO FOR INJECTIONS

WHEN NOT TO USE SODIUM ORTHOPHOSPHATE Na H PO FOR INJECTIONS

The absolute contraindication for the use of this preparation is pregnancy and breastfeeding. In cases where the patient's platelet count is less than 15,000, where renal failure has been diagnosed (urea >12mmol, creatinine >150 mmol/l), or where bone marrow damage with leukopenia and/or thrombocytopenia occurs, the use of this preparation is not recommended.

WHEN TO EXERCISE SPECIAL CAUTION WHEN USING SODIUM ORTHOPHOSPHATE Na H PO FOR INJECTIONS

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

USING SODIUM ORTHOPHOSPHATE Na H PO FOR INJECTIONS WITH OTHER MEDICINES

Tell your doctor about all the medicines you have taken recently, including those available without a prescription. The administration of estrogenic and androgenic preparations may affect the metabolism and retention of radioactive phosphorus-32. Due to the adverse effect on the bone marrow, this preparation should not be administered simultaneously with chemotherapy or radiotherapy (or shortly after completing these therapies), unless the expected benefits of its use outweigh the potential negative effects. Due to the delayed effect on bone marrow activity within 4 months of administration of P-32, cytotoxic agents should not be administered.

USING SODIUM ORTHOPHOSPHATE Na H PO FOR INJECTIONS WITH FOOD AND DRINK

No special precautions are recommended.

PREGNANCY AND BREASTFEEDING

The absolute contraindication for the use of this preparation is pregnancy and breastfeeding. The radiopharmaceutical may have mutagenic and teratogenic effects. Therefore, preparations with radioactive phosphorus P should not be administered during pregnancy, and it is recommended to avoid becoming pregnant for at least 3 months after receiving a dose of up to 200 MBq; for higher doses, this period should be longer. 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 does not experience menstruation 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 within the first ten days after menstruation. In case of uncertainty, non-radiation methods should always be considered. Breastfeeding should be discontinued after the first dose of the radiopharmaceutical due to the potential risk to the child's health. Breastfeeding can be resumed when the radiation dose received by the child during breastfeeding and contact with the mother is within the legally established norms.

DRIVING AND USING MACHINES

Sodium Orthophosphate Na H PO for injections has no effect on the ability to drive vehicles or operate machinery.

3. HOW TO USE THE MEDICINE SODIUM ORTHOPHOSPHATE Na H PO FOR INJECTIONS

ADMINISTRATION AND DOSAGE

Sodium Orthophosphate Na H PO for injections is intended for intravenous administration in various activities, depending on the therapy being conducted.

• In the treatment of polycythemia vera, the recommended dose is 74-111 MBq per square meter of body surface, but not more than 185 MBq. Another method involves administering the first dose of 111 MBq; if symptoms of the disease still occur after 3 months, a second dose, 25% higher than the first, should be administered. A single dose should not exceed 250 MBq.
• In the treatment of leukemia, 37-74 MBq is administered weekly until the white blood cell count decreases to the desired level.
• In the treatment of bone metastases, doses of 370 to 555 MBq can be administered at 3-4 month intervals to relieve pain when other forms of therapy, such as hormonal treatment, chemotherapy, and radiotherapy, have failed. Pain relief after P-32 therapy may occur several weeks after administration, resulting in improved well-being and reduced need for painkillers.

OVERDOSE OF SODIUM ORTHOPHOSPHATE Na H PO FOR INJECTIONS

The preparation is supplied in portions according to the order. The attending physician performs calculations of the activity of the doses administered to the patient, so the possibility of overdose is very limited. In the event of accidental overdose of the radioactive substance, excessive whole-body radiation rather than specific effects on blood cells should be expected. It is recommended to administer increased amounts of fluids to induce diuresis and bowel movements. Frequent emptying of the bladder is also recommended. Additionally, phosphate salts should be administered to reduce the incorporation of the radioactive radionuclide phosphorus into tissues and thus limit exposure.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Sodium Orthophosphate Na H PO for injections can cause side effects, although not everybody gets them. Treatment with Sodium Orthophosphate Na H PO for injections is associated with a risk of developing leukemia in 2-15% of patients within 10 years, similar to chemotherapy. Reporting side effects If you experience any side effects, including those not listed in this leaflet, please tell your doctor or a nuclear medicine specialist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Medical Devices, and Biocides of the Office for Registration of Medicinal Products, Medical Devices, and Biocides 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 SODIUM ORTHOPHOSPHATE Na H PO FOR INJECTIONS

ADMINISTRATION

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 at a specialized facility will ensure proper storage conditions for the medicine Sodium Orthophosphate Na H PO for injections.

6. OTHER INFORMATION

WHAT SODIUM ORTHOPHOSPHATE Na H PO FOR INJECTIONS CONTAINS

• The active substance of the medicine is sodium orthophosphate Na H PO [37-370 MBq/ml]
• Other ingredients of the medicine are disodium hydrogen phosphate dodecahydrate, sodium chloride, water for injections

WHAT SODIUM ORTHOPHOSPHATE Na H PO 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 (liquid and solid) should be stored in separate, tightly sealed 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