Sodium orthophosphate, na2h32po4, for injections

Sodium Orthophosphate Na₂H₃₂PO₄, for injection
Natrii phosphatis (P) solutio iniectabilis
Read the entire leaflet before using the 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 and should not be passed on to others, as it may harm them even if their symptoms are identical.
• If any adverse effects worsen or if any adverse effects not listed in this leaflet occur, inform your doctor immediately.

Contents of the leaflet:

1. What is Sodium Orthophosphate Na₂H₃₂PO₄, for injection and what is it used for?
2. Important information before using Sodium Orthophosphate Na₂H₃₂PO₄, for injection
3. How to use Sodium Orthophosphate Na₂H₃₂PO₄, for injection
4. Possible side effects
5. How to store Sodium Orthophosphate Na₂H₃₂PO₄, for injection
6. Other information

1. WHAT IS SODIUM ORTHOPHOSPHATE Na₂H₃₂PO₄, FOR INJECTION AND WHAT IS IT USED FOR?
Sodium Orthophosphate Na₂H₃₂PO₄, for injection is a radiopharmaceutical agent containing the active substance, the radioactive isotope phosphorus-32. This isotope has a short half-life of 14.29 days and emits beta particles (E = 1.71 MeV), which produce bremsstrahlung radiation when passing through matter.
This preparation is indicated for the treatment of polycythemia vera and essential thrombocythemia when other treatment methods have proven ineffective. It may also be used in the treatment of leukemia and other hematological disorders. Sodium Orthophosphate Na₂H₃₂PO₄, for injection can be used as a pain-relieving agent in bone metastases; however, its myelotoxicity must be taken into account.

2. IMPORTANT INFORMATION BEFORE USING SODIUM ORTHOPHOSPHATE Na₂H₃₂PO₄, FOR INJECTION

When not to use Sodium Orthophosphate Na₂H₃₂PO₄, for injection
Absolute contraindications for the use of this preparation are pregnancy and breastfeeding.
The preparation should not be used in patients with platelet counts below 15,000, in cases of renal failure (urea >12 mmol/L, creatinine >150 µmol/L), or in the presence of bone marrow damage with leukopenia and/or thrombocytopenia.

When to exercise special caution when using Sodium Orthophosphate Na₂H₃₂PO₄, for injection
In patients with urinary incontinence, a urinary catheter should be inserted prior to administration of the radiopharmaceutical. The urine produced during this time is radioactive; therefore, all hygiene procedures, especially emptying of urine containers, must be performed with particular care and while wearing rubber gloves to minimize the risk of contamination.

Using Sodium Orthophosphate Na₂H₃₂PO₄, for injection with other medicines
Inform your doctor about all medications you are currently taking, 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 its adverse effects on bone marrow, this preparation should not be administered concurrently with chemotherapy or radiotherapy (or shortly after completion of these therapies), unless the expected benefits outweigh the potential risks.
Because of the delayed effect on bone marrow activity occurring approximately 4 months after P-32 administration, cytotoxic agents should not be administered during this period.

Using Sodium Orthophosphate Na₂H₃₂PO₄, for injection with food and drink
No special precautions are recommended.

Pregnancy and breastfeeding
Pregnancy and breastfeeding are absolute contraindications for the use of this preparation.
Radiopharmaceuticals may have mutagenic and teratogenic effects. Therefore, radiopharmaceuticals containing radioactive phosphorus P should not be administered during pregnancy. It is also recommended to avoid conception for at least 3 months after receiving a dose up to 200 MBq; for higher doses, this period should be proportionally longer.
If administration of a radiopharmaceutical is necessary in women of childbearing potential, it must be confirmed that the woman is not pregnant. In women with menstrual irregularities, pregnancy must be ruled out. If a woman does not have her expected menstrual period, she should be considered pregnant until pregnancy is excluded. Examinations in women of childbearing age should be performed within the first 10 days after menstruation. In cases of uncertainty, alternative diagnostic methods not involving ionizing radiation should always be considered.
Breastfeeding must be discontinued after the first dose of the radiopharmaceutical due to the potential risk to the infant's health. Breastfeeding may be resumed when the radiation dose received by the infant during breastfeeding and contact with the mother falls within legally established limits.

Driving and operating machinery
Sodium Orthophosphate Na₂H₃₂PO₄, for injection has no influence on the ability to drive or operate mechanical devices.

3. HOW TO USE SODIUM ORTHOPHOSPHATE Na₂H₃₂PO₄, FOR INJECTION
Dosage and method of administration
Sodium Orthophosphate Na₂H₃₂PO₄, for injection is intended for intravenous administration at various activity levels 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 area, but not exceeding 185 MBq. Another approach involves administering an initial dose of 111 MBq; if symptoms persist after 3 months, a second dose 25% higher than the first should be administered. Single doses should not exceed 250 MBq.
• In leukemia, 37–74 MBq is administered weekly until white blood cell counts decrease to the desired level.
• In the treatment of bone metastases, doses of 370–555 MBq may be administered at intervals of 3–4 months to relieve pain when other therapies such as hormonal treatment, chemotherapy, and radiotherapy have failed. Pain relief following P-32 therapy may occur several weeks after radiopharmaceutical administration, manifesting as improved well-being and reduced need for analgesics.

Overdose of Sodium Orthophosphate Na₂H₃₂PO₄, for injection
The preparation is supplied in portions according to prescription. The treating physician calculates the administered activity, so the risk of overdose is very limited. In case of accidental overdose of the radioactive substance, excessive whole-body irradiation rather than specific blood cell effects may be expected. Increased fluid intake is recommended to promote diuresis and bowel movements. Frequent bladder emptying is advised. Additionally, phosphate salts should be administered to reduce the incorporation of radioactive phosphorus radionuclide into tissues and thereby limit radiation exposure.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Sodium Orthophosphate Na₂H₃₂PO₄, for injection may cause side effects, although not everyone experiences them.
Treatment with Sodium Orthophosphate Na₂H₃₂PO₄, for injection carries a risk of developing leukemia in 2–15% of patients within 10 years, similar to the risk associated with chemotherapy.

Reporting of side effects
If any adverse effects occur, including those not listed in this leaflet, inform your doctor or a nuclear medicine specialist.
Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 effects can also be reported to the marketing authorization holder.
Reporting side effects helps provide more information on the safety of the medicine.

5. HOW TO STORE SODIUM ORTHOPHOSPHATE Na₂H₃₂PO₄, FOR INJECTION
Storage conditions and expiry date are indicated on the packaging. Do not use the medicine after the expiry date stated on the label.
Trained personnel at the specialized facility will ensure appropriate storage conditions for Sodium Orthophosphate Na₂H₃₂PO₄, for injection.

6. OTHER INFORMATION

What Ortofosforan sodu, NaHPO, do wstrzykiwań contains

• The active substance is sodium orthophosphate NaHPO [37–370 MBq/ml]
• Other components of the medicinal product are: disodium hydrogen phosphate, dodecahydrate, sodium chloride, water for injections

What Ortofosforan sodu, NaHPO, do wstrzykiwań looks like and contents of the pack
The immediate container is a 10 ml glass vial closed with a rubber stopper and an aluminium seal, placed inside 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 medicinal product is supplied ready for use.
Radioactive waste – liquid (residual radiopharmaceutical solution) and solid (vials, stoppers, needles, syringes, lignin, cotton wool, others) – must be placed in separate tightly sealed containers located in a ventilated room. Once a container is full, it should be transferred to a Radioactive Waste Disposal Facility or stored in a separate ventilated room until radioactive decay of the radionuclide is complete.
Marketing Authorisation Holder and Manufacturer
Narodowe Centrum Badań Jądrowych
Andrzeja Sołtana 7
05-400 Otwock
Poland
Tel: +48 22 7180700
Fax: +48 22 7180350
e-mail: [email protected]