Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients

Sodium ascorbate
Ascorbic acid
Sodium chloride
Water Ultrapure

6.2   Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned insection 4.2.

6.3   Shelf life

The expiry date and time of LuNET-SRY is indicated on the packaging materials, and is limited to 72 hours from the end of its synthesis.

6.4   Special precautions for storage

Store at room temperature below 25°C.
Store in the original containers to protect from ionizing radiation.
Storage of radiopharmaceuticals should be in accordance with institutional and national regulations on radioactive material.


6.5   Nature and contents of container
Clear Type I glass vial, closed with a butyl rubber stopper and aluminum seal.
Each vial contains a volume of 12.5 mL of solution corresponding to an activity of 7,400 MBq at the date and time of infusion (ART).
The vial is enclosed within a poly(methyl methacrylate) (PMMA) box, stored inside a lead container for protective shielding.


6.6   Special precautions for disposal and other handling
The solution is intended for single use only.
General warning
Radiopharmaceuticals should be received, stored, transferred, administered and disposed of only by authorized personnel and in accordance with the regulations and appropriate licenses of the medical center.
Appropriate aseptic precautions should be taken, and adequate aseptic techniques should be used while handling the product.
Radiopharmaceuticals should be handled in line with radiation safety and pharmaceutical quality requirements.
Waterproof gloves and suitable personal protective equipment should be used. Use adequate shielding and minimize the exposure to ionizing radiation as low as reasonably achievable. Healthcare personnel are advised to limit the time of close contact with patients injected with LuNET-SRY.
For instruction on preparation of the medicinal product before administration, see section 9. If the integrity of the vial is compromised, it should not be used.
For additional recommendations on radiation safety, radiation protection and environmental hazards, see section 4.4.
Any unused product or waste material should be disposed of in accordance with local requirements.


7.     MARKETING AUTHORIZATION HOLDER

Manufacturer and License Holder:

S.R.Y Medical Services Ltd.
Kiryat Hadassah 1 Kalman Mann St.
POB 12000, 9112001, Jerusalem, Israel