מדינה: ישראל
שפה: אנגלית
מקור: Ministry of Health
MOLYBDATE (CONTAINING MO-99)
ISORAD LTD, ISRAEL
V09AA
RADIO-PHARMA GENERATOR
MOLYBDATE (CONTAINING MO-99) 400 MG
I.V
Required
ISORAD LTD., ISRAEL
TECHNETIUM (99M-TC) COMPOUNDS
Diagnostic agent for IV injection producer of Tc-99 for imaging of different organs.
2022-04-30
1 SUMMARY OF PRODUCT CHARACTERISTICS TECHNETIUM TC-99M GENERATOR MOLYBDATE (CONTAINING MO-99) RADIO-PHARMA GENERATOR FOR INTRAVENOUS USE TO BE USED IN DIAGNOSTIC INSTITUTES ONLY DESCRIPTION: Sodium Pertechnetate Tc 99m Injection, as eluted according to the elution instructions with Soreq Radiopharmaceutical’s Technetium Tc99m Generator, is in Sodium Chloride 0.9% as a sterile, non-pyrogenic, diagnostic radiopharmaceutical suitable for intravenous injection, oral administration, and direct instillation. The pH is 4.5-7.5. The eluate should be clear, colorless, and free from visible foreign material. Each eluate of the Technetium Tc 99m Generator should not contain more than 0.0056MBq (0.15 microcuries) of Molybdenum Mo99 per 37MBq (1 millicurie) of Technetium Tc 99m per administered dose at the time of administration, and not more than 10 micro-grams of aluminum per milliliter of the Technetium Tc 99m Generator eluate, both of which are recommended to be determined by the user before administration. Since the eluate does not contain an antimicrobial agent, it should not be used later than12 hours after the elution. Soreq Radiopharmaceutical’s Technetium Tc 99m Generator consists of a column containing fission produced Molybdenum Mo99 adsorbed on alumina. The terminally sterilized and sealed column is enclosed in a lead shield; the shield and other components are sealed in cylindrical plastic container with an attached handle. Built into the top surface are two recessed wells as it is shown in the sketch. Needles protruding from these two wells accommodate supplied sterile eluant charge vials and sterile eluate collection vials. The eluting solvent consist of 5ml or 15ml Sodium Chloride 0.9% solution, in prepacked septum-sealed vials. The eluate collection vial is evacuated sterile and non- pyrogenic. During and subsequent to elution, the eluate collection vial should be kept in a radiation shield. The Generator is shipped with a sterile needle seal over the charge needle and a vented needle cover over the coll קרא את המסמך השלם