Valsts: Baltkrievija
Valoda: krievu
Klimata pārmaiņas: Министерством здравоохранения Республики (Центр экспертиз и испытаний в здравоохранении)
S.A.L.F. S.p.A. Laboratorio Farmacologico, ИТАЛИЯ
изделия медицинского назначения
S.A.L.F. S.p.A. Laboratorio Farmacologico
2023-01-03
[EN] INSTRUCTION FOR USE SODIUM CHLORIDE 12% SOLUTION FOR THE DEGLYCEROLIZATION OF RED BLOOD CELLS TYPE OF DEVICE Medical Device of Class IIb. Sterile non-pyrogenic hypertonic solution. FORMULA Sodium Chloride 12 g, Water for injection q.s. to 100 ml. INDICATIONS SODIUM CHLORIDE 12% solution is indicated in the deglycerolization phase of cryopreserved red blood cells. INSTRUCTIONS FOR USE The device must be used by specialized health personnel and appropriately trained to operate according to the deglycerolization protocol in use. The cryopreservation of red blood cells, requires the initial separation of the red blood cells from whole blood and the addition of glycerol solution, limiting the cell damage when freezing unit s to - 80 ° C. The prepared red blood cells are appropriately labelled and frozen in appropriate containers. Thawing these units is a complex and very critical operation. It requires the use of various saline solutions added in sequence to the thawed cells (respectively Sodium Chloride 12%, Sodium Chloride 1,6%, Glucose 0,2% with Sodium Chloride 0,9%) which have the purpose to dilute and wash the red cells in way to remove glycerol and restore the original conditions. The sequence, volume and speed for adding these solutions are critical factors and the non-compliance to the process may cause irreversible damage to the red blood cells that rupture. The use of 12% Sodium Chloride solution must be followed by a washing step with an isotonic solution (Glucose 0,2% with Sodium Chloride 0,9%). SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE • Do not administer intravenously, the solution must not be taken orally • Check before use that the solution is clear, colorless, free from visible particles and that the bag is not damaged • Do not use any partial bags due to the risk of contamination due to loss of sterility • Do not introduce air • Microwave heating is not recommended • Failure to comply with aseptic technique, temperature, volumes and sequences required by the deglycerolization Izlasiet visu dokumentu