Расходные материалы для глицеролизации, деглицеролизации и отмывания эритроцитов крови: раствор для обработки эритроцитов Глицерол 57,1%, 500 мл

Land: Wit-Rusland

Taal: Russisch

Bron: Министерством здравоохранения Республики (Центр экспертиз и испытаний в здравоохранении)

Beschikbaar vanaf:

S.A.L.F. S.p.A. Laboratorio Farmacologico, ИТАЛИЯ

klasse:

изделия медицинского назначения

Geproduceerd door:

S.A.L.F. S.p.A. Laboratorio Farmacologico

Autorisatie datum:

2023-01-03

Productkenmerken

[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