Lactated Ringer’s IrrigationBaxter
Sterile Container System
potassium chloride and
calcium chloride solution, for slush Baxter Healthcare Corporation
Lactated Ringer’s Irrigation Baxter
Sterile Container System
Irrigation in the Baxter Sterile Container System is a sterile,
nonpyrogenic, isotonic solution for the preparation of slushed solution.
It contains no antimicrobial agents. Composition, osmolarity, pH, ionic
concentration and caloric content are shown in Table 1.
Osmolarity (mOsmol/L) (calc)
Ionic Composition (mEq/L)
Sodium Chloride, USP, (NaCl)
Sodium Lactate, (C3H5NaO3)
Potassium Chloride, USP, (KCl)
Calcium Chloride, USP (CaCl2·2H2O)
Lactated Ringer’s Irrigation
(6.0 to 7.5)
The Baxter Sterile
Container System is designed to provide a slush container with asterile exterior surface for use
within the surgical field. Within the overwrap, the unit is packaged in
a dispensing bag which maintains the sterility of this surface.
plastic slush container is fabricated from a specially formulated
polyvinyl chloride (PL 146 Plastic). The amount of water that can
permeate from inside the container into the overwrap is insufficient to
affect the solution significantly. Solutions in contact with the plastic
container can leach out certain of its chemical components in very small
amounts within the expiration period, e.g., di-2-ethylhexyl phthalate
(DEHP), up to 5 parts per million. However, the safety of the plastic
has been confirmed in tests in animals according to USP biological tests
for plastic containers as well as by culture toxicity
Slushed solution is
used to induce regional hypothermia in conditions such as certain open
heart and kidney surgical procedures by direct application of slushed
solution. The objective of regional hypothermia is to reduce cellular
metabolic activity so that body tissues can tolerate a period of total
or relative ischemia thereby inhibiting the formation and buildup of
destructive autolytic enzymes and anaerobic by-products usually produced
and accumulated in ischemic tissues.
INDICATIONS AND USAGE
Slushed solution is
used to create regional hypothermia in order to reduce and minimize
manifestations of warm-temperature ischemia. Temperature probes may be
used to determine requirements for replacement or addition of slushed
Not for injection.
For use in slush preparation for regional hypothermia.
direct contact between ice crystals and body tissues.
Experience in use
of slushed solutions in pediatrics is limited.
Mutagenesis and Impairment of Fertility
performed with slushed Lactated Ringer’s Irrigation have not
been performed to evaluate carcinogenic potential, mutagenic
potential, or effects on fertility.
Pregnancy Category C
Animal reproduction studies have not been
conducted with slushed Lactated Ringer’s
Irrigation. It is also not known whether slushed
Lactated Ringer’s Irrigation can cause fetal
harm when administered to a pregnant woman or
can affect reproduction capacity. Slushed
Lactated Ringer’s Irrigation should be given to a pregnant woman only if clearly
It is not
known whether this drug is excreted in human milk. Because many
drugs are excreted in human milk, caution should be exercised
when slushed Lactated Ringer’s irrigation is administered to a
effectiveness of slushed Lactated Ringer’s Irrigation in
pediatric patients have not been established by adequate and
well controlled trials; however, the use of electrolyte
solutions in the pediatric population is referenced in the
warnings, precautions and adverse reactions identified in the
label copy should be observed in the pediatric population.
administer unless seals of outer dispensing bag are
No serious adverse
reactions are known.
DOSAGE AND ADMINISTRATION
The volume of
slushed solution required will vary with patient’s age, clinical
condition, cooling effect desired and duration of cooling effect
desired, according to physician’s instructions.
Irrigation in the Baxter Sterile Container System is supplied as
pharmaceutical products to heat should be minimized. Avoid excessive
heat. Avoid freezing except during controlled slushing procedure. It is
recommended that this product be stored at room temperature (25ºC);
brief exposure up to 40ºC does not adversely affect this
DIRECTIONS FOR USE OF THE
BAXTER STERILE CONTAINER SYSTEM
Preparation of Slush
following instructions are intended only as guidelines for the
preparation of slush using the Baxter Sterile Container System.
specific procedure necessary to achieve the desired slush
consistency will depend on the type of freezer used, location of
the product in the freezer, and the utilization of freezer
product from shipping carton and place in freezer at a
temperature between minus 4°C and minus 15°C for 2 to 6 hours.
pre-cooled product will require less time to slush.
the freezing process, remove product from freezer periodically
and carefully massage to break up large frozen chunks of
product to freezer and repeat procedure until desired slush
consistency is obtained.
To Open: Use
prepare unit outside the surgical field.
overwrap down side at slit and remove dispensing bag which
contains the slush container.
unit to stand at room temperature for approximately 10 minutes
to allow container material to regain flexibility.
that all the seals of the dispensing bag are intact including
the tamper evident button. If any broken seals or holes are
detected, discard unit as sterility may be impaired.
tab of dispensing bag and peel open (Figure 1). Remove wrapped
inner slush container.
point of sterile transfer wrap (Figure 2), and pull forward then
back to expose sterile slush container (Figure 3). Caution
should be exercised to avoid touch contamination.
transfer sterile slush container to the surgical field.
sterile gloved hands, remove slush container from the sterile
transfer wrap (Figure 4). Place on surgical field or use
2. Grasp tab at top of slush container and peel directly across the width
of the container with a steady motion (Figure 5).
3. Slush is ready for dispensing.
IL 60015 USA
07-19-04-502 Rev. October
PL 146 are trademarks of Baxter International Inc.
sodium chloride, sodium lactate, potassium chloride and calcium chloride solution, for slush