sodium chloride injection, solution Hospira, Inc.
0.9% Sodium Chloride Injection, USP
Unit of Use System
0.9% Sodium Chloride Injection, USP is a sterile, nonpyrogenic
solution of sodium chloride in water for injection. It is administered via
a thermodilution catheter for measuring cardiac output.
mL contains sodium chloride 9 mg. Osmolar concentration is 0.308 mOsmol/mL
(calc). pH is 5.8 (4.5 to 7.0). Electrolyte content: Na+ 0.154
mEq/mL; Clˉ 0.154 mEq/mL. The solution contains no bacteriostat, antimicrobial
agent or added buffer and is intended for use only as a single-dose thermodilution
agent. When smaller amounts are required the unused portion should be discarded.
as directed, the Thermoject Unit of Use System provides for aseptic delivery
of cardiac output injectate. The solution may be used iced or at room temperature
for injection of measured boluses from 1 to 10 mL as required.
Sodium Chloride Injection, USP in the Thermoject System for cardiac output
monitoring may be classified as a thermodilution diagnostic aid.
Chloride, USP is chemically designated NaCl, a white crystalline powder, freely
soluble in water.
The semi-rigid vial is fabricated
from a specially formulated polyolefin. It is a copolymer of ethylene and
propylene. The safety of the plastic has been confirmed by tests in animals
according to USP biological standards for plastic containers. The container
requires no vapor barrier to maintain the proper drug concentration.
Used as a thermodilution agent for measuring cardiac output,
0.9% Sodium Chloride Injection, USP usually involves volumes too small to
affect electrolyte or water balance except possibly in neonates or very small
INDICATIONS AND USAGE
0.9% Sodium Chloride Injection, USP in the Thermoject System
is indicated for measurement of cardiac output by the thermodilution method.
Use only for Thermodilution as directed.
This solution is not intended and should not be used for
injection by the usual parenteral routes of administration, including infusion
via intravenous administration sets.
Use Aseptic Technique. See PRECAUTIONS.
Do not use unless the solution is clear and container undamaged.
Discard unused portion. Use only for Thermodilution as directed. The solution
should be inspected visually for particulate matter and discoloration prior
Carcinogenesis, Mutagenesis, Impairment of Fertility
Studies with 0.9% Sodium Chloride Injection in Plastic Vials
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
sodium chloride. It is also not known whether sodium chloride can cause fetal
harm when administered to a pregnant woman or can affect reproduction capacity.
Sodium chloride should be given to a pregnant woman only if clearly needed.
It is not known whether this drug is excreted in human milk.
Because many drugs are excreted in human milk, caution should be exercised
in 0.9% Sodium Chloride Injection in Plastic Vials is administered to a nursing
The safety and effectiveness in the pediatric population
are based on the similarity of the clinical conditions of the pediatric and
adult populations. In neonates or very small infants the volume of fluid may
affect fluid and electrolyte balance.
Reactions which may occur because of the solution or the
technique of administration include febrile response, tissue necrosis or infection,
local or systemic.
If an adverse reaction does occur,
discontinue the infusion, evaluate the patient and institute appropriate countermeasures.
In a small volume container, the solution is unlikely to
pose a threat of solute or fluid overload except possibly in neonates or very
DOSAGE AND ADMINISTRATION
The volume of bolus injection (1 to 10 mL) varies depending
on patient condition and requirements to produce an adequate thermodilution
cardiac output curve. Usually the smallest volume necessary to produce an
adequate curve is used so as to limit fluid dosage.
cardiac output measurement is desired, the vial and injector are connected
as shown under HOW SUPPLIED. Prime the injector. The injector is connected
securely to the side port of a 3-way stopcock attached to the RA proximal
port of a thermodilution catheter using the male luer lock. The hand should
be used to cradle the stopcock and Thermoject Syringe so a smooth, quick injection
can be made.
vial as little as possible to prevent change in temperature.
ADD SUBSEQUENT VIALS: Properly position the 3-way stopcock and disconnect
the unit. Remove the empty vial by rotating counterclockwise. Attach replacement
vial as before, i.e., rotate vial clockwise three times. Prime the injector
and reconnect the unit to the stopcock.
The final vial
used in a series of injections should be left in the injector so the system
remains closed in case subsequent cardiac output measurements are made.
List No. 1081
10 mL Thermoject Vials,
10 mL Thermoject
Empty Vial (For
USE ASEPTIC TECHNIQUE
Open carton using tear strip, remove carrying tray and contents.
Remove injector from tray; if iced injectate is desired,
submerge tray into ice bath without submerging the yellow vial caps.
Remove purple cap from empty vial, fill vial with desired
solution, replace cap and place injectate probe through hole in cap into solution
(tip should be submerged at least 3 cm).
CAUTION: Do not connect injector and vial until
ready to use.
When desired solution temperature is reached, remove cap
from injector and one vial.
Insert vial into injector and rotate clockwise (about three
turns) until medication enters needle.
CAUTION: Handle vial as little as possible to prevent
change in solution temperature.
Twist and pull luer cover to remove.
Hold vial and injector in vertical position with vial below
injector and prime the injector to remove all air from vial and injector.
Connect injector securely to the side port of a 3-way stopcock attached to
the RA proximal port of a thermodilution catheter.
TO ADD SUBSEQUENT VIALS. Properly position the 3-way stopcock
and disconnect the unit. Remove the empty vial by rotating counterclockwise.
Attach replacement vial and rotate vial clockwise three times. Prime the injector
and reconnect the unit to the stopcock.
Leave the last vial in the series in the injector to prevent
contamination of the needle and fluid path.
Store at 20 to 25°C (68 to 77°F). [See USP Controlled