sodium chloride (Sodium Chloride) injection
sodium chloride injection (Sodium Chloride) injection
[Baxter Healthcare Corporation]
DESCRIPTION
Sodium Chloride
Injection, USP is a sterile, nonpyrogenic solution for fluid and
electrolyte replenishment in single dose containers for intravenous
administration. It contains no antimicrobial agents. The pH is 5.0 (4.5
to 7.0). Composition, osmolarity, and ionic concentration are shown
below:
0.45% Sodium Chloride Injection, USP
contains 4.5 g/L Sodium Chloride, USP (NaCl) with an osmolarity of 154
mOsmol/L (calc). It contains 77 mEq/L sodium and 77 mEq/L chloride.
0.9% Sodium Chloride Injection, USP
contains 9 g/L Sodium Chloride, USP (NaCl) with an osmolarity of 308 mOsmol/L (calc). It contains 154
mEq/L sodium and 154 mEq/L chloride.
The VIAFLEX plastic
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 tissue culture toxicity studies.
CLINICAL PHARMACOLOGY
Sodium Chloride
Injection, USP has value as a source of water and electrolytes. It is
capable of inducing diuresis depending on the clinical condition of the
patient.
INDICATIONS AND USAGE
Sodium Chloride
Injection, USP is indicated as a source of water and electrolytes.
0.9% Sodium
Chloride Injection, USP is also indicated for use as a priming solution
in hemodialysis procedures.
CONTRAINDICATIONS
None
known.
WARNINGS
Sodium Chloride
Injection, USP should be used with great care, if at all, in patients
with congestive heart failure, severe renal insufficiency, and in
clinical states in which there exists edema with sodium retention.
The intravenous
administration of Sodium Chloride Injection, USP can cause fluid and/or
solute overloading resulting in dilution of serum electrolyte
concentrations, overhydration, congested states, or pulmonary edema. The
risk of dilutive states is inversely proportional to the electrolyte
concentration of the injections. The risk of solute overload causing
congested states with peripheral and pulmonary edema is directly
proportional to the electrolyte concentrations of the injections.
In patients with
diminished renal function, administration of Sodium Chloride Injection,
USP may result in sodium retention.
GENERAL PRECAUTIONS
Clinical evaluation and periodic laboratory determinations are necessary to monitor changes
in fluid balance, electrolyte concentrations, and acid base balance
during prolonged parenteral therapy or whenever the condition of the
patient warrants such evaluation.
Caution must be
exercised in the administration of Sodium Chloride Injection, USP to
patients receiving corticosteroids or corticotropin.
Carcinogenesis and
Mutagenesis and Impairment of Fertility
Studies
have not been performed with Sodium Chloride Injection, USP to evaluate the potential for carcinogenesis,
mutagenesis, or
impairment of fertility.
Pregnancy:
Teratogenic
Effects
Pregnancy Category C
Animal reproduction studies have not been
conducted with Sodium Chloride Injection, USP.
It is also not known whether Sodium Chloride
Injection, USP can cause fetal harm when
administered to a pregnant woman or can affect
reproduction capacity. Sodium Chloride
Injection, USP should be given to a pregnant
woman only if clearly needed.
Nursing Mothers
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 Sodium Chloride Injection, USP is administered to a nursing
mother.
Pediatric Use
Safety and
effectiveness of Sodium Chloride Injection, USP in pediatric
patients have not been established by adequate and well
controlled trials, however, the use of sodium chloride solutions
in the pediatric population is referenced in the medical
literature. The warnings, precautions and adverse reactions
identified in the label copy should be observed in the pediatric
population.
Geriatric Use
Clinical
studies of Sodium Chloride Injection, USP did not include
sufficient numbers of subjects aged 65 and over to determine
whether they respond differently from younger subjects. Other
reported clinical experience has not identified differences in
responses between the elderly and younger patients. In general,
dose selection for an elderly patient should be cautious,
usually starting at the low end of the dosing range, reflecting
the greater frequency of decreased hepatic, renal, or cardiac
function, and of concomitant disease or drug therapy.
This drug
is known to be substantially excreted by the kidney, and the
risk of toxic reactions to this drug may be greater in patients
with impaired renal function. Because elderly patients are more
likely to have decreased renal function, care should be taken in
dose selection, and it may be useful to monitor renal function.
Do not
administer unless solution is clear and seal is
intact.
ADVERSE REACTIONS
Reactions which may
occur because of the solution or the technique of administration include
febrile response, infection at the site of injection, venous thrombosis
or phlebitis extending from the site of injection, extravasation, and
hypervolemia.
If an adverse
reaction does occur, discontinue the infusion, evaluate the patient,
institute appropriate therapeutic countermeasures and save the remainder
of the fluid for examination if deemed necessary.
DOSAGE AND ADMINISTRATION
As directed by a physician. Dosage is dependent upon the age, weight and clinical
condition of the patient as well as laboratory determinations.
Parenteral drug products should be inspected visually for particulate matter and
discoloration prior to administration whenever solution and container
permit.
All injections in
VIAFLEX plastic containers are intended for intravenous administration
using sterile equipment.
Additives may be
incompatible. Complete information is not available. Those additives
known to be incompatible should not be used. Consult with pharmacist, if
available. If, in the informed judgment of the physician, it is deemed
advisable to introduce additives, use aseptic technique. Mix thoroughly
when additives have been introduced. Do not store solutions containing
additives.
HOW SUPPLIED
The available sizes
of each injection in VIAFLEX plastic containers are shown below:
| Code |
Size (mL) |
NDC |
Product Name |
| 2B1313 |
500 |
0338-0043-03 |
0.45%
Sodium Chloride Injection, USP
|
| 2B1314 |
1000 |
0338-0043-04 |
|
| 2B1355 |
100 |
0338-1452-48 |
|
| 2B1356 |
250 |
0338-1452-02 |
|
| 2B1300 |
25
Quad
Pack |
0338-0049-10 |
0.9% Sodium
Chloride Injection, USP
|
|
50 |
|
|
| 2B1306 |
Single pack |
0338-0049-41 |
|
| 2B1301 |
Quad pack |
0338-0049-11 |
|
| 2B1308 |
Multi pack |
0338-0049-31 |
|
|
100 |
|
|
| 2B1307 |
Single pack |
0338-0049-48 |
|
| 2B1302 |
Quad pack |
0338-0049-18 |
|
| 2B1309 |
Multi pack |
0338-0049-38 |
|
| 2B1321 |
150 |
0338-0049-01 |
|
| 2B1322 |
250 |
0338-0049-02 |
|
| 2B1323 |
500 |
0338-0049-03 |
|
| 2B1324 |
1000 |
0338-0049-04 |
|
Exposure of
pharmaceutical products to heat should be minimized. Avoid excessive
heat. It is recommended the product be stored at room temperature
(25°C/77°F); brief exposure up to 40°C (104°F) does not adversely affect
the product.
DIRECTIONS FOR USE OF
VIAFLEX PLASTIC CONTAINER
WARNING
Do not use
plastic containers in series connections. Such use could result
in air embolism due to residual air being drawn from the primary
container before administration of the fluid from the secondary
container is completed.
To Open
Tear
overwrap down side at slit and remove solution container. Some
opacity of the plastic due to moisture absorption during the
sterilization process may be observed. This is normal and does
not affect the solution quality or safety. The opacity will
diminish gradually. Check for minute leaks by squeezing inner
bag firmly. If leaks are found, discard solution as sterility
may be impaired. If supplemental medication is desired, follow
directions below.
Preparation for
Administration
1. Suspend
container from eyelet support.
2. Remove
plastic protector from outlet port at bottom of container.
3. Attach
administration set. Refer to complete directions accompanying
set.
To Add Medication
WARNING
Additives
may be incompatible.
To add medication
before solution administration
1. Prepare
medication site.
2. Using
syringe with 19 to 22 gauge needle, puncture resealable
medication port and inject.
3. Mix
solution and medication thoroughly. For high density medication
such as potassium chloride, squeeze ports while ports are
upright and mix thoroughly.
To add medication
during solution administration
1. Close
clamp on the set.
2. Prepare
medication site.
3. Using
syringe with 19 to 22 gauge needle, puncture resealable
medication port and inject.
4. Remove
container from IV pole and/or turn to an upright position.
5. Evacuate
both ports by squeezing them while container is in the upright
position.
6. Mix
solution and medication thoroughly.
7. Return
container to in-use position and continue administration.
Baxter Healthcare
Corporation
Deerfield,
IL 60015 USA
Printed in
USA
07-19-49-761
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Revised: 02/2006Baxter Healthcare Corporation