Annual Reference Guide - 2021 - 111

Your IV Solutions
0.9% Sodium Chloride Injection, USP, is a sterile, nonpyrogenic solution for fluid and
electrolyte replenishment in Fleboflex®
Fleboflex®
is a flexible container free of PVC, plasticizers, adhesives, and latex
The Fleboflex®
The Fleboflex®
container consists of a polypropylene multilayer film. Polypropylene is a highly compatible material.
It is used for the preparation of intravenous mixtures with drugs that have shown their incompatibility with other plastics
Fleboflex®
is totally collapsible, lightweight, and transparent
container meets the Class VI U.S. Pharmacopeia (USP) testing for plastic containers. These tests confirm
the biological safety of the container system
Medication and outlet ports designed with rigid and long tubes to avoid perforation due to needle insertion
High resistance to pressure cuffs responding satisfactorily to 400 mmHg pressure for 72 hours
Safe attachment of the infusion set due to its internal membrane
No parts of the cover have to be removed/broken in order to access the outlet port
Case
Description
0.9% Sodium Chloride injection, USP, 50 mL
0.9% Sodium Chloride injection, USP, 100 mL
0.9% Sodium Chloride injection, USP, 250 mL
0.9% Sodium Chloride Injection, USP, 500 mL
Packaging
115/case
70/case
28/case
20/case
0.9% Sodium Chloride injection, USP, 1000 mL 10/case
HSI Case HSI Each
Item #
Item #
(133-3120) (135-4398)
(133-3123) (135-4402)
(133-3124) (135-4408)
(131-0140) (133-4100)
(133-3143) (135-4413)
Important Safety Information
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.
Warnings
Hypersensitivity
Hypersensitivity and infusion reactions, including hypotension, pyrexia, tremor, chills, urticaria, rash, and
pruritus have been reported with 0.9% Sodium Chloride Injection, USP.
Stop the infusion immediately if signs or symptoms of a hypersensitivity reaction develop, such as
tachycardia, chest pain, dyspnea and flushing. Appropriate therapeutic countermeasures must be
instituted as clinically indicated.
Electrolyte Imbalances
Fluid Overload
Depending on the volume and rate of infusion, and the patient's underlying clinical condition, the
intravenous administration of Sodium Chloride Injection, USP can cause fluid disturbances such as
overhydration/hypervolemia and congested states, including pulmonary congestion and edema.
Avoid 0.9% Sodium Chloride Injection, USP in patients with or at risk for fluid and/or solute overloading.
If use cannot be avoided, monitor fluid balance, electrolyte concentrations, and acid base balance, as
needed and especially during prolonged use.
Hyponatremia
Sodium Chloride Injection, USP may cause hyponatremia. Hyponatremia can lead to acute hyponatremic
encephalopathy characterized by headache, nausea, seizures, lethargy, and vomiting. Patients with
brain edema are at particular risk of severe, irreversible and life-threatening brain injury. Avoid Sodium
Chloride Injection, USP in patients with or at risk for hyponatremia. If use cannot be avoided, monitor
serum sodium concentrations.
Hypernatremia
Hypernatremia may occur with Sodium Chloride Injection, USP. Conditions that may increase the risk
of hypernatremia, fluid overload and edema (central and peripheral), include patients with: primary
hyperaldosteronism; secondary hyperaldosteronism associated with, for example, hypertension,
congestive heart failure, liver disease (including cirrhosis), renal disease (including renal artery
stenosis, nephrosclerosis); and pre-eclampsia. Avoid Sodium Chloride Injection, USP in patients with,
or at risk for, hypernatremia. If use cannot be avoided, monitor serum sodium concentrations.
Precautions
Patients with Severe Renal Implant
Administration of Sodium Chloride Injection, USP in patients with or at risk of severe renal impairment,
may result in hypernatremia and/or fluid overload. Avoid Sodium Chloride Injection, USP in patients
with severe renal impairment or conditions that may cause sodium and/or potassium retention, fluid
overload, or edema. If use cannot be avoided, monitor patients with severe renal impairment for
development of these adverse reactions.
Transparent overwrap to
allow visual inspection with
peelable opening system.
plastic container for intravenous administration.
Drug Interactions
Other Products that Affect Fluid and/or Electrolyte Balance
Administration of Sodium Chloride Injection, USP to patients treated concomitantly with drugs
associated with sodium and fluid retention may increase the risk of hypernatremia and volume
overload. Avoid use of Sodium Chloride Injection, USP in patients receiving such products, such as
corticosteroids or corticotropin. If use cannot be avoided, monitor serum electrolytes, fluid balance
and acid-base balance.
Lithium
Renal sodium and lithium clearance may be increased during administration of 0.9% Sodium Chloride
Injection, USP. Monitor serum lithium concentrations during concomitant use.
Other Drugs that Increase the Risk of Hyponatremia
Administration of Sodium Chloride Injection, USP in patients treated concomitantly with medications
associated with hyponatremia may increase the risk of developing hyponatremia.
Avoid use of Sodium Chloride Injection, USP in patients receiving products, such as diuretics, and
certain antiepileptic and psychotropic medications. Drugs that increase the vasopressin effect reduce
renal electrolyte free water excretion and may also increase the risk of hyponatremia following
treatment with intravenous fluids. If use cannot be avoided, monitor serum sodium concentrations.
Pregnancy
Sodium Chloride Injection, USP should be given during pregnancy only if the potential benefit justifies
the potential risk to the fetus.
Lactation
It is not known whether this drug is present in human milk. Because many drugs are present in human
milk, caution should be exercised when Sodium Chloride Injection, USP is administered to a nursing
woman.
Pediatric Use
Closely monitor plasma electrolyte concentrations in pediatric patients who may have impaired ability
to regulate fluids and electrolytes. In very low birth weight infants, excessive or rapid administration
of Sodium Chloride Injection, USP may result in increased serum osmolality and risk of intracerebral
hemorrhage.
Children (including neonates and older children) are at increased risk of developing hyponatremia as
well as for developing hyponatremic encephalopathy.
Geriatric Use
Geriatric patients are at increased risk of developing electrolyte imbalances. Sodium Chloride Injection,
USP 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.
Adverse Reactions
The following adverse reactions have been reported in the post-marketing experience during use of
0.9% Sodium Chloride Injection, USP and include the following:
General disorders and administration site conditions (Infusion site erythema, injection site streaking,
burning sensation, and infusion site urticaria), Hypersensitvity reactions: (Hypotension, pyrexia, tremor,
chills, urticaria, rash, and pruritus), Metabolism and nutrition disorders (Hypernatremia, hyponatremia,
hyperchloremic metabolic acidosis) and Nervous System Disorders (Hyponatremic encephalopathy).
21MS3390
To order, visit: www.henryschein.com/medical
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Annual Reference Guide - 2021

Table of Contents for the Digital Edition of Annual Reference Guide - 2021