GI Guide - 2021 - 112

0.9% Sodium Chloride Injection, USP
in FLEBOFLEX and FLEBOFLEX LUER Plastic Container
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 ranges from 4.5 to 7.0.
Composition, osmolarity, and ionic concentration are shown below:
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 FLEBOFLEX and FLEBOFLEX LUER plastic containers are fabricated from latex-free polyolefins or polypropylene
plastic materials. The solution contact materials do not contain PVC, DEHP, or other plasticizers. The amount
of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly.
The suitability of the container materials has been established through biological evaluations, which have
shown the containers pass Class VI U.S. Pharmacopeia (USP) testing for plastic containers. These tests confirm
the biological safety of the container systems.
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
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.
The risk of hospital-acquired hyponatremia is increased in patients with cardiac or pulmonary failure, and in
patients with non-osmotic vasopressin release (including SIADH) treated with high volume of Sodium Chloride
Injection, USP.
The risk for hyponatremia is increased in pediatric patients, elderly patients, postoperative patients, those with
psychogenic polydipsia, and in patients treated with medications that increase the risk of hyponatremia (such as
diuretics, certain antiepileptic and psychotropic medications). See Drug Interactions.
Patients at increased risk for developing complications of hyponatremia such as hyponatremic encephalopathy,
include pediatric patients, women (in particular pre-menopausal women), patients with hypoxemia, and patients
with underlying central nervous system disease. Avoid Sodium Chloride Injection, USP in patients with or at risk for
hyponatremia. If use cannot be avoided, monitor serum sodium concentrations.
Rapid correction of hyponatremia is potentially dangerous with risk of serious neurologic complications. Brain
adaptations reducing risk of cerebral edema make the brain vulnerable to injury when chronic hyponatremia is
too rapidly corrected, which is known as osmotic demyelination syndrome (ODS). To avoid complications, monitor
serum sodium and chloride concentrations, fluid status, acid-base balance, and signs of neurologic complications.
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.
Certain medications such as corticosteroids or corticotropin, may also increase risk of sodium and fluid retention,
see Drug Interactions.
Avoid Sodium Chloride Injection, USP in patients with, or at risk for, hypernatremia. If use cannot be avoided,
monitor serum sodium concentrations.
Rapid correction of hypernatremia is potentially dangerous with risk of serious neurologic complications. Excessively
rapid correction of hypernatremia is also associated with a risk for serious neurologic complications such as
osmotic demyelination syndrome (ODS) with risk of seizures and cerebral edema.
PRECAUTIONS
Patients with Severe Renal Impairment
Administration of Sodium Chloride Injection, USP in patients with or at risk of severe renal impairment, may
result in hypernatremia and/or fluid overload (see WARNINGS). 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.
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
There are no adequate and well controlled studies with Sodium Chloride Injection, USP in pregnant women and
animal reproduction studies have not been conducted with this drug. Therefore, it is not known whether Sodium
Chloride Injection, USP can cause fetal harm when administered to a pregnant woman. 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
The use of Sodium Chloride Injection, USP in pediatric patients is based on clinical practice. (See DOSAGE AND
ADMINISTRATION).
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. Therefore, 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 other drug therapy. Consider monitoring renal function in elderly patients.
ADVERSE REACTIONS
Post-Marketing Adverse Reactions
The following adverse reactions have been identified during post approval use of Sodium Chloride Injection, USP.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to
reliably estimate their frequency or establish a causal relationship to drug exposure.
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.
Nervous System Disorders: Hyponatremic encephalopathy.
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.
OVERDOSAGE
Excessive administration of 0.9% Sodium Chloride Injection, USP can cause hypernatremia. Hypernatremia can
lead to CNS manifestations, including seizures, coma, cerebral edema and death.
Excessive administration of Sodium Chloride Injection, USP can cause fluid overload (which can lead to pulmonary
and/or peripheral edema). See WARNINGS and ADVERSE REACTIONS.
When assessing an overdose, any additives in the solution must also be considered. The effects of an overdose
may require immediate medical attention and treatment.
Interventions include discontinuation of Sodium Chloride Injection, USP administration, dose reduction, and other
measures as indicated for the specific clinical constellation (e.g., monitoring of fluid balance, electrolyte concentrations
and acid base balance).
DOSAGE AND ADMINISTRATION
Important Administration Instructions
* Sodium Chloride Injection, USP is intended for intravenous administration using sterile equipment.
* Do not connect flexible plastic containers in series in order to avoid air embolism due to possible residual air
contained in the primary container.
* Set the vent to the closed position on a vented intravenous administration set to prevent air embolism.
* Use a dedicated line without any connections to avoid air embolism.
* Do not pressurize intravenous solutions contained in flexible plastic containers to increase flow rates in order to
avoid air embolism due to incomplete evacuation of residual air in the container.
* Prior to infusion, visually inspect the solution for particulate matter and discoloration. The solution should be clear
and there should be no precipitates. Do not administer unless solution is clear, and container is undamaged.
Dosing Information
The choice of product, dosage, volume, rate, and duration of administration is dependent upon the age, weight and
clinical condition of the patient and concomitant therapy, and administration should be determined by a physician
experienced in intravenous fluid therapy.
Introduction of Additives
Additives may be incompatible.
Evaluate all additions to the plastic container for compatibility and stability of the resulting preparation. Consult
with a 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. After addition, if there is a discoloration and/or the appearance
of precipitates, insoluble complexes or crystals, do not use. Do not store solutions containing additives.
Discard any unused portion.
HOW SUPPLIED
The available sizes of 0.9% Sodium Chloride Injection, USP are shown below:
Size (mL)
NDC
Fleboflex bags:
50 (115 units in one carton) 76297-001-11
100 (70 units in one carton) 76297-001-21
250 (28 units in one carton) 76297-001-31
500 (20 units in one carton) 76297-001-01
1000 (10 units in one carton) 76297-001-41
Fleboflex Luer bags:
50 (90 units in one carton) 76297-001-51
100 (50 units in one carton) 76297-001-61
250 (32 units in one carton) 76297-001-71
500 (24 units in one carton) 76297-001-81
1000 (10 units in one carton) 76297-001-91
Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the
product be stored at 20° to 25°C (68° to 77°F); excursions are permitted between 15° to 30°C (59° to 86°F).
[see USP Controlled Room Temperature.] Store unit in moisture barrier overwrap. Brief exposure up to 40°C
(104°F) does not adversely affect the product.
DIRECTIONS FOR USE OF FLEBOFLEX PLASTIC CONTAINER
For Information on Risk of Air Embolism - see DOSAGE AND ADMINISTRATION.
To Open
Peel off the overwrap and remove solution container. Visually inspect the container. If the outlet port protector is
damaged, detached, or not present, discard container as solution path sterility may be impaired. 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. Fleboflex bags: Remove plastic protector from outlet port at bottom of container.
Fleboflex Luer bags: Break the twist-off administration port by means of torsion.
3. Attach administration set. Refer to complete directions accompanying set.
To Add Medication
Additives may be incompatible.
To add medication before solution administration
1. Prepare medication site.
2. Fleboflex bags: Using syringe with 19 to 22 gauge needle, puncture resealable medication port and inject.
Fleboflex Luer bags: Using syringe or vial, connect to the needle-free medication port and inject.
3. Mix solution and medication thoroughly.
To add medication during solution administration
1. Close clamp on the set.
2. Prepare medication site.
3. Fleboflex bags: Using syringe with 19 to 22 gauge needle, puncture resealable medication port and inject.
Fleboflex Luer bags: Using syringe or vial, connect to the needle-free medication port and inject.
4. Remove container from intravenous pole and/or turn to an upright position.
5. Mix solution and medication thoroughly.
6. Return container to in-use position and continue administration.
Laboratorios Grifols, S.A.
Murcia - SPAIN
Printed in SPAIN
Rev. 08/2020
GRIFOLS and FLEBOFLEX are trademarks of Grifols, S.A.
GRIFOLS
Laboratorios Grifols, S.A. Calle Marte nº4 - Polígono Industrial Los Llanos
30565 Las Torres de Cotillas- Murcia SPAIN
112
To order, visit: www.henryschein.com/medical
21MS3390
IV
US-FBX-2100001

http://www.henryschein.com/medical

GI Guide - 2021

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