POTASSIUM CHLORIDE IN SODIUM CHLORIDE- potassium chloride and sodium chloride injection, solution

United States - English - NLM (National Library of Medicine)

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Active ingredient:
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698), POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152, CHLORIDE ION - UNII:Q32ZN48698)
Available from:
Baxter Healthcare Corporation
INN (International Name):
SODIUM CHLORIDE
Composition:
SODIUM CHLORIDE 900 mg in 100 mL
Administration route:
INTRAVENOUS
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
Potassium Chloride in Sodium Chloride Injection, USP is indicated as a source of water and electrolytes. Potassium Chloride in Sodium Chloride Injection, USP is contraindicated in patients with:
Product summary:
Potassium Chloride in Sodium Chloride Injection, USP in VIAFLEX Plus Plastic Container is available as follows: Code Size (mL) NDC Product Name 2B1357 1000 0338-0704-34 20 mEq/L Potassium Chloride in 0.45% Sodium Chloride Injection, USP 2B1764 1000 0338-0691-04 20 mEq/L Potassium Chloride in 0.9% Sodium Chloride Injection, USP 2B1984 1000 0338-0695-04 40 mEq/L Potassium Chloride in 0.9% Sodium Chloride Injection, USP Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored between 20ºC to 25°C (68º F to 77°F). [See USP controlled room temperature.]; brief exposure up to 40° C (104° F) does not adversely affect the product.
Authorization status:
New Drug Application
Authorization number:
0338-0691-04, 0338-0695-04, 0338-0704-34

POTASSIUM CHLORIDE IN SODIUM CHLORIDE- potassium chloride and sodium

chloride injection, solution

Baxter Healthcare Corporation

----------

Potassium Chloride in Sodium Chloride Injection, USP

in Plastic Container

VIAFLEX Plus Container

DESCRIPTION

Potassium Chloride in Sodium Chloride Injection, USP is a sterile, nonpyrogenic, solution for fluid and

electrolyte replenishment in a single dose container for intravenous administration. It contains no

antimicrobial agents. Composition, osmolarity, pH and ionic concentration are shown in Table 1.

Table 1

Size

(mL)

Composition (g/L)

Osmolarity

(mOsmol/L)

(Calc.)

Ionic Concentration (mEq/L)

Sodium

Chloride,

(NaCl)

Potassium

Chloride,

(KCl)

SodiumPotas s ium Chloride

20 mEq/L

Potassium

Chloride

0.45%

Sodium

Chloride

Injection,

1000

(3.5

6.5)

20

20 mEq/L

Potassium

Chloride

0.9%

Sodium

Chloride

Injection,

1000

(3.5

6.5)

20

40 mEq/L

Potassium

Chloride

0.9%

Sodium

Chloride

Injection,

1000

(3.5

6.5)

40

Normal physiologic osmolarity range is approximately 280 to 310 mOsmol/L.

Administration of substantially hypertonic solutions (≥ 600 mOsmol/L) may cause vein

damage.

The VIAFLEX Plus plastic container is fabricated from a specially formulated polyvinyl chloride (PL

146 Plastic). VIAFLEX Plus on the container indicates the presence of a drug additive in a drug

vehicle. The VIAFLEX Plus plastic container system utilizes the same container as the VIAFLEX

plastic container system. 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

Potassium Chloride in 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

Potassium Chloride in Sodium Chloride Injection, USP is indicated as a source of water and

electrolytes.

CONTRAINDICATIONS

Potassium Chloride in Sodium Chloride Injection, USP is contraindicated in patients with:

WARNINGS

Hypers ens itivity

Hypersensitivity and infusion reactions, including anaphylaxis and chills, have been reported with

products containing potassium chloride and sodium chloride. Stop the infusion immediately if signs or

symptoms of a hypersensitivity or infusion reaction develops. Appropriate therapeutic countermeasures

must be instituted as clinically indicated.

Electrolyte Imbalances

Hyperkalemia

Potassium-containing solutions, including Potassium Chloride in Sodium Chloride Injection, USP may

increase the risk of hyperkalemia. Hyperkalemia can be asymptomatic and manifest only by increased

serum potassium concentrations and/or characteristic electrocardiographic (ECG) changes. Cardiac

conduction disorders (including complete heart block) and other cardiac arrhythmias, some fatal, can

develop at any time during hyperkalemia. Continuous electrocardiogram (ECG) monitoring may be

necessary to aid in the detection of cardiac arrhythmias due to hyperkalemia (see ADVERSE

REACTIONS).

To avoid life threatening hyperkalemia, do not administer Potassium Chloride in Sodium Chloride

Injection, USP as an intravenous push (i.e., intravenous injection manually with a syringe connected to

the intravenous access) without a quantitative infusion device.

Patients at increased risk of developing hyperkalemia and cardiac arrhythmias include those:

Known hypersensitivity to potassium chloride and/or sodium chloride (see WARNINGS).

Clinically significant hyperkalemia (see WARNINGS).

with conditions predisposing to hyperkalemia and/or associated with increased sensitivity to

Avoid use of Potassium Chloride in Sodium Chloride Injection, USP in patients with, or at risk for,

hyperkalemia. If use cannot be avoided, use a product with a low amount of potassium chloride, infuse

slowly and monitor serum potassium concentrations and ECGs.

Hypernatremia and Hyperchloremia

Electrolyte imbalances such as hypernatremia, hyperchloremia, and metabolic acidosis may occur with

Potassium Chloride in 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 Potassium Chloride in Sodium Chloride Injection, USP in patients with, or at risk for,

hypernatremia or hyperchloremia. If use cannot be avoided, monitor serum sodium and chloride

concentrations and acid-base balance.

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.

Hyponatremia

Potassium Chloride in 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

hypotonic Potassium Chloride in 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, premenopausal women), patients with

hypoxemia, and patients with underlying central nervous system disease. Avoid Potassium Chloride in

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

potassium, such as patients with severe renal impairment, acute dehydration, extensive tissue injury

or burns, certain cardiac disorders such as congestive heart failure or atrioventricular (AV) block

(especially if they receive digoxin).

who are at risk of experiencing hyperosmolality, acidosis, or undergoing correction of alkalosis

(conditions associated with a shift of potassium from intracellular to extracellular space).

treated concurrently or recently with agents or products that can cause or increase the risk of

hyperkalemia (see DRUG INTERACTIONS).

with cardiac arrhythmias.

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.

Fluid Overload

Depending on the volume and rate of infusion, and the patient’s underlying clinical condition, the

intravenous administration of Potassium Chloride in Sodium Chloride Injection, USP can cause

electrolyte disturbances such as overhydration/hypervolemia and congested states including central

(e.g., pulmonary edema) and peripheral edema.

Avoid Potassium Chloride in 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.

PRECAUTIONS

Patients with Severe Renal Impairment

Administration of sodium and potassium in patients with or at risk of severe renal impairment, may result

in hypernatremia, hyperkalemia and/or fluid overload (see WARNINGS). Avoid Potassium Chloride in

Sodium Chloride Injection, USP in patients with severe renal impairment. If use cannot be avoided,

monitor patients with severe renal impairment for development of these adverse reactions.

Drug Interactions

Lithium

Renal sodium and lithium clearance may be increased during administration of Potassium Chloride

in Sodium Chloride Injection, USP and result in decreased lithium concentrations. Monitor serum

lithium concentrations during concomitant use.

Other Products that Cause Hyperkalemia

Administration of Potassium Chloride in Sodium Chloride Injection, USP in patients treated

concurrently or recently with products that are associated with hyperkalemia increases the risk of

severe and potentially fatal hyperkalemia, in particular in the presence of other risk factors for

hyperkalemia. Avoid use of Potassium Chloride in Sodium Chloride Injection, USP in patients

receiving such products (e.g., potassium sparing diuretics, angiotensin-converting enzyme

inhibitors, angiotensin receptor blockers, or the immunosuppressants cyclosporine and

tacrolimus). If use cannot be avoided, monitor serum potassium concentrations.

Other Products that Affect Fluid and/or Electrolyte Balance

Administration of Potassium Chloride in Sodium Chloride Injection, USP in patients treated

concomitantly with medications associated with sodium and fluid retention may increase the risk of

hypernatremia and volume overload. Avoid use of Potassium Chloride in 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.

Other Drugs that Increase the Risk of Hyponatremia

Administration of Potassium Chloride in Sodium Chloride Injection, USP in patients treated

concomitantly with medications associated with hyponatremia may increase the risk of developing

hyponatremia.

Avoid use of Potassium Chloride in 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 from the use of Potassium Chloride in Sodium

Chloride Injection, USP in pregnant or lactating women and animal reproduction studies have not been

conducted with this drug. Therefore, it is also not known whether Potassium Chloride in Sodium

Chloride Injection, USP can cause fetal harm when administered to a pregnant woman or can affect

reproduction capacity. Potassium Chloride in Sodium Chloride Injection, USP should be given to a

pregnant woman only if the potential benefit justifies the potential risk to the fetus.

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 Potassium Chloride in Sodium Chloride Injection, USP is

administered to a nursing mother.

Pediatric Use

Pediatric patients are at increased risk of developing hyponatremia as well as for developing

encephalopathy as a complication of hyponatremia (see WARNINGS).

Geriatric Use

Geriatric patients are at increased risk of developing electrolyte imbalances. Potassium Chloride in

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

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.

The use of Potassium Chloride in Sodium Chloride Injection, USP in pediatric patients is based on

clinical practice. (See DOSAGE AND ADMINISTRATION). Safety and effectiveness of

Potassium Chloride in Sodium Chloride Injection, USP in pediatric patients have not been

established by adequate and well-controlled studies.

The following adverse reactions associated with the use of Potassium Chloride in Sodium

Chloride Injection, USP were identified in clinical trials or postmarketing reports. Because

postmarketing reactions were reported voluntarily from a population of uncertain size, it is not

always possible to estimate their frequency, reliably, or to establish a causal relationship to drug

exposure.

General disorders and administration site conditions: Chills, and infusion site pain.

Hypersensitivity reactions: generalized papules and erythema, rash, fever, vomiting, hypertension,

tachycardia.

Metabolism and nutrition disorders: Hyperkalemia, hyponatremia, hypernatremia, hyperchloremia

acidosis, fluid overload.

Cardiac disorders: Cardiac arrest as a manifestation of rapid intravenous administration and/or of

hyperkalemia.

Nervous System Disorders: Hyponatremic encephalopathy.

OVERDOSAGE

An increased infusion rate of Potassium Chloride in Sodium Chloride Injection, USP can cause:

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

Potassium Chloride in 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

hyperkalemia, manifestations may include disturbances in cardiac conduction and arrhythmias,

including bradycardia, heart block, asystole, ventricular tachycardia, ventricular fibrillation.

The presence of any ECG findings that are suspected to be caused by hyperkalemia should be

considered a medical emergency.

If hyperkalemia is present or suspected, discontinue the infusion immediately and institute close

ECG, laboratory and other monitoring and, as necessary, corrective therapy to reduce serum

potassium concentrations.

Muscle weakness (up to and including muscular and respiratory paralysis, paresthesia of

extremities) may occur as a complication of hyperkalemia.

hyponatremia, manifestations may include seizures, coma, cerebral edema and death).

hypernatremia, especially in patients with severe renal impairment.

hypotension.

gastrointestinal symptoms (ileus, nausea, vomiting, abdominal pain).

fluid overload (which can lead to central and/or peripheral edema). See WARNINGS and

ADVERSE REACTIONS.

Important Administration Instructions

Potassium Chloride in Sodium Chloride Injection, USP is intended for intravenous infusion using

sterile equipment.

To avoid life threatening hyperkalemia, do not administer Potassium Chloride in Sodium Chloride

Injection, USP as an intravenous push (i.e., intravenous injection manually with a syringe connected

to the intravenous access) without a quantitative infusion device (see WARNINGS).

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.

The choice of a central or peripheral venous route of infusion should depend on the osmolarity of

the final infusate. Solutions with osmolarity of greater than or equal to approximately 900

mOsm/L must be infused through a central catheter.

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.

Use of final filter is recommended during administration of all parenteral solutions, where

possible.

Dosing Information

HOW SUPPLIED

Potassium Chloride in Sodium Chloride Injection, USP in VIAFLEX Plus Plastic Container is available

as follows:

Code

Size

(mL)

NDC

Product Name

2B1357

1000

0338-0704-34

20 mEq/L Potassium

Chloride in 0.45% Sodium

Chloride Injection, USP

2B1764

1000

0338-0691-04

20 mEq/L Potassium

Chloride in 0.9% Sodium

Chloride Injection, USP

2B1984

1000

0338-0695-04

40 mEq/L Potassium

Chloride in 0.9% Sodium

Chloride Injection, USP

Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is

recommended the product be stored between 20ºC to 25°C (68º F to 77°F). [See USP controlled room

temperature.]; brief exposure up to 40° C (104° F) does not adversely affect the product.

DIRECTIONS FOR USE OF VIAFLEX PLUS PLASTIC CONTAINER

For information on risk of air embolism – see PRECAUTIONS.

To Open

Tear overwrap down side at slit 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.

The choice of the specific potassium chloride and sodium chloride formulation, dosage, volume,

rate and duration of administration is dependent upon the age, weight and clinical and metabolic

condition of the patient and concomitant therapy, and administration should be determined by a

physician experienced in intravenous fluid therapy.

Additional electrolyte supplementation may be indicated according to the clinical needs of the

patient. Additives can be introduced to the container; however, some 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. After addition, if there is a discoloration and/or the appearance of precipitates,

insoluble complexes or crystals, do not use. Mix thoroughly when additives have been

introduced. Do not store solutions containing additives. Discard any unused portion.

Rapid correction of hyponatremia and hypernatremia is potentially dangerous (risk of serious

neurologic complications). To avoid complications such as osmotic demyelination syndrome

(ODS) during administration, follow the important administration instructions, monitor serum

sodium and chloride concentrations, fluid status, acid-base balance, and signs of neurologic

complications.

Preparation for Administration

To Add Medication

Warning: Additives may be incompatible.

To add medication before solution administration

To add medication during solution administration

Baxter Healthcare Corporation

Deerfield, IL 60015 USA

Printed in USA

07-19-78-210

Rev. January 2019

Baxter, and Viaflex are trademarks of Baxter International Inc.

For Product Information

1-800-933-0303

PACKAGE LABELING - PRINCIPLE DISPLAY PANEL

Suspend container from eyelet support.

Remove plastic protector from outlet port at bottom of container.

Attach administration set. Refer to complete directions accompanying set.

Prepare medication site.

Using syringe with 19 to 22 gauge needle, puncture resealable medication port and inject.

Mix solution and medication thoroughly. For high density medication such as potassium chloride,

squeeze ports while ports are upright and mix thoroughly.

Close clamp on the set.

Prepare medication site.

Using syringe with 19 to 22 gauge needle, puncture resealable medication port and inject.

Remove container from IV pole and/or turn to an upright position.

Evacuate both ports by squeezing them while container is in the upright position.

Mix solution and medication thoroughly.

Return container to in use position and continue administration.

Container Label

Container Label

LOT EXP

2B1357

NDC 0338-0704-34

20 mEq

Potassium Chloride

(20 mEq/L)

Potassium Chloride in

0.45% Sodium Chloride Injection USP

1000 mL

EACH 100 mL CONTAINS 450 mg SODIUM CHLORIDE USP

150 mg POTASSIUM CHLORIDE USP pH 5.5 (3.5 TO 6.5)

mEq/L SODIUM 77 POTASSIUM 20 CHLORIDE 97

OSMOLARITY 194 mOsmol/L (CALC) HYPOTONIC STERILE

NONPYROGENIC SINGLE DOSE CONTAINER ADDITIVES MAY BE

INCOMPATIBLE CONSULT WITH PHARMACIST IF AVAILABLE WHEN

INTRODUCING ADDITIVES USE ASEPTIC TECHNIQUE MIX

THOROUGHLY DO NOT STORE USUAL DOSAGE INTRAVENOUSLY

AS DIRECTED BY A PHYSICIAN SEE DIRECTIONS CAUTIONS

SQUEEZE AND INSPECT INNER BAG WHICH MAINTAINS PRODUCT

STERILITY DISCARD IF LEAKS ARE FOUND MUST NOT BE USED

IN SERIES CONNECTIONS DO NOT USE UNLESS SOLUTION IS

CLEAR RX ONLY STORE UNIT IN MOISTURE BARRIER OVERWRAP

AT ROOM TEMPERATURE (25°C/77°F) UNTIL READY TO USE

AVOID EXCESSIVE HEAT SEE INSERT

VIAFLEX PLUS CONTAINER PL 146 PLASTIC

BAXTER VIAFLEX AND PL 146 ARE TRADEMARKS OF

BAXTER INTERNATIONAL INC

Baxter

BAXTER HEALTHCARE CORPORATION

DEERFIELD IL 60015 USA

MADE IN USA

FOR PRODUCT INFORMATION

1-800-933-0303

Carton Label

2B-13-57X 14-1000 ML

VIAFLEX PLUS CONTAINER

20 mEq POTASSIUM CHLORIDE IN

0.45% SODIUM CHLORIDE INJ

XXXXX

SECONDARY BAR CODE

(17) YYMM00 (10) XXXXX

XXXXX

PRIMARY BAR CODE

(01) 50303380704342

Container Label

LOT EXP

2B1764

NDC 0338-0691-04

DIN 00786209

1000 mL

EACH 100 mL CONTAINS 900 mg SODIUM CHLORIDE USP

150 mg POTASSIUM CHLORIDE USP pH 5.5 (3.5 TO 6.5)

mEq/L SODIUM 154 POTASSIUM 20 CHLORIDE 174

OSMOLARITY 348 mOsmol/L (CALC) STERILE

NONPYROGENIC SINGLE DOSE CONTAINER ADDITIVES MAY BE

INCOMPATIBLE CONSULT WITH PHARMACIST IF AVAILABLE

WHEN INTRODUCING ADDITIVES USE ASEPTIC TECHNIQUE MIX

THOROUGHLY DO NOT STORE DOSAGE INTRAVENOUSLY AS

DIRECTED BY A PHYSICIAN SEE DIRECTIONS CAUTIONS

SQUEEZE AND INSPECT INNER BAG WHICH MAINTAINS PRODUCT

STERILITY DISCARD IF LEAKS ARE FOUND MUST NOT BE USED

IN SERIES CONNECTIONS DO NOT USE UNLESS SOLUTION IS

CLEAR RX ONLY STORE UNIT IN MOISTURE BARRIER

OVERWRAP AT ROOM TEMPERATURE (25°C/77°F) UNTIL READY

TO USE AVOID EXCESSIVE HEAT SEE INSERT

VIAFLEX PLUS CONTAINER PL 146 PLASTIC

BAXTER VIAFLEX AND PL 146 ARE TRADEMARKS OF

BAXTER INTERNATIONAL INC

FOR PRODUCT INFORMATION 1-800-933-0303

Baxter

BAXTER HEALTHCARE CORPORATION

DEERFIELD IL 60015 USA

MADE IN USA

DISTRIBUTED IN CANADA BY

BAXTER CORPORATION

TORONTO ONTARIO CANADA

Carton Label

2B1764X 14-1000 ML

VIAFLEX ® PLUS CONTAINER

20 MEQ POTASSIUM CHLORIDE IN

0.9% SODIUM CHLORIDE INJ

XXXXX

SECONDARY BAR CODE

(17) XXXXX (10) XXXXX

XXXXX

PRIMARY BAR CODE

(01) 50303380691048

Container Label

LOT EXP

2B1984

NDC 0338-0695-04

DIN 00786217

1000 mL

EACH 100 mL CONTAINS 900 mg SODIUM CHLORIDE USP

300 mg POTASSIUM CHLORIDE USP pH 5.5 (3.5 TO 6.5)

mEq/L SODIUM 154 POTASSIUM 40 CHLORIDE 194

OSMOLARITY 388 mOsmol/L (CALC) STERILE

NONPYROGENIC SINGLE DOSE CONTAINER ADDITIVES MAY BE

INCOMPATIBLE CONSULT WITH PHARMACIST IF AVAILABLE

WHEN INTRODUCING ADDITIVES USE ASEPTIC TECHNIQUE MIX

THOROUGHLY DO NOT STORE DOSAGE INTRAVENOUSLY AS

DIRECTED BY A PHYSICIAN SEE DIRECTIONS CAUTIONS

SQUEEZE AND INSPECT INNER BAG WHICH MAINTAINS PRODUCT

STERILITY DISCARD IF LEAKS ARE FOUND MUST NOT BE USED

IN SERIES CONNECTIONS DO NOT USE UNLESS SOLUTION IS

CLEAR RX ONLY STORE UNIT IN MOISTURE BARRIER

OVERWRAP AT ROOM TEMPERATURE (25°C/77°F) UNTIL READY

TO USE AVOID EXCESSIVE HEAT SEE INSERT

VIAFLEX PLUS CONTAINER PL 146 PLASTIC

BAXTER VIAFLEX AND PL 146 ARE TRADEMARKS OF

BAXTER INTERNATIONAL INC

FOR PRODUCT INFORMATION 1-800-933-0303

Baxter

BAXTER HEALTHCARE CORPORATION

DEERFIELD IL 60015 USA

MADE IN USA

DISTRIBUTED IN CANADA BY

BAXTER CORPORATION

TORONTO ONTARIO CANADA

Carton Label

2B-19-84X 14-1000 ML

VIAFLEX ® PLUS CONTAINER

40 mEq POTASSIUM CHLORIDE IN

0.9% SODIUM CHLORIDE INJ

XXXXX

SECONDARY BAR CODE

(17) YYMM00 (10) XXXXX

XXXXX

PRIMARY BAR CODE

(01) 50303380695046

POTASSIUM CHLORIDE IN SODIUM CHLORIDE

potassium chloride and sodium chloride injection, solution

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:0 338 -0 6 9 5

Route of Administration

INTRAVENOUS

Active Ingredient/Active Moiety

Ingredient Name

Basis of

Stre ng th

Stre ng th

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X) (SODIUM CATION - UNII:LYR4M0 NH37, CHLORIDE

ION - UNII:Q32ZN48 6 9 8 )

SODIUM

CHLORIDE

9 0 0 mg

in 10 0 mL

PO TASSIUM CHLO RIDE (UNII: 6 6 0 YQ9 8 I10 ) (POTASSIUM CATION - UNII:29 5O53K152,

CHLORIDE ION - UNII:Q32ZN48 6 9 8 )

POTASSIUM

CHLORIDE

30 0 mg

in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 338 -0 6 9 5-0 4

14 in 1 CARTON

0 2/0 2/19 79

1

10 0 0 mL in 1 BAG; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

NDA0 176 48

0 2/0 2/19 79

POTASSIUM CHLORIDE IN SODIUM CHLORIDE

POTASSIUM CHLORIDE IN SODIUM CHLORIDE

potassium chloride and sodium chloride injection, solution

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:0 338 -0 6 9 1

Route of Administration

INTRAVENOUS

Active Ingredient/Active Moiety

Ingredient Name

Basis of

Stre ng th

Stre ng th

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X) (SODIUM CATION - UNII:LYR4M0 NH37, CHLORIDE

ION - UNII:Q32ZN48 6 9 8 )

SODIUM

CHLORIDE

9 0 0 mg

in 10 0 mL

PO TASSIUM CHLO RIDE (UNII: 6 6 0 YQ9 8 I10 ) (POTASSIUM CATION - UNII:29 5O53K152,

CHLORIDE ION - UNII:Q32ZN48 6 9 8 )

POTASSIUM

CHLORIDE

150 mg

in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 338 -0 6 9 1-0 4

14 in 1 CARTON

0 2/0 2/19 79

1

10 0 0 mL in 1 BAG; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

NDA0 176 48

0 2/0 2/19 79

POTASSIUM CHLORIDE IN SODIUM CHLORIDE

potassium chloride and sodium chloride injection, solution

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:0 338 -0 70 4

Route of Administration

INTRAVENOUS

Active Ingredient/Active Moiety

Ingredient Name

Basis of

Stre ng th

Stre ng th

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X) (SODIUM CATION - UNII:LYR4M0 NH37, CHLORIDE

ION - UNII:Q32ZN48 6 9 8 )

SODIUM

CHLORIDE

450 mg

in 10 0 mL

PO TASSIUM CHLO RIDE (UNII: 6 6 0 YQ9 8 I10 ) (POTASSIUM CATION - UNII:29 5O53K152,

CHLORIDE ION - UNII:Q32ZN48 6 9 8 )

POTASSIUM

CHLORIDE

150 mg

in 10 0 mL

Baxter Healthcare Corporation

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 338 -0 70 4-34

14 in 1 CARTON

0 2/0 2/19 79

1

10 0 0 mL in 1 BAG; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

NDA0 176 48

0 2/0 2/19 79

Labeler -

Baxter Healthcare Corporation (005083209)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Ba xte r

He a lthc a re

Co rpo ra tio n

0 59 140 76 4

MANUFACTURE(0 338 -0 6 9 5, 0 338 -0 6 9 1, 0 338 -0 70 4) , ANALYSIS(0 338 -0 6 9 5, 0 338 -0 6 9 1,

0 338 -0 70 4) , LABEL(0 338 -0 6 9 5, 0 338 -0 6 9 1, 0 338 -0 70 4) , PACK(0 338 -0 6 9 5, 0 338 -0 6 9 1, 0 338 -

0 70 4) , STERILIZE(0 338 -0 6 9 5, 0 338 -0 6 9 1, 0 338 -0 70 4)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Baxter Healthcare Co rpo ratio n

19 46 8 450 2

ANALYSIS(0 338 -0 6 9 5, 0 338 -0 6 9 1, 0 338 -0 70 4)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Ba xte r

He a lthc a re

Co rpo ra tio n

18 9 326 16 8

ANALYSIS(0 338 -0 6 9 5, 0 338 -0 6 9 1, 0 338 -0 70 4) , LABEL(0 338 -0 6 9 5, 0 338 -0 6 9 1, 0 338 -0 70 4) ,

MANUFACTURE(0 338 -0 6 9 5, 0 338 -0 6 9 1, 0 338 -0 70 4) , PACK(0 338 -0 6 9 5, 0 338 -0 6 9 1, 0 338 -

0 70 4) , STERILIZE(0 338 -0 6 9 5, 0 338 -0 6 9 1, 0 338 -0 70 4)

Revised: 1/2019

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