FDA Label for Potassium Chloride In Dextrose And Sodium Chloride

View Indications, Usage & Precautions

Potassium Chloride In Dextrose And Sodium Chloride Product Label

The following document was submitted to the FDA by the labeler of this product Baxter Healthcare Corporation. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Description



Potassium Chloride in 5% Dextrose and Sodium Chloride Injection, USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment and caloric supply in a single dose container for intravenous administration. It contains no antimicrobial agents. Composition, osmolarity, pH, ionic concentration and caloric content are shown in Table 1.

Table 1

Size (mL)

Composition (g/L)

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

Osmolarity (mOsmol/L)
(calc.)

pH

Ionic Concentration
(mEq/L)

Caloric Content (kCal/L)

**Dextrose Hydrous, USP

Sodium Chloride, USP (NaCl)

Potassium Chloride, USP (KCl)

Sodium

Potassium

Chloride

Potassium Chloride in 5% Dextrose and 0.2% Sodium Chloride Injection, USP

mEq Potassium

20 mEq
10 mEq

1000
500

50

2

1.5

361

4.5
(3.5 to 6.5)

34

20

54

170

40 mEq

1000

50

2

3

401

4.5
(3.5 to 6.5)

34

40

74

170

Potassium Chloride in 5% Dextrose and 0.33% Sodium Chloride Injection, USP

mEq Potassium

20 mEq
10 mEq

1000
500

50

3.3

1.5

405

4.5
(3.5 to 6.5)

56

20

76

170

Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP

mEq Potassium

10 mEq

1000

50

4.5

0.75

426

4.5
(3.5 to 6.5)

77

10

87

170

20 mEq
10 mEq

1000
500

50

4.5

1.5

447

4.5
(3.5 to 6.5)

77

20

97

170

30 mEq

1000

50

4.5

2.24

466

4.5
(3.5 to 6.5)

77

30

107

170

40 mEq

1000

50

4.5

3

487

4.5
(3.5 to 6.5)

77

40

117

170

Potassium Chloride in 5% Dextrose and 0.9% Sodium Chloride Injection, USP

mEq Potassium

20 mEq

1000

50

9

1.5

601

4.5
(3.5 to 6.5)

154

20

174

170

40 mEq

1000

50

9

3

641

4.5
(3.5 to 6.5)

154

40

194

170

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 5% Dextrose and Sodium Chloride Injection, USP has value as a source of water, electrolytes and calories. It is capable of inducing diuresis depending on the clinical condition of the patient.


Indications And Usage



Potassium Chloride in 5% Dextrose and Sodium Chloride Injection, USP is indicated as a source of water, electrolytes and calories.


Contraindications



Solutions containing dextrose may be contraindicated in patients with known allergy to corn or corn products.


Warnings



Potassium Chloride in 5% Dextrose and 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. Potassium Chloride in 5% Dextrose and Sodium Chloride Injection, USP should be used with great care, if at all, in patients with hyperkalemia, severe renal failure, and in conditions in which potassium retention is present.

Injections containing carbohydrates with low electrolyte concentration should not be administered simultaneously with blood through the same administration set because of the possibility of pseudoagglutination or hemolysis. The container label for these injections bears the statement: Do not administer simultaneously with blood.

The intravenous administration of Potassium Chloride in 5% Dextrose and 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 dilutional states is inversely proportional to the electrolyte concentrations of the injection. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of the injection.

In patients with diminished renal function, administration of Potassium Chloride in 5% Dextrose and Sodium Chloride Injection, USP may result in sodium or potassium retention.

In very low birth weight infants, excessive or rapid administration of dextrose injection may result in increased serum osmolality and possible intracerebral hemorrhage.

Potassium salts should never be administered by IV push.


Precautions



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.

Pressurizing intravenous solutions contained in flexible plastic containers to increase flow rates can result in air embolism if the residual air in the container is not fully evacuated prior to administration.

Use of a vented intravenous administration set with the vent in the open position could result in air embolism. Vented intravenous administration sets with the vent in the open position should not be used with flexible plastic containers.

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 Potassium Chloride in 5% Dextrose and Sodium Chloride Injection, USP to patients receiving corticosteroids or corticotropin.

Potassium Chloride in 5% Dextrose and Sodium Chloride Injection, USP should be used with caution in patients with overt or subclinical diabetes mellitus.

The osmolarity of Potassium Chloride in 5% Dextrose and Sodium Chloride Injection, USP ranges from 341 to 641 mOsmol/L (calc). Administration of hypertonic solutions may cause venous irritation, including phlebitis. Hyperosmolar solutions should be administered with caution, if at all, to patients with hyperosmolar states.


Carcinogenesis, Mutagenesis, Impairment Of Fertility



Studies with Potassium Chloride in 5% Dextrose and Sodium Chloride Injection, USP 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 Potassium Chloride in 5% Dextrose and Sodium Chloride Injection, USP. It is also not known whether Potassium Chloride in 5% Dextrose and Sodium Chloride Injection, USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Potassium Chloride in 5% Dextrose and 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 Potassium Chloride in 5% Dextrose and Sodium Chloride Injection, USP is administered to a nursing mother.

For patients receiving potassium supplement at greater than maintenance rates, frequent monitoring of serum potassium levels and serial EKGs are recommended.

Do not administer unless solution is clear and seal is intact.


Pediatric Use



The use of Potassium Chloride in 5% Dextrose and Sodium Chloride Injection, USP in pediatric patients is based on clinical practice. Newborns – especially those born premature and with low birth weight - are at increased risk of developing hypo- or hyperglycemia and therefore need close monitoring during treatment with intravenous glucose solutions to ensure adequate glycemic control in order to avoid potential long term adverse effects. Hypoglycemia in the newborn can cause prolonged seizures, coma and brain damage. Hyperglycemia has been associated with intraventricular hemorrhage, late onset bacterial and fungal infection, retinopathy of prematurity, necrotizing enterocolitis, bronchopulmonary dysplasia, prolonged length of hospital stay, and death.

Plasma electrolyte concentrations should be closely monitored in the pediatric population as this population may have impaired ability to regulate fluids and electrolytes.

The infusion of hypotonic fluids together with the non-osmotic secretion of ADH may result in hyponatremia in patients with acute volume depletion. Hyponatremia can lead to headache, nausea, seizures, lethargy, coma, cerebral edema and death, therefore acute symptomatic hyponatremic encephalopathy is considered a medical emergency (applies to solutions containing less than 0.9% Sodium Chloride Injection).


Geriatric Use



Clinical studies of Potassium Chloride in 5% Dextrose and 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 other drug therapy.


Adverse Reactions



- Hypersensitivity reactions, including anaphylaxis and chills

- Hyponatremia (applies to solutions containing less than 0.9% Sodium Chloride)

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

All injections in VIAFLEX Plus plastic containers are intended for intravenous administration using sterile equipment.

The dosage selection and constant infusion rate of intravenous dextrose must be selected with caution in pediatric patients, particularly neonates and low birth weight infants, because of the increased risk of hyperglycemia/hypoglycemia. Frequent monitoring of serum glucose concentrations is required when dextrose is prescribed to pediatric patients, particularly neonates and low birth weight infants. The infusion rate and volume depends on the age, weight, clinical and metabolic conditions of the patient, concomitant therapy and should be determined by the consulting physician experienced in pediatric intravenous fluid therapy.

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



Potassium Chloride in 5% Dextrose and Sodium Chloride Injection, USP in VIAFLEX Plus plastic container is available as follows:

Code

Size (mL)

NDC

Product Name

2B1614
2B1613

1000
500

0338-0663-04
0338-0663-03

20 mEq/L Potassium Chloride in 5% Dextrose and
0.2% Sodium Chloride Injection, USP

2B1473

500

0338-0603-03

20 mEq/L Potassium Chloride in 5% Dextrose and
0.33% Sodium Chloride Injection, USP

2B1644

1000

0338-0669-04

10 mEq/L Potassium Chloride in 5% Dextrose and
0.45% Sodium Chloride Injection, USP

2B1654
2B1653

1000
500

0338-0671-04
0338-0671-03

20 mEq/L Potassium Chloride in 5% Dextrose and
0.45% Sodium Chloride Injection, USP

2B1664

1000

0338-0673-04

30 mEq/L Potassium Chloride in 5% Dextrose and
0.45% Sodium Chloride Injection, USP

2B1674

1000

0338-0675-04

40 mEq/L Potassium Chloride in 5% Dextrose and
0.45% Sodium Chloride Injection, USP

2B2434

1000

0338-0803-04

20 mEq/L Potassium Chloride in 5% Dextrose and
0.9% Sodium Chloride Injection, USP

2B2454

1000

0338-0807-04

40 mEq/L Potassium Chloride in 5% Dextrose and
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 at room temperature (25°C); brief exposure up to 40°C 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.


Preparation For Administration



  • 1.Suspend container from eyelet support.
  • 2.Remove 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.

Other



Baxter Healthcare Corporation
Deerfield, IL 60015 USA
Printed in USA

Distributed in Canada by
Baxter Corporation
Mississauga, ON L5N 0C2

07-19-73-075

Rev. June 2014

Baxter, PL 146, and Viaflex are trademarks of
Baxter International Inc.


Package Label - Principal Display Panel



Container Label

Container Label

2B1614
NDC 0338-0663-04
DIN 00503142

20 mEq

Potassium
Chloride

(20 mEq/L)
Potassium Chloride in 5% Dextrose and
0.2% Sodium Chloride Injection USP

1000 mL
EACH 100 mL CONTAINS 5 g DEXTROSE HYDROUS USP
200 mg SODIUM CHLORIDE USP 150 mg POTASSIUM
CHLORIDE USP pH 4.5 (3.5 TO 6.5) mEq/L SODIUM 34
POTASSIUM 20 CHLORIDE 54 OSMOLARITY 361 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
ADMINISTER SIMULTANEOUSLY WITH BLOOD 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 logo
BAXTER HEALTHCARE CORPORATION
DEERFIELD IL 60015 USA

MADE IN USA

1

2

3

4

5

6

7

8

9

Carton Label

Carton Label

2B1614X 14-1000 ML

VIAFLEX(R) PLUS CONTAINER

20 MEQ POTASSIUM CHLORIDE IN 5% DEX
AND 0.2% SODIUM CHLORIDE INJ, USP

EXP
XXXXX

SECONDARY BAR CODE
(17) YYMM00 (10) XXXXX

LOT
XXXXX

PRIMARY BAR CODE
(01) 50303380663045

Container Label

LOT

EXP

2B1473
NDC 0338-0603-03
DIN 00786241

10 mEq

Potassium
Chloride

(20 mEq/L)
Potassium Chloride in 5% Dextrose and
0.33% Sodium Chloride Injection USP

500 mL
EACH 100 mL CONTAINS 5 g DEXTROSE HYDROUS USP
330 mg SODIUM CHLORIDE USP 150 mg POTASSIUM
CHLORIDE USP pH 4.5 (3.5 TO 6.5) mEq/L
SODIUM 56 POTASSIUM 20 CHLORIDE 76
HYPERTONIC OSMOLARITY 405 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 logo
BAXTER HEALTHCARE CORPORATION
DEERFIELD IL 60015 USA

MADE IN USA

Carton Label

Carton Label

2B1473Q

24-500 ML

VIAFLEX PLUS CONTAINER

10 MEQ POTASSIUM CHLORIDE IN
5% DEX AND 0.33% SODIUM CHLORIDE INJ, USP

EXP
XXXXX

SECONDARY BAR CODE
(17) YYMM00 (10) XXXXX

LOT
XXXXX

PRIMARY BAR CODE
(01) 50303380603034

Container Label

Container Label

LOT

EXP

2B1644
NDC 0338-0669-04
DIN 00790109

10 mEq

Potassium
Chloride

(10 mEq/L)
Potassium Chloride in 5% Dextrose and
0.45% Sodium Chloride Injection USP

1000 mL
EACH 100 mL CONTAINS 5 g DEXTROSE HYDROUS USP
450 mg SODIUM CHLORIDE USP 75 mg POTASSIUM
CHLORIDE USP pH 4.5 (3.5 TO 6.5) mEq/L
SODIUM 77 POTASSIUM 10 CHLORIDE 87
HYPERTONIC OSMOLARITY 426 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 logo
BAXTER HEALTHCARE CORPORATION
DEERFIELD IL 60015 USA

MADE IN USA

1
2
3
4
5
6
7
8
9

Carton Label

Carton Label

2B1644X

14-1000 ML

VIAFLEX(R) PLUS CONTAINER

10 MEQ POTASSIUM CHLORIDE IN 5% DEX
AND 0.45% SODIUM CHLORIDE INJ, USP

EXP
XXXXX

SECONDARY BAR CODE
(17) YYMM00 (10) XXXXX

LOT
XXXXX

PRIMARY BAR CODE
(01) 50303380669047

Container Label

Container Label

2B1653
NDC 0338-0671-03
DIN 00437999

10 mEq

Potassium
Chloride

(20 mEq/L)
Potassium Chloride in 5% Dextrose and
0.45% Sodium Chloride Injection USP

500 mL
EACH 100 mL CONTAINS 5 g DEXTROSE HYDROUS USP 450 mg SODIUM
CHLORIDE USP 150 mg POTASSIUM CHLORIDE USP pH 4.5 (3.5 TO
6.5) mEq/L SODIUM 77 POTASSIUM 20 CHLORIDE 97 HYPERTONIC
OSMOLARITY 447 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

Baxter logo
BAXTER HEALTHCARE CORPORATION
DEERFIELD IL 60015 USA

MADE IN USA

DISTRIBUTED IN CANADA BY
BAXTER CORPORATION
MISSISSAUGA ON L5N 0C2

VIAFLEX PLUS CONTAINER
PL 146 PLASTIC

FOR PRODUCT INFORMATION
1-800-933-0303

BAXTER VIAFLEX AND PL 146 ARE TRADEMARKS OF
BAXTER INTERNATIONAL INC

1

2

3

4

Carton Label

Carton Label

2B1653Q

24-500 ML

VIAFLEX PLUS CONTAINER

10 MEQ POTASSIUM CHLORIDE IN
5% DEX AND 0.45% SODIUM CHLORIDE INJ, USP

EXP
XXXXX

SECONDARY BAR CODE
(17) YYMM00 (10) XXXXX

LOT
XXXXX

PRIMARY BAR CODE
(01) 50303380671033

Container Label

Container Label

LOT

EXP

2B1664
NDC 0338-0673-04
DIN 00786284

30 mEq

Potassium
Chloride

(30 mEq/L)
Potassium Chloride in 5% Dextrose and
0.45% Sodium Chloride Injection USP

1000 mL
EACH 100 mL CONTAINS 5 g DEXTROSE HYDROUS USP
450 mg SODIUM CHLORIDE USP 224 mg POTASSIUM
CHLORIDE USP pH 4.5 (3.5 TO 6.5) mEq/L
SODIUM 77 POTASSIUM 30 CHLORIDE 107
HYPERTONIC OSMOLARITY 466 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 logo
BAXTER HEALTHCARE CORPORATION
DEERFIELD IL 60015 USA

MADE IN USA

1
2
3
4
5
6
7
8
9

Carton Label

Carton Label

2B1664X

14-1000 ML

VIAFLEX(R) PLUS CONTAINER

30 MEQ POTASSIUM CHLORIDE IN 5% DEX
AND 0.45% SODIUM CHLORIDE INJ, USP

EXP
XXXXX

SECONDARY BAR CODE
(17) YYMM00 (10) XXXXX

LOT
XXXXX

PRIMARY BAR CODE
(01) 50303380673044

Container Label

Container Label

LOT

EXP

2B1674
NDC 0338-0675-04
DIN 00438006

40 mEq

Potassium
Chloride

(40 mEq/L)
Potassium Chloride in 5% Dextrose and
0.45% Sodium Chloride Injection USP

1000 mL
EACH 100 mL CONTAINS 5 g DEXTROSE HYDROUS USP
450 mg SODIUM CHLORIDE USP 300 mg POTASSIUM
CHLORIDE USP pH 4.5 (3.5 TO 6.5) mEq/L
SODIUM 77 POTASSIUM 40 CHLORIDE 117
HYPERTONIC OSMOLARITY 487 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 logo
BAXTER HEALTHCARE CORPORATION
DEERFIELD IL 60015 USA

MADE IN USA

1
2
3
4
5
6
7
8
9

Carton Label

Carton Label

2B1674X

14-1000 ML

VIAFLEX(R) PLUS CONTAINER

40 MEQ POTASSIUM CHLORIDE IN 5% DEX
AND 0.45% SODIUM CHLORIDE INJ, USP

EXP
XXXXX

SECONDARY BAR CODE
(17) XXXXX (10) XXXXX

LOT
XXXXX

PRIMARY BAR CODE
(01) 50303380675048

Container Label

Container Label

LOT

EXP

2B2434
NDC 0338-0803-04
DIN 00786292

20 mEq
Potassium
Chloride

(20 mEq/L)
Potassium Chloride in 5% Dextrose and
0.9% Sodium Chloride Injection USP

1000 mL
EACH 100 mL CONTAINS 5 g DEXTROSE HYDROUS USP
900 mg SODIUM CHLORIDE USP 150 mg POTASSIUM
CHLORIDE USP pH 4.5 (3.5 TO 6.5) mEq/L
SODIUM 154 POTASSIUM 20 CHLORIDE 174
OSMOLARITY 601 mOsmol/L (CALC) HYPERTONIC
MAY CAUSE VEIN DAMAGE 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 logo
BAXTER HEALTHCARE CORPORATION
DEERFIELD IL 60015 USA

MADE IN USA

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Carton Label

Carton Label

2B2434X

14-1000 ML

VIAFLEX(R) PLUS CONTAINER

20 MEQ POTASSIUM CHLORIDE IN
5% DEX AND 0.9% SOD CHL INJ, USP

EXP
XXXXX

SECONDARY BAR CODE
(17) XXXXX (10) XXXXX

LOT
XXXXX

PRIMARY BAR CODE
(01) 50303380803045

Container Label

Container Label

LOT EXP

2B2454
NDC 0338-0807-04
DIN 00786306

40 mEq
Potassium
Chloride

(40 mEq/L)
Potassium Chloride in 5% Dextrose and
0.9% Sodium Chloride Injection USP

1000 mL
EACH 100 mL CONTAINS 5 g DEXTROSE HYDROUS USP 900
mg SODIUM CHLORIDE USP 300 mg POTASSIUM CHLORIDE
USP pH 4.5 (3.5 TO 6.5) mEq/L SODIUM 154
POTASSIUM 40 CHLORIDE 194 OSMOLARITY 641
mOsmol/L (CALC) HYPERTONIC MAY CAUSE VEIN DAMAGE
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 logo
BAXTER HEALTHCARE CORPORATION
DEERFIELD IL 60015 USA

MADE IN USA

DISTRIBUTED IN CANADA BY
BAXTER CORPORATION
MISSISSAUGA ON L5N 0C2

1

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3

5

6

7

8

9

Carton Label

Carton Label

2B2454X

14-1000 ML

VIAFLEX(R) PLUS CONTAINER

40 MEQ POTASSIUM CHLORIDE IN
5% DEX AND 0.9% SODIUM CHLORIDE INJ

EXP
XXXXX

SECONDARY BAR CODE
(17) YYMM00 (10) XXXXX

LOT
XXXXX

PRIMARY BAR CODE
(01) 50303380807043


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