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

DESCRIPTION

id: c017f325-101f-479d-b2cb-db82912b2313
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3

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)		Normal physiologic osmolarity range is approximately 280 to 310 mOsmol/L. Administration of substantially hypertonic solutions (≥ 600 mOsmol/L) may cause vein damage.Osmolarity (mOsmol/L) (Calc.)	pH	Ionic Concentration (mEq/L)
		Sodium Chloride, USP (NaCl)	Potassium Chloride, USP (KCl)			Sodium	Potassium	Chloride
20 mEq/L Potassium Chloride in 0.45% Sodium Chloride Injection, USP	1000	4.5	1.5	194	5.5 (3.5 to 6.5)	77	20	97
20 mEq/L Potassium Chloride in 0.9% Sodium Chloride Injection, USP	1000	9	1.5	348	5.5 (3.5 to 6.5)	154	20	174
40 mEq/L Potassium Chloride in 0.9% Sodium Chloride Injection, USP	1000	9	3	388	5.5 (3.5 to 6.5)	154	40	194

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

id: ffd08eee-9d34-482a-b5e4-75191572ae86
displayName: CLINICAL PHARMACOLOGY SECTION
FDA Article Code: 34090-1

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

id: 8d2b7e4d-bbbe-46c3-b7f3-ee4b9c488a05
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9

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

CONTRAINDICATIONS

id: ac3ee575-508c-4433-b1ea-6cb44f756b04
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3

None known

WARNINGS

id: 26c09200-71ec-45f4-80a4-c8ab1a54f7c2
displayName: WARNINGS SECTION
FDA Article Code: 34071-1

Potassium Chloride in 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 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. The intravenous administration of Potassium Chloride in 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 Sodium Chloride Injection, USP may result in sodium or potassium retention. Potassium salts should never be administered by IV push.

PRECAUTIONS

id: 10d1a4a6-0caa-4ed7-8457-f128ecfeb79d
displayName: PRECAUTIONS SECTION
FDA Article Code: 42232-9

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 Sodium Chloride Injection, USP to patients receiving corticosteroids or corticotropin.

ADVERSE REACTIONS

id: 3f06870d-202e-410f-abd7-ce08fbdb98a6
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4

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

id: 20b1001d-f385-4b8f-b904-ee62ba1aa074
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7

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 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. 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

id: 6e1565f4-919c-4670-b31a-3a36e4a6c6fa
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

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 at room temperature (25° C/77° F); brief exposure up to 40° C (104° F) does not adversely affect the product.

DIRECTION FOR USE OF VIAFLEX PLUS PLASTIC CONTAINER

id: b8d50d42-9660-4520-9ade-4caf0a0cc2b9
displayName: SPL UNCLASSIFIED SECTION
FDA Article Code: 42229-5

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.

PACKAGE LABELING – PRINCIPLE DISPLAY PANEL

id: 017e5bef-61df-4d2d-b6c8-7000cb124531
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

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 EXP
XXXXX SECONDARY BAR CODE
(17) YYMM00 (10) XXXXX LOT
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 EXP
XXXXX SECONDARY BAR CODE
(17) XXXXX (10) XXXXX LOT
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 EXP
XXXXX SECONDARY BAR CODE
(17) YYMM00 (10) XXXXX LOT
XXXXX PRIMARY BAR CODE
(01) 50303380695046