Sodium Chloride for Irrigation

Isotonic Solution for Irrigation.

For Irrigation Only.

Not for Injection.

Each 100 mL contains:

Sodium Chloride USP 0.9 g; Water for Injection USP qs

pH adjusted with Hydrochloric Acid NF

pH: 5.75 (4.50-7.00) 

Calculated Osmolarity: 308 mOsmol/liter

Concentration of Electrolytes (mEq/liter): Sodium 154; Chloride 154

0.9% Sodium Chloride Irrigation USP is sterile, nonpyrogenic, isotonic and contains no bacteriostatic or antimicrobial agents.

The formula of the active ingredient is:

The plastic container is made from a multilayered film specifically developed for parenteral drugs. It contains no plasticizers and exhibits virtually no leachables. The solution contact layer is a rubberized copolymer of ethylene and propylene. The container is nontoxic and biologically inert. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary.

Not made with natural rubber latex, PVC or DEHP.

0.9% Sodium Chloride Irrigation USP is utilized for a variety of clinical indications such as sterile irrigation of body cavities, tissues or wounds, indwelling urethral catheters, surgical drainage tubes, and for washing, rinsing or soaking surgical dressings, instruments and laboratory specimens. It also serves as a diluent or vehicle for drugs used for irrigation or other pharmaceutical preparations.

0.9% Sodium Chloride Irrigation USP provides an isotonic saline irrigation identical in composition with 0.9% Sodium Chloride Injection USP (normal saline).

Physiological irrigation solutions are considered generally compatible with living tissues and organs.

Sodium, the major cation of the extracellular fluid, functions primarily in the control of water distribution, fluid balance, and osmotic pressure of body fluids. Sodium is also associated with chloride and bicarbonate in the regulation of the acid-base equilibrium of body fluid.

Chloride, the major extracellular anion, closely follows the metabolism of sodium, and changes in the acid-base balance of the body are reflected by changes in the chloride concentration.

0.9% Sodium Chloride Irrigation USP is indicated for all general irrigation, washing, rinsing and dilution purposes which permit use of a sterile, nonpyrogenic electrolyte solution.

0.9% Sodium Chloride Irrigation USP is not for injection by usual parenteral routes.

An electrolyte solution should not be used for irrigation during electrosurgical procedures.

FOR IRRIGATION ONLY. NOT FOR INJECTION.

Irrigating fluids have been demonstrated to enter the systemic circulation in relatively large volumes; thus, irrigation solutions must be regarded as systemic drugs. Absorption of large amounts can cause fluid and/or solute overload 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 administered parenteral solutions. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentration.

Do not warm above 150°F (66°C).

After opening container, its contents should be used promptly to minimize the possibility of bacterial growth or pyrogen formation.

Discard unused portion of irrigating solution since it contains no preservatives.

Possible adverse effects arising from the irrigation of body cavities, tissues, or indwelling catheters and tubes can be minimized when proper procedures are followed. Displaced catheters or drainage tubes can lead to irrigation or infiltration of unintended structures or cavities. Excessive volume or pressure during irrigation of closed cavities may cause undue distension or disruption of tissues. Accidental contamination from careless technique may transmit infection.

If an adverse reaction does occur, discontinue administration of the irrigant, evaluate the patient, institute appropriate therapeutic countermeasures, and save the remainder of the fluid for examination if deemed necessary.

In the event of overhydration or solute overload, reevaluate the patient’s condition, and institute appropriate corrective treatment. Intravascular volume overload may respond to hemodialysis. See WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS.

As required for irrigation.

When used as a diluent, or vehicle for other drugs, the drug manufacturer's recommendations should be followed.

Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store.

Solutions should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permits.

0.9% Sodium Chloride Irrigation USP is supplied sterile and nonpyrogenic in single-dose 2000 mL and 3000 mL plastic containers packaged 4 per case.

Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at room temperature (25°C); however, brief exposure up to 40°C does not adversely affect the product.

Do not warm above 150°F (66°C).

Directions for Use of Plastic Container

Not for injection.

Not for use with pressurized irrigation systems.

Aseptic technique is required.

• Inspect irrigation bag: overwrap and primary bag.
• Do not use if overwrap has been damaged.
• Do not use unless solution is clear and closure is intact.
  
  Illustration 1

1. To open: Tear overwrap starting from the tear notches. (Figure 1)
   Illustration 2
2. Prepare medication port by removal of aluminum foil. (Figure 2a) 
   
   • Puncture resealable medication port by using 19 – 22 gauge needle and inject additive(s). (Figure 2b)
     Illustration 3
   • Mix solution and medication thoroughly. (Figure 3a)
   • Medication port must be swabbed with disinfection agent (e.g. iso-propanol or chlorhexidine) before re-puncturing.
   • Check admixture visually for particulate matter. (Figure 3b)
     Illustration 4
3. Remove aluminum foil from outlet/set port at the bottom of container (Figure 4a) and attach administration set (Figure 4b): use non-vented infusion set or close air vent on a vented set. Refer to directions for use accompanying the administration set.
   Illustration 5
4. Hang bag on IV Pole. (Figure 5)
   Illustration 6

Y36-002-963  LD-398-4

Package Insert

Rx only

Revised: June 2018

B. Braun Medical Inc.
Bethlehem, PA 18018-3524 USA
1-800-227-2862

0.9% SODIUM CHLORIDE IRRIGATION USP

ISOTONIC SOLUTION FOR IRRIGATION

REF R8205
NDC 0264-7388-50
LOT
EXP.

2000 mL

Each 100 mL contains
Sodium Chloride USP 0.9 g
Water for Injection USP qs

pH adjusted with
Hydrochloric Acid NF

pH: 5.75 (4.50-7.00)
Calc. Osmolarity: 308 mOsmol/liter

Electrolytes (mEq/liter):
Sodium 154  Chloride 154

Sterile, nonpyrogenic. Single unit container.
Discard unused portion.

Not for Injection. Use only if solution is clear and
container and seal are intact.

Warning: Do not warm above 150°F (66°C).

Recommended Storage: Room temperature (25°C).
Avoid excessive heat. Protect from freezing.

See Package Insert.

Not made with natural
rubber latex, PVC or DEHP.

Rx only

Y38-000-060     LD-253-7

B. Braun Medical Inc.
Bethlehem, PA 18018-3524 USA
1-800-227-2862

SET

0.9% Sodium Chloride Irrigation 2L Container Label

0.9% SODIUM CHLORIDE IRRIGATION USP

ISOTONIC SOLUTION FOR IRRIGATION

REF R8206
NDC 0264-7388-60
LOT
EXP.

3000 mL

Each 100 mL contains
Sodium Chloride USP 0.9 g
Water for Injection USP qs

pH adjusted with
Hydrochloric Acid NF

pH: 5.75 (4.50-7.00)
Calc. Osmolarity: 
308 mOsmol/liter

Electrolytes (mEq/liter):
Sodium 154  Chloride 154

Sterile, nonpyrogenic. Single unit container. Discard
unused portion.

Not for Injection. Use only if solution is clear
and container and seal are intact.

Warning: Do not warm above 150°F (66°C).

Recommended Storage: Room temperature
(25°C). Avoid excessive heat. Protect from
freezing.

See Package Insert.

Not made with natural
rubber latex, PVC or DEHP.

Rx only

Y38-000-061    LD-254-6

B. Braun Medical Inc.
Bethlehem, PA 18018-3524 USA
1-800-227-2862

SET

set arrow illustration

0.9% Sodium Chloride Irrigation 3L Container Label