Sodium Chloride Irrigant

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.

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.

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 or powered irrigation devices.

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.

1. To open: Tear overwrap starting from the tear notches. (Figure 1)
   
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)
   • 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)
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.
   
4. Hang bag on IV Pole. (Figure 5)
   

Y36-002-911  LD-398-3

Package Insert

Rx only

Revised: October 2015

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.

Rx only

Not made with  natural
rubber latex, PVC or DEHP.

SET

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

Y38-000-047     LD-253-6

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.

Rx only

Not made with natural
rubber latex, PVC or DEHP.

SET

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

Y38-000-048    LD-254-5