Get your patient on Ringers Irrigation - Sodium Chloride, Potassium Chloride, And Calcium Chloride Irrigant injection, Solution (Sodium Chloride, Potassium Chloride, And Calcium Chloride Irrigant)

Ringer’s Irrigation, USP is indicated for all general irrigation, washing and rinsing purposes which permit use of a sterile, nonpyrogenic electrolyte solution.

The dose is dependent upon the capacity or surface area of the structure to be irrigated and the nature of the procedure. When used as a vehicle for other drugs, the manufacturer’s recommendations should be followed.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution container permits. (See PRECAUTIONS .)

NOT FOR INJECTION BY USUAL PARENTERAL ROUTES.

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

Possible adverse effects arising from the irrigation of body cavities, tissues, or indwelling catheters and tubes are usually avoidable 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 distention or disruption of tissues. Accidental contamination from careless technique may transmit infection. Should any adverse reaction occur, discontinue the irrigant, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.

Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, use aseptic technique, mix thoroughly and do not store.

These products are sterile, nonpyrogenic solutions of electrolytes in water for injection intended only for sterile irrigation, washing and rinsing purposes.

Each 100 mL of Ringer’s Irrigation, USP contains: Sodium chloride 860 mg; potassium chloride 30 mg; calcium chloride dihydrate 33 mg. The pH is 5.7 (5.0 — 7.5). The solution is isotonic (309 mOsmol/liter, calc.) and has the following electrolyte content (mEq/liter): Na ⁺ 147.5; K ⁺ 4; Ca ⁺⁺ 4.5; Cl ⁻ 1.560000000000000e+02

The solution contains no bacteriostat, antimicrobial agent or added buffer and is intended only for use as single-dose or short procedure irrigation. When smaller volumes are required the unused portion should be discarded. Ringer’s Irrigation, USP may be classified as a sterile irrigant, wash, rinse and pharmaceutical vehicle.

Calcium Chloride, USP is chemically designated calcium chloride dihydrate (CaCl ₂ • 2H ₂ O), white fragments or granules freely soluble in water.

Potassium Chloride, USP is chemically designated KCl, a white granular powder freely soluble in water.

Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water.

Water for Injection, USP is chemically designated H ₂ O.

The semi-rigid container is fabricated from a specially formulated polyolefin. It is a copolymer of ethylene and propylene. The container requires no vapor barrier to maintain the proper drug concentration.

Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials.

Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period.

Ringer’s Irrigation, USP exerts a mechanical cleansing action for sterile irrigation of body cavities, tissues or wounds, indwelling urethral catheters and surgical drainage tubes, and for washing, rinsing or soaking surgical dressings, instruments and laboratory specimens. It also serves as a vehicle for drugs used for irrigation or other pharmaceutical preparations.

Ringer’s Irrigation, USP provides an isotonic irrigation with the same ionic constituents as Ringer’s Injection, USP, a modification of Ringer’s solution (also called Ringer’s mixture) originally used only as a topical physiologic salt solution.

Ringer’s Irrigation, USP is considered generally compatible with living tissues and organs.

Calcium Chloride in water dissociates to provide calcium (Ca ⁺⁺ ) and chloride (Cl ⁻ ) ions. They are normal constituents of the body fluids and are dependent on various physiologic mechanisms for maintenance of balance between intake and output. Approximately 80% of body calcium is excreted in the feces as insoluble salts; urinary excretion accounts for the remaining 20%.

Potassium chloride in water dissociates to provide potassium (K ⁺ ) and chloride (Cl ⁻ ) ions. Potassium is the chief cation of body cells (160 mEq/liter of intracellular water). It is found in low concentration in plasma and extracellular fluids (3.5 to 5.0 mEq/liter in a healthy adult). Potassium plays an important role in electrolyte balance.

Normally about 80 to 90% of the potassium intake is excreted in the urine; the remainder in the stools and to a small extent, in the perspiration. The kidney does not conserve potassium well so that during fasting or in patients on a potassium free diet, potassium loss from the body continues resulting in potassium depletion.

Sodium chloride in water dissociates to provide sodium (Na ⁺ ) and chloride (Cl ⁻ ) ions. Sodium (Na ⁺ ) is the principal cation of the extracellular fluid and plays a large part in the therapy of fluid and electrolyte disturbances. Chloride (Cl ⁻ ) has an integral role in buffering action when oxygen and carbon dioxide exchange occurs in the red blood cells. The distribution and excretion of sodium (Na ⁺ ) and chloride (Cl ⁻ ) are largely under the control of the kidney which maintains a balance between intake and output.

Water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight. Average normal adult daily requirement ranges from two to three liters (1.0 to 1.5 liters each for insensible water loss by perspiration and urine production).

Water balance is maintained by various regulatory mechanisms. Water distribution depends primarily on the concentration of electrolytes in the body compartments and sodium (Na ⁺ ) plays a major role in maintaining physiologic equilibrium.

Ringer’s Irrigation, USP is supplied in a single-dose 1000 mL semi-rigid irrigation container (NDC No. 0409–6140–09; NDC No. 0990-6140-09).

ICU Medical is transitioning NDC codes from the "0409" to a "0990" labeler code. Both NDC codes are expected to be in the market for a period of time.

Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing.

Revised: July, 2020

EN-5962

Manufactured for ICU Medical, Inc., Lake Forest, Illinois, 60045, USA