Sodium Chloride, Soldium Lactate, Potassium Chloride And Calcium Chloride

INDICATIONS AND USAGE Lactated Ringer’s Irrigation is indicated for use as an arthroscopic irrigating fluid with endoscopic instruments during arthroscopic procedures requiring distension and irrigation of the knee, shoulder, elbow, or other bone joints.

DOSAGE AND ADMINISTRATION The volume and/or rate of solution needed will vary with the nature and duration of the arthroscopic procedure. This solution, as it is packaged, is not intended for IV administration or injection. The container must not be vented (See Precautions ). Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Do not administer unless the solution is clear and the seal is intact. If particulate matter or discoloration is found, contact Baxter Customer Service Aseptic technique should be used when applying this product. The contents of an opened container should be used promptly to minimize the possibility of bacterial growth or pyrogen formation. Discard the unused portion of irrigating solution since no antimicrobial agent has been added. When using Lactated Ringer’s Irrigation for pour irrigation, prevent contact of the fluid with the external surface of the container. Lactated Ringer’s Irrigation is for single-patient use only. Microwave heating of irrigation fluids is not recommended. If desired, Lactated Ringer’s Irrigation may be warmed in a water bath or oven to not more than 45° C while maintaining sterility. Lactated Ringer’s Irrigation that has been warmed must not be returned to storage. Cetriaxone must not be mixed with calcium-containing solutions, including Lactated Ringer’s Irrigation. Additives may be incompatible with Lactated Ringer’s Irrigation. Additives known or determined to be incompatible should not be used. As with all parenteral solutions, compatibility of the additives with the solution must be assessed before addition, by checking for, for example, a possible color change and/or the appearance of precipitates, insoluble complexes, or crystals. Before adding a substance or medication, verify that it is soluble and/or stable in water and that the pH range of Lactated Ringer’s Irrigation is appropriate. The instructions for use of the medication to be added and other relevant literature must be consulted. When making additions to Lactated Ringer’s Irrigation, aseptic technique must be used. Mix the solution thoroughly when additives have been introduced. Do not store solutions containing additives.

ADVERSE REACTIONS Post-Marketing Adverse Reactions No adverse reactions were identified in Baxter’s Adverse Event Reporting System database with Lactated Ringer’s Irrigation. Class Reactions Adverse reactions reported with Lactated Ringer’s Irrigation (manufacturer unspecified) are: Fluid absorption manifested by Pulmonary edema, Edema, and Electrolyte disturbances. Though not indicated for intravenous administration, absorption of irrigation fluid into tissue or vasculature through a perforation or open wound is possible. As a result, adverse reactions reported with Lactated Ringer’s solutions with and without Dextrose for intravenous administration may be applicable and include: • Hypersensitivity reactions, including Anaphylactic/Anaphylactoid reactions, with the following manifestations: Angioedema, Chest pain, Chest discomfort, Decreased heart rate, Tachycardia, Blood pressure decreased, Respiratory distress, Bronchospasm, Dyspnea, Cough, Urticaria, Rash, Pruritus, Erythema, Flushing, Throat irritation, Paresthesias, Hypoesthesia oral, Dysgeusia, Nausea, Anxiety, Headache, Hyperkalemia • Pyrexia Overdose In the event of clinically relevant absorption of irrigation fluid, the patients must be evaluated and corrective measures instituted as appropriate.