Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Lactated Ringer's Irrigation is supplied sterile and nonpyrogenic in single-dose 3000 mL flexible irrigation container packaged 4 per case. NDC REF Size 0264-7389-60 R8306 3000 mL Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. Store at 20°–25°C (68°–77°F) [see USP Controlled Room Temperature]; however, brief exposure up to 40°C does not adversely affect the product. Do not warm container over 150°F (66°C).; PRINCIPAL DISPLAY PANEL - 3 Liter Container LACTATED RINGER’S IRRIGATION ISOTONIC SOLUTION FOR IRRIGATION CONTRAINDICATIONS: NOT FOR INJECTION REF R8306 NDC 0264-7389-60 LOT EXP. 3000 mL Each 100 mL contains Sodium Chloride 600 mg; Sodium Lactate, Anhyd 310 mg; Potassium Chloride 30 mg; Calcium Chloride, Dihydrate 20 mg in Water for Injection. Contains NaOH and may contain HCI for pH adjustment. Electrolytes per 1000 mL (Not including pH adjustment): Sodium 130 mEq; Potassium 4 mEq; Calcium 3 mEq; Chloride 109 mEq; Lactate 28 mEq. 273 mOsmol/liter (Calc.) pH 6.75 (6.0 to 7.5) Sterile, nonpyrogenic. Use only if solution is clear and container and seal are intact. Warnings: Do not warm container over 150°F (66°C). Single unit container. Contains no bacteriostatic agent. Discard unused portion. Use aseptic technique. Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Avoid excessive heat. Protect from freezing. Do not remove overwrap until ready for use. See Package Insert. Not made with natural rubber latex, PVC or DEHP. Rx only Y38-000-062 LD-252-4 B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862 SET Lactated Ringer's Irrigation 3L Container Label Lactated Ringer's Irrigation 3L Container Label
- HOW SUPPLIED Lactated Ringer's Irrigation is supplied sterile and nonpyrogenic in single-dose 3000 mL flexible irrigation container packaged 4 per case. NDC REF Size 0264-7389-60 R8306 3000 mL Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. Store at 20°–25°C (68°–77°F) [see USP Controlled Room Temperature]; however, brief exposure up to 40°C does not adversely affect the product. Do not warm container over 150°F (66°C).
- PRINCIPAL DISPLAY PANEL - 3 Liter Container LACTATED RINGER’S IRRIGATION ISOTONIC SOLUTION FOR IRRIGATION CONTRAINDICATIONS: NOT FOR INJECTION REF R8306 NDC 0264-7389-60 LOT EXP. 3000 mL Each 100 mL contains Sodium Chloride 600 mg; Sodium Lactate, Anhyd 310 mg; Potassium Chloride 30 mg; Calcium Chloride, Dihydrate 20 mg in Water for Injection. Contains NaOH and may contain HCI for pH adjustment. Electrolytes per 1000 mL (Not including pH adjustment): Sodium 130 mEq; Potassium 4 mEq; Calcium 3 mEq; Chloride 109 mEq; Lactate 28 mEq. 273 mOsmol/liter (Calc.) pH 6.75 (6.0 to 7.5) Sterile, nonpyrogenic. Use only if solution is clear and container and seal are intact. Warnings: Do not warm container over 150°F (66°C). Single unit container. Contains no bacteriostatic agent. Discard unused portion. Use aseptic technique. Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Avoid excessive heat. Protect from freezing. Do not remove overwrap until ready for use. See Package Insert. Not made with natural rubber latex, PVC or DEHP. Rx only Y38-000-062 LD-252-4 B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862 SET Lactated Ringer's Irrigation 3L Container Label Lactated Ringer's Irrigation 3L Container Label
Overview
Lactated Ringer’s Irrigation is a sterile, nonpyrogenic solution of electrolytes in water for injection intended only for sterile irrigation, washing and rinsing purposes. The composition is based on a modification of the injectable formula originally known as Hartmann’s Solution. Each 100 mL of Lactated Ringer’s Irrigation contains: Sodium chloride 600 mg; sodium lactate, anhydrous 310 mg; potassium chloride 30 mg; calcium chloride, dihydrate 20 mg. The pH is 6.75 (6.0 — 7.5). The solution is isotonic (273 mOsmol/liter, calc.) and has the following electrolyte content (mEq/liter): Sodium (Na + ) 130; potassium (K + ) 4; calcium (Ca ++ ) 3; chloride (Cl¯) 109 and lactate (CH 3 CH(OH)COO¯) 28. Contains sodium hydroxide and may contain hydrochloric acid for pH adjustment. The solution contains no bacteriostatic or antimicrobial agent or added buffer and is intended only for use as a single-dose or short procedure irrigation. When smaller volumes are required, the unused portion should be discarded. Lactated Ringer’s Irrigation 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. Sodium Lactate, USP is chemically designated C 3 H 5 NaO 3 , a 60% aqueous solution miscible in water. It has the following structural formula: Water for Injection, USP is chemically designated H 2 O. The plastic container is made from a multilayered film specifically developed for parenteral drugs. It contains no plasticizers. The solution contact layer is a rubberized copolymer of ethylene and propylene. 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. Structural Formula
Indications & Usage
Lactated Ringer’s Irrigation is indicated for all general irrigation, washing and rinsing purposes which permit use of a sterile, nonpyrogenic electrolyte solution.
Dosage & Administration
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. Drug Interactions Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, use aseptic technique, mix thoroughly and do not store. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution container permits. (See PRECAUTIONS .)
Warnings & Precautions
WARNINGS FOR IRRIGATION ONLY. NOT FOR INJECTION. Irrigating fluids have been demonstrated to enter the systemic circulation in relatively large volumes; thus this irrigation must be regarded as a systemic drug. Absorption of large amounts 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 administered parenteral solutions. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of such solutions. Do not warm container over 150°F (66°C).
Contraindications
NOT FOR INJECTION BY USUAL PARENTERAL ROUTES. An electrolyte solution should not be used for irrigation during electrosurgical procedures.
Adverse Reactions
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 distension 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.
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