Ringers

ADVERSE REACTIONS Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation and hypervolemia. If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.

DESCRIPTION This product is a sterile, nonpyrogenic solutions containing isotonic concentrations of electrolytes in water for injection. The solution is isotonic. The solution is administered by intravenous infusion for parenteral replacement of extracellular losses of fluid and electrolytes, with or without minimal carbohydrate calories. Each 100 mL of Ringer's Injection, USP contains sodium chloride 860 mg, potassium chloride 30 mg and calcium chloride, dihydrate 33 mg. May contain hydrochloric acid and/or sodium hydroxide for pH adjustment. A liter provides 147 mEq sodium (Na + ), 4 mEq potassium (K + ), 4 mEq calcium (Ca ++ ) and 155 mEq chloride (Cl − ). The electrolyte content is isotonic (309 mOsmol/liter, calc.) in relation to the extracellular fluid (approx. 280 mOsmol/liter). The pH of the solution is 5.4 (5.0 − 7.5). The solution contains no bacteriostat, antimicrobial agent or added buffer (except for pH adjustment) and is intended only for use as a single-dose injection. When smaller doses are required the unused portion should be discarded. The solution is a parenteral fluid, nutrient and/or electrolyte replenisher. Dextrose, USP is chemically designated D-glucose, monohydrate (C 6 H 12 O 6 ∙ H 2 O), a hexose sugar freely soluble in water. It has the following structural formula: Calcium Chloride, USP is chemically designated calcium chloride, dihydrate (CaCl 2 ∙ 2 H 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 NaCI, a white crystalline powder freely soluble in water. Water for Injection, USP is chemically designated H 2 O. The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solution inside the plastic container also can leach out certain chemical components in very small amounts before the expiration period is attained. However, the safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers. structural formula dextrose

DOSAGE AND ADMINISTRATION The dose is dependent upon the age, weight and clinical condition of the patient. Drug Interactions Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, use aseptic technique, mix thoroughly and do not store. The presence of calcium limits their compatibility with certain drugs that form precipitates of calcium salts, and also prohibits their simultaneous infusion through the same administration set as blood because of the likelihood of coagulation. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See PRECAUTIONS .

INDICATIONS AND USAGE This solution is indicated for parenteral replacement of extracellular losses of fluid and electrolytes, with or without minimal carbohydrate calories, as required by the clinical condition of the patient.

WARNINGS Solutions containing calcium ions should not be administered simultaneously through the same administration set as blood because of the likelihood of coagulation. Solutions which contain potassium should be used with great care, if at all, in patients with hyperkalemia, severe renal failure and in conditions in which potassium retention is present. Solutions containing sodium ions should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency and in clinical states in which there exists edema with sodium retention. In patients with diminished renal function, administration of solutions containing sodium or potassium ions may result in sodium or potassium retention. Solutions containing lactate ions should be used with great care in patients with metabolic or respiratory alkalosis. The administration of lactate ions should be done with great care where there is an increased level or an impaired utilization of lactate ions, as in severe hepatic insufficiency. The intravenous administration of these solutions 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.

OVERDOSAGE In the event of overhydration or solute overload, re-evaluate the patient and institute appropriate corrective measures. See WARNINGS , PRECAUTIONS , and ADVERSE REACTIONS .

Drug Interactions Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, use aseptic technique, mix thoroughly and do not store. The presence of calcium limits their compatibility with certain drugs that form precipitates of calcium salts, and also prohibits their simultaneous infusion through the same administration set as blood because of the likelihood of coagulation. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See PRECAUTIONS .

CLINICAL PHARMACOLOGY When administered intravenously, this solution provides a source of water and electrolytes with or without minimal carbohydrate calories. The electrolyte content resembles that of the principal ionic constituents of normal plasma and the solution therefore is suitable for parenteral replacement of extracellular losses of fluid and electrolytes, with or without carbohydrate calories. 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 found in low concentration in plasma and extracellular fluids (3.5 to 5.0 mEq/liter in a healthy adult). It is the chief cation of body cells (160 mEq/liter of intracellular water). 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.

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Ringers SODIUM CHLORIDE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE POTASSIUM CHLORIDE POTASSIUM CATION CHLORIDE ION CALCIUM CHLORIDE CALCIUM CATION CHLORIDE ION SODIUM CHLORIDE SODIUM CATION CHLORIDE ION HYDROCHLORIC ACID SODIUM HYDROXIDE WATER

NDA018251

Ringers

SODIUM CHLORIDE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE

0990-7982

HUMAN PRESCRIPTION DRUG

INTRAVENOUS

PRINCIPAL DISPLAY PANEL - 1000 mL Bag Label 1000 mL NDC 0990-7982-09 RINGER'S INJECTION, USP EACH 100 mL CONTAINS SODIUM CHLORIDE 860 mg; POTASSIUM CHLORIDE 30 mg; CALCIUM CHLORIDE, DIHYDRATE 33 mg IN WATER FOR INJECTION. MAY CONTAIN HCl OR NaOH FOR pH ADJUSTMENT. ELECTROLYTES PER 1000 mL: SODIUM 147 mEq; POTASSIUM 4 mEq; CALCIUM 4 mEq; CHLORIDE 155 mEq. 309 mOsmol/LITER (CALC.). pH 5.4 (5.0 TO 7.5). DO NOT ADMINISTER CALCIUM CONTAINING SOLUTIONS CONCURRENTLY WITH STORED BLOOD. ADDITIVES MAY BE INCOMPATIBLE. CONSULT WITH PHARMACIST, IF AVAILABLE. WHEN INTRODUCING ADDITIVES, USE ASEPTIC TECHNIQUE, MIX THOROUGHLY AND DO NOT STORE. SINGLE-DOSE CONTAINER. FOR INTRAVENOUS OR SUBCUTANEOUS USE. USUAL DOSAGE: SEE INSERT. STERILE, NONPYROGENIC. USE ONLY IF SOLUTION IS CLEAR AND CONTAINER IS UNDAMAGED. MUST NOT BE USED IN SERIES CONNECTIONS. Rx ONLY 3 V CONTAINS DEHP IMP0000056 ICU Medical, Inc., Lake Forest, Illinois, 60045, USA icumedical PRINCIPAL DISPLAY PANEL - 1000 mL Bag Label

Flexible Plastic Container Rx only

Pediatric Use The safety and effectiveness in the pediatric population are based on the similarity of the clinical conditions of the pediatric and adult populations. In neonates or very small infants the volume of fluid may affect fluid and electrolyte balance.

Pregnancy Category C Animal reproduction studies have not been conducted with Ringer's Injection, USP,. It is also not known whether this injection can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. This injection should be given to a pregnant woman only if clearly needed.

HOW SUPPLIED This solution is supplied in a single-dose flexible plastic container as follows: NDC No. Product Name Container Size (mL) 0409–7982–09 Ringer's Inj., USP 1000 0990-7982-09 Ringer's Inj., USP 1000 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. Protect from freezing. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Revised: March, 2020 IFU0000173 ICU Medical, Inc., Lake Forest, Illinois, 60045, USA

PRECAUTIONS Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid balance, electrolyte concentrations and acid-base balance during prolonged parenteral therapy or whenever the condition of the patient warrants such evaluation. Caution must be exercised in the administration of parenteral fluids, especially those containing sodium ions, to patients receiving corticosteroids or corticotropin. Potassium containing solutions should be used with caution in the presence of cardiac disease, particularly in digitalized patients or in the presence of renal disease. Solutions containing lactate ions should be used with caution as excess administration may result in metabolic alkalosis. Do not administer unless solution is clear and container is undamaged. Discard unused portion. Pregnancy Category C Animal reproduction studies have not been conducted with Ringer's Injection, USP,. It is also not known whether this injection can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. This injection should be given to a pregnant woman only if clearly needed. Pediatric Use The safety and effectiveness in the pediatric population are based on the similarity of the clinical conditions of the pediatric and adult populations. In neonates or very small infants the volume of fluid may affect fluid and electrolyte balance.