Calcium chloride, Potassium chloride, Sodium chloride and Sodium lactate

Lactated Ringer’s Injection is indicated for use as a source of water and electrolytes or as an alkalinizing agent in adults and pediatric patients.

Lactated Ringer’s Injection is a source of water, electrolytes, and produces an alkalinizing effect. • 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. • Potassium, the principal cation of intracellular fluid, participates in carbohydrate utilization and protein synthesis and is critical in the regulation of nerve conduction and muscle contraction, particularly in the heart. • 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.

• The recommended dosage and duration are based on the patient’s age, weight, clinical condition, and concomitant therapy. • To reduce the risk of air embolism, adhere to the preparation instructions. • Lactated Ringer’s Injection is for intravenous use. • Do not administer Lactated Ringer’s Injection simultaneously with ceftriaxone in neonates (28 days of age or younger) due to serious risks. • See full prescribing information for information dosage considerations, preparation, administration, and drug incompatibilities.

Lactated Ringer’s Injection is contraindicated in: • Neonates (28 days of age or younger) who are receiving concomitant treatment with ceftriaxone, even if separate infusion lines are used, due to the risk of fatal ceftriaxone-calcium salt precipitation in the neonate’s bloodstream. • Patients with known hypersensitivity to any of the components of Lactated Ringer’s Injection. • Concomitant treatment with ceftriaxone in neonates (28 days of age or younger). • Patients with known hypersensitivity to any of the components of Lactated Ringer’s Injection.

• Serious Risks with Inappropriate Use with Ceftriaxone: Deaths have occurred in neonates (28 days of age or younger) who received concomitant intravenous calcium-containing solutions with ceftriaxone. In patients older than 28 days, ceftriaxone and Lactated Ringer’s Injection may be administered sequentially if the infusion lines are thoroughly flushed between infusions. • Air Embolism: Use a non-vented infusion set or close the vent on a vented set and use a dedicated line without any connections. Pressure infusion is not recommended to increase flow rates, but if necessary, remove all air from the bag prior to initiating infusion. • Hypersensitivity Reactions: Stop the Lactated Ringer’s Injection infusion immediately if signs or symptoms of a hypersensitivity reaction develop.

The following serious adverse reactions are discussed in greater detail in other sections of the labeling: • Serious Risk with Concomitant Use with Ceftriaxone • Air Embolism • Hypersensitivity Reactions • Potassium Imbalances • Hyponatremia • Hypercalcemia • Fluid Overload • Acid/Base Imbalances The following adverse reactions have been identified during post approval use of Lactated Ringer’s products. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure: General Disorders and Administration Site Conditions: Phlebitis, extravasation, infusion site inflammation, infusion site swelling, infusion site rash, infusion site pruritus, infusion site erythema, infusion site pain, infusion site burning, and infusion site hypoaesthesia.

• Drugs that Affect Electrolyte and/or Fluid Balance: Avoid concomitant use. If concomitant use cannot be avoided, closely monitor electrolyte concentrations and fluid balance. • Lithium: Avoid concomitant use. If concomitant use is unavoidable, monitor serum lithium concentrations more frequently. • Digoxin: consider reducing the volume or rate of Lactated Ringer’s Injection due to the increased risk of digoxin toxicity with calcium-containing solutions. • Drugs with pH-Dependent Renal Elimination: Renal clearance of acidic drugs may be increased. In contrast, renal clearance of alkaline drugs may be decreased.

Store at room temperature (recommended 25°C/77°F). Brief exposure up to 40°C (104°F) does not adversely affect the product.