B Braun L7500 - Lactated Ringer's Injection USP, 1000 mL, 12/CS

B Braun L7500 – Lactated Ringer’s Injection USP, 1000 mL, 12/CS

L7500 Lactated Ringer’s Injection USP, 1000 mL

Lactated Ringer’s Injection USP is sterile, nonpyrogenic and contains no bacteriostatic or antimicrobial agents. This product is intended for intravenous administration in a single dose container. This solution is indicated for use in adults and pediatric patients as a source of electrolytes and water for hydration.

Each 100 mL of B Braun L7500 Lactated Ringers Injection USP contains:

• Sodium Chloride USP 0.6 g; Sodium Lactate 0.31 g
• Potassium Chloride USP 0.03 g; Calcium Chloride Dihydrate USP 0.02 g
• Water for Injection USP qs
• pH may be adjusted with Hydrochloric Acid NF or Sodium Hydroxide NF
• pH: 6.2 (6.0-7.5)
• Calculated Osmolarity: 275 mOsmol/liter
• Concentration of Electrolytes (mEq/liter):
• Sodium 130; Potassium 4; Calcium 3; Chloride 110; Lactate (CH3CH(OH)COO) 28

Clinical Pharmacology

Lactated Ringers Injection USP provides electrolytes and is a source of water for hydration. It is capable of inducing diuresis depending on the clinical condition of the patient. This solution also contains lactate which produces a metabolic 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 acidbase balance of the body are reflected by changes in the chloride concentration. Calcium, an important cation, provides the framework of bones and teeth in the form of calcium phosphate and calcium carbonate. In the ionized form, calcium is essential for the functional mechanism of the clotting of blood, normal cardiac function, and regulation of neuromuscular irritability.

Sodium lactate is a racemic salt containing both the levo form, which is oxidized by the liver to bicarbonate, and the dextro form, which is converted to glycogen. Lactate is slowly metabolized to carbon dioxide and water, accepting one hydrogen ion and resulting in the formation of bicarbonate for the lactate consumed. These reactions depend on oxidative cellular activity.

B. Braun L7500 Dosage and Administration

This solution is for intravenous use only. Dosage is to be directed by a physician and is dependent upon age, weight, clinical condition of the patient and laboratory determinations. Frequent laboratory determinations and clinical evaluation are essential to monitor changes in blood glucose and electrolyte concentrations, and fluid and electrolyte balance during prolonged parenteral therapy.

Fluid administration should be based on calculated maintenance or replacement fluid requirements for each patient. The presence of calcium ions in this solution should be considered when phosphate is present in additive solutions, in order to avoid precipitation. Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Ceftriaxone must not be administered simultaneously with calcium-containing intravenous solutions such as Lactated Ringers Injection USP via a Y-site. However, in patients other than neonates, ceftriaxone and Lactated Ringers Injection USP may be administered sequentially if the infusion lines are thoroughly flushed between infusions with a compatible fluid.

B. Braun L7500 Excel IV Container Features

Excel IV containers by B. Braun are biologically inert and not made with PVC or DEHP, therefore these containers minimize patient exposure to the toxic DEHP plasticizer compared to using PVC containers that contain DEHP.

B. Braun L7500 Excel IV Container Specifications

• Manufacturer: B. Braun L7500
• Application: Replacement Preparation
• Container Type: Flexible Bag
• Dosage Form: IV Solution
• Generic Drug Name: Lactated Ringer’s Solution
• Type: Intravenous
• Volume: 1,000 mL
• EXCEL Flexible Plastic Bag