LACTATED RINGERS- sodium chloride, sodium lactate, potassium chloride, and calcium chloride injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698), SODIUM LACTATE (UNII: TU7HW0W0QT) (LACTIC ACID - UNII:33X04XA5AT, SODIUM CATION - UNII:LYR4M0NH37), POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152, CHLORIDE ION - UNII:Q32ZN48698), CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB, CHLORIDE ION - UNII:Q32ZN48698)

Available from:

B. Braun Medical Inc.

INN (International Name):

SODIUM CHLORIDE

Composition:

SODIUM CHLORIDE 0.6 g in 100 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

This solution is indicated for use in adults and pediatric patients as a source of electrolytes and water for hydration. The use of Lactated Ringer’s Injection USP is contraindicated in neonates (28 days of age or younger) 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 [see Warnings, Drug Interactions, Pediatric Use ]. This solution is contraindicated where the administration of sodium, potassium, calcium, lactate, or chloride could be clinically detrimental. Lactate administration is contraindicated in severe metabolic acidosis or alkalosis, and in severe liver disease or anoxic states which affect lactate metabolism.

Product summary:

Lactated Ringer's Injection USP is supplied sterile and nonpyrogenic in EXCEL® Containers. The 1000 mL containers are packaged 12 per case, the 500 mL and 250 mL containers are packaged 24 per case. Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at room temperature (25°C); however, brief exposure up to 40°C does not adversely affect the product.

Authorization status:

New Drug Application

Summary of Product characteristics

LACTATED RINGERS- SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE,
AND
CALCIUM CHLORIDE INJECTION, SOLUTION
B. BRAUN MEDICAL INC.
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LACTATED RINGER'S INJECTION USP
DESCRIPTION
RX ONLY
Each 100 mL of Lactated Ringer's 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 (CH CH(OH)COO ) 28
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.
The formulas of the active ingredients are:
INGREDIENTS
MOLECULAR FORMULAMOLECULAR WEIGHT
Sodium Chloride USP
NaCl
58.44
Sodium Lactate
CH CH(OH)COONa
112.06
Potassium Chloride USP
KCl
74.55
Calcium Chloride Dihydrate USP
CaCl
•2H O
147.02
Not made with natural rubber latex, PVC or DEHP.
The plastic container is made from a multilayered film specifically
developed for
parenteral drugs. It contains no plasticizers and exhibits virtually
no leachables. The
solution contact layer is a rubberized copolymer of ethylene and
propylene. The
container is nontoxic and biologically inert. 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.
Addition of medication should be accomplished using complete aseptic
technique.
The closure system has two ports; the one for the administration set
has a tamper
evident plastic protector and the other is a medication addition site.
Refer to the
Directions for Use of the container.
CLINICAL PHARMACOLOGY
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Lactated Ringer's Injection USP provide