LACTATED RINGERS- sodium chloride, sodium lactate, potassium chloride, 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) (SODIUM CATION - UNII:LYR4M0NH37, LACTIC ACID, UNSPECIFIED FORM - UNII:33X04XA5AT), CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB, CHLORIDE ION - UNII:Q32ZN48698), POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152, CHLORIDE ION - UNII:Q32ZN48698)

Available from:

HF Acquisition Co LLC, DBA HealthFirst

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

These solutions are 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. Solutions containing lactate are NOT FOR USE IN THE TREATMENT OF LACTIC ACIDOSIS. To Open: Tear outer wrap at notch and remove solution container. If supplemental medication is desired, follow directions below before preparing for administration. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. To Add Medication Prepare additive port. Using aseptic technique and an additive delivery needle of appropriate length, puncture resealable additive port at target area, inner diaphragm and inject. Withdraw needle after injecting medication. The additive port may be protected by covering with an additive cap. Mix container contents thoroughly. Preparation for Administration (Use aseptic technique) Close flow control clamp of administration set. Remove cover from outlet port at bottom of container. Insert piercing pin of administration set into port with a twisting motion until the set is firmly seated. NOTE: See full directions on administration set carton. Suspend container from hanger. Squeeze and release drip chamber to establish proper fluid level in chamber. Open flow control clamp and clear air from set. Close clamp. Attach set to venipuncture device. If device is not indwelling, prime and make venipuncture. Regulate rate of administration with flow control clamp. WARNING: DO NOT USE FLEXIBLE CONTAINER IN SERIES CONNECTIONS.

Product summary:

LACTATED RINGER'S INJECTION, USP is supplied in the following dosage forms. NDC 51662-1516 LACTATED RINGER'S INJECTION, USP 1000mL BAG HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 Also supplied in the following manufacture supplied dosage forms These solutions are supplied in single-dose flexible plastic containers as follows: ICU Medical is transitioning NDC codes from "0409" to a"0990" labeler code. Both NDC codes are expected to be in the market for a period of time. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. Revised: April, 2018 EN-4688

Authorization status:

New Drug Application

Summary of Product characteristics

LACTATED RINGERS- SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE,
CALCIUM CHLORIDE INJECTION, SOLUTION
HF ACQUISITION CO LLC, DBA HEALTHFIRST
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LACTATED RINGER'S INJECTION, USP 1000ML BAG
SPL UNCLASSIFIED
Flexible Plastic Container
Rx only
DESCRIPTION
These products are sterile, nonpyrogenic solutions each containing
isotonic
concentrations of electrolytes (with or without dextrose) in water for
injection. The
solutions containing dextrose and electrolytes are hypertonic; those
containing only
electrolytes are isotonic. They are administered by intravenous
infusion for parenteral
replacement of extracellular losses of fluid and electrolytes, with or
without minimal
carbohydrate calories.
Each 100 mL of Lactated Ringer's Injection, USP contains sodium
chloride 600 mg,
sodium lactate, anhydrous 310 mg, potassium chloride 30 mg and calcium
chloride,
dihydrate 20 mg. May contain hydrochloric acid and/or sodium hydroxide
for pH
adjustment. A liter provides 9 calories (from lactate), sodium (Na+),
130 mEq,
potassium (K+) 4 mEq, calcium (Ca++) 3 mEq, chloride (Cl−) 109 mEq
and lactate
[CH3CH(OH) COO−] 28 mEq. The electrolyte content is isotonic (273
mOsmol/liter, calc.)
in relation to the extracellular fluid (approx. 280 mOsmol/liter). The
pH of the solution is
6.6 (6.0 − 7.5).
Each 100 mL of Lactated Ringer's and 5% Dextrose Injection, USP
contains dextrose,
hydrous 5 g plus the same ingredients and mEq values as Lactated
Ringer's Injection,
USP (contains only hydrochloric acid for pH adjustment). A liter
provides 179 calories
(from dextrose and lactate) and has a hypertonic osmolar concentration
of 525 mOsmol
(calc.). The pH is 4.9 (4.0 − 6.5).
The solutions contain no bacteriostat, antimicrobial agent or added
buffer (except for pH
adjustment) and each is intended only for use as a single-dose
injection. When smaller
doses are required the unused portion should be discarded.
The solutions are parenteral fluid, nutrient and/or electrolyte
replenishers.
Dextrose, USP is chemically designated D-glu