LACTATED RINGERS- sodium chloride, sodium lactate, potassium chloride, and calcium chloride irrigant

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 - UNII:33X04XA5AT), 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:

IRRIGATION

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Lactated Ringer's Irrigation is indicated for all general irrigation, washing and rinsing purposes which permit use of a sterile, nonpyrogenic electrolyte solution. NOT FOR INJECTION BY USUAL PARENTERAL ROUTES. An electrolyte solution should not be used for irrigation during electrosurgical procedures.

Product summary:

Lactated Ringer's Irrigation is supplied sterile and nonpyrogenic in PIC™ (Plastic Irrigation Container). The 1000 mL containers are packaged 16 per case. Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature.] However, brief exposure up to 40°C does not adversely affect the product. Do not warm above 150°F (66°C).

Authorization status:

New Drug Application

Summary of Product characteristics

LACTATED RINGERS- SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE,
AND
CALCIUM CHLORIDE IRRIGANT
B. BRAUN MEDICAL INC.
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LACTATED RINGER'S IRRIGATION
Y36-002-965 LD-780-1
Package Insert
PIC™ (PLASTIC IRRIGATION CONTAINER)
_FOR ALL GENERAL IRRIGATION, WASHING AND RINSING PURPOSES_
NOT FOR INJECTION BY USUAL PARENTERAL•ROUTES
SEMI-RIGID IRRIGATION CONTAINER
ISOTONIC SOLUTION FOR IRRIGATION.
FOR IRRIGATION ONLY. NOT FOR INJECTION.
RX ONLY
DESCRIPTION
Lactated Ringer's Irrigation is a sterile, nonpyrogenic, solution of
electrolytes in water for
injection intended only for sterile irrigation, washing and rinsing
purposes. The
composition is based on a modification of the injectable formula
originally known as
Hartmann's Solution.
Each 100 mL 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 adjusted with Hydrochloric Acid NF
pH: 6.75 (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
The solution contains no bacteriostat, antimicrobial agent or added
buffer (except for pH
adjustment) and is intended only for use as a single-dose or short
procedure irrigation.
When smaller volumes are required the unused portions should be
discarded. Lactated
Ringer's Irrigation may be classified as a sterile irrigant, wash,
rinse and pharmaceutical
vehicle.
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
3
−
3
Calcium Chloride Dihydrate USP
CaCl
•2H O
147.01
The plastic container is a copolymer of ethylene and propylene
formulated and
developed for parenteral drugs. The copolymer contains no plasticizers
and exhibits
virtually no leachability. The plastic container is also virtually
impermeable to vapor
transmission and therefore, requires no ove