LACTATED RINGERS IRRIGATION- sodium chloride, sodium lactate, potassium chloride and calcium chloride 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 600 mg 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 single-dose 3000 mL flexible irrigation container packaged 4 per case. Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. Store at 20°–25°C (68°–77°F) [see USP Controlled Room Temperature]; however, brief exposure up to 40°C does not adversely affect the product. Do not warm container over 150°F (66°C).

Authorization status:

New Drug Application

Summary of Product characteristics

LACTATED RINGERS IRRIGATION- SODIUM CHLORIDE, SODIUM LACTATE,
POTASSIUM
CHLORIDE AND CALCIUM CHLORIDE SOLUTION
B. BRAUN MEDICAL INC.
----------
LACTATED RINGER'S IRRIGATION
_FOR ALL GENERAL IRRIGATION, WASHING AND RINSING PURPOSES_
NOT FOR INJECTION BY USUAL PARENTERAL ROUTES
FLEXIBLE IRRIGATION CONTAINER
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 of Lactated Ringer’s Irrigation contains: Sodium
chloride 600 mg; sodium
lactate, anhydrous 310 mg; potassium chloride 30 mg; calcium chloride,
dihydrate 20
mg. The pH is 6.75 (6.0 — 7.5). The solution is isotonic (273
mOsmol/liter, calc.) and has
the following electrolyte content (mEq/liter): Sodium (Na ) 130;
potassium (K ) 4;
calcium (Ca
) 3; chloride (Cl¯) 109 and lactate (CH CH(OH)COO¯) 28. Contains
sodium
hydroxide and may contain hydrochloric acid for pH adjustment.
The solution contains no bacteriostatic or antimicrobial agent or
added buffer and is
intended only for use as a single-dose or short procedure irrigation.
When smaller
volumes are required, the unused portion should be discarded. Lactated
Ringer’s
Irrigation may be classified as a sterile irrigant, wash, rinse and
pharmaceutical vehicle.
Calcium Chloride, USP is chemically designated calcium chloride,
dihydrate (CaCl
•
2H O), white fragments or granules freely soluble in water.
Potassium Chloride, USP is chemically designated KCl, a white granular
powder freely
soluble in water.
Sodium Chloride, USP is chemically designated NaCl, a white
crystalline powder freely
soluble in water.
Sodium Lactate, USP is chemically designated C H NaO , a 60% aqueous
solution
miscible in water.
It has the following structural formula:
+
+
++
3
2
2
3
5
3
Water for Injection, USP is chemically designated H O.
The plastic container is made from a m