LACTATED RINGERS- sodium chloride, potassium chloride, sodium lactate 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) (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:

Baxter Healthcare Corporation

INN (International Name):

SODIUM CHLORIDE

Composition:

SODIUM CHLORIDE 600 mg in 100 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Lactated Ringer’s Injection, USP is indicated as a source of water and electrolytes or as an alkalinizing agent. Lactated Ringer’s Injection, USP is contraindicated in:

Product summary:

Lactated Ringer’s Injection, USP in VIAFLEX plastic container is available as follows: Code Size (mL) NDC 2B2322 250 0338-0117-02 2B2323 500 0338-0117-03 2B2324 1000 0338-0117-04 Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored at room temperature (25°C); 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, POTASSIUM CHLORIDE, SODIUM LACTATE
AND CALCIUM
CHLORIDE INJECTION, SOLUTION
BAXTER HEALTHCARE CORPORATION
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LACTATED RINGER’S INJECTION, USP
IN VIAFLEX PLASTIC CONTAINER
DESCRIPTION
Lactated Ringer’s Injection, USP is a sterile, nonpyrogenic solution
for fluid and electrolyte
replenishment in single dose containers for intravenous
administration. It contains no antimicrobial
agents. Composition, osmolarity, pH, ionic concentration and caloric
content are shown in Table 1.
TABLE 1
Composition (g/L)
Ionic Concentration (mEq/L)
Size
(mL)
Sodium
Chloride,
USP,
(NaCl)
Sodium
Lactate,
(C H NaO )
Potassium
Chloride,
USP,
(KCl)
Calcium
Chloride,
USP
(CaCl
·2H O)
Osmolarity
(mOsmol/L)
(calc)
pH SodiumPOTAS S IUM CalciumChloride Lactate
Caloric
Content
(kcal/L)
Lactated
Ringer’s
Injection,
USP
250
500
1000
6
3.1
0.3
0.2
273
6.5
(6.0
to
7.5)
130
4
2.7
109
28
9
The VIAFLEX plastic container is fabricated from a specially
formulated polyvinyl chloride (PL 146
Plastic). The amount of water that can permeate from inside the
container into the overwrap is
insufficient to affect the solution significantly. Solutions in
contact with the plastic container can leach
out certain of its chemical components in very small amounts within
the expiration period, e.g., di-2-
ethylhexyl phthalate (DEHP), up to 5 parts per million. However, the
safety of the plastic has been
confirmed in tests in animals according to USP biological tests for
plastic containers as well as by
tissue culture toxicity studies.
CLINICAL PHARMACOLOGY
Lactated Ringer’s Injection, USP has value as a source of water and
electrolytes. It is capable of
inducing diuresis depending on the clinical condition of the patient.
Lactated Ringer’s Injection, USP produces a metabolic alkalinizing
effect. Lactate ions are metabolized
ultimately to carbon dioxide and water, which requires the consumption
of hydrogen cations.
INDICATIONS AND USAGE
Lactated Ringer’s Injection, USP is indicated as a source of water
and electroly