LACTATED RINGERS sodium chloride potassium and calcium injection solution

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

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Prenos Lastnosti izdelka (SPC)
11-01-2018

Aktivna sestavina:

SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698)

Dostopno od:

B. Braun Medical Inc.

INN (mednarodno ime):

SODIUM CHLORIDE

Sestava:

SODIUM CHLORIDE 0.6 g in 100 mL

Tip zastaranja:

PRESCRIPTION DRUG

Status dovoljenje:

New Drug Application

Lastnosti izdelka

                                LACTATED RINGERS- SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE,
AND CALCIUM
CHLORIDE INJECTION, SOLUTION
B. BRAUN MEDICAL INC.
----------
LACTATED RINGER'S INJECTION USP
DESCRIPTION
Each 100 mL of Lactated Ringer's Injection USP contains:
Sodium Chloride USP 0.6 g; Sodium Lactate USP 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: 274 mOsmol/liter
Concentration of Electrolytes (mEq/liter): Sodium 130; Potassium 4;
Calcium 3; Chloride 109; 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 FORMULA
MOLECULAR
WEIGHT
Sodium Chloride USP
NaCl
58.44
Sodium Lactate USP
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 homogenous blend of polypropylene
and thermoplastic modifier
specifically developed for parenteral drugs. The container is nontoxic
and biologically inert. The
container is a closed system and is not dependent upon entry of
external air during administration.
Addition of medication should be accomplished using complete aseptic
technique.
The closure system has two ports; one for the administration set and
the other is a medication addition
site. Each port has a tamper evident cover. Refer to the Directions
for Use of the container.
CLINICAL PHARMACOLOGY
Lactated Ringer's Injection USP provides electrolytes and is a source
of water for hydration. It is
capable of inducing diuresis depending on the clinical condition of
the patient. This solution also
contains lactate which produces a metabolic alkalinizing effect.
Sodium, the major cation of the extracellular fl
                                
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