RINGERS- sodium chloride, calcium chloride, and potassium chloride injection, solution

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698, SODIUM CATION - UNII:LYR4M0NH37), CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB, CHLORIDE ION - UNII:Q32ZN48698), POTASSIUM CHLORIDE (UNII: 660YQ98I10) (CHLORIDE ION - UNII:Q32ZN48698, POTASSIUM CATION - UNII:295O53K152)

제공처:

B. Braun Medical Inc.

INN (국제 이름):

SODIUM CHLORIDE

구성:

SODIUM CHLORIDE 0.86 g in 100 mL

관리 경로:

INTRAVENOUS

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

This solution is indicated for use in adults and pediatric patients as a source of electrolytes and water for hydration. The use of Ringer’s Injection USP is contraindicated in neonates (28 days of age or younger) receiving concomitant treatment with ceftriaxone, even if separate infusion lines are used, due to the risk of fatal ceftriaxone-calcium salt precipitation in the neonate’s bloodstream [see Warnings, Drug Interactions, Pediatric Use ]. This solution is contraindicated where the administration of sodium, potassium, calcium, or chloride could be clinically detrimental.

제품 요약:

Ringer's Injection USP is supplied sterile and nonpyrogenic in EXCEL® Containers packaged 12 per case. Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at room temperature (25°C).

승인 상태:

New Drug Application

제품 특성 요약

RINGERS- SODIUM CHLORIDE, CALCIUM CHLORIDE, AND POTASSIUM CHLORIDE
INJECTION,
SOLUTION
B. BRAUN MEDICAL INC.
----------
_EXCEL® CONTAINER_
RINGER'S INJECTION USP
DESCRIPTION
Each 100 mL of Ringer's Injection USP contains:
Sodium Chloride USP 0.86 g; Calcium Chloride Dihydrate USP 0.033 g;
Potassium
Chloride USP 0.03 g; Water for Injection USP qs
pH: 5.8 (5.0–7.5) Calculated Osmolarity: 310 mOsmol/liter
Concentration of Electrolytes (mEq/liter): Sodium 147; Potassium 4;
Calcium 4.5;
Chloride 156
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 FORMULAMOLECULAR WEIGHT
Sodium Chloride USP
NaCl
58.44
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 multilayered film specifically
developed for
parenteral drugs. It contains no plasticizers and exhibits virtually
no leachables. The
solution contact layer is a rubberized copolymer of ethylene and
propylene. The
container is nontoxic and biologically inert. The container-solution
unit is a closed system
and is not dependent upon entry of external air during administration.
The container is
overwrapped to provide protection from the physical environment and to
provide an
additional moisture barrier when necessary.
Addition of medication should be accomplished using complete aseptic
technique.
The closure system has two ports; the one for the administration set
has a tamper
evident plastic protector and the other is a medication addition site.
Refer to the
Directions for Use of the container.
CLINICAL PHARMACOLOGY
Ringer's Injection USP provides electrolytes and is a source of water
for hydration. It is
2
2
capable of inducing diuresis depending on the clinical condition of
the patient.
Sodium, the major cation of the extracellular fluid, functions
pr