POTASSIUM CHLORIDE IN SODIUM CHLORIDE- sodium chloride and potassium 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), POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152, CHLORIDE ION - UNII:Q32ZN48698)

Available from:

B. Braun Medical Inc.

INN (International Name):

SODIUM CHLORIDE

Composition:

SODIUM CHLORIDE 0.9 g in 100 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Potassium Chloride in 0.9% Sodium Chloride Injection is indicated for use in adults and pediatric patients as a source of electrolytes and water for hydration. Potassium Chloride in 0.9% Sodium Chloride Injection is contraindicated in clinical conditions where additives of sodium, potassium or chloride could be clinically detrimental.

Product summary:

Potassium Chloride in 0.9% Sodium Chloride Injection 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); however, brief exposure up to 40°C does not adversely affect the product. Storage in automated dispensing machines: Brief exposure up to 2 weeks to ultraviolet or fluorescent light does not adversely affect the product labeling legibility; prolonged exposure can cause fading of the red label. Rotate stock frequently.

Authorization status:

New Drug Application

Summary of Product characteristics

POTASSIUM CHLORIDE IN SODIUM CHLORIDE- SODIUM CHLORIDE AND POTASSIUM
CHLORIDE SOLUTION
B. BRAUN MEDICAL INC.
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POTASSIUM CHLORIDE IN 0.9% SODIUM CHLORIDE INJECTION
DESCRIPTION
Each 100 mL of 0.15% POTASSIUM CHLORIDE IN 0.9% SODIUM CHLORIDE
INJECTION
(20 MEQ K /LITER) contains: Sodium Chloride USP 0.9 g
Potassium Chloride USP 0.15 g; Water for Injection USP qs
pH may be adjusted with Hydrochloric Acid NF
pH: 5.6 (3.5–6.5) Calculated Osmolarity: 350 mOsmol/liter
Concentration of Electrolytes (mEq/liter):
Sodium 154 Potassium 20 Chloride 174
Potassium Chloride in 0.9% Sodium Chloride Injection is sterile,
nonpyrogenic, hypertonic
and contains no bacteriostatic or antimicrobial agents. This product
is intended for
intravenous administration.
The formulas of the active ingredients are:
INGREDIENTS
MOLECULAR
FORMULA
MOLECULAR
WEIGHT
Sodium Chloride USP
NaCl
58.44
Potassium Chloride USP
KCl
74.55
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
Potassium Chloride in 0.9% Sodium Chloride Injection provides
electrolytes and is a
source of water for hydration. It is capable of inducing diuresis
depending on the clinical
condition of the patient.
+
Sodium, the major c