POTASSIUM CHLORIDE IN DEXTROSE AND SODIUM CHLORIDE- dextrose, sodium chloride, and potassium chloride injection

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

DEXTROSE (UNII: IY9XDZ35W2) (DEXTROSE - UNII:IY9XDZ35W2), SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698), POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152)

Disponível em:

B. Braun Medical Inc.

DCI (Denominação Comum Internacional):

DEXTROSE

Composição:

DEXTROSE 5 g in 100 mL

Via de administração:

INTRAVENOUS

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

These intravenous solutions are indicated for use in adults and pediatric patients as sources of electrolytes, calories and water for hydration. These solutions are contraindicated where the administration of sodium, potassium or chloride could be clinically detrimental. Solutions containing dextrose may be contraindicated in patients with hypersensitivity to corn products.

Resumo do produto:

Potassium Chloride in Dextrose and Sodium Chloride Injections USP are supplied in EXCEL® Containers. The 1000 mL containers are 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).

Status de autorização:

New Drug Application

Características técnicas

POTASSIUM CHLORIDE IN DEXTROSE AND SODIUM CHLORIDE- DEXTROSE,
SODIUM CHLORIDE, AND POTASSIUM CHLORIDE INJECTION
B. BRAUN MEDICAL INC.
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POTASSIUM CHLORIDE IN DEXTROSE AND SODIUM CHLORIDE INJECTIONS USP
DESCRIPTION
(See chart below for quantitative information.)
Potassium Chloride in Dextrose and Sodium Chloride Injections USP are
sterile,
nonpyrogenic and contain no bacteriostatic or antimicrobial agents.
These products are
intended for intravenous administration.
The formulas of the active ingredients are:
INGREDIENTS
MOLECULAR
FORMULA
MOLECULAR
WEIGHT
Sodium Chloride USP
Potassium Chloride USP
NaCl
KCl
58.44
74.55
Hydrous Dextrose USP
198.17
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.
COMPOSITION – EACH 100 ML CONTAINS:
SOLUTION
HYDROUS
DEXTROSE
USP
SODIUM
CHLORIDE
USP
POTASSIUM
CHLORIDE
USP
CONCENTRATION OF
ELECTROLYTES (MEQ/LITER)
CALORIES
PER
LITER
CALCULATED
OSMOLARITY
MOSMOL/LITER
PH
SODIUMPOTASSIUMCHLORIDE
0.15%
Potassium
Chloride in
5%
Dextrose
and
0.20%
Sodium
Chloride
Injection
USP
5 g
0.2 g
0.15 g
34
20
54
170
360
4.4
(3.5–
6.5)
Water for Injection USP qs
0.075%
Potassium
Chloride in
5%
Dextrose
and
0.45%
Sodium
Chloride
Injection
USP
5 g
0.45 g
0.075 g
77
10
87
170
425
4.4
(3.5–
6.5)
0.15%
Potassium
Chloride in
5%
Dextrose
and
0.45%
Sodium
Chloride
Injection
USP
5 g
0.45 g
0.15 g
77
20
97
170
445
4.4
(3.5–
6.5)
0.22%
Potassium
Chloride in
5%
Dextrose
and
0.45%
Sodium
Chloride
Injection
USP
5 g
0.45 g
0.22 g
77
30
107
170
465
4.4
(3.