POTASSIUM CHLORIDE IN LACTATED RINGERS AND DEXTROSE- dextrose monohydrate, sodium chloride, sodium lactate, potassium chloride,

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK), 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)

Διαθέσιμο από:

Baxter Healthcare Corporation

INN (Διεθνής Όνομα):

DEXTROSE MONOHYDRATE

Σύνθεση:

DEXTROSE MONOHYDRATE 5 g in 100 mL

Οδός χορήγησης:

INTRAVENOUS

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP are indicated as a source of water, electrolytes, and calories or as alkalinizing agents. Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP is contraindicated in:

Περίληψη προϊόντος:

Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP in VIAFLEX Plus plastic containers is available as shown below: Code Size (mL) NDC Product Name 2B2224 1000 0338-0811-04 20 mEq/L Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP 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.

Καθεστώς αδειοδότησης:

New Drug Application

Αρχείο Π.Χ.Π.

POTASSIUM CHLORIDE IN LACTATED RINGERS AND DEXTROSE- DEXTROSE
MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE,
CALCIUM CHLORIDE INJECTION,
SOLUTION
BAXTER HEALTHCARE CORPORATION
----------
POTASSIUM CHLORIDE IN LACTATED RINGER’S AND
5% DEXTROSE INJECTION, USP
IN PLASTIC CONTAINER
VIAFLEX PLUS CONTAINER
DESCRIPTION
Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection,
USP is a sterile, nonpyrogenic
solution for fluid and electrolyte replenishment and caloric supply in
a single dose container for
intravenous administration. It contains no antimicrobial agents.
Composition, osmolarity, pH, ionic
concentration and caloric content are shown below:
TABLE 1.
*
†
Composition (g/L)
Potassium
Chloride
in
Lactated
Ringer’s
and 5%
Dextrose
Injection,
USP
mEq
Potassium
added
20 mEq
1000
50
6
3.1
1.79
0.2
565
DEXTROSE IS DERIVED FROM CORN.
Dextrose is derived from corn.
TABLE 2.
pH
Ionic Concentration (mEq/L)
Caloric
Content
(kcal/L)
Potassium
Chloride in
Lactated
Ringer’s and
5% Dextrose
Injection,
USP
Sodium
POTAS S IUM
Calcium
Chloride
Lactate
mEq Potassium
Normal physiologic osmolarity range is approximately 280 to 310
mOsmol/L.
The chemical structure for Dextrose Hydrous, USP is shown below.
Size
(mL)
Osmolarity
(mOsmol/L)
(calc.)
*
Dextrose
Hydrous,
USP
†
Sodium
Chloride,
USP
(NaCl)
Sodium
Lactate,
(C H NaO )
3
5
3
Potassium
Chloride,
USP
(KCl)
Calcium
Chloride,
USP
(CaCl
•2H O)
2
2
added
20 mEq
5.0
(3.5 to 6.5)
130
24
3
129
28
170
The VIAFLEX Plus plastic container is fabricated from a specially
formulated polyvinyl chloride (PL
146 Plastic). VIAFLEX Plus on the container indicates the presence of
a drug additive in a drug
vehicle. The VIAFLEX Plus plastic container system utilizes the same
container as the VIAFLEX
plastic container system. 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