DEXTROSE AND SODIUM CHLORIDE- dextrose monohydrate and sodium chloride injection, solution

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK), SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698)

Հասանելի է:

Fresenius Kabi USA, LLC

Կառավարման երթուղին:

INTRAVENOUS

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

Intravenous solutions containing dextrose and sodium chloride are indicated for parenteral replenishment of fluid, minimal carbohydrate calories, and sodium chloride as required by the clinical condition of the patient. None known.

Ապրանքի ամփոփագիր:

5% Dextrose and 0.45 % Sodium Chloride Injection, USP is supplied in single-dose flexible plastic containers in 250 mL, 500 mL and 1000 mL sizes as follows: The container closure is not made with natural rubber latex. Non-PVC, Non-DEHP, Sterile. Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. Store at 20 ° to 25 °C (68 ° to 77 °F). [See USP Controlled Room Temperature.] Manufactured for: Lake Zurich, IL 60047 Made in Germany 451684 www.fresenius-kabi.com/us Issued: September 2020

Լիազորման կարգավիճակը:

Abbreviated New Drug Application

Ապրանքի հատկությունները

DEXTROSE AND SODIUM CHLORIDE- DEXTROSE MONOHYDRATE AND SODIUM CHLORIDE
INJECTION,
SOLUTION
FRESENIUS KABI USA, LLC
----------
5% DEXTROSE AND 0.45% SODIUM CHLORIDE INJECTION, USP
Rx only
DESCRIPTION
5% Dextrose and 0.45% Sodium Chloride Injection, USP solutions are
sterile and nonpyrogenic. They
are large volume parenteral solutions containing 5 grams per 100 mL of
Dextrose monohydrate and 0.45
grams per 100 mL of Sodium Chloride in water for injection intended
for intravenous administration.
Each 100 mL of 5% Dextrose and 0.45% Sodium Chloride Injection, USP
contains dextrose, hydrous
5g and sodium chloride 0.45 g in water for injection. Electrolytes per
1000 mL: sodium (Na ), 77 mEq;
chloride (Cl ) 77 mEq. The osmolarity is 406 mOsmol/L (calc.), which
is hypertonic. The caloric value
is 170 kcal/L. The pH is 4.3 (3.5 to 6.5).
5% Dextrose and 0.45% Sodium Chloride Injection, USP contains no
bacteriostat, antimicrobial agent or
added buffer and is intended only as a single-dose injection. When
smaller doses are required the
unused portion should be discarded.
5% Dextrose and 0.45% Sodium Chloride Injection, USP is a parenteral
fluid, nutrient and electrolyte
replenisher.
Dextrose, USP is chemically designated D-glucose monohydrate (C H O
• H O), a hexose sugar
freely soluble in water. It has the following structural formula:
Sodium Chloride, USP is chemically designated NaCl, a white
crystalline powder freely soluble in
water.
Water for Injection, USP is chemically designated H O.
The flexible container is fabricated from a specially formulated
non-plasticized, film containing
polypropylene and thermoplastic elastomers (FREE_flex_
bag). The amount of water that can permeate
from the container into the overwrap is insufficient to affect the
solution significantly.
Solutions in contact with the flexible container can leach out certain
of the container's chemical
components in very small amounts within the expiration period. The
suitability of the container material
has been confirmed by tests in animals according