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

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Fresenius Kabi USA, LLC

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. Check flexible container solution composition, lot number, and expiry date. Do not remove solution container from its overwrap until immediately before use. Use sterile equipment and aseptic technique. To Open - Turn solution container over so that the text is face down. Using the pre-cut corner tabs, peel open the overwrap and remove solution container. - Check the solution container for leaks by squeezing firmly. If leaks are found, or if the seal is not intact, discard the solution. - Do not use if the solution is cloudy or a precipitate is present. To Add Medication - Identify WHITE Additive Port with arrow pointing toward container. - Immediately before injecting additives, break off WHITE Additive Port Cap with the arrow pointing toward container. - Hold base of WHITE Additiv

Product summary:

Dextrose and Sodium Chloride Injection, USP are supplied in single-dose flexible plastic containers in various sizes as shown in the accompanying Table. The container closure is not made with natural rubber latex. Non-PVC, Non-DEHP, Sterile. 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 451679 www.fresenius-kabi.com/us Issued: September 2020

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DEXTROSE AND SODIUM CHLORIDE - DEXTROSE MONOHYDRATE AND SODIUM
CHLORIDE INJECTION,
SOLUTION
FRESENIUS KABI USA, LLC
----------
DEXTROSE AND SODIUM CHLORIDE- dextrose monohydrate and sodium chloride
injection,
solution Dextrose and Sodium Chloride Injection, USP
Rx only
DESCRIPTION
Dextrose and Sodium Chloride Injection, USP solutions are sterile and
nonpyrogenic. They are large
volume parenteral solutions containing 5 grams per 100 mL of Dextrose
and 0.3 grams per 100 mL of
Sodium Chloride in water for injection intended for intravenous
administration.
See Table for summary of content and characteristics of these
solutions.
The solutions contain no bacteriostat, antimicrobial agent or added
buffer and each is intended only as a
single-dose injection. When smaller doses are required the unused
portion should be discarded.
The solutions are parenteral fluid, nutrient and electrolyte
replenishers.
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 to USP biological tests for plastic
containers.
CLINICAL PHARMACOLOGY
When administered intravenously, these solutions provide a source of
water, carbohydrate and
electrolytes.
Solutions which provide combinations of hypotonic or isotonic
concentrations of dextrose and of
sodium c