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. 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 Additi

Ապրանքի ամփոփագիր:

5% Dextrose and 0.9% Sodium Chloride Injection, USP is supplied in single-dose flexible plastic containers in 500 mL and 1000 mL sizes as follows: 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, Illinois 60047 Made in Germany 451685 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 0.9% 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
monohydrate and 0.9 grams per
100 mL of Sodium Chloride in water for injection intended for
intravenous administration. Electrolytes
per 1000 mL: sodium (Na ), 154 mEq; chloride (Cl ) 154 mEq. The
osmolarity is 560 mOsmol/L (calc.),
which is hypertonic. The caloric value is 170 kcal/L. The pH is 4.3
(3.5 to 6.5).
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.
+
-
6
12
6
2
2
®
Solutions which provide combinations