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:

ICU Medical Inc.

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. To Open: Tear outer wrap at notch and remove solution container. If supplemental medication is desired, follow directions below before preparing for administration. To Add Medication - Prepare additive port. - Using aseptic technique and an additive delivery needle of appropriate length, puncture resealable additive port at target area, inner diaphragm and inject. Withdraw needle after injecting medication. - The additive port may be protected by covering with an additive cap. - Mix container contents thoroughly. Preparation for Administration (Use aseptic technique) - Close flow control clamp of administration set. - Remove cover from outlet port at bottom of container. - Insert piercing pin of administration set into port with a twisting motion until the set is firmly seated. NOTE: When using a vented administration set, replace bacterial retentive air filter with piercing pin cover. Insert piercing pin with twisting motion until shoulder of air filter housing rests against the outlet port flange. - Suspend container from hanger. - Squeeze and release drip chamber to establish proper fluid level in chamber. - Attach venipuncture device to set. - Open clamp to expel air from set and venipuncture device. Close clamp. - Perform venipuncture. - Regulate rate of administration with flow control clamp. WARNING: Do not use flexible container in series connections.

Product summary:

Dextrose and Sodium Chloride Injection, USP are supplied in single-dose flexible plastic containers in various sizes and concentrations as shown in the accompanying Table. Grams/100 mL Per 1000 mL NDC No. Product Dextrose (hydrous) Sodium Chloride Sodium Na+ Chloride Cl¯ Caloric Value Tonicity Osmolarity mOsmol/L (calc) pH Container size (mL) 0409-7924-02* 0990-7924-02* 5% Dextrose and 0.225% Sodium Chloride Inj., USP 5 0.225 38.5 mEq 38.5 mEq 170 Hypertonic 329 4.3 (3.5 to 6.5) 250 0409-7924-03† 0990-7924-03*, † 5% Dextrose and 0.225% Sodium Chloride Inj., USP 5 0.225 38.5 mEq 38.5 mEq 170 Hypertonic 329 4.3 (3.5 to 6.5) 500 0409-7924-09*, † 0990-7924-09*, † 5% Dextrose and 0.225% Sodium Chloride Inj., USP 5 0.225 38.5 mEq 38.5 mEq 170 Hypertonic 329 4.3 (3.5 to 6.5) 1000 0409-7925-03† 0990-7925-03*, † 5% Dextrose and 0.3% Sodium Chloride Inj., USP 5 0.3 51 mEq 51 mEq 170 Hypertonic 355 4.3 (3.5 to 6.5) 500 0409-7925-09*, † 0990-7925-09*, † 5% Dextrose and 0.3% Sodium Chloride Inj., USP 5 0.3 51 mEq 51 mEq 170 Hypertonic 355 4.3 (3.5 to 6.5) 1000 0409-7926-02* 0990-7926-02* 5% Dextrose and 0.45% Sodium Chloride Inj., USP 5 0.45 77 mEq 77 mEq 170 Hypertonic 406 4.3 (3.5 to 6.5) 250 0409-7926-03† 0990-7926-03*, † 5% Dextrose and 0.45% Sodium Chloride Inj., USP 5 0.45 77 mEq 77 mEq 170 Hypertonic 406 4.3 (3.5 to 6.5) 500 0409-7926-09*, † 0990-7926-09*, † 5% Dextrose and 0.45% Sodium Chloride Inj., USP 5 0.45 77 mEq 77 mEq 170 Hypertonic 406 4.3 (3.5 to 6.5) 1000 0409-7941-03† 0990-7941-03*, † 5% Dextrose and 0.9% Sodium Chloride Inj., USP 5 0.9 154 mEq 154 mEq 170 Hypertonic 560 4.3 (3.5 to 6.5) 500 0409-7941-09*, † 0990-7941-09*, † 5% Dextrose and 0.9% Sodium Chloride Inj., USP 5 0.9 154 mEq 154 mEq 170 Hypertonic 560 4.3 (3.5 to 6.5) 1000 ICU Medical is transitioning NDC codes from "0409" to "0990" labeler code. Both NDC codes are expected to be in the market for a period of time. Protect from freezing. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Revised: August, 2020 IFU0000261

Authorization status:

New Drug Application

Summary of Product characteristics

DEXTROSE AND SODIUM CHLORIDE- DEXTROSE MONOHYDRATE AND SODIUM
CHLORIDE INJECTION, SOLUTION
ICU MEDICAL INC.
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DEXTROSE AND SODIUM CHLORIDE
INJECTION, USP
FLEXIBLE PLASTIC CONTAINER
Rx only
DESCRIPTION
Dextrose and Sodium Chloride Injection, USP solutions are sterile and
nonpyrogenic.
They are large volume parenteral solutions containing various
concentrations and
combinations of these drugs 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 plastic container is fabricated from a specially
formulated polyvinylchloride.
Water can permeate from inside the container into the overwrap but not
in amounts
sufficient to affect the solution significantly. Solutions in contact
with the plastic
container may leach out certain chemical components from the plastic
in very small
amounts; however, biological testing was supportive of the safety of
the plastic
container materials. Exposure to temperatures above 25°C/77°F during
transport and
storage will lead to minor losses in moisture content. Higher
temperatures lead to
greater losses. It is unlikely that these minor losses will lead to
clinically significant
changes within the expiration period.
CLINICAL PHARMACOLOGY
When administered intravenously, these solutions provide a source of
water,
carbohydrate and electrolytes.
6
12
6
2
2
Solutions which provide combinations of hypotonic or