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Flexible Plastic Container Rx only INSTRUCTIONS FOR USE 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.

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 6 H 12 O 6 • H 2 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 2 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. Dextrose structural formula

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 chloride are suitable for parenteral maintenance or replacement of water and electrolyte requirements with minimal carbohydrate calories. Solutions containing carbohydrate in the form of dextrose restore blood glucose levels and provide calories. Carbohydrate in the form of dextrose may aid in minimizing liver glycogen depletion and exerts a protein-sparing action. Dextrose injected parenterally undergoes oxidation to carbon dioxide and water. Sodium chloride in water dissociates to provide sodium (Na + ) and chloride (Cl¯) ions. Sodium (Na + ) is the principal cation of the extracellular fluid and plays a large part in the therapy of fluid and electrolyte disturbances. Chloride (Cl¯) has an integral role in buffering action when oxygen and carbon dioxide exchange occurs in the red blood cells. The distribution and excretion of sodium (Na + ) and chloride (Cl¯) are largely under the control of the kidney which maintains a balance between intake and output. Water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight. Average normal adult daily requirements range from two to three liters (1.0 to 1.5 liters each for insensible water loss by perspiration and urine production). Water balance is maintained by various regulatory mechanisms. Water distribution depends primarily on the concentration of electrolytes in the body compartments and sodium (Na + ) plays a major role in maintaining physiologic equilibrium.

INDICATIONS AND USAGE 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.

WARNINGS Solutions containing sodium ions should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency and in clinical states in which there exists edema with sodium retention. Excessive administration of potassium-free solutions may result in significant hypokalemia. In patients with diminished renal function, administration of solutions containing sodium ions may result in sodium retention. The intravenous administration of these solutions can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema. The risk of dilutional states is inversely proportional to the electrolyte concentrations of administered parenteral solutions. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of such solutions.

PRECAUTIONS Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid balance, electrolyte concentrations and acid-base balance during prolonged parenteral therapy or whenever the condition of the patient warrants such evaluation. Solutions containing dextrose should be used with caution in patients with known subclinical or overt diabetes mellitus. Caution must be exercised in the administration of parenteral fluids, especially those containing sodium ions to patients receiving corticosteroids or corticotropin. Do not administer unless solution is clear and container is undamaged. Discard unused portion. Pregnancy Category C. Animal reproduction studies have not been conducted with dextrose or sodium chloride. It is also not known whether dextrose or sodium chloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Dextrose or sodium chloride should be given to a pregnant woman only if clearly needed. Pediatric Use. The safety and effectiveness in the pediatric population are based on the similarity of the clinical conditions of the pediatric and adult populations. In neonates or very small infants, the volume of fluid may affect fluid and electrolyte balance. Frequent monitoring of serum glucose concentrations is required when dextrose is prescribed to pediatric patients, particularly neonates and low birth weight infants. In very low birth weight infants, excessive or rapid administration of dextrose injection may result in increased serum osmolality and possible intracerebral hemorrhage. Geriatric Use. An evaluation of current literature revealed no clinical experience identifying differences in response between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Sodium ions are known to be substantially excreted by the kidney, and the risk of toxic reactions may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

ADVERSE REACTIONS Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation and hypervolemia. If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.

DOSAGE AND ADMINISTRATION The dose is dependent upon the age, weight and clinical condition of the patient. As reported in the literature, the dosage and constant infusion rate of intravenous dextrose must be selected with caution in pediatric patients, particularly neonates and low birth weight infants, because of the increased risk of hyperglycemia/hypoglycemia. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See PRECAUTIONS . Drug Interactions Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, use aseptic technique, mix thoroughly and do not store.

HOW SUPPLIED 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. Content and Characteristics 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 Manufactured by ICU Medical, Inc., Lake Forest, Illinois, 60045, USA 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 Manufactured for ICU Medical, Inc., Lake Forest, Illinois, 60045, USA 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

<table width="95%"><caption>Content and Characteristics</caption><col width="15%" align="left" valign="top"/><col width="12%" align="left" valign="top"/><col width="8%" align="center" valign="top"/><col width="8%" align="center" valign="top"/><col width="8%" align="center" valign="top"/><col width="8%" align="center" valign="top"/><col width="8%" align="center" valign="top"/><col width="9%" align="center" valign="top"/><col width="8%" align="center" valign="top"/><col width="8%" align="center" valign="top"/><col width="8%" align="center" valign="top"/><tbody><tr><td styleCode="Lrule Rrule Toprule Botrule" align="left" valign="top"/><td styleCode="Lrule Rrule Toprule Botrule" align="left" valign="middle"/><td styleCode="Lrule Rrule Toprule Botrule" colspan="2" align="center" valign="bottom"><paragraph><content styleCode="bold"><content styleCode="emphasis"><content styleCode="underline">Grams/100 mL</content></content></content></paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" colspan="3" align="center" valign="bottom"><paragraph><content styleCode="bold"><content styleCode="emphasis"><content styleCode="underline">Per 1000 mL</content></content></content></paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="bottom"/><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="bottom"/><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="bottom"/><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="bottom"/></tr><tr><td styleCode="Lrule Rrule Toprule Botrule" align="left" valign="middle"><paragraph><content styleCode="bold"><content styleCode="emphasis">NDC No.</content></content></paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="left" valign="middle"><paragraph><content styleCode="bold"><content styleCode="emphasis">Product</content></content></paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="bottom"><paragraph><content styleCode="bold"><content styleCode="emphasis">Dextrose</content></content></paragraph><paragraph><content styleCode="bold"><content styleCode="emphasis">(hydrous)</content></content></paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="bottom"><paragraph><content styleCode="bold"><content styleCode="emphasis">Sodium</content></content></paragraph><paragraph><content styleCode="bold"><content styleCode="emphasis">Chloride</content></content></paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="bottom"><paragraph><content styleCode="bold"><content styleCode="emphasis">Sodium</content></content></paragraph><paragraph><content styleCode="bold"><content styleCode="emphasis">Na⁺</content></content></paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="bottom"><paragraph><content styleCode="bold"><content styleCode="emphasis">Chloride</content></content></paragraph><paragraph><content styleCode="bold"><content styleCode="emphasis">Cl&#xAF;</content></content></paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="bottom"><paragraph><content styleCode="bold"><content styleCode="emphasis">Caloric</content></content></paragraph><paragraph><content styleCode="bold"><content styleCode="emphasis">Value</content></content></paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="bottom"><paragraph><content styleCode="bold"><content styleCode="emphasis">Tonicit

t styleCode="emphasis">Caloric</content></content></paragraph><paragraph><content styleCode="bold"><content styleCode="emphasis">Value</content></content></paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="bottom"><paragraph><content styleCode="bold"><content styleCode="emphasis">Tonicit y</content></content></paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="bottom"><paragraph><content styleCode="bold"><content styleCode="emphasis">Osmolarity mOsmol/L (calc)</content></content></paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="bottom"><paragraph><content styleCode="bold"><content styleCode="emphasis">pH</content></content></paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="bottom"><paragraph><content styleCode="bold"><content styleCode="emphasis">Container</content></content></paragraph><paragraph><content styleCode="bold"><content styleCode="emphasis">size (mL) </content></content></paragraph></td></tr><tr><td styleCode="Lrule Rrule Toprule Botrule" align="left" valign="top"><paragraph>0409-7924-02<footnote ID="foot1">Manufactured by ICU Medical, Inc., Lake Forest, Illinois, 60045, USA</footnote> 0990-7924-02<footnoteRef IDREF="foot1"/></paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="left" valign="top"><paragraph>5% Dextrose and 0.225% Sodium Chloride Inj., USP</paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"><paragraph>5</paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"><paragraph>0.225</paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"><paragraph>38.5 mEq</paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"><paragraph>38.5 mEq</paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"><paragraph>170</paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"><paragraph>Hypertonic</paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"><paragraph>329</paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"><paragraph>4.3 (3.5 to 6.5)</paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"><paragraph>250</paragraph></td></tr><tr><td styleCode="Lrule Rrule Toprule Botrule" align="left" valign="top"><paragraph>0409-7924-03<footnote ID="foot2">Manufactured for ICU Medical, Inc., Lake Forest, Illinois, 60045, USA</footnote> 0990-7924-03<footnoteRef IDREF="foot1"/>^,<footnoteRef IDREF="foot2"/></paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="left" valign="top"><paragraph>5% Dextrose and 0.225% Sodium Chloride Inj., USP</paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"><paragraph>5</paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"><paragraph>0.225</paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"><paragraph>38.5 mEq</paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"><paragraph>38.5 mEq</paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"><paragraph>170</paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"><paragraph>Hypertonic</paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"><paragraph>329</paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"><paragraph>4.3 (3.5 to 6.5)</paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"><paragraph>500</paragraph></td></tr><tr><td

"Lrule Rrule Toprule Botrule" align="center" valign="top"><paragraph>329</paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"><paragraph>4.3 (3.5 to 6.5)</paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"><paragraph>500</paragraph></td></tr><tr><td styleCode="Lrule Rrule Toprule Botrule" align="left" valign="top"><paragraph>0409-7924-09<footnoteRef IDREF="foot1"/>^,<footnoteRef IDREF="foot2"/> 0990-7924-09<footnoteRef IDREF="foot1"/>^,<footnoteRef IDREF="foot2"/></paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="left" valign="top"><paragraph>5% Dextrose and 0.225% Sodium Chloride Inj., USP</paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"><paragraph>5</paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"><paragraph>0.225</paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"><paragraph>38.5 mEq</paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"><paragraph>38.5 mEq</paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"><paragraph>170</paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"><paragraph>Hypertonic</paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"><paragraph>329</paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"><paragraph>4.3 (3.5 to 6.5)</paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"><paragraph>1000</paragraph></td></tr><tr><td styleCode="Lrule Rrule Toprule Botrule" align="left" valign="top"><paragraph>0409-7925-03<footnoteRef IDREF="foot2"/> 0990-7925-03<footnoteRef IDREF="foot1"/>^,<footnoteRef IDREF="foot2"/></paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="left" valign="top"><paragraph>5% Dextrose and 0.3% Sodium Chloride Inj., USP</paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"><paragraph>5</paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"><paragraph>0.3</paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"><paragraph>51 mEq</paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"><paragraph>51 mEq</paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"><paragraph>170</paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"><paragraph>Hypertonic</paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"><paragraph>355</paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"><paragraph>4.3 (3.5 to 6.5)</paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"><paragraph>500</paragraph></td></tr><tr><td styleCode="Lrule Rrule Toprule Botrule" align="left" valign="top"><paragraph>0409-7925-09<footnoteRef IDREF="foot1"/>^,<footnoteRef IDREF="foot2"/> 0990-7925-09<footnoteRef IDREF="foot1"/>^,<footnoteRef IDREF="foot2"/></paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="left" valign="top"><paragraph>5% Dextrose and 0.3% Sodium Chloride Inj., USP</paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"><paragraph>5</paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"><paragraph>0.3</paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"><paragraph>51 mEq</paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"><paragraph>51 mEq</para

/paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"><paragraph>0.3</paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"><paragraph>51 mEq</paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"><paragraph>51 mEq</para graph></td><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"><paragraph>170</paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"><paragraph>Hypertonic</paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"><paragraph>355</paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"><paragraph>4.3 (3.5 to 6.5)</paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"><paragraph>1000</paragraph></td></tr><tr><td styleCode="Lrule Rrule Toprule Botrule" align="left" valign="top"><paragraph>0409-7926-02<footnoteRef IDREF="foot1"/> 0990-7926-02<footnoteRef IDREF="foot1"/></paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="left" valign="top"><paragraph>5% Dextrose and 0.45% Sodium Chloride Inj., USP</paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"><paragraph>5</paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"><paragraph>0.45</paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"><paragraph>77 mEq</paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"><paragraph>77 mEq</paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"><paragraph>170</paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"><paragraph>Hypertonic</paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"><paragraph>406</paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"><paragraph>4.3 (3.5 to 6.5)</paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"><paragraph>250</paragraph></td></tr><tr><td styleCode="Lrule Rrule Toprule Botrule" align="left" valign="top"><paragraph>0409-7926-03<footnoteRef IDREF="foot2"/> 0990-7926-03<footnoteRef IDREF="foot1"/>^,<footnoteRef IDREF="foot2"/></paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="left" valign="top"><paragraph>5% Dextrose and 0.45% Sodium Chloride Inj., USP</paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"><paragraph>5</paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"><paragraph>0.45</paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"><paragraph>77 mEq</paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"><paragraph>77 mEq</paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"><paragraph>170</paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"><paragraph>Hypertonic</paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"><paragraph>406</paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"><paragraph>4.3 (3.5 to 6.5)</paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"><paragraph>500</paragraph></td></tr><tr><td styleCode="Lrule Rrule Toprule Botrule" align="left" valign="top"><paragraph>0409-7926-09<footnoteRef IDREF="foot1"/>^,<footnoteRef IDREF="foot2"/> 0990-7926-09<footnoteRef IDREF="foot1"/>^,<footnoteRef IDREF="foot2"/></paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="left" valign="top"><para

"Lrule Rrule Toprule Botrule" align="left" valign="top"><paragraph>0409-7926-09<footnoteRef IDREF="foot1"/>^,<footnoteRef IDREF="foot2"/> 0990-7926-09<footnoteRef IDREF="foot1"/>^,<footnoteRef IDREF="foot2"/></paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="left" valign="top"><para graph>5% Dextrose and 0.45% Sodium Chloride Inj., USP</paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"><paragraph>5</paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"><paragraph>0.45</paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"><paragraph>77 mEq</paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"><paragraph>77 mEq</paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"><paragraph>170</paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"><paragraph>Hypertonic</paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"><paragraph>406</paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"><paragraph>4.3 (3.5 to 6.5)</paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"><paragraph>1000</paragraph></td></tr><tr><td styleCode="Lrule Rrule Toprule Botrule" align="left" valign="top"><paragraph>0409-7941-03<footnoteRef IDREF="foot2"/> 0990-7941-03<footnoteRef IDREF="foot1"/>^,<footnoteRef IDREF="foot2"/></paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="left" valign="top"><paragraph>5% Dextrose and 0.9% Sodium Chloride Inj., USP</paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"><paragraph>5</paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"><paragraph>0.9</paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"><paragraph>154 mEq</paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"><paragraph>154 mEq</paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"><paragraph>170</paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"><paragraph>Hypertonic</paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"><paragraph>560</paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"><paragraph>4.3 (3.5 to 6.5)</paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"><paragraph>500</paragraph></td></tr><tr><td styleCode="Lrule Rrule Toprule Botrule" align="left" valign="top"><paragraph>0409-7941-09<footnoteRef IDREF="foot1"/>^,<footnoteRef IDREF="foot2"/> 0990-7941-09<footnoteRef IDREF="foot1"/>^,<footnoteRef IDREF="foot2"/></paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="left" valign="top"><paragraph>5% Dextrose and 0.9% Sodium Chloride Inj., USP</paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"><paragraph>5</paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"><paragraph>0.9</paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"><paragraph>154 mEq</paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"><paragraph>154 mEq</paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"><paragraph>170</paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"><paragraph>Hypertonic</paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"><paragraph>560</paragraph></td><td st

d styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"><paragraph>170</paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"><paragraph>Hypertonic</paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"><paragraph>560</paragraph></td><td st yleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"><paragraph>4.3 (3.5 to 6.5)</paragraph></td><td styleCode="Lrule Rrule Toprule Botrule" align="center" valign="top"><paragraph>1000</paragraph></td></tr></tbody></table>

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 6 H 12 O 6 • H 2 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 2 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. dexsod-struc-01.jpg

Pregnancy Category C. Animal reproduction studies have not been conducted with dextrose or sodium chloride. It is also not known whether dextrose or sodium chloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Dextrose or sodium chloride should be given to a pregnant woman only if clearly needed.

Pediatric Use. The safety and effectiveness in the pediatric population are based on the similarity of the clinical conditions of the pediatric and adult populations. In neonates or very small infants, the volume of fluid may affect fluid and electrolyte balance. Frequent monitoring of serum glucose concentrations is required when dextrose is prescribed to pediatric patients, particularly neonates and low birth weight infants. In very low birth weight infants, excessive or rapid administration of dextrose injection may result in increased serum osmolality and possible intracerebral hemorrhage.

Geriatric Use. An evaluation of current literature revealed no clinical experience identifying differences in response between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Sodium ions are known to be substantially excreted by the kidney, and the risk of toxic reactions may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

INSTRUCTIONS FOR USE: 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 1. 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. 2. Check the solution container for leaks by squeezing firmly. If leaks are found, or if the seal is not intact, discard the solution. 3. Do not use if the solution is cloudy or a precipitate is present. To Add Medication 1. Identify WHITE Additive Port with arrow pointing toward container. 2. Immediately before injecting additives, break off WHITE Additive Port Cap with the arrow pointing toward container. 3. Hold base of WHITE Additive Port horizontally. 4. Insert needle horizontally through the center of WHITE Additive Port's septum and inject additives. 5. Mix container contents thoroughly. For high density medication such as potassium chloride, squeeze ports while ports are upright and mix thoroughly. Preparation for Administration 1. Immediately before inserting the infusion set, break off BLUE Infusion Port Cap with the arrow pointing away from container. 2. Use a non-vented infusion set or close the air-inlet on a vented set. 3. Close the roller clamp of the infusion set. 4. Hold the base of BLUE Infusion Port. 5. Insert spike through BLUE Infusion Port by rotating wrist slightly until the spike is inserted. NOTE: See full directions accompanying administration set. WARNING: Do not use flexible container in series connections.

HOW SUPPLIED Dextrose and Sodium Chloride Injection, USP are supplied in single-dose flexible plastic containers in various sizes as shown in the accompanying Table. Content and Characteristics Grams/100 mL Per 1000 mL Product Code NDC No. Product Dextrose (hydrous) Sodium Chloride Sodium Na + Chloride Cl – Caloric Tonicity Osmolarity mOsmol/L (calc) pH Container 867175 63323-867-75 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) 250 mL Bag 867174 63323-867-74 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 mL Bag 867110 63323-867-10 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 mL Bag 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 dexsod-img-02.jpg

<table ID="_Reft300" styleCode="Noautorules" width="100%"><caption>Content and Characteristics </caption><col width="8%"/><col width="7%"/><col width="8%"/><col width="9%"/><col width="8%"/><col width="8%"/><col width="8%"/><col width="7%"/><col width="10%"/><col width="10%"/><col width="5%"/><col width="9%"/><tbody><tr><td colspan="3" styleCode="Rrule Botrule Lrule Toprule " valign="middle"/><td align="center" colspan="2" styleCode="Rrule Botrule Lrule Toprule " valign="middle"><paragraph><content styleCode="bold">Grams/100 mL</content></paragraph></td><td align="center" colspan="3" styleCode="Rrule Botrule Lrule Toprule " valign="middle"><paragraph><content styleCode="bold">Per 1000 mL</content></paragraph></td><td colspan="4" styleCode="Rrule Botrule Lrule Toprule " valign="middle"/></tr><tr><td align="center" styleCode="Rrule Lrule Botrule " valign="middle"><paragraph><content styleCode="bold">Product Code</content></paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph><content styleCode="bold">NDC No.</content></paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph><content styleCode="bold">Product</content></paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph><content styleCode="bold">Dextrose (hydrous)</content></paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph><content styleCode="bold">Sodium Chloride</content></paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph><content styleCode="bold">Sodium Na⁺</content></paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph><content styleCode="bold">Chloride Cl^&#x2013;</content></paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph><content styleCode="bold">Caloric</content></paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph><content styleCode="bold">Tonicity</content></paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph><content styleCode="bold">Osmolarity mOsmol/L (calc)</content></paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph><content styleCode="bold">pH</content></paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph><content styleCode="bold">Container</content></paragraph></td></tr><tr><td align="center" styleCode="Rrule Lrule Botrule " valign="middle"><paragraph>867175</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>63323-867-75</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>5% Dextrose and 0.3% Sodium Chloride Inj., USP</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>5</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>0.3</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>51 mEq</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>51 mEq</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule B

" valign="middle"><paragraph>0.3</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>51 mEq</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>51 mEq</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule B otrule " valign="middle"><paragraph>170</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>Hypertonic</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>355</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>4.3 (3.5 to 6.5)</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>250 mL Bag</paragraph></td></tr><tr><td align="center" styleCode="Rrule Lrule Botrule " valign="middle"><paragraph>867174</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>63323-867-74</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>5% Dextrose and 0.3% Sodium Chloride Inj., USP</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>5</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>0.3</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>51 mEq</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>51 mEq</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>170</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>Hypertonic</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>355</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>4.3 (3.5 to 6.5)</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>500 mL Bag</paragraph></td></tr><tr><td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="middle"><paragraph>867110</paragraph></td><td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="middle"><paragraph>63323-867-10</paragraph></td><td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="middle"><paragraph>5% Dextrose and 0.3% Sodium Chloride Inj., USP</paragraph></td><td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="middle"><paragraph>5</paragraph></td><td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="middle"><paragraph>0.3</paragraph></td><td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="middle"><paragraph>51 mEq</paragraph></td><td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="middle"><paragraph>51 mEq</paragraph></td><td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="middle"><paragraph>170</paragraph></td><td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="middle"><paragraph>Hypertonic</paragraph></td><td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="middle"><paragraph>355</paragraph></td><td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="middle"><paragraph>4.3 (3.5 to 6.5)</paragraph></td><td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="middle"><paragraph>1000 mL Bag</paragraph></td></tr></tbody></table>

<table width="100%"><col width="98%"/><tbody><tr><td styleCode="Rrule Botrule Lrule Toprule " valign="top"><paragraph><content styleCode="bold">5% Dextrose and 0.45% Sodium Chloride Injection, USP</content></paragraph></td></tr></tbody></table>

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 5 g 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 6 H 12 O 6 • H 2 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 2 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. Structural Formula

PRECAUTIONS Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid balance, electrolyte concentrations and acid-base balance during prolonged parenteral therapy or whenever the condition of the patient warrants such evaluation. Solutions containing dextrose should be used with caution in patients with known subclinical or overt diabetes mellitus. Caution must be exercised in the administration of parenteral fluids, especially those containing sodium ions to patients receiving corticosteroids or corticotropin. Do not administer unless solution is clear and container is undamaged. Discard unused portion. Pregnancy: Teratogenic effects Pregnancy. Animal reproduction studies have not been conducted with dextrose or sodium chloride. It is also not known whether dextrose or sodium chloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Dextrose or sodium chloride should be given to a pregnant woman only if clearly needed. Pediatric Use. The safety and effectiveness in the pediatric population are based on the similarity of the clinical conditions of the pediatric and adult populations. In neonates or very small infants, the volume of fluid may affect fluid and electrolyte balance. Frequent monitoring of serum glucose concentrations is required when dextrose is prescribed to pediatric patients, particularly neonates and low birth weight infants. In very low birth weight infants, excessive or rapid administration of dextrose injection may result in increased serum osmolality and possible intracerebral hemorrhage. Geriatric Use. An evaluation of current literature revealed no clinical experience identifying differences in response between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Sodium ions are known to be substantially excreted by the kidney, and the risk of toxic reactions may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

Pregnancy. Animal reproduction studies have not been conducted with dextrose or sodium chloride. It is also not known whether dextrose or sodium chloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Dextrose or sodium chloride should be given to a pregnant woman only if clearly needed.

ADVERSE REACTIONS Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation and hypervolemia. If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary. To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DOSAGE AND ADMINISTRATION The dose is dependent upon the age, weight and clinical condition of the patient. As reported in the literature, the dosage and constant infusion rate of intravenous dextrose must be selected with caution in pediatric patients, particularly neonates and low birth weight infants, because of the increased risk of hyperglycemia/hypoglycemia. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See PRECAUTIONS . Drug Interactions Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, use aseptic technique, mix thoroughly and do not store. INSTRUCTIONS FOR USE: 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 1. 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. 2. Check the solution container for leaks by squeezing firmly. If leaks are found, or if the seal is not intact, discard the solution. 3. Do not use if the solution is cloudy or a precipitate is present. To Add Medication 1. Identify WHITE Additive Port with arrow pointing toward container. 2. Immediately before injecting additives, break off WHITE Additive Port Cap with the arrow pointing toward container. 3. Hold base of WHITE Additive Port horizontally. 4. Insert needle horizontally through the center of WHITE Additive Port's septum and inject additives. 5. Mix container contents thoroughly. Preparation for Administration 1. Immediately before inserting the infusion set, break off BLUE Infusion Port Cap with the arrow pointing away from container. 2. Use a non-vented infusion set or close the air-inlet on a vented set. 3. Close the roller clamp of the infusion set. 4. Hold the base of BLUE Infusion Port. 5. Insert spike through BLUE Infusion Port by rotating wrist slightly until the spike is inserted. NOTE : See full directions accompanying administration set. WARNING: Do not use flexible container in series connections.

INSTRUCTIONS FOR USE: 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 1. 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. 2. Check the solution container for leaks by squeezing firmly. If leaks are found, or if the seal is not intact, discard the solution. 3. Do not use if the solution is cloudy or a precipitate is present. To Add Medication 1. Identify WHITE Additive Port with arrow pointing toward container. 2. Immediately before injecting additives, break off WHITE Additive Port Cap with the arrow pointing toward container. 3. Hold base of WHITE Additive Port horizontally. 4. Insert needle horizontally through the center of WHITE Additive Port's septum and inject additives. 5. Mix container contents thoroughly. Preparation for Administration 1. Immediately before inserting the infusion set, break off BLUE Infusion Port Cap with the arrow pointing away from container. 2. Use a non-vented infusion set or close the air-inlet on a vented set. 3. Close the roller clamp of the infusion set. 4. Hold the base of BLUE Infusion Port. 5. Insert spike through BLUE Infusion Port by rotating wrist slightly until the spike is inserted. NOTE : See full directions accompanying administration set. WARNING: Do not use flexible container in series connections.

HOW SUPPLIED 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: Product Code Unit of Sale Each 869175 NDC 63323-869-75 Package of 30 NDC 63323-869-05 One 250 mL free flex ® bag 869174 NDC 63323-869-74 Package of 20 NDC 63323-869-04 One 500 mL free flex ® bag 869110 NDC 63323-869-10 Package of 10 NDC 63323-869-01 One 1,000 mL free flex ® bag 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.] Lake Zurich, IL 60047 www.fresenius-kabi.com/us Revised: November 2023 Fresenius Kabi Logo

<table width="100%"><col width="24%"/><col width="24%"/><col width="49%"/><tbody><tr><td styleCode="Rrule Botrule Lrule Toprule " valign="top"><paragraph><content styleCode="bold">Product Code</content></paragraph></td><td styleCode="Rrule Botrule Lrule Toprule " valign="top"><paragraph><content styleCode="bold">Unit of Sale</content></paragraph></td><td styleCode="Rrule Botrule Lrule Toprule " valign="top"><paragraph><content styleCode="bold">Each</content></paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>869175</paragraph></td><td styleCode="Rrule Lrule Toprule Botrule " valign="top"><paragraph>NDC 63323-869-75</paragraph><paragraph>Package of 30</paragraph></td><td styleCode="Rrule Lrule Toprule Botrule " valign="top"><paragraph>NDC 63323-869-05</paragraph><paragraph>One 250 mL <content styleCode="bold">free</content><content styleCode="italics">flex^&#xAE;</content> bag</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>869174</paragraph></td><td styleCode="Rrule Lrule Toprule Botrule " valign="top"><paragraph>NDC 63323-869-74</paragraph><paragraph>Package of 20</paragraph></td><td styleCode="Rrule Lrule Toprule Botrule " valign="top"><paragraph>NDC 63323-869-04</paragraph><paragraph>One 500 mL <content styleCode="bold">free</content><content styleCode="italics">flex^&#xAE;</content> bag</paragraph></td></tr><tr><td styleCode="Rrule Botrule Lrule Toprule " valign="top"><paragraph>869110</paragraph></td><td styleCode="Rrule Botrule Lrule Toprule " valign="top"><paragraph>NDC 63323-869-10</paragraph><paragraph>Package of 10</paragraph></td><td styleCode="Rrule Botrule Lrule Toprule " valign="top"><paragraph>NDC 63323-869-01</paragraph><paragraph>One 1,000 mL <content styleCode="bold">free</content><content styleCode="italics">flex^&#xAE;</content> bag</paragraph></td></tr></tbody></table>

<table width="100%"><col width="98%"/><tbody><tr><td styleCode="Rrule Botrule Lrule Toprule " valign="top"><paragraph><content styleCode="bold">5% Dextrose and 0.9% Sodium Chloride Injection, USP</content></paragraph></td></tr></tbody></table>

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 6 H 12 O 6 • H 2 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 2 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. Structural Formula

HOW SUPPLIED 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: Product Code Unit of Sale Each 870110 NDC 63323-870-10 Package of 20 NDC 63323-870-01 One 500 mL free flex ® bag 870174 NDC 63323-870-74 Package of 10 NDC 63323-870-04 One 1,000 mL free flex ® bag 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.] Lake Zurich, IL 60047 www.fresenius-kabi.com/us Revised: November 2023 Fresenius Kabi Logo

<table width="99.96%"><col width="28%"/><col width="38%"/><col width="32%"/><tbody><tr><td styleCode="Rrule Botrule Lrule Toprule " valign="top"><paragraph><content styleCode="bold">Product Code</content></paragraph></td><td styleCode="Rrule Botrule Lrule Toprule " valign="top"><paragraph><content styleCode="bold">Unit of Sale</content></paragraph></td><td styleCode="Rrule Botrule Lrule Toprule " valign="top"><paragraph><content styleCode="bold">Each</content></paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>870110</paragraph></td><td styleCode="Rrule Lrule Toprule Botrule " valign="top"><paragraph>NDC 63323-870-10</paragraph><paragraph>Package of 20</paragraph></td><td styleCode="Rrule Lrule Toprule Botrule " valign="top"><paragraph>NDC 63323-870-01</paragraph><paragraph>One 500 mL <content styleCode="bold">free</content><content styleCode="italics">flex^&#xAE;</content>bag</paragraph></td></tr><tr><td styleCode="Rrule Botrule Lrule Toprule " valign="top"><paragraph>870174</paragraph></td><td styleCode="Rrule Botrule Lrule Toprule " valign="top"><paragraph>NDC 63323-870-74</paragraph><paragraph>Package of 10</paragraph></td><td styleCode="Rrule Botrule Lrule Toprule " valign="top"><paragraph>NDC 63323-870-04</paragraph><paragraph>One 1,000 mL <content styleCode="bold">free</content><content styleCode="italics">flex^&#xAE;</content>bag</paragraph></td></tr></tbody></table>