Drug Facts
Composition & Profile
Identifiers & Packaging
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; PRINCIPAL DISPLAY PANEL - 1000 mL Bag Label - NDC 0990-7924-09 1000 mL NDC 0990-7924-09 5% DEXTROSE and 0.225% SODIUM CHLORIDE Injection, USP EACH 100 mL CONTAINS DEXTROSE, HYDROUS 5 g; SODIUM CHLORIDE 225 mg IN WATER FOR INJECTION. ELECTROLYTES PER 1000 mL: SODIUM 38.5 mEq; CHLORIDE 38.5 mEq. 329 mOsmol/LITER (CALC). pH 4.3 (3.5 to 6.5). ADDITIVES MAY BE INCOMPATIBLE. CONSULT WITH PHARMACIST, IF AVAILABLE. WHEN INTRODUCING ADDITIVES, USE ASEPTIC TECHNIQUE, MIX THOROUGHLY AND DO NOT STORE. SINGLE-DOSE CONTAINER. FOR I.V. USE. USUAL DOSAGE: SEE INSERT. STERILE, NONPYROGENIC. USE ONLY IF SOLUTION IS CLEAR AND CONTAINER IS UNDAMAGED. MUST NOT BE USED IN SERIES CONNECTIONS. Rx ONLY 3 V CONTAINS DEHP IM-4424 icu medical ICU Medical, Inc., Lake Forest, Illinois, 60045, USA PRINCIPAL DISPLAY PANEL - 1000 mL Bag Label - NDC 0990-7924-09; PRINCIPAL DISPLAY PANEL - 1000 mL Bag Overwrap - NDC 0990-7924-09 2 HDPE TO OPEN TEAR AT NOTCH DO NOT REMOVE FROM OVERWRAP UNTIL READY FOR USE. AFTER REMOVING THE OVERWRAP, CHECK FOR MINUTE LEAKS BY SQUEEZING CONTAINER FIRMLY. IF LEAKS ARE FOUND, DISCARD SOLUTION AS STERILITY MAY BE IMPAIRED. RECOMMENDED STORAGE: ROOM TEMPERATURE (25°C). AVOID EXCESSIVE HEAT. PROTECT FROM FREEZING. SEE INSERT. 98-4321-R14-3/98 PRINCIPAL DISPLAY PANEL - 1000 mL Bag Overwrap - NDC 0990-7924-09; PRINCIPAL DISPLAY PANEL - 1000 mL Bag Label - NDC 0990-7925-09 1000 mL NDC 0990-7925-09 5% DEXTROSE and 0.3% SODIUM CHLORIDE Injection, USP EACH 100 mL CONTAINS DEXTROSE, HYDROUS 5 g; SODIUM CHLORIDE 300 mg IN WATER FOR INJECTION. ELECTROLYTES PER 1000 mL: SODIUM 51 mEq; CHLORIDE 51 mEq. 355 mOsmol/LITER (CALC). pH 4.3 (3.5 to 6.5) ADDITIVES MAY BE INCOMPATIBLE. CONSULT WITH PHARMACIST, IF AVAILABLE. WHEN INTRODUCING ADDITIVES, USE ASEPTIC TECHNIQUE, MIX THOROUGHLY AND DO NOT STORE. SINGLE-DOSE CONTAINER. FOR I.V. USE. USUAL DOSAGE: SEE INSERT. STERILE, NONPYROGENIC. USE ONLY IF SOLUTION IS CLEAR AND CONTAINER IS UNDAMAGED. MUST NOT BE USED IN SERIES CONNECTIONS. Rx ONLY 3 V CONTAINS DEHP IMP0000052 icu medical ICU Medical, Inc., Lake Forest, Illinois, 60045, USA PRINCIPAL DISPLAY PANEL - 1000 mL Bag Label - NDC 0990-7925-09; PRINCIPAL DISPLAY PANEL - 1000 mL Bag Label - NDC 0990-7926-09 1000 mL NDC 0990-7926-09 5% DEXTROSE and 0.45% SODIUM CHLORIDE Injection, USP EACH 100 mL CONTAINS DEXTROSE, HYDROUS 5 g; SODIUM CHLORIDE 450 mg IN WATER FOR INJECTION. ELECTROLYTES PER 1000 mL: SODIUM 77 mEq; CHLORIDE 77 mEq. 406 mOsmol/LITER (CALC). pH 4.3 (3.5 to 6.5). ADDITIVES MAY BE INCOMPATIBLE. CONSULT WITH PHARMACIST, IF AVAILABLE. WHEN INTRODUCING ADDITIVES, USE ASEPTIC TECHNIQUE, MIX THOROUGHLY AND DO NOT STORE. SINGLE-DOSE CONTAINER. FOR I.V. USE. USUAL DOSAGE: SEE INSERT. STERILE, NONPYROGENIC. USE ONLY IF SOLUTION IS CLEAR AND CONTAINER IS UNDAMAGED. MUST NOT BE USED IN SERIES CONNECTIONS. Rx ONLY 3 V CONTAINS DEHP icu medical IM-4425 ICU Medical, Inc., Lake Forest, Illinois, 60045, USA PRINCIPAL DISPLAY PANEL - 1000 mL Bag Label - NDC 0990-7926-09; PRINCIPAL DISPLAY PANEL - 1000 mL Bag Label - NDC 0990-7941-09 1000 mL NDC 0990-7941-09 5% DEXTROSE and 0.9% SODIUM CHLORIDE Injection, USP EACH 100 mL CONTAINS DEXTROSE, HYDROUS 5 g; SODIUM CHLORIDE 900 mg IN WATER FOR INJECTION. ELECTROLYTES PER 1000 mL: SODIUM 154 mEq; CHLORIDE 154 mEq. 560 mOsmol/LITER (CALC). pH 4.3 (3.5 to 6.5) ADDITIVES MAY BE INCOMPATIBLE. CONSULT WITH PHARMACIST, IF AVAILABLE. WHEN INTRODUCING ADDITIVES, USE ASEPTIC TECHNIQUE, MIX THOROUGHLY AND DO NOT STORE. SINGLE-DOSE CONTAINER. FOR I.V. USE. USUAL DOSAGE: SEE INSERT. STERILE, NONPYROGENIC. USE ONLY IF SOLUTION IS CLEAR AND CONTAINER IS UNDAMAGED. MUST NOT BE USED IN SERIES CONNECTIONS. Rx ONLY 3 V CONTAINS DEHP icu medical IM-4427 ICU Medical, Inc., Lake Forest, Illinois, 60045, USA PRINCIPAL DISPLAY PANEL - 1000 mL Bag Label - NDC 0990-7941-09
- 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
- PRINCIPAL DISPLAY PANEL - 1000 mL Bag Label - NDC 0990-7924-09 1000 mL NDC 0990-7924-09 5% DEXTROSE and 0.225% SODIUM CHLORIDE Injection, USP EACH 100 mL CONTAINS DEXTROSE, HYDROUS 5 g; SODIUM CHLORIDE 225 mg IN WATER FOR INJECTION. ELECTROLYTES PER 1000 mL: SODIUM 38.5 mEq; CHLORIDE 38.5 mEq. 329 mOsmol/LITER (CALC). pH 4.3 (3.5 to 6.5). ADDITIVES MAY BE INCOMPATIBLE. CONSULT WITH PHARMACIST, IF AVAILABLE. WHEN INTRODUCING ADDITIVES, USE ASEPTIC TECHNIQUE, MIX THOROUGHLY AND DO NOT STORE. SINGLE-DOSE CONTAINER. FOR I.V. USE. USUAL DOSAGE: SEE INSERT. STERILE, NONPYROGENIC. USE ONLY IF SOLUTION IS CLEAR AND CONTAINER IS UNDAMAGED. MUST NOT BE USED IN SERIES CONNECTIONS. Rx ONLY 3 V CONTAINS DEHP IM-4424 icu medical ICU Medical, Inc., Lake Forest, Illinois, 60045, USA PRINCIPAL DISPLAY PANEL - 1000 mL Bag Label - NDC 0990-7924-09
- PRINCIPAL DISPLAY PANEL - 1000 mL Bag Overwrap - NDC 0990-7924-09 2 HDPE TO OPEN TEAR AT NOTCH DO NOT REMOVE FROM OVERWRAP UNTIL READY FOR USE. AFTER REMOVING THE OVERWRAP, CHECK FOR MINUTE LEAKS BY SQUEEZING CONTAINER FIRMLY. IF LEAKS ARE FOUND, DISCARD SOLUTION AS STERILITY MAY BE IMPAIRED. RECOMMENDED STORAGE: ROOM TEMPERATURE (25°C). AVOID EXCESSIVE HEAT. PROTECT FROM FREEZING. SEE INSERT. 98-4321-R14-3/98 PRINCIPAL DISPLAY PANEL - 1000 mL Bag Overwrap - NDC 0990-7924-09
- PRINCIPAL DISPLAY PANEL - 1000 mL Bag Label - NDC 0990-7925-09 1000 mL NDC 0990-7925-09 5% DEXTROSE and 0.3% SODIUM CHLORIDE Injection, USP EACH 100 mL CONTAINS DEXTROSE, HYDROUS 5 g; SODIUM CHLORIDE 300 mg IN WATER FOR INJECTION. ELECTROLYTES PER 1000 mL: SODIUM 51 mEq; CHLORIDE 51 mEq. 355 mOsmol/LITER (CALC). pH 4.3 (3.5 to 6.5) ADDITIVES MAY BE INCOMPATIBLE. CONSULT WITH PHARMACIST, IF AVAILABLE. WHEN INTRODUCING ADDITIVES, USE ASEPTIC TECHNIQUE, MIX THOROUGHLY AND DO NOT STORE. SINGLE-DOSE CONTAINER. FOR I.V. USE. USUAL DOSAGE: SEE INSERT. STERILE, NONPYROGENIC. USE ONLY IF SOLUTION IS CLEAR AND CONTAINER IS UNDAMAGED. MUST NOT BE USED IN SERIES CONNECTIONS. Rx ONLY 3 V CONTAINS DEHP IMP0000052 icu medical ICU Medical, Inc., Lake Forest, Illinois, 60045, USA PRINCIPAL DISPLAY PANEL - 1000 mL Bag Label - NDC 0990-7925-09
- PRINCIPAL DISPLAY PANEL - 1000 mL Bag Label - NDC 0990-7926-09 1000 mL NDC 0990-7926-09 5% DEXTROSE and 0.45% SODIUM CHLORIDE Injection, USP EACH 100 mL CONTAINS DEXTROSE, HYDROUS 5 g; SODIUM CHLORIDE 450 mg IN WATER FOR INJECTION. ELECTROLYTES PER 1000 mL: SODIUM 77 mEq; CHLORIDE 77 mEq. 406 mOsmol/LITER (CALC). pH 4.3 (3.5 to 6.5). ADDITIVES MAY BE INCOMPATIBLE. CONSULT WITH PHARMACIST, IF AVAILABLE. WHEN INTRODUCING ADDITIVES, USE ASEPTIC TECHNIQUE, MIX THOROUGHLY AND DO NOT STORE. SINGLE-DOSE CONTAINER. FOR I.V. USE. USUAL DOSAGE: SEE INSERT. STERILE, NONPYROGENIC. USE ONLY IF SOLUTION IS CLEAR AND CONTAINER IS UNDAMAGED. MUST NOT BE USED IN SERIES CONNECTIONS. Rx ONLY 3 V CONTAINS DEHP icu medical IM-4425 ICU Medical, Inc., Lake Forest, Illinois, 60045, USA PRINCIPAL DISPLAY PANEL - 1000 mL Bag Label - NDC 0990-7926-09
- PRINCIPAL DISPLAY PANEL - 1000 mL Bag Label - NDC 0990-7941-09 1000 mL NDC 0990-7941-09 5% DEXTROSE and 0.9% SODIUM CHLORIDE Injection, USP EACH 100 mL CONTAINS DEXTROSE, HYDROUS 5 g; SODIUM CHLORIDE 900 mg IN WATER FOR INJECTION. ELECTROLYTES PER 1000 mL: SODIUM 154 mEq; CHLORIDE 154 mEq. 560 mOsmol/LITER (CALC). pH 4.3 (3.5 to 6.5) ADDITIVES MAY BE INCOMPATIBLE. CONSULT WITH PHARMACIST, IF AVAILABLE. WHEN INTRODUCING ADDITIVES, USE ASEPTIC TECHNIQUE, MIX THOROUGHLY AND DO NOT STORE. SINGLE-DOSE CONTAINER. FOR I.V. USE. USUAL DOSAGE: SEE INSERT. STERILE, NONPYROGENIC. USE ONLY IF SOLUTION IS CLEAR AND CONTAINER IS UNDAMAGED. MUST NOT BE USED IN SERIES CONNECTIONS. Rx ONLY 3 V CONTAINS DEHP icu medical IM-4427 ICU Medical, Inc., Lake Forest, Illinois, 60045, USA PRINCIPAL DISPLAY PANEL - 1000 mL Bag Label - NDC 0990-7941-09
Overview
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
Indications & 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.
Dosage & 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.
Warnings & Precautions
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.
Contraindications
None known.
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.
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