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Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING Dextrose Injection, 20%, 30%, 40%, 50%, and 70% USP are sterile hypertonic solutions of dextrose supplied in single-dose, partial-fill flexible containers (see Tables 1 and 2 ) for intravenous administration after appropriate admixture or dilution [see Dosage and Administration ( 2.1 )] . Do not remove container from the overwrap until intended for use. Table 2: Strengths, Fill Volume, and NDC # of Dextrose Injection 20%, 30%, 40%, 50%, and 70% Strength Fill Volume NDC# 20% (0.2 grams/mL) 500 mL 0409-7935-19 0990-7935-19 30% (0.3 grams/mL) 500 mL 0409-8004-15 0990-8004-15 40% (0.4 grams/mL) 500 mL 0409-7937-19 0990-7937-19 50% (0.5 grams/mL) 500 mL 0409-7936-19 0990-7936-19 70% (0.7 grams/mL) 500 mL 0409-7918-19 0990-7918-19 ICU Medical is transitioning NDC codes from the "0409" to a "0990" labeler code. Both NDC codes are expected to be in the market for a period of time. Use the product immediately after mixing and the introduction of additives. Store between 20°C to 25°C (68°F to 77°F). [See USP controlled room temperature.] Do not freeze.; PRINCIPAL DISPLAY PANEL - 70 g/100 mL Bag Label 500 mL NDC 0990-7918-19 DEXTROSE INJECTION, USP 70% IN 1000 mL PARTIAL-FILL CONTAINER EACH 100 mL CONTAINS DEXTROSE, HYDROUS, USP 70 g IN WATER FOR INJECTION. HYPERTONIC OSMOLARITY 3532 mOsmol/LITER (calc). pH 4.3 (3.2 to 6.5) SPECIFIC GRAVITY 1.236 CAUTION: HYPERTONIC. ADMINISTER ONLY AFTER DILUTION VIA CENTRAL VENOUS CATHETER. STERILE, NONPYROGENIC. SINGLE DOSE CONTAINER. DOSAGE AND ADMINISTRATION: SEE PACKAGE INSERT. CAUTION: DO NOT USE UNLESS SOLUTION IS CLEAR, CLOSURE IS INTACT, AND CONTAINER IS UNDAMAGED. CHECK FOR MINUTE LEAKS BY SQUEEZING FIRMLY. IF LEAKS ARE FOUND DISCARD CONTAINER AND CONTENTS AS STERILITY MAY BE IMPAIRED. MUST NOT BE USED IN SERIES CONNECTIONS. ADDITIVES MAY BE INCOMPATIBLE. CONSULT WITH PHARMACIST, IF AVAILABLE. WHEN INTRODUCING ADDITIVES, USE ASEPTIC TECHNIQUE, MIX THOROUGHLY AND DO NOT STORE. RECOMMENDED STORAGE: ROOM TEMPERATURE (25°C/77°F). AVOID EXCESSIVE HEAT. PROTECT FROM FREEZING. Rx ONLY IM-4402 ICU Medical, Inc., Lake Forest, Illinois, 60045, USA 3 v CONTAINS DEHP 70% icu medical PPRINCIPAL DISPLAY PANEL - 70 g/100 mL Bag Label; PRINCIPAL DISPLAY PANEL - 70 g/100 mL Bag Overwrap TO OPEN — TEAR AT NOTCH The overwrap is a moisture and oxygen barrier. Do not remove unit from overwrap until ready for use. Visually inspect overwrap for tears or holes. Discard unit if overwrap is damaged. Use unit promptly when pouch is opened. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. See insert. After removing the overwrap, check for minute leaks by squeezing container firmly. If leaks are found, discard solution as sterility may be impaired. Rx only WR-0551 ICU Medical, Inc., Lake Forest, Illinois, 60045, USA icu medical PRINCIPAL DISPLAY PANEL - 70 g/100 mL Bag Overwrap; PRINCIPAL DISPLAY PANEL - 20 g/100 mL Bag Label 500 mL IN 1000 mL PARTIAL-FILL CONTAINER NDC 0990-7935-19 20% DEXTROSE Injection, USP EACH 100 mL CONTAINS DEXTROSE, HYDROUS 20 g IN WATER FOR INJECTION. 1009 mOsmol/LITER (CALC.) pH 4.3 (3.2 to 6.5) CAUTION: HYPERTONIC. ADMINISTER ONLY AFTER DILUTION. DEXTROSE SOLUTIONS WITHOUT SALTS SHOULD NOT BE USED IN BLOOD TRANSFUSIONS BECAUSE OF POSSIBLE ROULEAU FORMATION. 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 INTRAVENOUS 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-4404 ICU Medical, Inc., Lake Forest, Illinois, 60045, USA PRINCIPAL DISPLAY PANEL - 20 g/100 mL Bag Label; PRINCIPAL DISPLAY PANEL - 20 g/100 mL Bag Overwrap TO OPEN — TEAR AT NOTCH The overwrap is a moisture and oxygen barrier. Do not remove unit from overwrap until ready for use. Visually inspect overwrap for tears or holes. Discard unit if overwrap is damaged. Use unit promptly when pouch is opened. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. See insert. After removing the overwrap, check for minute leaks by squeezing container firmly. If leaks are found, discard solution as sterility may be impaired. Rx only WR-0552 ICU Medical, Inc., Lake Forest, Illinois, 60045, USA icu medical PRINCIPAL DISPLAY PANEL - 20 g/100 mL Bag Overwrap; PRINCIPAL DISPLAY PANEL - 50 g/100 mL Bag Label 500 mL NDC 0990-7936-19 DEXTROSE INJECTION, USP 50% IN 1000 mL PARTIAL-FILL CONTAINER EACH 100 mL CONTAINS DEXTROSE, HYDROUS, USP 50 g IN WATER FOR INJECTION. HYPERTONIC OSMOLARITY 2523 mOsmol/LITER (calc). pH 4.3 (3.2 to 6.5) SPECIFIC GRAVITY 1.170 CAUTION: HYPERTONIC. ADMINISTER ONLY AFTER DILUTION VIA CENTRAL VENOUS CATHETER. STERILE, NONPYROGENIC. SINGLE DOSE CONTAINER. DOSAGE AND ADMINISTRATION: SEE PACKAGE INSERT. CAUTION: DO NOT USE UNLESS SOLUTION IS CLEAR, CLOSURE IS INTACT, AND CONTAINER IS UNDAMAGED. CHECK FOR MINUTE LEAKS BY SQUEEZING FIRMLY. IF LEAKS ARE FOUND DISCARD CONTAINER AND CONTENTS AS STERILITY MAY BE IMPAIRED. MUST NOT BE USED IN SERIES CONNECTIONS. ADDITIVES MAY BE INCOMPATIBLE. CONSULT WITH PHARMACIST, IF AVAILABLE. WHEN INTRODUCING ADDITIVES, USE ASEPTIC TECHNIQUE, MIX THOROUGHLY AND DO NOT STORE. RECOMMENDED STORAGE: ROOM TEMPERATURE (25°C/77°F). AVOID EXCESSIVE HEAT. PROTECT FROM FREEZING. Rx ONLY IM-4433 ICU Medical, Inc., Lake Forest, Illinois, 60045, USA 3 v CONTAINS DEHP 50% icu medical PRINCIPAL DISPLAY PANEL - 50 g/100 mL Bag Label; PRINCIPAL DISPLAY PANEL - 50 g/100 mL Bag Overwrap TO OPEN — TEAR AT NOTCH The overwrap is a moisture and oxygen barrier. Do not remove unit from overwrap until ready for use. Visually inspect overwrap for tears or holes. Discard unit if overwrap is damaged. Use unit promptly when pouch is opened. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. See insert. After removing the overwrap, check for minute leaks by squeezing container firmly. If leaks are found, discard solution as sterility may be impaired. Rx only WR-0555 ICU Medical, Inc., Lake Forest, Illinois, 60045, USA icu medical PRINCIPAL DISPLAY PANEL - 50 g/100 mL Bag Overwrap; PRINCIPAL DISPLAY PANEL - 40 g/100 mL Bag Label 500 mL IN 1000 mL PARTIAL-FILL CONTAINER NDC 0990-7937-19 40% DEXTROSE Injection, USP EACH 100 mL CONTAINS DEXTROSE, HYDROUS 40 g IN WATER FOR INJECTION. 2018 mOsmol/LITER (CALC.) pH 4.3 (3.2 to 6.5) CAUTION: HYPERTONIC. ADMINISTER ONLY AFTER DILUTION VIA CENTRAL VENOUS CATHETER. DEXTROSE SOLUTIONS WITHOUT SALTS SHOULD NOT BE USED IN BLOOD TRANSFUSIONS BECAUSE OF POSSIBLE ROULEAU FORMATION. 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 INTRAVENOUS 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-4434 ICU Medical, Inc., Lake Forest, Illinois, 60045, USA PRINCIPAL DISPLAY PANEL - 40 g/100 mL Bag Label; PRINCIPAL DISPLAY PANEL - 40 g/100 mL Bag Overwrap TO OPEN — TEAR AT NOTCH The overwrap is a moisture and oxygen barrier. Do not remove unit from overwrap until ready for use. Visually inspect overwrap for tears or holes. Discard unit if overwrap is damaged. Use unit promptly when pouch is opened. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. See insert. After removing the overwrap, check for minute leaks by squeezing container firmly. If leaks are found, discard solution as sterility may be impaired. Rx only WR-0557 ICU Medical, Inc., Lake Forest, Illinois, 60045, USA icu medical PRINCIPAL DISPLAY PANEL - 40 g/100 mL Bag Overwrap; PRINCIPAL DISPLAY PANEL - 30 g/100 mL Bag Label 500 mL IN 1000 mL PARTIAL-FILL CONTAINER NDC 0990-8004-15 30% DEXTROSE Injection, USP EACH 100 mL CONTAINS DEXTROSE, HYDROUS 30 g IN WATER FOR INJECTION. 1514 mOsmol/LITER (CALC.) pH 4.3 (3.2 to 6.5) CAUTION: HYPERTONIC. ADMINISTER ONLY AFTER DILUTION VIA CENTRAL VENOUS CATHETER. DEXTROSE SOLUTIONS WITHOUT SALTS SHOULD NOT BE USED IN BLOOD TRANSFUSIONS BECAUSE OF POSSIBLE ROULEAU FORMATION. 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 INTRAVENOUS 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-4436 ICU Medical, Inc., Lake Forest, Illinois, 60045, USA icu medical PRINCIPAL DISPLAY PANEL - 30 g/100 mL Bag Label; PRINCIPAL DISPLAY PANEL - 30 g/100 mL Bag Overwrap TO OPEN — TEAR AT NOTCH The overwrap is a moisture and oxygen barrier. Do not remove unit from overwrap until ready for use. Visually inspect overwrap for tears or holes. Discard unit if overwrap is damaged. Use unit promptly when pouch is opened. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. See insert. After removing the overwrap, check for minute leaks by squeezing container firmly. If leaks are found, discard solution as sterility may be impaired. Rx only WR-0560 ICU Medical, Inc., Lake Forest, Illinois, 60045, USA icu medical PRINCIPAL DISPLAY PANEL - 30 g/100 mL Bag Overwrap
- 16 HOW SUPPLIED/STORAGE AND HANDLING Dextrose Injection, 20%, 30%, 40%, 50%, and 70% USP are sterile hypertonic solutions of dextrose supplied in single-dose, partial-fill flexible containers (see Tables 1 and 2 ) for intravenous administration after appropriate admixture or dilution [see Dosage and Administration ( 2.1 )] . Do not remove container from the overwrap until intended for use. Table 2: Strengths, Fill Volume, and NDC # of Dextrose Injection 20%, 30%, 40%, 50%, and 70% Strength Fill Volume NDC# 20% (0.2 grams/mL) 500 mL 0409-7935-19 0990-7935-19 30% (0.3 grams/mL) 500 mL 0409-8004-15 0990-8004-15 40% (0.4 grams/mL) 500 mL 0409-7937-19 0990-7937-19 50% (0.5 grams/mL) 500 mL 0409-7936-19 0990-7936-19 70% (0.7 grams/mL) 500 mL 0409-7918-19 0990-7918-19 ICU Medical is transitioning NDC codes from the "0409" to a "0990" labeler code. Both NDC codes are expected to be in the market for a period of time. Use the product immediately after mixing and the introduction of additives. Store between 20°C to 25°C (68°F to 77°F). [See USP controlled room temperature.] Do not freeze.
- PRINCIPAL DISPLAY PANEL - 70 g/100 mL Bag Label 500 mL NDC 0990-7918-19 DEXTROSE INJECTION, USP 70% IN 1000 mL PARTIAL-FILL CONTAINER EACH 100 mL CONTAINS DEXTROSE, HYDROUS, USP 70 g IN WATER FOR INJECTION. HYPERTONIC OSMOLARITY 3532 mOsmol/LITER (calc). pH 4.3 (3.2 to 6.5) SPECIFIC GRAVITY 1.236 CAUTION: HYPERTONIC. ADMINISTER ONLY AFTER DILUTION VIA CENTRAL VENOUS CATHETER. STERILE, NONPYROGENIC. SINGLE DOSE CONTAINER. DOSAGE AND ADMINISTRATION: SEE PACKAGE INSERT. CAUTION: DO NOT USE UNLESS SOLUTION IS CLEAR, CLOSURE IS INTACT, AND CONTAINER IS UNDAMAGED. CHECK FOR MINUTE LEAKS BY SQUEEZING FIRMLY. IF LEAKS ARE FOUND DISCARD CONTAINER AND CONTENTS AS STERILITY MAY BE IMPAIRED. MUST NOT BE USED IN SERIES CONNECTIONS. ADDITIVES MAY BE INCOMPATIBLE. CONSULT WITH PHARMACIST, IF AVAILABLE. WHEN INTRODUCING ADDITIVES, USE ASEPTIC TECHNIQUE, MIX THOROUGHLY AND DO NOT STORE. RECOMMENDED STORAGE: ROOM TEMPERATURE (25°C/77°F). AVOID EXCESSIVE HEAT. PROTECT FROM FREEZING. Rx ONLY IM-4402 ICU Medical, Inc., Lake Forest, Illinois, 60045, USA 3 v CONTAINS DEHP 70% icu medical PPRINCIPAL DISPLAY PANEL - 70 g/100 mL Bag Label
- PRINCIPAL DISPLAY PANEL - 70 g/100 mL Bag Overwrap TO OPEN — TEAR AT NOTCH The overwrap is a moisture and oxygen barrier. Do not remove unit from overwrap until ready for use. Visually inspect overwrap for tears or holes. Discard unit if overwrap is damaged. Use unit promptly when pouch is opened. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. See insert. After removing the overwrap, check for minute leaks by squeezing container firmly. If leaks are found, discard solution as sterility may be impaired. Rx only WR-0551 ICU Medical, Inc., Lake Forest, Illinois, 60045, USA icu medical PRINCIPAL DISPLAY PANEL - 70 g/100 mL Bag Overwrap
- PRINCIPAL DISPLAY PANEL - 20 g/100 mL Bag Label 500 mL IN 1000 mL PARTIAL-FILL CONTAINER NDC 0990-7935-19 20% DEXTROSE Injection, USP EACH 100 mL CONTAINS DEXTROSE, HYDROUS 20 g IN WATER FOR INJECTION. 1009 mOsmol/LITER (CALC.) pH 4.3 (3.2 to 6.5) CAUTION: HYPERTONIC. ADMINISTER ONLY AFTER DILUTION. DEXTROSE SOLUTIONS WITHOUT SALTS SHOULD NOT BE USED IN BLOOD TRANSFUSIONS BECAUSE OF POSSIBLE ROULEAU FORMATION. 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 INTRAVENOUS 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-4404 ICU Medical, Inc., Lake Forest, Illinois, 60045, USA PRINCIPAL DISPLAY PANEL - 20 g/100 mL Bag Label
- PRINCIPAL DISPLAY PANEL - 20 g/100 mL Bag Overwrap TO OPEN — TEAR AT NOTCH The overwrap is a moisture and oxygen barrier. Do not remove unit from overwrap until ready for use. Visually inspect overwrap for tears or holes. Discard unit if overwrap is damaged. Use unit promptly when pouch is opened. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. See insert. After removing the overwrap, check for minute leaks by squeezing container firmly. If leaks are found, discard solution as sterility may be impaired. Rx only WR-0552 ICU Medical, Inc., Lake Forest, Illinois, 60045, USA icu medical PRINCIPAL DISPLAY PANEL - 20 g/100 mL Bag Overwrap
- PRINCIPAL DISPLAY PANEL - 50 g/100 mL Bag Label 500 mL NDC 0990-7936-19 DEXTROSE INJECTION, USP 50% IN 1000 mL PARTIAL-FILL CONTAINER EACH 100 mL CONTAINS DEXTROSE, HYDROUS, USP 50 g IN WATER FOR INJECTION. HYPERTONIC OSMOLARITY 2523 mOsmol/LITER (calc). pH 4.3 (3.2 to 6.5) SPECIFIC GRAVITY 1.170 CAUTION: HYPERTONIC. ADMINISTER ONLY AFTER DILUTION VIA CENTRAL VENOUS CATHETER. STERILE, NONPYROGENIC. SINGLE DOSE CONTAINER. DOSAGE AND ADMINISTRATION: SEE PACKAGE INSERT. CAUTION: DO NOT USE UNLESS SOLUTION IS CLEAR, CLOSURE IS INTACT, AND CONTAINER IS UNDAMAGED. CHECK FOR MINUTE LEAKS BY SQUEEZING FIRMLY. IF LEAKS ARE FOUND DISCARD CONTAINER AND CONTENTS AS STERILITY MAY BE IMPAIRED. MUST NOT BE USED IN SERIES CONNECTIONS. ADDITIVES MAY BE INCOMPATIBLE. CONSULT WITH PHARMACIST, IF AVAILABLE. WHEN INTRODUCING ADDITIVES, USE ASEPTIC TECHNIQUE, MIX THOROUGHLY AND DO NOT STORE. RECOMMENDED STORAGE: ROOM TEMPERATURE (25°C/77°F). AVOID EXCESSIVE HEAT. PROTECT FROM FREEZING. Rx ONLY IM-4433 ICU Medical, Inc., Lake Forest, Illinois, 60045, USA 3 v CONTAINS DEHP 50% icu medical PRINCIPAL DISPLAY PANEL - 50 g/100 mL Bag Label
- PRINCIPAL DISPLAY PANEL - 50 g/100 mL Bag Overwrap TO OPEN — TEAR AT NOTCH The overwrap is a moisture and oxygen barrier. Do not remove unit from overwrap until ready for use. Visually inspect overwrap for tears or holes. Discard unit if overwrap is damaged. Use unit promptly when pouch is opened. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. See insert. After removing the overwrap, check for minute leaks by squeezing container firmly. If leaks are found, discard solution as sterility may be impaired. Rx only WR-0555 ICU Medical, Inc., Lake Forest, Illinois, 60045, USA icu medical PRINCIPAL DISPLAY PANEL - 50 g/100 mL Bag Overwrap
- PRINCIPAL DISPLAY PANEL - 40 g/100 mL Bag Label 500 mL IN 1000 mL PARTIAL-FILL CONTAINER NDC 0990-7937-19 40% DEXTROSE Injection, USP EACH 100 mL CONTAINS DEXTROSE, HYDROUS 40 g IN WATER FOR INJECTION. 2018 mOsmol/LITER (CALC.) pH 4.3 (3.2 to 6.5) CAUTION: HYPERTONIC. ADMINISTER ONLY AFTER DILUTION VIA CENTRAL VENOUS CATHETER. DEXTROSE SOLUTIONS WITHOUT SALTS SHOULD NOT BE USED IN BLOOD TRANSFUSIONS BECAUSE OF POSSIBLE ROULEAU FORMATION. 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 INTRAVENOUS 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-4434 ICU Medical, Inc., Lake Forest, Illinois, 60045, USA PRINCIPAL DISPLAY PANEL - 40 g/100 mL Bag Label
- PRINCIPAL DISPLAY PANEL - 40 g/100 mL Bag Overwrap TO OPEN — TEAR AT NOTCH The overwrap is a moisture and oxygen barrier. Do not remove unit from overwrap until ready for use. Visually inspect overwrap for tears or holes. Discard unit if overwrap is damaged. Use unit promptly when pouch is opened. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. See insert. After removing the overwrap, check for minute leaks by squeezing container firmly. If leaks are found, discard solution as sterility may be impaired. Rx only WR-0557 ICU Medical, Inc., Lake Forest, Illinois, 60045, USA icu medical PRINCIPAL DISPLAY PANEL - 40 g/100 mL Bag Overwrap
- PRINCIPAL DISPLAY PANEL - 30 g/100 mL Bag Label 500 mL IN 1000 mL PARTIAL-FILL CONTAINER NDC 0990-8004-15 30% DEXTROSE Injection, USP EACH 100 mL CONTAINS DEXTROSE, HYDROUS 30 g IN WATER FOR INJECTION. 1514 mOsmol/LITER (CALC.) pH 4.3 (3.2 to 6.5) CAUTION: HYPERTONIC. ADMINISTER ONLY AFTER DILUTION VIA CENTRAL VENOUS CATHETER. DEXTROSE SOLUTIONS WITHOUT SALTS SHOULD NOT BE USED IN BLOOD TRANSFUSIONS BECAUSE OF POSSIBLE ROULEAU FORMATION. 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 INTRAVENOUS 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-4436 ICU Medical, Inc., Lake Forest, Illinois, 60045, USA icu medical PRINCIPAL DISPLAY PANEL - 30 g/100 mL Bag Label
- PRINCIPAL DISPLAY PANEL - 30 g/100 mL Bag Overwrap TO OPEN — TEAR AT NOTCH The overwrap is a moisture and oxygen barrier. Do not remove unit from overwrap until ready for use. Visually inspect overwrap for tears or holes. Discard unit if overwrap is damaged. Use unit promptly when pouch is opened. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. See insert. After removing the overwrap, check for minute leaks by squeezing container firmly. If leaks are found, discard solution as sterility may be impaired. Rx only WR-0560 ICU Medical, Inc., Lake Forest, Illinois, 60045, USA icu medical PRINCIPAL DISPLAY PANEL - 30 g/100 mL Bag Overwrap
Overview
Dextrose Injection, USP 20%, 30%, 40%, 50% and 70% are sterile, nonpyrogenic, hypertonic solutions of Dextrose, USP in Water for Injection in a polyvinylchloride flexible plastic container for intravenous administration after appropriate admixture or dilution [see Dosage and Administration ( 2.1 )] . Partial-fill containers, designed to facilitate admixture or dilution to provide dextrose in various concentrations, are available in various sizes. See Table 1 for the content and characteristics of these concentrated solutions . The solutions contain no bacteriostatic, antimicrobial agent or added buffer and are intended only for use as a single-dose injection following admixture or dilution. The pH is 4.3 (range is 3.2 to 6.5). Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Table 1. Contents and Characteristics of Dextrose Injection 20%, 30%, 40%, 50%, and 70% Strength Fill Volume Amount of Dextrose Hydrous per Container kcal Caloric value calculated on the basis of 3.4 kcal/g of dextrose, hydrous. per Container mOsmol per liter 20% (0.2 grams/mL) 500 mL 100 grams 340 1009 30% (0.3 grams/mL) 500 mL 150 grams 510 1514 40% (0.4 grams/mL) 500 mL 200 grams 680 2018 50% (0.5 grams/mL) 500 mL 250 grams 850 2523 70% (0.7 grams/mL) 500 mL 350 grams 1190 3532 Dextrose, USP is chemically designated D-glucose, monohydrate (C 6 H 12 O 6 • H 2 O), a hexose sugar freely soluble in water. The molecular weight of dextrose (D-glucose) monohydrate is 198.17. It has the following structural formula: Dextrose may be derived from corn. Water for Injection, USP is chemically designated H 2 O. Dextrose Injection contains no more than 25 mcg/L of aluminum. Structural Formula for Dextrose Injection, USP
Indications & Usage
Dextrose Injection 20%, 30%, 40%, 50% and 70%, mixed with amino acids or other compatible intravenous fluids, is indicated as a source of calories for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. Dextrose Injection 20%, 30%, 40%, 50% and 70%, mixed with amino acids or other compatible intravenous fluids, is indicated as a source of calories for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient or contraindicated ( 1 )
Dosage & Administration
• Must be diluted with compatible intravenous fluids or used as admixture, prior to administration. Not for direct intravenous infusion . ( 2.1 ) • Only for slow intravenous infusion only into a: ( 2.1 ) o Central vein , if final dextrose concentration is greater than 5% or osmolality is greater than 900 mOsm/L o Peripheral vein , if final dextrose concentration 5% or less and osmolality is less than 900 mOsm/L • Individualize dosage based on the patient's clinical condition, body weight, nutritional/fluid requirements, as well as additional energy given orally/enterally ( 2.2 ) • Discontinue infusion of concentrated dextrose solutions slowly and/or administer 5% dextrose ( 2.3 ) 2.1 Important Preparation and Administration Instructions Dextrose Injection is supplied in the following five strengths: 20%, 30%, 40%, 50% and 70% [see How Supplied/Storage and Handling ( 16 )] . Prior to administration, Dextrose Injection must be diluted with other compatible intravenous fluids or used as an admixture with amino acids. It is not for direct intravenous infusion . Preparation Prior to Administration • Because additives may be incompatible, evaluate all additions to the plastic container for compatibility and stability of the resulting preparation. Consult with a pharmacist, if available. If it is deemed advisable to introduce additives, use aseptic technique and mix thoroughly. • Inspect Dextrose Injection to ensure precipitates have not formed during the mixing or addition of additives. Discard the bag if precipitates are observed. Some opacity of the plastic container (due to moisture absorption during sterilization process) may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. • Use promptly after admixing or dilution. • For single use only; discard unused portion Important Administration Instructions • Set the vent to the closed position on a vented intravenous administration set to prevent air embolism. • Use a dedicated line without any connections to avoid air embolism. • Prior to infusion, visually inspect the diluted dextrose solution for particulate matter. The solution should be clear and there should be no precipitates. Do not administer unless solution is clear and container is undamaged. • The choice of a central or peripheral venous route of infusion should depend on the osmolarity of the final infusate. Solutions with greater than 5% dextrose or with osmolarity of greater than or equal to 900 mOsm/L must be infused through a central catheter [see Warnings and Precautions ( 5.5 )] . 2.2 Dosing Information Caution: Dextrose Injection is not for direct intravenous infusion. Prior to administration, Dextrose Injection must be diluted with other compatible intravenous fluids or used as an admixture with amino acids. Individualize the dosage of Dextrose Injection based on the patient's clinical condition (ability to adequately metabolize dextrose), body weight, nutritional and fluid requirements, as well as additional energy given orally or enterally to the patient. The administration rate should be governed, especially during the first few day of therapy, by the patient's tolerance to dextrose. Daily intake of amino acids and dextrose should be increased gradually to the maximum required dose as indicated by frequent determinations of blood glucose levels. 2.3 Discontinuation of Dextrose Injection To reduce the risk of hypoglycemia, a gradual decrease in flow rate in the last hour of infusion should be considered.
Warnings & Precautions
• Hyperglycemia or Hyperosmolar Hyperglycemic State : Monitor blood glucose and administer insulin as needed ( 5.1 ) • Hypersensitivity Reactions : Monitor for signs and symptoms and discontinue infusion if reactions occur ( 5.2 ) • Risk of Infection : Monitor for signs and symptoms and laboratory parameters ( 5.3 ) • Refeeding Syndrome : Monitory laboratory parameters ( 5.4 ) • Vein Damage and Thrombosis : Administer solutions containing more than 5% dextrose as the final concentration or solutions with an osmolarity ≥ 900 mOsm/L through a central vein ( 2.1 , 5.5 ) • Aluminum Toxicity : Dextrose Injection contains aluminum that may be toxic. Patients with impaired renal function, and preterm infants, at higher risk. Limit aluminum to less than 4 mcg/kg/day ( 5.6 , 8.4 ) • Parenteral Nutrition Associated Liver Disease : increased risk in patients who receive parenteral nutrition for extended periods of time, especially preterm infants; monitor liver function tests, if abnormalities occur consider discontinuation or dosage reduction. ( 5.7 , 8.4 ) • Electrolyte Imbalance and Fluid Overload : monitor daily fluid balance, blood electrolyte levels, correct as needed. ( 5.8 , 8.4 ) 5.1 Hyperglycemia and Hyperosmolar Hyperglycemic State The use of dextrose infusions in patients with diabetes mellitus or impaired glucose tolerance may worsen hyperglycemia. Administration of dextrose at a rate exceeding the patient's utilization rate may lead to hyperglycemia, coma, and death. Patients with underlying confusion and renal impairment who receive dextrose infusions, may be at greater risk of developing hyperosmolar hyperglycemic state. Monitor blood glucose levels and treat hyperglycemia to maintain optimum levels while administering Dextrose Injection. Insulin may be administered or adjusted to maintain optimal blood glucose levels during Dextrose Injection administration. 5.2 Hypersensitivity Reactions Hypersensitivity reactions including anaphylaxis have been reported with dextrose infusions. Stop infusion immediately and treat patient accordingly if signs or symptoms of a hypersensitivity reaction develop. Signs or symptoms may include: tachypnea, dyspnea, hypoxia, bronchospasm, tachycardia, hypotension, cyanosis, vomiting, nausea, headache, sweating, dizziness, altered mentation, flushing, rash, urticaria, erythema, pyrexia, and chills. 5.3 Risk of Infections Patients who require parenteral nutrition are at high risk of infections because the nutritional components of these solutions can support microbial growth. The risk of infection is increased in patients with malnutrition-associated immunosuppression, hyperglycemia exacerbated by dextrose infusion, long-term use and poor maintenance of intravenous catheters, or immunosuppressive effects of other concomitant conditions, drugs, or other components of the parenteral formulation (e.g., lipid emulsion). To decrease the risk of infectious complications, ensure aseptic technique in catheter placement and maintenance, as well as aseptic technique in the preparation and administration of the nutritional formula. Monitor for signs and symptoms (including fever and chills) of early infections, including laboratory test results (including leukocytosis and hyperglycemia) and frequent checks of the parenteral access device and insertion site for edema, redness and discharge. 5.4 Refeeding Syndrome Refeeding severely undernourished patients may result in refeeding syndrome, characterized by the intracellular shift of potassium, phosphorus, and magnesium as the patient becomes anabolic. Thiamine deficiency and fluid retention may also develop. To prevent these complications, monitor severely undernourished patients and slowly increase nutrient intakes. 5.5 Vein Damage and Thrombosis Dextrose Injection is for admixture with amino acids or dilution with other compatible intravenous fluids. It is not for direct intravenous infusion. Administer solutions containing more than 5% dextrose or with an osmolarity of ≥ 900 mOsm/L through a central vein [see Dosage and Administration ( 2.1 )] . The infusion of hypertonic solutions into a peripheral vein may result in vein irritation, vein damage, and/or thrombosis. The primary complication of peripheral access is venous thrombophlebitis, which manifests as pain, erythema, tenderness or a palpable cord. Remove the catheter as soon as possible, if thrombophlebitis develops. 5.6 Aluminum Toxicity Dextrose Injection contains no more than 25 mcg/L of aluminum. However, with prolonged parenteral administration in patients with renal impairment, the aluminum contained in Dextrose Injection may reach toxic levels. Preterm infants are at greater risk because their kidneys are immature, and they require large amounts of concomitant calcium and phosphate solutions that contain aluminum. Patients with renal impairment, including preterm infants, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day, accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration of total parenteral nutrition products. 5.7 Risk of Parenteral Nutrition Associated Liver Disease Parenteral Nutrition Associated Liver Disease (PNALD) has been reported in patients who receive parenteral nutrition for extended periods of time, especially preterm infants, and can present as cholestasis or steatohepatitis. The exact etiology is not entirely clear and is likely multifactorial. If Dextrose Injection-treated patients develop abnormal liver function tests consider discontinuation or dosage reduction. 5.8 Electrolyte Imbalance and Fluid Overload Electrolyte deficits, particularly in serum potassium and phosphate, may occur during prolonged use of concentrated dextrose solutions. Depending on the volume and rate of infusion, the intravenous administration of concentrated dextrose 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 in the administered solution. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations in the solution. Monitor blood electrolyte levels, correct fluid and electrolyte imbalances, and administer essential vitamins and minerals as needed. Monitor daily fluid balance.
Contraindications
The use of Dextrose Injection is contraindicated in patients: • who are severely dehydrated as hypertonic dextrose solution can worsen the patient's hyperosmolar state. • with known hypersensitivity to dextrose [see Warnings and Precautions (5.2) ] . • Severe dehydration ( 4 ) • Known hypersensitivity to dextrose ( 4 )
Adverse Reactions
The following adverse reactions from voluntary reports or clinical studies have been reported with Dextrose Injection. Because many of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. • Hyperglycemia and hyperosmolar hyperglycemic state [see Warnings and Precautions ( 5.1 )] . • Hypersensitivity reactions [see Warnings and Precautions ( 5.2 )] . • Risk of infections [see Warnings and Precautions ( 5.3 )] . • Refeeding syndrome [see Warnings and Precautions ( 5.4 )] . • Vein damage and thrombosis [see Warnings and Precautions ( 5.5 )] . • Aluminum toxicity [see Warnings and Precautions ( 5.6 )] . • Risk of parenteral nutrition associated liver disease [see Warnings and Precautions ( 5.7 )] . • Electrolyte imbalance and fluid overload [see Warnings and Precautions ( 5.8 )] . The most common adverse reactions are hyperosmolar syndrome, infection both systemic and at the injection site, vein thrombosis or phlebitis, and hypervolemia. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact ICU Medical, Inc. at 1-800-441-4100, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
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