INFORMATION FOR PATIENTS SECTION.


17 PATIENT COUNSELING INFORMATION Inform patients, caregivers or home healthcare providers of the following risks of Dextrose and Sodium Chloride Injection:oHypersensitivity reactions [see Warnings and Precautions (5.1)]oHyperglycemia and hyperosmolar hyperglycemic state [see Warnings and Precautions (5.2)]oHyponatremia [see Warnings and Precautions (5.3)]oHypokalemia [see Warnings and Precautions (5.4)]oHypernatremia and hyperchloremia [see Warnings and Precautions (5.5)]oFluid overload [see Warnings and Precautions (5.6)]oRefeeding syndrome [see Warnings and Precautions (5.7)]Baxter Healthcare Corporation Deerfield, IL 60015 USAPrinted in USADistributed in Canada by Baxter Corporation Mississauga, ON L5N 0C207-19-74-506Baxter, and Viaflex and PL 146 are trademarks of Baxter International Inc.For Product Information1-800-933-0303. oHypersensitivity reactions [see Warnings and Precautions (5.1)]. oHyperglycemia and hyperosmolar hyperglycemic state [see Warnings and Precautions (5.2)]. oHyponatremia [see Warnings and Precautions (5.3)]. oHypokalemia [see Warnings and Precautions (5.4)]. oHypernatremia and hyperchloremia [see Warnings and Precautions (5.5)]. oFluid overload [see Warnings and Precautions (5.6)]. oRefeeding syndrome [see Warnings and Precautions (5.7)].

ADVERSE REACTIONS SECTION.


6 ADVERSE REACTIONS - Anaphylactic reaction, hypersensitivity, and chills- Hyponatremia (applies to solutions containing less than 0.9% Sodium Chloride)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.. Adverse reactions include electrolyte imbalances, hyperglycemia, and hypervolemia and injection site reactions. (6)To report SUSPECTED ADVERSE REACTIONS, contact Baxter Healthcare at 1-866-888-2472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

CLINICAL PHARMACOLOGY SECTION.


12 CLINICAL PHARMACOLOGY Dextrose and Sodium Chloride Injection, USP has value as source of water, electrolytes, and calories. It is capable of inducing diuresis depending on the clinical condition of the patient.. 12.1 Mechanism of Action Dextrose and Sodium Chloride Injection is source of water, electrolytes and calories. It is capable of inducing diuresis depending on the clinical condition of the patient.

CONTRAINDICATIONS SECTION.


4 CONTRAINDICATIONS Dextrose and Sodium Chloride Injection is contraindicated in patients with:oknown hypersensitivity to dextrose and/or sodium chloride [see Warnings and Precautions 5.1)]oclinically significant hyperglycemia [see Warnings and Precautions (5.2)] oknown hypersensitivity to dextrose and/or sodium chloride [see Warnings and Precautions 5.1)]. oclinically significant hyperglycemia [see Warnings and Precautions (5.2)] oKnown hypersensitivity to dextrose, or sodium chloride (4, 5.1)oClinically significant hyperglycemia (4, 5.2). oKnown hypersensitivity to dextrose, or sodium chloride (4, 5.1). oClinically significant hyperglycemia (4, 5.2).

LACTATION SECTION.


8.2 Lactation Risk SummarySodium is present in human breast milk. There are no data on the effects of Dextrose and Sodium Chloride Injection on breastfed infant or the effects on milk production.The developmental and health benefits of breastfeeding should be considered along with the mothers clinical need for Dextrose and Sodium Chloride Injection and any potential adverse effects on the breastfed infant from Dextrose and Sodium Chloride Injection or from the underlying maternal condition.

MECHANISM OF ACTION SECTION.


12.1 Mechanism of Action Dextrose and Sodium Chloride Injection is source of water, electrolytes and calories. It is capable of inducing diuresis depending on the clinical condition of the patient.

DESCRIPTION SECTION.


11 DESCRIPTION Dextrose and Sodium Chloride Injection, USP is sterile, nonpyrogenic solution for fluid and electrolyte replenishment and caloric supply in single-dose containers for intravenous administration. It contains no antimicrobial agents. Composition, osmolarity, pH, ionic concentration and caloric content are shown in Table 1.Table 1.Size (mL)Composition (g/L)Normal physiologic osmolarity range is approximately 280 to 310 mOsmol/L.Osmolarity (mOsmol/L) (calc.)pHIonic Concentration (mEq/L)Caloric Content (kcal/L)Dextrose Hydrous, USPSodium Chloride, USP (NaCl)SodiumChloride2.5% Dextrose and 0.45% Sodium Chloride Injection, USP1000254.52804.5(3.2 to 6.5)7777855% Dextrose and 0.2% Sodium Chloride Injection, USP25050010005023214.0(3.2 to 6.5)34341705% Dextrose and 0.33% Sodium Chloride Injection, USP2505001000503.33654.0(3.2 to 6.5)56561705% Dextrose and 0.45% Sodium Chloride Injection, USP5001000504.54064.0(3.2 to 6.5)77771705% Dextrose and 0.9% Sodium Chloride Injection, USP50010005095604.0(3.2 to 6.5)154154170Dextrose is derived from corn.The VIAFLEX Plus plastic container is fabricated from specially formulated polyvinyl chloride (PL 146 Plastic). The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies.. Dextrose Structural Formula.

DOSAGE & ADMINISTRATION SECTION.


2 DOSAGE AND ADMINISTRATION oOnly for intravenous infusion. (2.1)oSee full prescribing information for information on preparation, administration, dosing considerations and instructions for use. (2.1, 2.2, 2.3). oOnly for intravenous infusion. (2.1). oSee full prescribing information for information on preparation, administration, dosing considerations and instructions for use. (2.1, 2.2, 2.3). 2.1 Important Administration Instructions oDextrose and Sodium Chloride Injection is only for intravenous infusion. oThe osmolarity of Dextrose and Sodium Chloride Injection, ranges from 280 to 560 mOsmol/L (calc). Peripheral administration is generally acceptable; however; consider central vein administration if there is peripheral vein irritation, phlebitis, and/or associated pain.oDo not administer Dextrose and Sodium Chloride Injection simultaneously with blood products through the same administration set because of the possibility of pseudoagglutination or hemolysis.oTo prevent air embolism, use non-vented infusion set or close the vent on vented set, avoid multiple connections, do not connect flexible containers in series, fully evacuate residual gas in the container prior to administration, do not pressurize the flexible container to increase flow rates, and if administration is controlled by pumping device, turn off pump before the container runs dry.oPrior to infusion, visually inspect the 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.oUse of final filter is recommended during administration of parenteral solutions, where possible.. oDextrose and Sodium Chloride Injection is only for intravenous infusion. oThe osmolarity of Dextrose and Sodium Chloride Injection, ranges from 280 to 560 mOsmol/L (calc). Peripheral administration is generally acceptable; however; consider central vein administration if there is peripheral vein irritation, phlebitis, and/or associated pain.. oDo not administer Dextrose and Sodium Chloride Injection simultaneously with blood products through the same administration set because of the possibility of pseudoagglutination or hemolysis.. oTo prevent air embolism, use non-vented infusion set or close the vent on vented set, avoid multiple connections, do not connect flexible containers in series, fully evacuate residual gas in the container prior to administration, do not pressurize the flexible container to increase flow rates, and if administration is controlled by pumping device, turn off pump before the container runs dry.. oPrior to infusion, visually inspect the 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.. oUse of final filter is recommended during administration of parenteral solutions, where possible.. 2.2 Recommended Dosage The choice of the specific, sodium chloride, and dextrose concentrations, rate and volume depends on the age, weight, clinical and metabolic conditions of the patient and concomitant therapy. Electrolyte supplementation may be indicated according to the clinical needs of the patient.The administration rate should be governed, especially for premature infants with low birth weight, during the first few days of therapy, by the patients tolerance to dextrose. Increase the infusion rate gradually as indicated by frequent monitoring of blood glucose concentrations [see Warnings and Precautions (5.2), Use in Specific Populations (8.4)].. 2.3 Instructions for Use To OpenoDo not remove container from overwrap until ready to use.oTear overwrap down side at slit and remove solution container.oVisually inspect the container. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. Evaluate the following:If the outlet port protector is damaged, detached, or not present, discard container.Check to ensure the solution is clear and there are no precipitates. Discard if there is color change and/or the appearance of precipitates, insoluble complexes or crystals.Check for minute leaks by squeezing inner bag firmly. If leaks are found, discard container.Preparation for Administration1.Suspend container from eyelet support.2.Remove protector from outlet port at bottom of container.3.Attach administration set. Refer to complete directions accompanying set.To Add MedicationoAdditives may be incompatible. Complete information is not available. Do not use additives known or determined to be incompatible.oConsult with pharmacist, if available. If, in the informed judgment of the healthcare provider, it is deemed advisable to introduce additives, use aseptic technique.oWhen introducing additives, consult the instructions for use of the medication to be added and other relevant literature.oBefore adding substance or medication, verify that it is soluble and/or stable in Dextrose and Sodium Chloride Injection and that the pH range of Dextrose and Sodium Chloride Injection is appropriate.To Add Medication Before Solution Administration1.Prepare medication site.2.Using syringe with 19 to 22-gauge needle, puncture resealable medication port and inject.3.Mix solution and medication thoroughly. For high density medication such as potassium chloride, squeeze ports while ports are upright and mix thoroughly.4.After addition, check to ensure the solution is clear and there are no precipitates. Discard if there is color change and/or the appearance of precipitates, insoluble complexes or crystals.To Add Medication During Solution Administration1.Close clamp on the set.2.Prepare medication site.3.Using syringe with 19 to 22-gauge needle, puncture resealable medication port and inject.4.Remove container from IV pole and/or turn to an upright position.5.Evacuate both ports by squeezing them while container is in the upright position.6.Mix solution and medication thoroughly.7.After addition, check to ensure the solution is clear and there are no precipitates. Discard if there is color change and/or the appearance of precipitates, insoluble complexes or crystals, do not use.8.Return container to in use position and continue with administration.StorageoUse promptly; do not store solutions containing additives.oSingle-dose container.oDiscard any unused portion.. oDo not remove container from overwrap until ready to use.. oTear overwrap down side at slit and remove solution container.. oVisually inspect the container. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. Evaluate the following:If the outlet port protector is damaged, detached, or not present, discard container.Check to ensure the solution is clear and there are no precipitates. Discard if there is color change and/or the appearance of precipitates, insoluble complexes or crystals.Check for minute leaks by squeezing inner bag firmly. If leaks are found, discard container.. If the outlet port protector is damaged, detached, or not present, discard container.. Check to ensure the solution is clear and there are no precipitates. Discard if there is color change and/or the appearance of precipitates, insoluble complexes or crystals.. Check for minute leaks by squeezing inner bag firmly. If leaks are found, discard container.. 1.Suspend container from eyelet support.. 2.Remove protector from outlet port at bottom of container.. 3.Attach administration set. Refer to complete directions accompanying set.. oAdditives may be incompatible. Complete information is not available. Do not use additives known or determined to be incompatible.. oConsult with pharmacist, if available. If, in the informed judgment of the healthcare provider, it is deemed advisable to introduce additives, use aseptic technique.. oWhen introducing additives, consult the instructions for use of the medication to be added and other relevant literature.. oBefore adding substance or medication, verify that it is soluble and/or stable in Dextrose and Sodium Chloride Injection and that the pH range of Dextrose and Sodium Chloride Injection is appropriate.. 1.Prepare medication site.. 2.Using syringe with 19 to 22-gauge needle, puncture resealable medication port and inject.. 3.Mix solution and medication thoroughly. For high density medication such as potassium chloride, squeeze ports while ports are upright and mix thoroughly.. 4.After addition, check to ensure the solution is clear and there are no precipitates. Discard if there is color change and/or the appearance of precipitates, insoluble complexes or crystals.. 1.Close clamp on the set.. 2.Prepare medication site.. 3.Using syringe with 19 to 22-gauge needle, puncture resealable medication port and inject.. 4.Remove container from IV pole and/or turn to an upright position.. 5.Evacuate both ports by squeezing them while container is in the upright position.. 6.Mix solution and medication thoroughly.. 7.After addition, check to ensure the solution is clear and there are no precipitates. Discard if there is color change and/or the appearance of precipitates, insoluble complexes or crystals, do not use.. 8.Return container to in use position and continue with administration.. oUse promptly; do not store solutions containing additives.. oSingle-dose container.. oDiscard any unused portion.

DOSAGE FORMS & STRENGTHS SECTION.


3 DOSAGE FORMS AND STRENGTHS Dextrose and Sodium Chloride Injection are clear solutions in 250 mL, 500 mL and 1000 mL single-dose, flexible containers:250 mL flexible containero5% Dextrose and 0.2% Sodium Chloride Injection, USP500 mL flexible containero5% Dextrose and 0.2% Sodium Chloride Injection, USPo5% Dextrose and 0.33% Sodium Chloride Injection, USPo5% Dextrose and 0.45% Sodium Chloride Injection, USPo5% Dextrose and 0.9% Sodium Chloride Injection, USP1000 mL flexible containero2.5% Dextrose and 0.45% Sodium Chloride Injection, USPo5% Dextrose and 0.2% Sodium Chloride Injection, USPo5% Dextrose and 0.45% Sodium Chloride Injection, USPo5% Dextrose and 0.9% Sodium Chloride Injection, USP. o5% Dextrose and 0.2% Sodium Chloride Injection, USP. o5% Dextrose and 0.2% Sodium Chloride Injection, USP. o5% Dextrose and 0.33% Sodium Chloride Injection, USP. o5% Dextrose and 0.45% Sodium Chloride Injection, USP. o5% Dextrose and 0.9% Sodium Chloride Injection, USP. o2.5% Dextrose and 0.45% Sodium Chloride Injection, USP. o5% Dextrose and 0.2% Sodium Chloride Injection, USP. o5% Dextrose and 0.45% Sodium Chloride Injection, USP. o5% Dextrose and 0.9% Sodium Chloride Injection, USP. Dextrose and Sodium Chloride Injection is available in multiple strengths. See full prescribing information for detailed description of each product. (3).

DRUG INTERACTIONS SECTION.


7 DRUG INTERACTIONS oOther Products that Affect Glycemic Control, Vasopressin or Fluid and/or Electrolyte Balance: Monitor blood glucose concentrations, fluid balance serum electrolyte concentrations and acid-base balance. (7.1)oLithium: Decreased lithium concentrations with concomitant use; monitor serum lithium concentrations. (7.2). oOther Products that Affect Glycemic Control, Vasopressin or Fluid and/or Electrolyte Balance: Monitor blood glucose concentrations, fluid balance serum electrolyte concentrations and acid-base balance. (7.1). oLithium: Decreased lithium concentrations with concomitant use; monitor serum lithium concentrations. (7.2). 7.1 Other Products that Affect Glycemic Control, Vasopressin or Fluid and/or Electrolyte Balance Dextrose and Sodium Chloride Injection can affect glycemic control, vasopressin and fluid and/or electrolyte balance [see Warnings and Precautions (5.2, 5.3, 5.4, 5.5, 5.6)]. Monitor blood glucose concentrations, fluid balance, serum electrolyte concentrations and acid-base balance when using Dextrose and Sodium Chloride Injection in patients treated with other substances that affect glycemic control, vasopressin or fluid and/or electrolyte balance.. 7.2 Lithium Renal sodium and lithium clearance may be increased during administration of Dextrose and Sodium Chloride Injection resulting in decreased serum lithium concentrations. Monitor serum lithium concentrations during concomitant use.

GERIATRIC USE SECTION.


8.5 Geriatric Use Clinical studies of Dextrose and Sodium Chloride Injection did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.Elderly patients are at increased risk of developing hyponatremia as well as for developing hyponatremic encephalopathy [see Warnings and Precautions (5.3)]. Dextrose and Sodium Chloride Injection is known to be substantially excreted by the kidney, and the risk of adverse reactions to this product may be greater in patients with impaired renal function [see Warnings and Precautions (5.2, 5.5)].Dose selection for an elderly patient should be cautious, 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.

HOW SUPPLIED SECTION.


16 HOW SUPPLIED/STORAGE AND HANDLING Dextrose and Sodium Chloride Injection are clear solutions in 250 mL, 500 mL and 1000 mL single-dose, flexible containers available as follows:CodeSize (mL)NDCProduct Name2B102410000338-0073-042.5% Dextrose and 0.45% Sodium Chloride Injection, USP2B10922500338-0077-025% Dextrose and 0.2% Sodium Chloride Injection, USP2B10935000338-0077-032B109410000338-0077-042B10835000338-0081-035% Dextrose and 0.33% Sodium Chloride Injection, USP2B10735000338-0085-035% Dextrose and 0.45% Sodium Chloride Injection, USP2B107410000338-0085-042B10635000338-0089-035% Dextrose and 0.9% Sodium Chloride Injection, USP2B106410000338-0089-04Storage: Avoid excessive heat. Store at room temperature (25C/77F); brief exposure up to 40C/104F does not adversely affect the product.

INDICATIONS & USAGE SECTION.


1 INDICATIONS AND USAGE Dextrose and Sodium Chloride Injection is indicated as source of water, electrolytes and calories. Dextrose and Sodium Chloride Injection is indicated as source of water, electrolytes and calories. (1).

OVERDOSAGE SECTION.


10 OVERDOSAGE Excessive administration of Dextrose and Sodium Chloride Injection can cause:Electrolyte and Fluid DisordersoHyperglycemia, hyperosmolality, and adverse effects on water and electrolyte balance, and corresponding complications, which can be fatal [see Warnings and Precautions (5.2)]. oHyponatremia, manifestations may include seizures, coma, cerebral edema and death) [see Warnings and Precautions (5.3)].oHypernatremia, especially in patients with severe renal impairment [see Warnings and Precautions (5.5)].oFluid overload (which can lead to central and/or peripheral edema) [see Warnings and Precautions (5.6)]. When assessing an overdose, any additives in the solution must also be considered. Clinically significant overdose of Dextrose and Sodium Chloride Injection may, therefore, constitute medical emergency. The effects of an overdose may require immediate medical attention and treatment.Interventions include discontinuation of the infusion, dose reduction, monitoring of fluid balance, electrolyte concentrations and acid-base balance and institution of appropriate corrective measures such as administration of exogenous insulin.. oHyperglycemia, hyperosmolality, and adverse effects on water and electrolyte balance, and corresponding complications, which can be fatal [see Warnings and Precautions (5.2)]. oHyponatremia, manifestations may include seizures, coma, cerebral edema and death) [see Warnings and Precautions (5.3)].. oHypernatremia, especially in patients with severe renal impairment [see Warnings and Precautions (5.5)].. oFluid overload (which can lead to central and/or peripheral edema) [see Warnings and Precautions (5.6)].

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.


PACKAGE/LABEL PRINCIPAL DISPLAY PANEL Container Label Container Label LOT EXP2B1063NDC 0338-0089-035% Dextrose and0.9% Sodium ChlorideInjection USP500 mL EACH 100 mL CONTAINS g DEXTROSE HYDROUS USP 900 mg SODIUM CHLORIDE USP pH 4.0 (3.2 TO 6.5) mEq/L SODIUM 154 CHLORIDE 154 HYPERTONIC OSMOLARITY 560 mOsmol/L (CALC) STERILENONPYROGENIC SINGLE DOSE CONTAINER ADDITIVES MAY BE INCOMPATIBLE CONSULT WITH PHARMACIST IF AVAILABLE WHEN INTRODUCING ADDITIVES USE ASEPTIC TECHNIQUE MIX THOROUGHLY DO NOT STORE DOSAGE INTRAVENOUSLY AS DIRECTED BY PHYSICIAN SEE DIRECTIONS CAUTIONS SQUEEZE AND INSPECT INNER BAG WHICH MAINTAINS PRODUCT STERILITY DISCARD IF LEAKS ARE FOUND MUST NOT BE USED IN SERIES CONNECTIONS DO NOT USE UNLESS SOLUTION IS CLEAR RX ONLY STORE UNIT IN MOISTURE BARRIER OVERWRAP AT ROOM TEMPERATURE (25C/77F) UNTIL READY TO USE AVOID EXCESSIVE HEAT SEE INSERTVIAFLEX CONTAINER PL 146 PLASTICBAXTER VIAFLEX AND PL 146 ARE TRADEMARKS OF BAXTER INTERNATIONAL INCFOR PRODUCT INFORMATION 1-800-933-0303BAXTER LogoBAXTER HEALTHCARE CORPORATIONDEERFIELD IL 60015 USAMADE IN USA1234Carton Label Carton Label 2B1063Q 24-500 ML VIAFLEX(R) CONTAINER 5% DEXTROSE AND 0.9% SODIUM CHLORIDE INJ, USP EXP XXXXX SECONDARY BAR CODE (17) YYMM00 (10) XXXXX LOT XXXXX PRIMARY BAR CODE (01) 50303380089036Container Label Container Label LOT EXP2B1024NDC 0338-0073-042.5% Dextrose and 0.45% Sodium ChlorideInjection USP1000 mLEACH 100 mL CONTAINS 2.5 DEXTROSE HYDROUS USP 450 mg SODIUM CHLORIDE USP pH 4.0 (3.2 TO 6.5) mEq/L SODIUM 77 CHLORIDE 77 OSMOLARITY 280 mOsmol/L (CALC) STERILE NONPYROGENIC SINGLE DOSE CONTAINER ADDITIVES MAY BE INCOMPATIBLE CONSULT WITH PHARMACIST IF AVAILABLE WHEN INTRODUCING ADDITIVES USE ASEPTIC TECHNIQUE MIX THOROUGHLY DO NOT STORE DOSAGE INTRAVENOUSLY AS DIRECTED BY PHYSICIAN SEE DIRECTIONS CAUTIONS SQUEEZE AND INSPECT INNER BAG WHICH MAINTAINS PRODUCT STERILITY DISCARD IF LEAKS ARE FOUND MUST NOT BE USED IN SERIES CONNECTIONS DO NOT USE UNLESS SOLUTION IS CLEAR RX ONLY STORE UNIT IN MOISTURE BARRIER OVERWRAP AT ROOM TEMPERATURE (25C/77F) UNTIL READY TO USE AVOID EXCESSIVE HEAT SEE INSERTVIAFLEX CONTAINER PL 146 PLASTIC BAXTER VIAFLEX AND PL 146 ARE TRADEMARKS OFBAXTER INTERNATIONAL INCFOR PRODUCT INFORMATION 1-800-933-0303Baxter LogoBAXTER HEALTHCARE CORPORATIONDEERFIELD IL 60015 USAMADE IN USA123456789Carton Label Carton Label 2B1024X 14-1000 MLVIAFLEX(R) CONTAINER2.5% DEXTROSE AND0.45% SODIUM CHLORIDE INJ, USPEXPXXXXXSECONDARY BAR CODE(17) XXXXX (10) XXXXXLOTXXXXXPRIMARY BAR CODE(01) 50303380073042Container Label Container Label LOT EXP2B1092NDC 0338-0077-025% Dextrose and0.2% Sodium ChlorideInjection USP250 mL EACH 100 mL CONTAINS g DEXTROSE HYDROUS USP 200 mg SODIUM CHLORIDE USP pH 4.0 (3.2 TO 6.5) mEq/L SODIUM 34 CHLORIDE 34 OSMOLARITY 321 mOsmol/L (CALC) STERILE NONPYROGENIC SINGLE DOSE CONTAINER ADDITIVES MAY BE INCOMPATIBLE CONSULT WITH PHARMACIST IF AVAILABLE WHEN INTRODUCING ADDITIVES USE ASEPTIC TECHNIQUE MIX THOROUGHLY DO NOT STORE DOSAGE INTRAVENOUSLY AS DIRECTED BY PHYSICIAN SEE DIRECTIONS CAUTIONS SQUEEZE AND INSPECT INNER BAG WHICH MAINTAINS PRODUCT STERILITY DISCARD IF LEAKS ARE FOUND MUST NOT BE USED IN SERIES CONNECTIONS DO NOT USE UNLESS SOLUTION IS CLEAR RX ONLY STORE UNIT IN MOISTURE BARRIER OVERWRAP AT ROOM TEMPERATURE (25C/77F) UNTIL READY TO USE AVOID EXCESSIVE HEAT SEE INSERTVIAFLEX CONTAINER PL 146 PLASTICBAXTER VIAFLEX AND PL 146 ARE TRADEMARKS OF BAXTER INTERNATIONAL INCFOR PRODUCT INFORMATION 1-800-933-0303BAXTER LogoBAXTER HEALTHCARE CORPORATIONDEERFIELD IL 60015 USAMADE IN USA50100150200Carton Label Carton Label Carton Label 2B1092Q 36-250 MLVIAFLEX(R) CONTAINER5% DEXTROSE AND0.2% SODIUM CHLORIDE INJ, USPEXPXXXXXSECONDARY BAR CODE(17) YYMM00 (10) XXXXXLOTXXXXXPRIMARY BAR CODE(01) 50303380077026Container Label Container Label Container Label LOT EXP2B1083NDC 0338-0081-035% Dextrose and0.33% Sodium ChlorideInjection USP500 mLEACH 100 mL CONTAINS g DEXTROSE HYDROUS USP 330 mg SODIUM CHLORIDE USP pH 4.0 (3.2 TO 6.5) mEq/L SODIUM 56 CHLORIDE 56 OSMOLARITY 356 mOsmol/L (CALC) STERILE NONPYROGENIC SINGLE DOSE CONTAINER ADDITIVES MAY BE INCOMPATIBLE CONSULT WITH PHARMACIST IF AVAILABLE WHEN INTRODUCING ADDITIVES USE ASEPTIC TECHNIQUE MIX THOROUGHLY DO NOT STORE DOSAGE INTRAVENOUSLY AS DIRECTED BY PHYSICIAN SEE DIRECTIONS CAUTIONS SQUEEZE AND INSPECT INNER BAG WHICH MAINTAINS PRODUCT STERILITY DISCARD IF LEAKS ARE FOUND MUST NOT BE USED IN SERIES CONNECTIONS DO NOT USE UNLESS SOLUTION IS CLEAR RX ONLY STORE UNIT IN MOISTURE BARRIER OVERWRAP ROOM TEMPERATURE (25C/77F) UNTIL READY TO USE AVOID EXCESSIVE HEAT SEE INSERTVIAFLEX CONTAINER PL 146 PLASTICBAXTER VIAFLEX AND PL 146 ARE TRADEMARKS OFBAXTER INTERNATIONAL INCFOR PRODUCT INFORMATION 1-800-933-0303Baxter LogoBAXTER HEALTHCARE CORPORATIONDEERFIELD IL 60015 USAMADE IN USA07-25-34-0961234Carton Label Carton Label 2B1083Q 24-500 MLVIAFLEX(R) CONTAINER5% DEXTROSE AND 0.33% SODIUM CHLORIDE INJ, USPEXPXXXXXSECONDARY BAR CODE(17) XXXXX (10) XXXXXLOTXXXXXPRIMARY BAR CODE(01) 50303380081030Container Label Container Label LOT EXP2B1073 NDC 0338-0085-035% Dextrose and0.45% Sodium ChlorideInjection USP500 mLEACH 100 mL CONTAINS g DEXTROSE HYDROUS USP 450 mg SODIUM CHLORIDE USP pH 4.0 (3.2 TO 6.5) mEq/L SODIUM 77 CHLORIDE 77 HYPERTONIC OSMOLARITY 406 mOsmol/L (CALC) STERILE NONPYROGENIC SINGLE DOSE CONTAINER ADDITIVES MAY BE INCOMPATIBLE CONSULT WITH PHARMACIST IF AVAILABLE WHEN INTRODUCING ADDITIVES USE ASEPTIC TECHNIQUE MIX THOROUGHLY DO NOT STORE DOSAGE INTRAVENOUSLY AS DIRECTED BY PHYSICIAN SEE DIRECTIONS CAUTIONS SQUEEZE AND INSPECT INNER BAG WHICH MAINTAINS PRODUCT STERILITY DISCARD IF LEAKS ARE FOUND MUST NOT BE USED IN SERIES CONNECTIONS DO NOT USE UNLESS SOLUTION IS CLEAR RX ONLY STORE UNIT IN MOISTURE BARRIER OVERWRAP AT ROOM TEMPERATURE (25C/77F) UNTIL READY TO USE AVOID EXCESSIVE HEAT SEE INSERTVIAFLEX CONTAINER PL 146 PLASTICBAXTER VIAFLEX AND PL 146 ARE TRADEMARKS OF BAXTER INTERNATIONAL INCFOR PRODUCT INFORMATION 1-800-933-0303BAXTER LogoBAXTER HEALTHCARE CORPORATIONDEERFIELD IL 60015 USAMADE IN USA1234Carton Label Carton Label 2B1073Q 24-500 MLVIAFLEX(R) CONTAINER5% DEXTROSE AND0.45% SODIUM CHLORIDE INJ, USPEXPXXXXXSECONDARY BAR CODE(17) YYMM00 (10) XXXXXLOTXXXXXPRIMARY BAR CODE(01) 50303380085038. Dextrose and Sodium Chloride Representative Container Label NDC 0338-0089-03. Dextrose Sodium Chloride Representatve Carton Label NDC 0338-0089-036. Dextrose Sodium Chloride Representative Container Label NDC 0338-0073-04. Dextrose Sodium Chloride Representative Carton Label NDC 0338-0073-042. Dextrose Sodium Chloride Representative Container Label NDC 0338-0077-02. Dextrose and Sodium Chloride Representative Carton Label 0338-0077-02 Dextrose and Sodium Chloride Representative Container Label 0338-0081-03. Dextrose and Sodium Chloride Representative Carton Label 0338-0081-03. Dextrose Sodium Chloride Representative Container Label NDC 0338-0085-03. Dextrose Sodium Chloride Representative Carton Label NDC 0338-0085-038.

PEDIATRIC USE SECTION.


8.4 Pediatric Use The safety profile of Dextrose and Sodium Chloride Injection in pediatric patients is similar to adults.Neonates, especially premature infants with low birth weight, are at increased risk of developing hypo- or hyperglycemia and therefore need close monitoring during treatment with intravenous glucose solutions to ensure adequate glycemic control in order to avoid potential long-term adverse effects.Closely monitor plasma electrolyte concentrations in pediatric patients who may have impaired ability to regulate fluids and electrolytes. In very low birth weight infants, excessive or rapid administration of Dextrose and Sodium Chloride Injection may result in increased serum osmolality and risk of intracerebral hemorrhage.Children (including neonates and older children) are at increased risk of developing hyponatremia as well as for developing hyponatremic encephalopathy.

PREGNANCY SECTION.


8.1 Pregnancy Risk SummaryAppropriate administration of Dextrose and Sodium Chloride Injection during pregnancy is not expected to cause adverse developmental outcomes, including congenital malformations. Animal reproduction studies have not been conducted with Dextrose and Sodium Chloride Injection.The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is to 4% and 15 to 20%, respectively.

RECENT MAJOR CHANGES SECTION.


Contraindications (4)08/2019 Warnings and Precautions (5.1, 5.2, 5.3, 5.4, 5.5, 5.6, 5.7)08/2019. Contraindications (4)08/2019. Warnings and Precautions (5.1, 5.2, 5.3, 5.4, 5.5, 5.6, 5.7)08/2019.

SPL UNCLASSIFIED SECTION.


2.1 Important Administration Instructions oDextrose and Sodium Chloride Injection is only for intravenous infusion. oThe osmolarity of Dextrose and Sodium Chloride Injection, ranges from 280 to 560 mOsmol/L (calc). Peripheral administration is generally acceptable; however; consider central vein administration if there is peripheral vein irritation, phlebitis, and/or associated pain.oDo not administer Dextrose and Sodium Chloride Injection simultaneously with blood products through the same administration set because of the possibility of pseudoagglutination or hemolysis.oTo prevent air embolism, use non-vented infusion set or close the vent on vented set, avoid multiple connections, do not connect flexible containers in series, fully evacuate residual gas in the container prior to administration, do not pressurize the flexible container to increase flow rates, and if administration is controlled by pumping device, turn off pump before the container runs dry.oPrior to infusion, visually inspect the 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.oUse of final filter is recommended during administration of parenteral solutions, where possible.. oDextrose and Sodium Chloride Injection is only for intravenous infusion. oThe osmolarity of Dextrose and Sodium Chloride Injection, ranges from 280 to 560 mOsmol/L (calc). Peripheral administration is generally acceptable; however; consider central vein administration if there is peripheral vein irritation, phlebitis, and/or associated pain.. oDo not administer Dextrose and Sodium Chloride Injection simultaneously with blood products through the same administration set because of the possibility of pseudoagglutination or hemolysis.. oTo prevent air embolism, use non-vented infusion set or close the vent on vented set, avoid multiple connections, do not connect flexible containers in series, fully evacuate residual gas in the container prior to administration, do not pressurize the flexible container to increase flow rates, and if administration is controlled by pumping device, turn off pump before the container runs dry.. oPrior to infusion, visually inspect the 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.. oUse of final filter is recommended during administration of parenteral solutions, where possible.

USE IN SPECIFIC POPULATIONS SECTION.


8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk SummaryAppropriate administration of Dextrose and Sodium Chloride Injection during pregnancy is not expected to cause adverse developmental outcomes, including congenital malformations. Animal reproduction studies have not been conducted with Dextrose and Sodium Chloride Injection.The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is to 4% and 15 to 20%, respectively.. 8.2 Lactation Risk SummarySodium is present in human breast milk. There are no data on the effects of Dextrose and Sodium Chloride Injection on breastfed infant or the effects on milk production.The developmental and health benefits of breastfeeding should be considered along with the mothers clinical need for Dextrose and Sodium Chloride Injection and any potential adverse effects on the breastfed infant from Dextrose and Sodium Chloride Injection or from the underlying maternal condition.. 8.4 Pediatric Use The safety profile of Dextrose and Sodium Chloride Injection in pediatric patients is similar to adults.Neonates, especially premature infants with low birth weight, are at increased risk of developing hypo- or hyperglycemia and therefore need close monitoring during treatment with intravenous glucose solutions to ensure adequate glycemic control in order to avoid potential long-term adverse effects.Closely monitor plasma electrolyte concentrations in pediatric patients who may have impaired ability to regulate fluids and electrolytes. In very low birth weight infants, excessive or rapid administration of Dextrose and Sodium Chloride Injection may result in increased serum osmolality and risk of intracerebral hemorrhage.Children (including neonates and older children) are at increased risk of developing hyponatremia as well as for developing hyponatremic encephalopathy.. 8.5 Geriatric Use Clinical studies of Dextrose and Sodium Chloride Injection did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.Elderly patients are at increased risk of developing hyponatremia as well as for developing hyponatremic encephalopathy [see Warnings and Precautions (5.3)]. Dextrose and Sodium Chloride Injection is known to be substantially excreted by the kidney, and the risk of adverse reactions to this product may be greater in patients with impaired renal function [see Warnings and Precautions (5.2, 5.5)].Dose selection for an elderly patient should be cautious, 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.. 8.6 Renal Impairment Administration of Dextrose and Sodium Chloride Injection in patients with renal impairment may result in hyperosmolar hyperglycemic state, hyponatremia, and/or fluid overload. Monitor patients with renal impairment for development of these adverse reactions [see Warnings and Precautions (5.2, 5.3, 5.5, 5.6)].

WARNINGS AND PRECAUTIONS SECTION.


5 WARNINGS AND PRECAUTIONS oHypersensitivity Reactions: Monitor for signs and symptoms and discontinue infusion if reactions occur. (5.1)oHyperglycemia or Hyperosmolar Hyperglycemic State: Monitor blood glucose and administer insulin as needed. (5.2, 8.4)oHyponatremia, Hypokalemia, Hypernatremia and Hyperchloremia: Avoid in patients with or at risk for hypo-/hypernatremia and hypokalemia. If use cannot be avoided, monitor serum sodium and potassium concentrations. (5.3, 5.4, 5.5, 8.4)oFluid Overload: Avoid in patients with or at risk for fluid and/or solute overloading. If use cannot be avoided, monitor daily fluid balance and electrolyte, concentrations and acid-base balance, as needed and especially during prolonged use. (5.6)oRefeeding Syndrome: Monitor severely undernourished patients and slowly increase nutrient intake. (5.7). oHypersensitivity Reactions: Monitor for signs and symptoms and discontinue infusion if reactions occur. (5.1). oHyperglycemia or Hyperosmolar Hyperglycemic State: Monitor blood glucose and administer insulin as needed. (5.2, 8.4). oHyponatremia, Hypokalemia, Hypernatremia and Hyperchloremia: Avoid in patients with or at risk for hypo-/hypernatremia and hypokalemia. If use cannot be avoided, monitor serum sodium and potassium concentrations. (5.3, 5.4, 5.5, 8.4). oFluid Overload: Avoid in patients with or at risk for fluid and/or solute overloading. If use cannot be avoided, monitor daily fluid balance and electrolyte, concentrations and acid-base balance, as needed and especially during prolonged use. (5.6). oRefeeding Syndrome: Monitor severely undernourished patients and slowly increase nutrient intake. (5.7). 5.1 Hypersensitivity Reactions Hypersensitivity and infusion reactions, including anaphylaxis, have been reported with Dextrose and Sodium Chloride Injection [see Adverse Reactions (6)]. Stop the infusion immediately if signs or symptoms of hypersensitivity or infusion reaction develops [see Contraindications (4)]. Appropriate therapeutic countermeasures must be instituted as clinically indicated.. 5.2 Hyperglycemia and Hyperosmolar Hyperglycemic State The use of dextrose infusions in patients with impaired glucose tolerance may worsen hyperglycemia. Administration of dextrose at rate exceeding the patients utilization rate may lead to hyperglycemia, coma, and death.Hyperglycemia is associated with an increase in serum osmolality, resulting in osmotic diuresis, dehydration and electrolyte losses. Patients with underlying central nervous system disease and renal impairment who receive dextrose infusions, may be at greater risk of developing hyperosmolar hyperglycemic state.Monitor blood glucose concentrations and treat hyperglycemia to maintain concentrations within normal limits while administering Dextrose and Sodium Chloride Injection. Insulin may be administered or adjusted to maintain optimal blood glucose concentrations.. 5.3 Hyponatremia Dextrose and Sodium Chloride Injection is hypertonic solution [see Description, Table (11)]. In the body, however, glucose containing fluids can become extremely physiologically hypotonic due to rapid glucose metabolization. Monitoring of serum sodium is particularly important for hypotonic fluids.Depending on the tonicity of the solution, the volume and rate of infusion, and depending on patients underlying clinical condition and capability to metabolize glucose, intravenous administration of glucose can cause electrolyte disturbances, most importantly hypo- or hyperosmotic hyponatremia.The risk for hyponatremia is increased, in pediatric patients, elderly patients, postoperative patients, those with psychogenic polydipsia and in patients treated with medications that increase the risk of hyponatremia (such as certain diuretic, antiepileptic and psychotropic medications) [see Drug Interactions (7.1)]. Acute hyponatremia can lead to acute hyponatremic encephalopathy characterized by headache, nausea, seizures, lethargy and vomiting. Patients with brain edema are at particular risk of severe, irreversible and life-threatening brain injury. Patients at increased risk for developing complications of hyponatremia, such as hyponatremic encephalopathy include pediatric patients; women, in particular, premenopausal women; patients with hypoxemia; and in patients with underlying central nervous system disease [see Use in Specific Populations (8.4, 8.5)].Avoid Dextrose and Sodium Chloride Injection in patients with or at risk for hyponatremia. If use cannot be avoided, monitor serum sodium concentrations.Rapid correction of hyponatremia is potentially dangerous with risk of serious neurologic complications such as osmotic demyelination syndrome with risk of seizures and cerebral edema. To avoid complications, monitor serum sodium and chloride concentrations, fluid status, acid-base balance, and signs of neurologic complications.High volume infusion must be used with close monitoring in patients with cardiac or pulmonary failure, and in patients with non-osmotic vasopressin release (including SIADH), due to the risk of hospital-acquired hyponatremia.. 5.4 Hypokalemia Excessive administration of Dextrose and Sodium Chloride Injection may result in significant hypokalemia. Hypokalemic periodic paralysis, metabolic alkalosis, increased gastrointestinal losses (e.g. diarrhea, vomiting), prolonged low potassium diet, or primary hyperaldosteronism may increase the risk of hypokalemia.Avoid the administration of Dextrose and Sodium Chloride Injection in patients with or at risk of hypokalemia or taking medications that may increase the risk. If use cannot be avoided, monitor serum potassium levels.. 5.5 Hypernatremia and Hyperchloremia Electrolyte imbalances such as hypernatremia and hyperchloremia, leading to metabolic acidosis may occur with solutions containing 0.9% sodium chloride.Conditions that may increase the risk of hypernatremia, fluid overload and edema (central and peripheral), include patients with pre-eclampsia, primary hyperaldosteronism and secondary hyperaldosteronism associated with, for example, hypertension, congestive heart failure, severe renal impairment, liver disease (including cirrhosis), and renal disease (including renal artery stenosis, nephrosclerosis).Medications such as corticosteroids or corticotropin, may increase the risk of sodium and fluid retention.Avoid in patients with or at risk for hypernatremia. If use cannot be avoided, monitor serum sodium concentrations.Rapid correction of hypernatremia is potentially dangerous with risk of serious neurologic complications. Excessively rapid correction of hypernatremia is also associated with risk for serious neurologic complications such as osmotic demyelination syndrome (ODS) with risk of seizures and cerebral edema.. 5.6 Fluid Overload Depending on the volume and rate of infusion, the patients underlying clinical condition and capability to metabolize dextrose, intravenous administration of Dextrose and Sodium Chloride Injection can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema.Avoid Dextrose and Sodium Chloride Injection in patients with or at risk for fluid and/or solute overloading. If use cannot be avoided, monitor fluid balance, electrolyte concentrations, and acid-base balance as needed and especially during prolonged use.. 5.7 Refeeding Syndrome Refeeding severely undernourished patients may result in the refeeding syndrome that is characterized by the shift of potassium, phosphorus, and magnesium intracellularly as the patient becomes anabolic. Thiamine deficiency and fluid retention may also develop. To prevent these complications, monitor severely undernourished patients and slowly increasing nutrient intake.