Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING Dextrose Injection, USP are clear, colorless, sterile solutions of dextrose supplied in VIAFLO dripless access containers (DAC) and non-DAC plastic containers are shown below. VIAFLO DAC will not drip once the spike is removed. VIAFLO non-DAC will drip once the spike is removed from the administration port. Product Description Size Code NDC Dextrose Injection 5%, USP (0.05 grams/mL) 50mL (DAC) 50mL (Non-DAC) 100mL (DAC) 100mL (Non-DAC) 250 mL (DAC) 250 mL (Non-DAC) 500 mL (DAC) 500 mL (Non-DAC) 1000 mL (DAC) 1000 mL (Non-DAC) 1000mL (DAC) UE0086DG UE0086G UE0087DG UE0087G UE0062D UE0062 UE0063D UE0063 UE0064D UE0064 UE0064DG 0338-9651-75 0338-9649-75 0338-9655-60 0338-9653-60 0338-0062-30 0338-0074-30 0338-0066-20 0338-0078-20 0338-0070-10 0338-0082-10 0338-0070-12 Do not remove container from the overwrap until intended for use. Use the product immediately after mixing and the introduction of additives. Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored at room temperature (25°C/77°F); brief exposure up to 40°C/104°F does not adversely affect the product.; PACKAGE/LABEL PRINCIPAL DISPLAY PANEL Container Label Baxter NDC 0338-9651-75 UE0086DG 50mL Viaflo 5% Dextrose Injection USP pH 4.0 (3.2-6.5) Osmolarity 252 mOsmol/L (calc) Sterile non pyrogenic Single dose container Each 50 mL contains 2.5 g Dextrose Hydrous USP Read Package Leaflet for full information Additives may be incompatible Dosage Intravenously as directed by a physician Cautions Must not be used in series connections Do not administer simultaneously with blood Do not use unless solution is clear Rx Only Store unit in moisture barrier overwrap at room temperature (25°C/77°F) until ready to use Avoid excessive heat See insert VIAFLO is not made from natural rubber latex, DEHP, or PVC 7 Symbol Baxter and Viaflo are trademarks of Baxter International Inc. For product information 1-800-933-0303 Baxter Healthcare Corporation Deerfield IL 60015 USA Made in Spain UN-35-04-151 1 Lot Expiry (01) 00303389651758 Carton Label UE0086DG 75 x 50 mL ( ≈ 6 kg) 5% Dextrose Injection, USP Formula per 50 mL Dextrose Hydrous 2.5 g Water for Injection Osmolarity 252 mOsmol/L (calc) pH 4.0 (3.5-6.5) IV administration. Read package insert before use. Keep out of reach and sight of children. Do not connect partially used drugs. Baxter Healthcare Corporation Deerfield IL 60015 USA Made in Spain Viaflo P333E750 ?? - 0001 Lot: ???????? Expiry: YYYY/MM (01)50303389651753(17)YYMM00(10)???????? UE0086DG 75 x 50 mL ( ≈ 6 kg) 5% Dextrose Injection, USP Viaflo 2D Barcode Lot: ???????? Expiry: YYYY/MM (01)50303389651753(17)YYMM00(10)???????? Container Label Baxter NDC 0338-9649-75 UE0086G 50mL Viaflo 5% Dextrose Injection USP pH 4.0 (3.2-6.5) Osmolarity 252 mOsmol/L (calc) Sterile non pyrogenic Single dose container Each 50 mL contains 2.5 g Dextrose Hydrous USP Read Package Leaflet for full information Additives may be incompatible Dosage Intravenously as directed by a physician Cautions Must not be used in series connections Do not administer simultaneously with blood Do not use unless solution is clear Rx Only Store unit in moisture barrier overwrap at room temperature (25°C/77°F) until ready to use Avoid excessive heat See insert VIAFLO is not made from natural rubber latex, DEHP, or PVC 7 Symbol Baxter and Viaflo are trademarks of Baxter International Inc For product information 1-800-933-0303 Baxter Healthcare Corporation Deerfield IL 60015 USA Made in Spain UN-35-04-348 1 Lot Expiry (01)00303389649755 Carton Label UE0086G 75 x 50 mL ( ≈ 6 kg) 5% Dextrose Injection, USP Formula per 50 mL Dextrose Hydrous 2.5 g Water for Injection Osmolarity 252 mOsmol/L (calc) pH 4.0 (3.5-6.5) IV administration. Read package insert before use. Keep out of reach and sight of children. Do not connect partially used drugs. Baxter Healthcare Corporation Deerfield IL 60015 USA Made in Spain Viaflo P333E746 ?? - 0001 Lot: ???????? Expiry: YYYY/MM (01)50303389649750(17)YYMM00(10)???????? UE0086G 75 x 50 mL ( ≈ 6 kg) 5% Dextrose Injection, USP Viaflo 2D Barcode Lot: ???????? Expiry: YYYY/MM (01) 50303389649750(17)YYMM00(10)???????? Container Label Baxter NDC 0338-9655-60 UE0087DG 100mL Viaflo 5% Dextrose Injection USP pH 4.0 (3.2-6.5) Osmolarity 252 mOsmol/L (calc) Sterile non pyrogenic Single dose container Each 100 mL contains 5 g Dextrose Hydrous USP Read Package Leaflet for full information Additives may be incompatible Dosage Intravenously as directed by a physician Cautions Must not be used in series connections Do not administer simultaneously with blood Do not use unless solution is clear Rx Only Store unit in moisture barrier overwrap at room temperature (25°C/77°F) until ready to use Avoid excessive heat See insert VIAFLO is not made from natural rubber latex, DEHP, or PVC 7 Symbol Baxter and Viaflo are trademarks of Baxter International Inc For product information 1-800-933-0303 Baxter Healthcare Corporation Deerfield IL 60015 USA Made in Spain UN-35-04-152 1 Lot Expiry (01)00303389655602 Carton Label UE0087DG 60 x 100 mL ( ≈ 8 kg) 5% Dextrose Injection, USP Formula per 100 mL Dextrose Hydrous 5 g Water for Injection Osmolarity 252 mOsmol/L (calc) pH 4.0 (3.5-6.5) IV administration. Read package insert before use. Keep out of reach and sight of children. Do not connect partially used drugs. Baxter Healthcare Corporation Deerfield IL 60015 USA Made in Spain Viaflo P333E751 ?? - 0001 Lot: ???????? Expiry: YYYY/MM (01)50303389655607(17)YYMM00(10)???????? UE0087DG 60 x 100 mL ( ≈ 8 kg) 5% Dextrose Injection, USP Viaflo 2D Barcode Lot: ???????? Expiry: YYYY/MM (01)50303389655607(17)YYMM00(10)???????? Container Label Baxter NDC 0338-9653-60 UE0087G 100mL Viaflo 5% Dextrose Injection USP pH 4.0 (3.2-6.5) Osmolarity 252 mOsmol/L (calc) Sterile non pyrogenic Single dose container Each 100 mL contains 5 g Dextrose Hydrous USP Read Package Leaflet for full information Additives may be incompatible Dosage Intravenously as directed by a physician Cautions Must not be used in series connections Do not administer simultaneously with blood Do not use unless solution is clear Rx Only Store unit in moisture barrier overwrap at room temperature (25°C/77°F) until ready to use Avoid excessive heat See insert VIAFLO is not made from natural rubber latex, DEHP, or PVC 7 Symbol Baxter and Viaflo are trademarks of Baxter International Inc For product information 1-800-933-0303 Baxter Healthcare Corporation Deerfield IL 60015 USA Made in Spain UN-35-04-349 1 Lot Expiry (01)00303389653608 Carton Label UE0087G 60 x 100 mL ( ≈ 8 kg) 5% Dextrose Injection, USP Formula per 100 mL Dextrose Hydrous 5 g Water for Injection Osmolarity 252 mOsmol/L (calc) pH 4.0 (3.5-6.5) IV administration. Read package insert before use. Keep out of reach and sight of children. Do not connect partially used drugs. Baxter Healthcare Corporation Deerfield IL 60015 USA Made in Spain Viaflo P333E747 ?? - 0001 Lot: ???????? Expiry: YYYY/MM (01)50303389653603(17)YYMM00(10)???????? UE0087G 60 x 100 mL ( ≈ 8 kg) 5% Dextrose Injection, USP Viaflo 2D Barcode Lot: ???????? Expiry: YYYY/MM (01)50303389653603(17)YYMM00(10)???????? Baxter Viaflo 5% Dextrose Injection USP UE0062D 0338-0062-30 250 mL Sterile non pyrogenic Single dose container pH 4.0 (3.2-6.5) Osmolarity 252 mOsm/L (calc) Each 100 mL contains 5 g Dextrose Hydrous USP 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 a 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 administer simultaneously with blood Do not use unless solution is clear Rx Only Store unit in moisture barrier overwrap at room temperature (25°C/77°F) until ready to use Avoid excessive heat See insert VIAFLO is not made from natural rubber latex, DEHP, or PVC Baxter and Viaflo are trademarks of Baxter International Inc. For product information 1-800-933-0303 Baxter Healthcare Corporation Deerfield IL 60015 USA Made in Spain BAR CODE Lot UN- Expiry 50 100 150 200 Baxter Viaflo 5% Dextrose Injection USP UE0062 0338-0074-30 250 mL Sterile non pyrogenic Single dose container pH 4.0 (3.2-6.5) Osmolarity 252 mOsm/L (calc) Each 100 mL contains 5 g Dextrose Hydrous USP 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 a 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 administer simultaneously with blood Do not use unless solution is clear Rx Only Store unit in moisture barrier overwrap at room temperature (25°C/77°F) until ready to use Avoid excessive heat See insert VIAFLO is not made from natural rubber latex, DEHP, or PVC Baxter and Viaflo are trademarks of Baxter International Inc. For product information 1-800-933-0303 Baxter Healthcare Corporation Deerfield IL 60015 USA Made in Spain BAR CODE Lot UN- Expiry 50 100 150 200 Baxter Viaflo 5% Dextrose Injection USP UE0063D 0338-0066-20 500 mL Sterile non pyrogenic Single dose container pH 4.0 (3.2-6.5) Osmolarity 252 mOsm/L (calc) Each 100 mL contains 5 g Dextrose Hydrous USP 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 a 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 administer simultaneously with blood Do not use unless solution is clear Rx Only Store unit in moisture barrier overwrap at room temperature (25°C/77°F) until ready to use Avoid excessive heat See insert VIAFLO is not made from natural rubber latex, DEHP, or PVC Baxter and Viaflo are trademarks of Baxter International Inc. For product information 1-800-933-0303 Baxter Healthcare Corporation Deerfield IL 60015 USA Made in Spain BAR CODE Lot UN-35-03-406 Expiry 50 100 150 200 250 300 350 400 450 Baxter Viaflo 5% Dextrose Injection USP UE0063 0338-0078-20 500 mL Sterile non pyrogenic Single dose container pH 4.0 (3.2-6.5) Osmolarity 252 mOsm/L (calc) Each 100 mL contains 5 g Dextrose Hydrous USP 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 a 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 administer simultaneously with blood Do not use unless solution is clear Rx Only Store unit in moisture barrier overwrap at room temperature (25°C/77°F) until ready to use Avoid excessive heat See insert VIAFLO is not made from natural rubber latex, DEHP, or PVC Baxter and Viaflo are trademarks of Baxter International Inc. For product information 1-800-933-0303 Baxter Healthcare Corporation Deerfield IL 60015 USA Made in Spain BAR CODE Lot UN-35-03-405 Expiry 50 100 150 200 250 300 350 400 450 Baxter Viaflo 5% Dextrose Injection USP UE0064D 0338-0070-10 1000 mL Sterile non pyrogenic Single dose container pH 4.0 (3.2-6.5) Osmolarity 252 mOsm/L (calc) Each 100 mL contains 5 g Dextrose Hydrous USP 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 a 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 administer simultaneously with blood Do not use unless solution is clear Rx Only Store unit in moisture barrier overwrap at room temperature (25°C/77°F) until ready to use Avoid excessive heat See insert VIAFLO is not made from natural rubber latex, DEHP, or PVC Baxter and Viaflo are trademarks of Baxter International Inc. For product information 1-800-933-0303 Baxter Healthcare Corporation Deerfield IL 60015 USA Made in Spain BAR CODE Lot UN- Expiry 100 200 300 400 500 600 700 800 900 Baxter Viaflo 5% Dextrose Injection USP UE0064 0338-0082-10 1000 mL Sterile non pyrogenic Single dose container pH 4.0 (3.2-6.5) Osmolarity 252 mOsm/L (calc) Each 100 mL contains 5 g Dextrose Hydrous USP 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 a 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 administer simultaneously with blood Do not use unless solution is clear Rx Only Store unit in moisture barrier overwrap at room temperature (25°C/77°F) until ready to use Avoid excessive heat See insert VIAFLO is not made from natural rubber latex, DEHP, or PVC Baxter and Viaflo are trademarks of Baxter International Inc. For product information 1-800-933-0303 Baxter Healthcare Corporation Deerfield IL 60015 USA Made in Spain BAR CODE Lot UN- Expiry 100 200 300 400 500 600 700 800 900 Representative Container Label 0338-9651-75 Representative Carton Label 0338-9651-75 Representative Container Label 0338-9649-75 Representative Carton Label 0338-9649-75 Representative Container Label 0338-9655-60 Representative Carton Label 0338-9655-60 Representative Container Label 0338-9653-60 Representative Carton Label 0338-9653-60 Representative Container Label 0338-0062-30 Representative Container Label 0338-0074-30 Representative Container Label 0338-0066-20 Representative Container Label 0338-0078-20 Representative Container Label 0338-0070-10 Representative Container Label 0338-0082-10
- 16 HOW SUPPLIED/STORAGE AND HANDLING Dextrose Injection, USP are clear, colorless, sterile solutions of dextrose supplied in VIAFLO dripless access containers (DAC) and non-DAC plastic containers are shown below. VIAFLO DAC will not drip once the spike is removed. VIAFLO non-DAC will drip once the spike is removed from the administration port. Product Description Size Code NDC Dextrose Injection 5%, USP (0.05 grams/mL) 50mL (DAC) 50mL (Non-DAC) 100mL (DAC) 100mL (Non-DAC) 250 mL (DAC) 250 mL (Non-DAC) 500 mL (DAC) 500 mL (Non-DAC) 1000 mL (DAC) 1000 mL (Non-DAC) 1000mL (DAC) UE0086DG UE0086G UE0087DG UE0087G UE0062D UE0062 UE0063D UE0063 UE0064D UE0064 UE0064DG 0338-9651-75 0338-9649-75 0338-9655-60 0338-9653-60 0338-0062-30 0338-0074-30 0338-0066-20 0338-0078-20 0338-0070-10 0338-0082-10 0338-0070-12 Do not remove container from the overwrap until intended for use. Use the product immediately after mixing and the introduction of additives. Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored at room temperature (25°C/77°F); brief exposure up to 40°C/104°F does not adversely affect the product.
- PACKAGE/LABEL PRINCIPAL DISPLAY PANEL Container Label Baxter NDC 0338-9651-75 UE0086DG 50mL Viaflo 5% Dextrose Injection USP pH 4.0 (3.2-6.5) Osmolarity 252 mOsmol/L (calc) Sterile non pyrogenic Single dose container Each 50 mL contains 2.5 g Dextrose Hydrous USP Read Package Leaflet for full information Additives may be incompatible Dosage Intravenously as directed by a physician Cautions Must not be used in series connections Do not administer simultaneously with blood Do not use unless solution is clear Rx Only Store unit in moisture barrier overwrap at room temperature (25°C/77°F) until ready to use Avoid excessive heat See insert VIAFLO is not made from natural rubber latex, DEHP, or PVC 7 Symbol Baxter and Viaflo are trademarks of Baxter International Inc. For product information 1-800-933-0303 Baxter Healthcare Corporation Deerfield IL 60015 USA Made in Spain UN-35-04-151 1 Lot Expiry (01) 00303389651758 Carton Label UE0086DG 75 x 50 mL ( ≈ 6 kg) 5% Dextrose Injection, USP Formula per 50 mL Dextrose Hydrous 2.5 g Water for Injection Osmolarity 252 mOsmol/L (calc) pH 4.0 (3.5-6.5) IV administration. Read package insert before use. Keep out of reach and sight of children. Do not connect partially used drugs. Baxter Healthcare Corporation Deerfield IL 60015 USA Made in Spain Viaflo P333E750 ?? - 0001 Lot: ???????? Expiry: YYYY/MM (01)50303389651753(17)YYMM00(10)???????? UE0086DG 75 x 50 mL ( ≈ 6 kg) 5% Dextrose Injection, USP Viaflo 2D Barcode Lot: ???????? Expiry: YYYY/MM (01)50303389651753(17)YYMM00(10)???????? Container Label Baxter NDC 0338-9649-75 UE0086G 50mL Viaflo 5% Dextrose Injection USP pH 4.0 (3.2-6.5) Osmolarity 252 mOsmol/L (calc) Sterile non pyrogenic Single dose container Each 50 mL contains 2.5 g Dextrose Hydrous USP Read Package Leaflet for full information Additives may be incompatible Dosage Intravenously as directed by a physician Cautions Must not be used in series connections Do not administer simultaneously with blood Do not use unless solution is clear Rx Only Store unit in moisture barrier overwrap at room temperature (25°C/77°F) until ready to use Avoid excessive heat See insert VIAFLO is not made from natural rubber latex, DEHP, or PVC 7 Symbol Baxter and Viaflo are trademarks of Baxter International Inc For product information 1-800-933-0303 Baxter Healthcare Corporation Deerfield IL 60015 USA Made in Spain UN-35-04-348 1 Lot Expiry (01)00303389649755 Carton Label UE0086G 75 x 50 mL ( ≈ 6 kg) 5% Dextrose Injection, USP Formula per 50 mL Dextrose Hydrous 2.5 g Water for Injection Osmolarity 252 mOsmol/L (calc) pH 4.0 (3.5-6.5) IV administration. Read package insert before use. Keep out of reach and sight of children. Do not connect partially used drugs. Baxter Healthcare Corporation Deerfield IL 60015 USA Made in Spain Viaflo P333E746 ?? - 0001 Lot: ???????? Expiry: YYYY/MM (01)50303389649750(17)YYMM00(10)???????? UE0086G 75 x 50 mL ( ≈ 6 kg) 5% Dextrose Injection, USP Viaflo 2D Barcode Lot: ???????? Expiry: YYYY/MM (01) 50303389649750(17)YYMM00(10)???????? Container Label Baxter NDC 0338-9655-60 UE0087DG 100mL Viaflo 5% Dextrose Injection USP pH 4.0 (3.2-6.5) Osmolarity 252 mOsmol/L (calc) Sterile non pyrogenic Single dose container Each 100 mL contains 5 g Dextrose Hydrous USP Read Package Leaflet for full information Additives may be incompatible Dosage Intravenously as directed by a physician Cautions Must not be used in series connections Do not administer simultaneously with blood Do not use unless solution is clear Rx Only Store unit in moisture barrier overwrap at room temperature (25°C/77°F) until ready to use Avoid excessive heat See insert VIAFLO is not made from natural rubber latex, DEHP, or PVC 7 Symbol Baxter and Viaflo are trademarks of Baxter International Inc For product information 1-800-933-0303 Baxter Healthcare Corporation Deerfield IL 60015 USA Made in Spain UN-35-04-152 1 Lot Expiry (01)00303389655602 Carton Label UE0087DG 60 x 100 mL ( ≈ 8 kg) 5% Dextrose Injection, USP Formula per 100 mL Dextrose Hydrous 5 g Water for Injection Osmolarity 252 mOsmol/L (calc) pH 4.0 (3.5-6.5) IV administration. Read package insert before use. Keep out of reach and sight of children. Do not connect partially used drugs. Baxter Healthcare Corporation Deerfield IL 60015 USA Made in Spain Viaflo P333E751 ?? - 0001 Lot: ???????? Expiry: YYYY/MM (01)50303389655607(17)YYMM00(10)???????? UE0087DG 60 x 100 mL ( ≈ 8 kg) 5% Dextrose Injection, USP Viaflo 2D Barcode Lot: ???????? Expiry: YYYY/MM (01)50303389655607(17)YYMM00(10)???????? Container Label Baxter NDC 0338-9653-60 UE0087G 100mL Viaflo 5% Dextrose Injection USP pH 4.0 (3.2-6.5) Osmolarity 252 mOsmol/L (calc) Sterile non pyrogenic Single dose container Each 100 mL contains 5 g Dextrose Hydrous USP Read Package Leaflet for full information Additives may be incompatible Dosage Intravenously as directed by a physician Cautions Must not be used in series connections Do not administer simultaneously with blood Do not use unless solution is clear Rx Only Store unit in moisture barrier overwrap at room temperature (25°C/77°F) until ready to use Avoid excessive heat See insert VIAFLO is not made from natural rubber latex, DEHP, or PVC 7 Symbol Baxter and Viaflo are trademarks of Baxter International Inc For product information 1-800-933-0303 Baxter Healthcare Corporation Deerfield IL 60015 USA Made in Spain UN-35-04-349 1 Lot Expiry (01)00303389653608 Carton Label UE0087G 60 x 100 mL ( ≈ 8 kg) 5% Dextrose Injection, USP Formula per 100 mL Dextrose Hydrous 5 g Water for Injection Osmolarity 252 mOsmol/L (calc) pH 4.0 (3.5-6.5) IV administration. Read package insert before use. Keep out of reach and sight of children. Do not connect partially used drugs. Baxter Healthcare Corporation Deerfield IL 60015 USA Made in Spain Viaflo P333E747 ?? - 0001 Lot: ???????? Expiry: YYYY/MM (01)50303389653603(17)YYMM00(10)???????? UE0087G 60 x 100 mL ( ≈ 8 kg) 5% Dextrose Injection, USP Viaflo 2D Barcode Lot: ???????? Expiry: YYYY/MM (01)50303389653603(17)YYMM00(10)???????? Baxter Viaflo 5% Dextrose Injection USP UE0062D 0338-0062-30 250 mL Sterile non pyrogenic Single dose container pH 4.0 (3.2-6.5) Osmolarity 252 mOsm/L (calc) Each 100 mL contains 5 g Dextrose Hydrous USP 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 a 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 administer simultaneously with blood Do not use unless solution is clear Rx Only Store unit in moisture barrier overwrap at room temperature (25°C/77°F) until ready to use Avoid excessive heat See insert VIAFLO is not made from natural rubber latex, DEHP, or PVC Baxter and Viaflo are trademarks of Baxter International Inc. For product information 1-800-933-0303 Baxter Healthcare Corporation Deerfield IL 60015 USA Made in Spain BAR CODE Lot UN- Expiry 50 100 150 200 Baxter Viaflo 5% Dextrose Injection USP UE0062 0338-0074-30 250 mL Sterile non pyrogenic Single dose container pH 4.0 (3.2-6.5) Osmolarity 252 mOsm/L (calc) Each 100 mL contains 5 g Dextrose Hydrous USP 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 a 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 administer simultaneously with blood Do not use unless solution is clear Rx Only Store unit in moisture barrier overwrap at room temperature (25°C/77°F) until ready to use Avoid excessive heat See insert VIAFLO is not made from natural rubber latex, DEHP, or PVC Baxter and Viaflo are trademarks of Baxter International Inc. For product information 1-800-933-0303 Baxter Healthcare Corporation Deerfield IL 60015 USA Made in Spain BAR CODE Lot UN- Expiry 50 100 150 200 Baxter Viaflo 5% Dextrose Injection USP UE0063D 0338-0066-20 500 mL Sterile non pyrogenic Single dose container pH 4.0 (3.2-6.5) Osmolarity 252 mOsm/L (calc) Each 100 mL contains 5 g Dextrose Hydrous USP 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 a 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 administer simultaneously with blood Do not use unless solution is clear Rx Only Store unit in moisture barrier overwrap at room temperature (25°C/77°F) until ready to use Avoid excessive heat See insert VIAFLO is not made from natural rubber latex, DEHP, or PVC Baxter and Viaflo are trademarks of Baxter International Inc. For product information 1-800-933-0303 Baxter Healthcare Corporation Deerfield IL 60015 USA Made in Spain BAR CODE Lot UN-35-03-406 Expiry 50 100 150 200 250 300 350 400 450 Baxter Viaflo 5% Dextrose Injection USP UE0063 0338-0078-20 500 mL Sterile non pyrogenic Single dose container pH 4.0 (3.2-6.5) Osmolarity 252 mOsm/L (calc) Each 100 mL contains 5 g Dextrose Hydrous USP 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 a 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 administer simultaneously with blood Do not use unless solution is clear Rx Only Store unit in moisture barrier overwrap at room temperature (25°C/77°F) until ready to use Avoid excessive heat See insert VIAFLO is not made from natural rubber latex, DEHP, or PVC Baxter and Viaflo are trademarks of Baxter International Inc. For product information 1-800-933-0303 Baxter Healthcare Corporation Deerfield IL 60015 USA Made in Spain BAR CODE Lot UN-35-03-405 Expiry 50 100 150 200 250 300 350 400 450 Baxter Viaflo 5% Dextrose Injection USP UE0064D 0338-0070-10 1000 mL Sterile non pyrogenic Single dose container pH 4.0 (3.2-6.5) Osmolarity 252 mOsm/L (calc) Each 100 mL contains 5 g Dextrose Hydrous USP 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 a 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 administer simultaneously with blood Do not use unless solution is clear Rx Only Store unit in moisture barrier overwrap at room temperature (25°C/77°F) until ready to use Avoid excessive heat See insert VIAFLO is not made from natural rubber latex, DEHP, or PVC Baxter and Viaflo are trademarks of Baxter International Inc. For product information 1-800-933-0303 Baxter Healthcare Corporation Deerfield IL 60015 USA Made in Spain BAR CODE Lot UN- Expiry 100 200 300 400 500 600 700 800 900 Baxter Viaflo 5% Dextrose Injection USP UE0064 0338-0082-10 1000 mL Sterile non pyrogenic Single dose container pH 4.0 (3.2-6.5) Osmolarity 252 mOsm/L (calc) Each 100 mL contains 5 g Dextrose Hydrous USP 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 a 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 administer simultaneously with blood Do not use unless solution is clear Rx Only Store unit in moisture barrier overwrap at room temperature (25°C/77°F) until ready to use Avoid excessive heat See insert VIAFLO is not made from natural rubber latex, DEHP, or PVC Baxter and Viaflo are trademarks of Baxter International Inc. For product information 1-800-933-0303 Baxter Healthcare Corporation Deerfield IL 60015 USA Made in Spain BAR CODE Lot UN- Expiry 100 200 300 400 500 600 700 800 900 Representative Container Label 0338-9651-75 Representative Carton Label 0338-9651-75 Representative Container Label 0338-9649-75 Representative Carton Label 0338-9649-75 Representative Container Label 0338-9655-60 Representative Carton Label 0338-9655-60 Representative Container Label 0338-9653-60 Representative Carton Label 0338-9653-60 Representative Container Label 0338-0062-30 Representative Container Label 0338-0074-30 Representative Container Label 0338-0066-20 Representative Container Label 0338-0078-20 Representative Container Label 0338-0070-10 Representative Container Label 0338-0082-10
Overview
Dextrose Injection, USP is sterile, non-pyrogenic solutions of Dextrose, USP in Water for Injection in a flexible plastic container for intravenous administration as a source of water and calories. Partial-fill containers, designed to facilitate admixture when necessary, are available in 250 mL, 500 mL, and 1000 mL sizes. See Table 1 for the content and characteristics of this solution. The solution contains no bacteriostatic, antimicrobial agent or added buffer and is intended only for use as a single-dose injection. The pH range is 4.0 (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 5%, USP 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 Osmolarity (mOsmol per liter) Dextrose Injection 5%, USP (0.05 grams/mL) 50 mL 2.5 grams 8.5 252 100 mL 5 grams 17 252 250 mL 12.5 grams 42.5 252 500 mL 25 grams 85 252 1000 mL 50 grams 170 252 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: Water for Injection, USP is chemically designated H 2 O. Dextrose is derived from corn. VIAFLO is a flexible plastic container fabricated from a multilayer sheeting (PL-2442) composed of Polypropylene (PP), Polyamide (PA) and Polyethylene (PE). Two different administration connectors are available with VIAFLO containers. The VIAFLO dripless access container (DAC) will not drip once the spike is removed. The non-DAC VIAFLO will drip once the spike is removed from the administration port. VIAFLO is not made with natural rubber latex, DEHP, or PVC. Dextrose Hydrous Structural Formula
Indications & Usage
Dextrose Injection is indicated as source of water and calories. Dextrose Injection is indicated as a source of water and calories. ( 1 )
Dosage & Administration
• Only for intravenous infusion. ( 2.1 ) • See 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 • Dextrose Injection is intended for intravenous use. • Peripheral administration of 5% dextrose is generally acceptable, however, consider central vein when administering more than 5% dextrose or with an osmolarity of at least 900 mOsm/L or when there is peripheral vein irritation, phlebitis, and/or associated pain [see Warnings and Precautions (5.3) ] . • Do not administer Dextrose Injection simultaneously with blood products through the same administration set because of the possibility of pseudoagglutination or hemolysis. • To prevent air embolism, use a non-vented infusion set or close the vent on a 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 a pumping device, turn off pump before the container runs dry. • 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. • Use of a final filter is recommended during administration of parenteral solutions, where possible. 2.2 Recommended Dosage The choice of dextrose concentration, 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 patient’s tolerance to dextrose. Increase the infusion rate gradually as indicated by frequent monitoring of blood glucose concentrations [see Warnings and Precautions (5.1 ), Use in Specific Populations (8.4) ] . 2.3 Instructions for Use To Open • Do not remove from overpouch until ready to use. • Tear overwrap down side at slit and remove solution container. Small amounts of moisture may be found on the solution container from water permeating from inside the container. The amount of permeated water is insufficient to affect the solution significantly. If larger amounts of water are found, the container should be checked for tears or leaks. • Visually 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 a color change and/or the appearance of precipitates, insoluble complexes or crystals. • Check for minute leaks by squeezing the inner bag firmly. If leaks are found, discard container. Preparation for Administration 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. To Add Medication • Additives may be incompatible. Complete information is not available. Do not use additives known or determined to be incompatible. • Consult with pharmacist, if available. If, in the informed judgment of the healthcare provider, it is deemed advisable to introduce additives, use aseptic technique. • When introducing additives, consult the instructions for use of the medication to be added and other relevant literature. • Before adding a substance or medication, verify that it is soluble and/or stable in Dextrose Injection and that the pH range of Dextrose Injection is appropriate. To Add Medication Before Solution Administration 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 a color change and/or the appearance of precipitates, insoluble complexes or crystals. To Add Medication During Solution Administration 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 a color change and/or the appearance of precipitates, insoluble complexes or crystals, do not use. 8. Return container to in-use position and continue administration. Storage • Use promptly; do not store solutions containing additives. • Single-dose container. • Discard any unused portion.
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 ) • Vein Damage and Thrombosis : Consider central vein when administering more than 5% dextrose or with an osmolarity of at least 900 mOsm/L or when there is peripheral vein irritation, phlebitis, and/or associated pain. ( 2.2 , 5.3 ) • Hyponatremia : Avoid in patients with or at risk for hyponatremia. If use cannot be avoided, monitor serum sodium concentrations. ( 5.4 ) • Electrolyte Imbalance and Fluid Overload : Avoid in patients with or at risk for fluid and/or solute overloading. If use cannot be avoided, monitor daily fluid balance, electrolyte concentrations, and acid-base balance, as needed and especially during prolonged use. ( 5.5 ) • Refeeding Syndrome : Monitor severely undernourished patients and slowly increase nutrient intake. ( 5.6 ) 5.1 Hyperglycemia and Hyperosmolar Hyperglycemic State The use of dextrose infusions in patients with 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. Hyperglycemia is associated with an increase in serum osmolality, resulting in osmotic diuresis, dehydration and electrolyte losses [see Warnings and Precautions (5.5) ]. Patients with underlying CNS disease 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 levels within normal limits 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 and infusion reactions, including anaphylaxis, have been reported with Dextrose Injection [see Adverse Reactions (6) ]. Stop infusion immediately and treat patient accordingly if signs or symptoms of a hypersensitivity reaction develop. Appropriate therapeutic countermeasures must be instituted as clinically indicated. 5.3 Vein Damage and Thrombosis Peripheral administration of 5% Dextrose Injection is generally acceptable, however, consider central vein when administering more than 5% dextrose or with an osmolarity of ≥ at least 900 mOsm/L or when there is peripheral vein irritation, phlebitis, and/or associated pain [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. 5.4 Hyponatremia 5% Dextrose Injection is an isotonic solution [see Description, Table 1 (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 a patient’s underlying clinical condition and capability to metabolize glucose, intravenous administration of glucose can cause electrolyte disturbances, most importantly hypo- or hyperosmotic hyponatremia. Monitor serum sodium to minimize the risk of 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 diuretics, certain antiepileptic and psychotropic medications). Close clinical monitoring may be warranted. 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 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. Brain adaptations reducing risk of cerebral edema make the brain vulnerable to injury when chronic hyponatremia is too rapidly corrected, which is known as osmotic demyelination syndrome (ODS). 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. 5.5 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 patient’s underlying clinical condition and capability to metabolize dextrose, intravenous administration of Dextrose Injection can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, (including hypoosmotic hyponatremia), 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. Avoid Dextrose Injection in patients with or at risk for fluid and/or solute overloading. If use cannot be avoided, monitor fluid balance, blood electrolyte levels, concentration of glucose, acid-base balance, correct fluid and electrolyte imbalances during prolonged parenteral therapy or whenever the condition of the patient or the rate of administration warrants such evaluation and acid-base balance as needed and especially during prolonged use. Additional monitoring is recommended for patients with water and electrolyte disturbances that could be aggravated by increased glucose, insulin administration and/or free water load. Patients at increased risk for developing hyponatremic encephalopathy include pediatric patients; elderly patients, women, in particular premenopausal women; patients with hypoxemia; and patients with underlying CNS disease [see Use in Specific Populations (8.4, 8.5) ]. 5.6 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 intake.
Contraindications
The use of Dextrose Injection is contraindicated in patients with: • Clinically significant hyperglycemia [ see Warnings and Precautions (5.1) ] . • Known hypersensitivity to dextrose [ see Warnings and Precautions (5.2) ]. • Clinically significant hyperglycemia. ( 4 ) • Known hypersensitivity to dextrose. ( 4 )
Adverse Reactions
The following adverse reactions associated with the use of dextrose injection were identified in clinical trials or postmarketing reports. Because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency, reliably, or to establish a causal relationship to drug exposure. The following clinically significant adverse reactions are described elsewhere in the labeling: • Hyperglycemia and hyperosmolar hyperglycemic state [see Warnings and Precautions (5.1 )] • Hypersensitivity Reactions : anaphylaxis, pruritis, bronchospasm, cyanosis, angioedema, hypotension, pyrexia, chills, and rash [see Warnings and Precautions (5.2 )] • Infusion Site Reactions : infusion site phlebitis, infusion site erythema, vein damage and thrombosis [see Warnings and Precautions (5.3 )] • Hyponatremia and hyponatremic encephalopathy [see Warnings and Precautions (5.4 )] • Electrolyte imbalance, fluid overload and hypervolemia [see Warnings and Precautions (5.5 )] • Refeeding syndrome [see Warnings and Precautions (5.6 )] The most common adverse reactions are, hyperglycemia, hypersensitivity reactions, hyponatremia, infection both systemic and at the injection site, vein thrombosis or phlebitis, and electrolyte imbalance. ( 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.
Drug Interactions
Other 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 ) 7.1 Other Products that Affect Glycemic Control, Vasopressin or Fluid and/or Electrolyte Balance Dextrose Injection can affect glycemic control, vasopressin and fluid and/or electrolyte balance [see Warnings and Precautions (5.1 , 5.4 , 5.5 )] . Monitor blood glucose concentrations, fluid balance, serum electrolyte concentrations and acid-base balance when using Dextrose Injection in patients treated with other substances that affect glycemic control, vasopressin or fluid and/or electrolyte balance.
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