Potassium Chloride in Dextrose and Sodium Chloride DEXTROSE SODIUM CHLORIDE AND POTASSIUM CHLORIDE B. BRAUN MEDICAL INC. FDA Approved (See chart below for quantitative information.) Potassium Chloride in Dextrose and Sodium Chloride Injections USP are sterile, nonpyrogenic and contain no bacteriostatic or antimicrobial agents. These products are intended for intravenous administration. The formulas of the active ingredients are: Ingredients Molecular Formula Molecular Weight Sodium Chloride USP Potassium Chloride USP NaCl KCl 58.44 74.55 Hydrous Dextrose USP 198.17 Not made with natural rubber latex, PVC or DEHP. The plastic container is made from a multilayered film specifically developed for parenteral drugs. It contains no plasticizers and exhibits virtually no leachables. The solution contact layer is a rubberized copolymer of ethylene and propylene. The container is nontoxic and biologically inert. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary. Composition – Each 100 mL contains: Solution Hydrous Dextrose USP Sodium Chloride USP Potassium Chloride USP Concentration of Electrolytes (mEq/liter) Calories per liter Calculated Osmolarity mOsmol/liter pH Sodium Potassium Chloride Water for Injection USP qs 0.15% Potassium Chloride in 5% Dextrose and 0.20% Sodium Chloride Injection USP 5 g 0.2 g 0.15 g 34 20 54 170 360 4.4 (3.5–6.5) 0.075% Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection USP 5 g 0.45 g 0.075 g 77 10 87 170 425 4.4 (3.5–6.5) 0.15% Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection USP 5 g 0.45 g 0.15 g 77 20 97 170 445 4.4 (3.5–6.5) 0.22% Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection USP 5 g 0.45 g 0.22 g 77 30 107 170 465 4.4 (3.5–6.5) 0.30% Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection USP 5 g 0.45 g 0.3 g 77 40 117 170 490 4.4 (3.5–6.5) 0.15% Potassium Chloride in 5% Dextrose and 0.9% Sodium Chloride Injection USP 5 g 0.9 g 0.15 g 154 20 174 170 600 4.4 (3.5–6.5) Addition of medication should be accomplished using complete aseptic technique. The closure system has two ports; the one for the administration set has a tamper evident plastic protector and the other is a medication addition site. Refer to the Directions for Use of the container. Chemical Structure

Drug Facts

Composition & Profile

Strengths
1000 ml 0.15 % 5 % 0.20 % 0.075 % 0.45 % 0.22 % 0.30 % 0.9 %
Quantities
1000 ml 100 ml
Treats Conditions
Indications And Usage These Intravenous Solutions Are Indicated For Use In Adults And Pediatric Patients As Sources Of Electrolytes Calories And Water For Hydration

Identifiers & Packaging

Container Type BOTTLE
UNII
IY9XDZ35W2 451W47IQ8X 660YQ98I10
Packaging

HOW SUPPLIED Potassium Chloride in Dextrose and Sodium Chloride Injections USP are supplied in EXCEL ® Containers. The 1000 mL containers are packaged 12 per case. Canada DIN NDC REF Size 0.15% Potassium Chloride in 5% Dextrose and 0.20% Sodium Chloride Injection USP (20 mEq K + /liter) 01931598 0264-7645-00 L6450 1000 mL 0.075% Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection USP (10 mEq K + /liter) 0264-7634-00 L6340 1000 mL 0.15% Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection USP (20 mEq K + /liter) 01931547 0264-7635-00 L6350 1000 mL 0.22% Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection USP (30 mEq K + /liter) 0264-7636-00 L6360 1000 mL 0.30% Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection USP (40 mEq K + /liter) 01931571 0264-7638-00 L6380 1000 mL 0.15% Potassium Chloride in 5% Dextrose and 0.9% Sodium Chloride Injection USP (20 mEq K + /liter) 01931644 0264-7652-00 L6520 1000 mL Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at room temperature (25°C).; PRINCIPAL DISPLAY PANEL - 1000 mL Container Label 0.075% Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection USP REF L6340 NDC 0264-7634-00 1000 mL EXCEL ® CONTAINER 10 mEq K + /liter Y94-003-346 LD-258-3 Each 100 mL contains: Hydrous Dextrose USP 5 g; Sodium Chloride USP 0.45 g; Potassium Chloride USP 0.075 g; Water for Injection USP qs pH: 4.4 (3.5-6.5); Calc. Osmolarity: 425 mOsmol/liter, hypertonic Electrolytes (mEq/liter): Na + 77; K + 10; Cl – 87 Sterile, nonpyrogenic. Single dose container. Do not use in series connection. For intravenous use only. Use only if solution is clear and container and seals are intact. WARNINGS: Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store. Recommended Storage: Room temperature (25°C). Avoid excessive heat. Protect from freezing. See Package Insert. Do not remove overwrap until ready for use. After removing the overwrap, check for minute leaks by squeezing container firmly. If leaks are found, discard solution as sterility may be impaired. Not made with natural rubber latex, PVC or DEHP. Rx only EXCEL is a registered trademark of B. Braun Medical Inc. B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862 Y94-003-285 LD-166-3 EXP LOT Recycle 7 1000 mL_Container Label_L6340; PRINCIPAL DISPLAY PANEL - 1000 mL Container Label 0.15% Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection USP REF L6350 NDC 0264-7635-00 DIN 01931547 SG SIN13887P 1000 mL EXCEL ® CONTAINER 20 mEq K + /liter Y94-003-347 LD-265-4 Each 100 mL contains: Hydrous Dextrose USP 5 g; Sodium Chloride USP 0.45 g; Potassium Chloride USP 0.15 g; Water for Injection USP qs pH: 4.4 (3.5-6.5); Calc. Osmolarity: 445 mOsmol/liter, hypertonic Electrolytes (mEq/liter): Na + 77; K + 20; Cl – 97 Sterile, nonpyrogenic. Single dose container. Do not use in series connection. For intravenous use only. Use only if solution is clear and container and seals are intact. WARNINGS: Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store. Recommended Storage: Room temperature (25°C). Avoid excessive heat. Protect from freezing. See Package Insert. Do not remove overwrap until ready for use. After removing the overwrap, check for minute leaks by squeezing container firmly. If leaks are found, discard solution as sterility may be impaired. Not made with natural rubber latex, PVC or DEHP. Rx only EXCEL is a registered trademark of B. Braun Medical Inc. B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862 In Canada, distributed by: B. Braun of Canada, Ltd. Scarborough, Ontario M1H 2W4 Y94-003-493 LD-158-6 EXP LOT Y94-003-493 Recycle 7 Y94-003-493; PRINCIPAL DISPLAY PANEL - 1000 mL Container Label 0.22% Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection USP REF L6360 NDC 0264-7636-00 SG SIN13888P 1000 mL EXCEL ® CONTAINER 30 mEq K + /liter Y94-003-348 LD-266-3 Each 100 mL contains: Hydrous Dextrose USP 5 g; Sodium Chloride USP 0.45 g; Potassium Chloride USP 0.22 g; Water for Injection USP qs pH: 4.4 (3.5-6.5); Calc. Osmolarity: 465 mOsmol/liter, hypertonic Electrolytes (mEq/liter): Na + 77; K + 30; Cl – 107 Sterile, nonpyrogenic. Single dose container. Do not use in series connection. For intravenous use only. Use only if solution is clear and container and seals are intact. WARNINGS: Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store. Recommended Storage: Room temperature (25°C). Avoid excessive heat. Protect from freezing. See Package Insert. Do not remove overwrap until ready for use. After removing the overwrap, check for minute leaks by squeezing container firmly. If leaks are found, discard solution as sterility may be impaired. Not made with natural rubber latex, PVC or DEHP. Rx only EXCEL is a registered trademark of B. Braun Medical Inc. B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862 Y94-003-494 LD-157-5 EXP LOT Y94-003-494 Recycle 7 Y94-003-494; PRINCIPAL DISPLAY PANEL - 1000 mL Container Label 0.30% Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection USP REF L6380 NDC 0264-7638-00 DIN 01931571 SG SIN13889P 1000 mL EXCEL ® CONTAINER 40 mEq K + /liter Y94-003-349 LD-274-3 Each 100 mL contains: Hydrous Dextrose USP 5 g; Sodium Chloride USP 0.45 g; Potassium Chloride USP 0.3 g; Water for Injection USP qs pH: 4.4 (3.5-6.5); Calc. Osmolarity: 490 mOsmol/liter, hypertonic Electrolytes (mEq/liter): Na + 77; K + 40; Cl – 117 Sterile, nonpyrogenic. Single dose container. Do not use in series connection. For intravenous use only. Use only if solution is clear and container and seals are intact. WARNINGS: Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store. Recommended Storage: Room temperature (25°C). Avoid excessive heat. Protect from freezing. See Package Insert. Do not remove overwrap until ready for use. After removing the overwrap, check for minute leaks by squeezing container firmly. If leaks are found, discard solution as sterility may be impaired. Not made with natural rubber latex, PVC or DEHP. Rx only EXCEL is a registered trademark of B. Braun Medical Inc. B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862 In Canada, distributed by: B. Braun of Canada, Ltd. Scarborough, Ontario M1H 2W4 Y94-003-495 LD-156-5 EXP LOT Y94-003-495 Recycle 7 Y94-003-495; PRINCIPAL DISPLAY PANEL - 1000 mL Container Label 0.15% Potassium Chloride in 5% Dextrose and 0.20% Sodium Chloride Injection USP REF L6450 NDC 0264-7645-00 DIN 01931598 1000 mL EXCEL ® CONTAINER 20 mEq K + /liter Y94-003-350 LD-506-2 Each 100 mL contains: Hydrous Dextrose USP 5 g; Sodium Chloride USP 0.2 g; Potassium Chloride USP 0.15 g; Water for Injection USP qs pH: 4.4 (3.5-6.5); Calc. Osmolarity: 360 mOsmol/liter, hypertonic Electrolytes (mEq/liter): Na + 34; K + 20; Cl – 54 Sterile, nonpyrogenic. Single dose container. Do not use in series connection. For intravenous use only. Use only if solution is clear and container and seals are intact. WARNINGS: Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store. Recommended Storage: Room temperature (25°C). Avoid excessive heat. Protect from freezing. See Package Insert. Do not remove overwrap until ready for use. After removing the overwrap, check for minute leaks by squeezing container firmly. If leaks are found, discard solution as sterility may be impaired. Not made with natural rubber latex, PVC or DEHP. Rx only EXCEL is a registered trademark of B. Braun Medical Inc. B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862 In Canada, distributed by: B. Braun of Canada, Ltd. Scarborough, Ontario M1H 2W4 Y94-003-279 LD-163-3 EXP LOT Recycle 7 1000 mL_Container Label_L6450; PRINCIPAL DISPLAY PANEL - 1000 mL Container Label 0.15% Potassium Chloride in 5% Dextrose and 0.9% Sodium Chloride Injection USP REF L6520 NDC 0264-7652-00 DIN 01931644 SG SIN13886P 1000 mL EXCEL ® CONTAINER 20 mEq K + /liter Y94-003-351 LD-504-2 Each 100 mL contains: Hydrous Dextrose USP 5 g; Sodium Chloride USP 0.9 g; Potassium Chloride USP 0.15 g; Water for Injection USP qs pH: 4.4 (3.5-6.5); Calc. Osmolarity: 600 mOsmol/liter, hypertonic Electrolytes (mEq/liter): Na + 154; K + 20; Cl – 174 Sterile, nonpyrogenic. Single dose container. Do not use in series connection. For intravenous use only. Use only if solution is clear and container and seals are intact. WARNINGS: Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store. Recommended Storage: Room temperature (25°C). Avoid excessive heat. Protect from freezing. See Package Insert. Do not remove overwrap until ready for use. After removing the overwrap, check for minute leaks by squeezing container firmly. If leaks are found, discard solution as sterility may be impaired. Not made with natural rubber latex, PVC or DEHP. Rx only EXCEL is a registered trademark of B. Braun Medical Inc. B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862 In Canada, distributed by: B. Braun of Canada, Ltd. Scarborough, Ontario M1H 2W4 Y94-003-496 LD-155-5 EXP LOT Y94-003-496 Recycle 7 Y94-003-496

Package Descriptions
  • HOW SUPPLIED Potassium Chloride in Dextrose and Sodium Chloride Injections USP are supplied in EXCEL ® Containers. The 1000 mL containers are packaged 12 per case. Canada DIN NDC REF Size 0.15% Potassium Chloride in 5% Dextrose and 0.20% Sodium Chloride Injection USP (20 mEq K + /liter) 01931598 0264-7645-00 L6450 1000 mL 0.075% Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection USP (10 mEq K + /liter) 0264-7634-00 L6340 1000 mL 0.15% Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection USP (20 mEq K + /liter) 01931547 0264-7635-00 L6350 1000 mL 0.22% Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection USP (30 mEq K + /liter) 0264-7636-00 L6360 1000 mL 0.30% Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection USP (40 mEq K + /liter) 01931571 0264-7638-00 L6380 1000 mL 0.15% Potassium Chloride in 5% Dextrose and 0.9% Sodium Chloride Injection USP (20 mEq K + /liter) 01931644 0264-7652-00 L6520 1000 mL Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at room temperature (25°C).
  • PRINCIPAL DISPLAY PANEL - 1000 mL Container Label 0.075% Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection USP REF L6340 NDC 0264-7634-00 1000 mL EXCEL ® CONTAINER 10 mEq K + /liter Y94-003-346 LD-258-3 Each 100 mL contains: Hydrous Dextrose USP 5 g; Sodium Chloride USP 0.45 g; Potassium Chloride USP 0.075 g; Water for Injection USP qs pH: 4.4 (3.5-6.5); Calc. Osmolarity: 425 mOsmol/liter, hypertonic Electrolytes (mEq/liter): Na + 77; K + 10; Cl – 87 Sterile, nonpyrogenic. Single dose container. Do not use in series connection. For intravenous use only. Use only if solution is clear and container and seals are intact. WARNINGS: Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store. Recommended Storage: Room temperature (25°C). Avoid excessive heat. Protect from freezing. See Package Insert. Do not remove overwrap until ready for use. After removing the overwrap, check for minute leaks by squeezing container firmly. If leaks are found, discard solution as sterility may be impaired. Not made with natural rubber latex, PVC or DEHP. Rx only EXCEL is a registered trademark of B. Braun Medical Inc. B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862 Y94-003-285 LD-166-3 EXP LOT Recycle 7 1000 mL_Container Label_L6340
  • PRINCIPAL DISPLAY PANEL - 1000 mL Container Label 0.15% Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection USP REF L6350 NDC 0264-7635-00 DIN 01931547 SG SIN13887P 1000 mL EXCEL ® CONTAINER 20 mEq K + /liter Y94-003-347 LD-265-4 Each 100 mL contains: Hydrous Dextrose USP 5 g; Sodium Chloride USP 0.45 g; Potassium Chloride USP 0.15 g; Water for Injection USP qs pH: 4.4 (3.5-6.5); Calc. Osmolarity: 445 mOsmol/liter, hypertonic Electrolytes (mEq/liter): Na + 77; K + 20; Cl – 97 Sterile, nonpyrogenic. Single dose container. Do not use in series connection. For intravenous use only. Use only if solution is clear and container and seals are intact. WARNINGS: Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store. Recommended Storage: Room temperature (25°C). Avoid excessive heat. Protect from freezing. See Package Insert. Do not remove overwrap until ready for use. After removing the overwrap, check for minute leaks by squeezing container firmly. If leaks are found, discard solution as sterility may be impaired. Not made with natural rubber latex, PVC or DEHP. Rx only EXCEL is a registered trademark of B. Braun Medical Inc. B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862 In Canada, distributed by: B. Braun of Canada, Ltd. Scarborough, Ontario M1H 2W4 Y94-003-493 LD-158-6 EXP LOT Y94-003-493 Recycle 7 Y94-003-493
  • PRINCIPAL DISPLAY PANEL - 1000 mL Container Label 0.22% Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection USP REF L6360 NDC 0264-7636-00 SG SIN13888P 1000 mL EXCEL ® CONTAINER 30 mEq K + /liter Y94-003-348 LD-266-3 Each 100 mL contains: Hydrous Dextrose USP 5 g; Sodium Chloride USP 0.45 g; Potassium Chloride USP 0.22 g; Water for Injection USP qs pH: 4.4 (3.5-6.5); Calc. Osmolarity: 465 mOsmol/liter, hypertonic Electrolytes (mEq/liter): Na + 77; K + 30; Cl – 107 Sterile, nonpyrogenic. Single dose container. Do not use in series connection. For intravenous use only. Use only if solution is clear and container and seals are intact. WARNINGS: Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store. Recommended Storage: Room temperature (25°C). Avoid excessive heat. Protect from freezing. See Package Insert. Do not remove overwrap until ready for use. After removing the overwrap, check for minute leaks by squeezing container firmly. If leaks are found, discard solution as sterility may be impaired. Not made with natural rubber latex, PVC or DEHP. Rx only EXCEL is a registered trademark of B. Braun Medical Inc. B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862 Y94-003-494 LD-157-5 EXP LOT Y94-003-494 Recycle 7 Y94-003-494
  • PRINCIPAL DISPLAY PANEL - 1000 mL Container Label 0.30% Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection USP REF L6380 NDC 0264-7638-00 DIN 01931571 SG SIN13889P 1000 mL EXCEL ® CONTAINER 40 mEq K + /liter Y94-003-349 LD-274-3 Each 100 mL contains: Hydrous Dextrose USP 5 g; Sodium Chloride USP 0.45 g; Potassium Chloride USP 0.3 g; Water for Injection USP qs pH: 4.4 (3.5-6.5); Calc. Osmolarity: 490 mOsmol/liter, hypertonic Electrolytes (mEq/liter): Na + 77; K + 40; Cl – 117 Sterile, nonpyrogenic. Single dose container. Do not use in series connection. For intravenous use only. Use only if solution is clear and container and seals are intact. WARNINGS: Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store. Recommended Storage: Room temperature (25°C). Avoid excessive heat. Protect from freezing. See Package Insert. Do not remove overwrap until ready for use. After removing the overwrap, check for minute leaks by squeezing container firmly. If leaks are found, discard solution as sterility may be impaired. Not made with natural rubber latex, PVC or DEHP. Rx only EXCEL is a registered trademark of B. Braun Medical Inc. B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862 In Canada, distributed by: B. Braun of Canada, Ltd. Scarborough, Ontario M1H 2W4 Y94-003-495 LD-156-5 EXP LOT Y94-003-495 Recycle 7 Y94-003-495
  • PRINCIPAL DISPLAY PANEL - 1000 mL Container Label 0.15% Potassium Chloride in 5% Dextrose and 0.20% Sodium Chloride Injection USP REF L6450 NDC 0264-7645-00 DIN 01931598 1000 mL EXCEL ® CONTAINER 20 mEq K + /liter Y94-003-350 LD-506-2 Each 100 mL contains: Hydrous Dextrose USP 5 g; Sodium Chloride USP 0.2 g; Potassium Chloride USP 0.15 g; Water for Injection USP qs pH: 4.4 (3.5-6.5); Calc. Osmolarity: 360 mOsmol/liter, hypertonic Electrolytes (mEq/liter): Na + 34; K + 20; Cl – 54 Sterile, nonpyrogenic. Single dose container. Do not use in series connection. For intravenous use only. Use only if solution is clear and container and seals are intact. WARNINGS: Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store. Recommended Storage: Room temperature (25°C). Avoid excessive heat. Protect from freezing. See Package Insert. Do not remove overwrap until ready for use. After removing the overwrap, check for minute leaks by squeezing container firmly. If leaks are found, discard solution as sterility may be impaired. Not made with natural rubber latex, PVC or DEHP. Rx only EXCEL is a registered trademark of B. Braun Medical Inc. B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862 In Canada, distributed by: B. Braun of Canada, Ltd. Scarborough, Ontario M1H 2W4 Y94-003-279 LD-163-3 EXP LOT Recycle 7 1000 mL_Container Label_L6450
  • PRINCIPAL DISPLAY PANEL - 1000 mL Container Label 0.15% Potassium Chloride in 5% Dextrose and 0.9% Sodium Chloride Injection USP REF L6520 NDC 0264-7652-00 DIN 01931644 SG SIN13886P 1000 mL EXCEL ® CONTAINER 20 mEq K + /liter Y94-003-351 LD-504-2 Each 100 mL contains: Hydrous Dextrose USP 5 g; Sodium Chloride USP 0.9 g; Potassium Chloride USP 0.15 g; Water for Injection USP qs pH: 4.4 (3.5-6.5); Calc. Osmolarity: 600 mOsmol/liter, hypertonic Electrolytes (mEq/liter): Na + 154; K + 20; Cl – 174 Sterile, nonpyrogenic. Single dose container. Do not use in series connection. For intravenous use only. Use only if solution is clear and container and seals are intact. WARNINGS: Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store. Recommended Storage: Room temperature (25°C). Avoid excessive heat. Protect from freezing. See Package Insert. Do not remove overwrap until ready for use. After removing the overwrap, check for minute leaks by squeezing container firmly. If leaks are found, discard solution as sterility may be impaired. Not made with natural rubber latex, PVC or DEHP. Rx only EXCEL is a registered trademark of B. Braun Medical Inc. B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862 In Canada, distributed by: B. Braun of Canada, Ltd. Scarborough, Ontario M1H 2W4 Y94-003-496 LD-155-5 EXP LOT Y94-003-496 Recycle 7 Y94-003-496

Overview

(See chart below for quantitative information.) Potassium Chloride in Dextrose and Sodium Chloride Injections USP are sterile, nonpyrogenic and contain no bacteriostatic or antimicrobial agents. These products are intended for intravenous administration. The formulas of the active ingredients are: Ingredients Molecular Formula Molecular Weight Sodium Chloride USP Potassium Chloride USP NaCl KCl 58.44 74.55 Hydrous Dextrose USP 198.17 Not made with natural rubber latex, PVC or DEHP. The plastic container is made from a multilayered film specifically developed for parenteral drugs. It contains no plasticizers and exhibits virtually no leachables. The solution contact layer is a rubberized copolymer of ethylene and propylene. The container is nontoxic and biologically inert. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary. Composition – Each 100 mL contains: Solution Hydrous Dextrose USP Sodium Chloride USP Potassium Chloride USP Concentration of Electrolytes (mEq/liter) Calories per liter Calculated Osmolarity mOsmol/liter pH Sodium Potassium Chloride Water for Injection USP qs 0.15% Potassium Chloride in 5% Dextrose and 0.20% Sodium Chloride Injection USP 5 g 0.2 g 0.15 g 34 20 54 170 360 4.4 (3.5–6.5) 0.075% Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection USP 5 g 0.45 g 0.075 g 77 10 87 170 425 4.4 (3.5–6.5) 0.15% Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection USP 5 g 0.45 g 0.15 g 77 20 97 170 445 4.4 (3.5–6.5) 0.22% Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection USP 5 g 0.45 g 0.22 g 77 30 107 170 465 4.4 (3.5–6.5) 0.30% Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection USP 5 g 0.45 g 0.3 g 77 40 117 170 490 4.4 (3.5–6.5) 0.15% Potassium Chloride in 5% Dextrose and 0.9% Sodium Chloride Injection USP 5 g 0.9 g 0.15 g 154 20 174 170 600 4.4 (3.5–6.5) Addition of medication should be accomplished using complete aseptic technique. The closure system has two ports; the one for the administration set has a tamper evident plastic protector and the other is a medication addition site. Refer to the Directions for Use of the container. Chemical Structure

Indications & Usage

These intravenous solutions are indicated for use in adults and pediatric patients as sources of electrolytes, calories and water for hydration.

Dosage & Administration

These solutions are for intravenous use only. Dosage is to be directed by a physician and is dependent upon age, weight, clinical condition of the patient and laboratory determinations. Frequent laboratory determinations and clinical evaluation are essential to monitor changes in blood glucose and electrolyte concentrations, and fluid and electrolyte balance during prolonged parenteral therapy. When a hypertonic solution is to be administered peripherally, it should be slowly infused through a small bore needle, placed well within the lumen of a large vein to minimize venous irritation. Carefully avoid infiltration. Usually, up to 40 mEq of potassium per liter daily is sufficient to replace normal loss in adults. Typical infusion rates should not exceed 10 mEq per hour or 120 mEq per day. Pediatric patients may require 2 to 3 mEq per kg of body weight daily. See WARNINGS and PRECAUTIONS for pediatric use. Fluid administration should be based on calculated maintenance or replacement fluid requirements for each patient. Dextrose may be administered to normal individuals at a rate of 0.5 g/kg/hour without producing glycosuria. At the maximum infusion rate of 0.8 g/kg/hour, approximately 95% of the dextrose is retained. Potassium Chloride in Dextrose and Sodium Chloride Injections USP should not be administered simultaneously with blood through the same administration set because of the possibility of pseudoagglutination or hemolysis. Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Warnings & Precautions
WARNINGS The administration of intravenous solutions can cause fluid and/or solute overload resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema. The risk of dilutional states is inversely proportional to the electrolyte concentration. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentration. Solutions containing sodium ions should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency, and in clinical states in which there is sodium retention with edema. In patients with diminished renal function, administration of solutions containing sodium or potassium ions may result in sodium or potassium retention. Solutions containing potassium ions should be used with great care, if at all, in patients with hyperkalemia, severe renal failure, and in conditions in which potassium retention is present. To avoid life-threatening hyperkalemia, do not administer Potassium Chloride in Dextrose and Sodium Chloride Injections USP as an intravenous push (i.e., intravenous injection manually with a syringe connected to the intravenous access, without a quantitative infusion device).
Contraindications

These solutions are contraindicated where the administration of sodium, potassium or chloride could be clinically detrimental. Solutions containing dextrose may be contraindicated in patients with hypersensitivity to corn products.

Adverse Reactions

Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation and hypervolemia. Too rapid infusion of hypertonic solutions may cause local pain and venous irritation. Rate of administration should be adjusted according to tolerance. Use of the largest peripheral vein and a small bore needle is recommended. (See DOSAGE AND ADMINISTRATION .) Symptoms may result from an excess or deficit of one or more of the ions present in the solution; therefore, frequent monitoring of electrolyte levels is essential. Hypernatremia may be associated with edema and exacerbation of congestive heart failure due to the retention of water, resulting in an expanded extracellular fluid volume. Reactions reported with the use of potassium-containing solutions include nausea, vomiting, abdominal pain and diarrhea. The signs and symptoms of potassium intoxication include paresthesias of the extremities, areflexia, muscular or respiratory paralysis, mental confusion, weakness, hypotension, cardiac arrhythmias, heart block, electrocardiographic abnormalities and cardiac arrest. Potassium deficits result in disruption of neuromuscular function, and intestinal ileus and dilatation. If infused in large amounts, chloride ions may cause a loss of bicarbonate ions, resulting in an acidifying effect. The physician should also be alert to the possibility of adverse reaction to drug additives. Prescribing information for drug additives to be administered in this manner should be consulted. 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.

Storage & Handling

Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at room temperature (25°C).


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