dextrose monohydrate - Medications

Lidocaine Hydrochloride and 5% Dextrose Injection USP is a sterile, nonpyrogenic solution prepared from lidocaine hydrochloride and dextrose in water for injection. Lidocaine hydrochloride is designated chemically as 2-(Diethylamino)-2',6'-acetoxylidide monohydrochloride. The solution serves as a cardiac antiarrhythmic agent intended for intravenous use. Composition - Each 100 mL contains: Solution Lidocaine Hydrochloride Anhydrous USP Hydrous Dextrose USP pH Calculated Osmolarity mOsmol/liter 0.4% Lidocaine HCl and 5% Dextrose Injection USP 0.4 g 5 g 4.4 (3.0–7.0) 280 0.8% Lidocaine HCl and 5% Dextrose Injection USP 0.8 g 5 g 4.2 (3.0–7.0) 305 Water for Injection USP qs The formulas of the active ingredients are: Lidocaine Hydrochloride Anhydrous USP (M.W. 270.80) Hydrous Dextrose USP (M.W. 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. The closure system has two ports; the one for the administration set has a tamper evident plastic protector. Refer to the Directions for Use of the container. Chemical Structure Chemical Structure

Normosol-M and 5% Dextrose Injection (Multiple Electrolytes and 5% Dextrose Injection Type 1, USP) is a sterile, nonpyrogenic, hypertonic solution of balanced maintenance electrolytes and 5% dextrose injection in water for injection. The solution is administered by intravenous infusion for parenteral maintenance of routine daily fluid and electrolyte requirements with minimal carbohydrate calories. Each 100 mL contains dextrose, hydrous 5 g, sodium chloride, 234 mg, potassium acetate, 128 mg and magnesium acetate, anhydrous 21 mg. May contain hydrochloric acid for pH adjustment. The electrolyte content (not including hydrochloric acid) and other characteristics are as follows: Sodium (Na + ) 40 mEq/liter Potassium (K + ) 13 mEq/liter Magnesium (Mg ++ ) 3 mEq/liter Chloride (Cl − ) 40 mEq/liter Bicarbonate (HCO 3 − ) as acetate 16 mEq/liter Caloric value (dextrose) 170 Calories/liter Tonicity Hypertonic Osmolarity 363 mOsmol/liter (calc.) pH (range) 5.0 (4.0 to 6.5) The solution contains no bacteriostat, antimicrobial agent or added buffer (except for pH adjustment) and is intended only for use as a single-dose injection. When smaller doses are required the unused portion should be discarded. Normosol-M and 5% Dextrose Injection is a parenteral fluid, electrolyte and nutrient replenisher. Dextrose, USP is chemically designated D-glucose monohydrate (C 6 H 12 O 6 • H 2 O), a hexose sugar freely soluble in water. It has the following structural formula: Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water. Potassium Acetate, USP is chemically designated CH 3 COOK, colorless crystals or white crystalline powder very soluble in water. Magnesium acetate is chemically designated Mg (C 2 H 3 O 2 ) 2 , colorless or white crystals very soluble in water. Water for Injection, USP is chemically designated H 2 O. The flexible plastic container is fabricated from a specially formulated polyvinyl chloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. structural formula dextrose

Normosol-R and 5% Dextrose Injection is a sterile, nonpyrogenic solution of balanced electrolytes (with dextrose) in water for injection. The solution is administered by intravenous infusion for parenteral replacement of acute losses of extracellular fluid (with minimal carbohydrate calories). Each 100 mL of Normosol-R and 5% Dextrose Injection contains dextrose 5 g; sodium chloride 526 mg; sodium acetate, anhydrous 222 mg; sodium gluconate 502 mg; potassium chloride 37 mg; magnesium chloride, hexahydrate 30 mg; pH adjusted with hydrochloric acid. See TABLE for summary of electrolyte content, caloric value and characteristics of this solution. The solution contains no bacteriostat, antimicrobial agent or added buffer (except for pH adjustment) and is intended only for use as a single-dose injection. When smaller doses are required the unused portion should be discarded. Normosol-R and 5% Dextrose Injection is a parenteral fluid, electrolyte and nutrient replenisher. Dextrose, USP is chemically designated D-glucose monohydrate (C 6 H 12 O 6 • H 2 0), a hexose sugar freely soluble in water. It has the following structural formula: Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water. Potassium Chloride, USP is chemically designated KCl, a white granular powder freely soluble in water. Magnesium Chloride, USP is chemically designated magnesium chloride hexahydrate (MgCl 2 • 6H 2 O) deliquescent crystals very soluble in water. Sodium Acetate, USP, is chemically designated sodium acetate anhydrous (C 2 H 3 NaO 2 ), a hygroscopic powder soluble in water. It has the following structural formula: Sodium gluconate is chemically designated C 6 H 11 NaO 7 , the normal sodium salt of gluconic acid soluble in water. It has the following structural formula: Water for Injection, USP is chemically designated H 2 0. The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. structural formula dextrose USP structural formula sodium acetate usp structural formula sodium gluconate

ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE SOLUTION (CPD) Sterile, non-pyrogenic fluid path. Sterilized by steam. This product is free of natural rubber latex.

PERIKABIVEN is a sterile, hypertonic emulsion, for peripheral or central venous administration, in a Three Chamber Bag. The product contains no added sulfites. Chamber 1 contains Dextrose monohydrate solution for fluid replenishment and caloric supply. Chamber 2 contains the Amino Acid solution with Electrolytes, which comprises essential and nonessential amino acids provided with electrolytes. Chamber 3 contains Intralipid ® 20% (a 20% Lipid Injectable Emulsion), prepared for intravenous administration as a source of calories and essential fatty acids. See below for formulations of each chamber and Table 2 for strength, pH, osmolarity, ionic concentration and caloric content of PERIKABIVEN when all the chambers are mixed together. Chamber 1: Contains sterile, hypertonic solution of Dextrose, USP in water for injection with a pH range of 3.5 to 5.5. Dextrose, USP is chemically designated D-glucose, monohydrate (C 6 H 12 O 6 • H 2 O) and has the following structure: Dextrose is derived from corn. Chamber 2 : Contains a sterile solution of amino acids and electrolytes in water for injection. In addition, glacial acetic acid has been added to adjust the pH so that the final solution pH is 5.4 to 5.8. The formulas for the individual electrolytes and amino acids are as follows: Electrolytes Sodium Acetate Trihydrate, USP CH 3 COONax3H 2 O Potassium Chloride, USP KCl Sodium Glycerophosphate C 3 H 5 (OH) 2 PO 4 Na 2 xH 2 O Magnesium Sulfate Heptahydrate, USP MgSO 4 x7H 2 O Calcium Chloride Dihydrate, USP CaCl 2 x2H 2 O Essential Amino Acids Lysine (added as the hydrochloride salt) H 2 N(CH 2 ) 4 CH(NH 2 )COOH.HCl Phenylalanine CH 2 CH(NH 2 )COOH Leucine (CH 3 ) 2 CHCH 2 CH(NH 2 )COOH Valine (CH 3 ) 2 CHCH(NH 2 )COOH Histidine CH 2 CH(NH 2 )COOH Threonine CH 3 CH(OH)CH(NH 2 )COOH Methionine CH 3 S(CH 2 ) 2 CH(NH 2 )COOH Isoleucine CH 3 CH 2 CH(CH 3 )CH(NH 2 )COOH Tryptophan CH 2 CH(NH 2 )COOH Nonessential Amino Acids Alanine CH 3 CH(NH 2 )COOH Arginine H 2 NC(NH)NH(CH 2 ) 3 CH(NH 2 )COOH Glycine H 2 NCH 2 COOH Proline Glutamic Acid HOOC(CH 2 ) 2 CH(NH 2 )COOH Serine HOCH 2 CH(NH 2 )COOH Aspartic Acid HOOCCH 2 CH(NH 2 )COOH Tyrosine Chamber 3: Contains a 20% Lipid Injectable Emulsion (Intralipid ® 20%) which is made up of 20% Soybean Oil, 1.2% Egg Yolk Phospholipids, 2.25% Glycerin, and water for injection. In addition, sodium hydroxide has been added to adjust the pH. The final product pH range is 6 to 9. The soybean oil is a refined natural product consisting of a mixture of neutral triglycerides of predominantly unsaturated fatty acids with the following structure: where are saturated and unsaturated fatty acid residues. The major component fatty acids are linoleic (48 to 58 %), oleic (17 to 30%), palmitic (9 to 13%), linolenic (5 to 11%) and stearic acid (2.5 to 5%). These fatty acids have the following chemical and structural formulas: Linoleic acid C 18 H 32 O 2 Oleic acid C 18 H 34 O 2 Palmitic acid C 16 H 32 O 2 Linolenic acid C 18 H 30 O 2 Stearic acid C 18 H 36 O 2 Purified egg phosphatides are a mixture of naturally occurring phospholipids which are isolated from the egg yolk. These phospholipids have the following general structure: contain saturated and unsaturated fatty acids that abound in neutral fats. R3 is primarily either the choline or ethanolamine ester of phosphoric acid. Glycerin is chemically designated C 3 H 8 O 3 and is a clear colorless, hygroscopic syrupy liquid. It has the following structural formula: 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 oxygen and moisture barrier when necessary. An oxygen absorber is placed between the inner bag and the overpouch. The container is not made with natural rubber latex or polyvinyl chloride (PVC). PERIKABIVEN contains no more than 25 mcg/L of aluminum. Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure

Potassium Chloride in 5% Dextrose Injection, USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment and caloric supply in a single-dose container for intravenous administration. It contains no antimicrobial agents. Composition, osmolarity, pH, ionic concentration and caloric content are shown in Table 1 . Table 1 * Normal physiologic osmolarity range is approximately 280 to 310 mOsmol/L. ** Size (mL) Composition (g/L) Ionic Concentration (mEq/L) Caloric Content (kcal/L) Potassium Chloride in 5% Dextrose Injection, USP **Dextrose Hydrous, USP Potassium Chloride, USP (KCl) *Osmolarity (mOsmol/L) (calc.) pH Potassium Chloride mEq Potassium 10 mEq 1000 50 0.75 272 4.5 (3.5 to 6.5) 10 10 170 20 mEq 1000 50 1.5 293 4.5 (3.5 to 6.5) 20 20 170 D-Glucose monohydrate Dextrose is derived from corn. The flexible plastic container is fabricated from a specially formulated nonplasticized, film containing polypropylene and thermoplastic elastomers ( free flex ® bag). The amount of water that can permeate from the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the flexible container can leach out certain of the container's chemical components in very small amounts within the expiration period. The suitability of the container material has been confirmed by tests in animals according to USP biological tests for plastic containers. Structural Formula

Potassium Chloride in Dextrose Injection, USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment and caloric supply in a single-dose container 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.) pH Ionic Concentration (mEq/L) Caloric Content (kcal/L) **Dextrose Hydrous, USP Potassium Chloride, USP (KCl) Potassium Chloride Potassium Chloride in 5% Dextrose Injection, USP mEq Potassium 20 mEq 1000 50 1.5 293 4.5 (3.5 to 6.5) 20 20 170 Dextrose is derived from corn. The VIAFLEX Plus plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). VIAFLEX Plus on the container indicates the presence of a drug additive in a drug vehicle. The VIAFLEX Plus plastic container system utilizes the same container as the VIAFLEX plastic container system. 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 5 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. D-Glucose monohydrate Structural Formula

Potassium Chloride in Dextrose Injection, USP is a sterile and nonpyrogenic solution in water for injection. This solution is for administration by intravenous infusion only. See Table for summary of content and characteristics of this solution. This solution contains no bacteriostat, antimicrobial agent or added buffer and is intended only for use as a single-dose injection. When smaller doses are required the unused portion should be discarded. This solution is a parenteral fluid, nutrient and electrolyte replenisher. Dextrose, USP is chemically designated D-glucose monohydrate (C 6 H 12 O 6 ∙ H 2 O), a hexose sugar freely soluble in water. It has the following structural formula: Potassium Chloride, USP is chemically designated KCl, a white granular powder freely soluble in water. Water for Injection, USP is chemically designated H 2 O. The flexible plastic container is fabricated from a specially formulated polyvinyl chloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. Chemical Structure

Intravenous solutions with potassium chloride (I.V. solutions with KCl) are sterile and nonpyrogenic solutions in water for injection. They are for administration by intravenous infusion only. See table below for summary of content and characteristics of these solutions. Table 1 COMPOSITION (g/L) Approx. Ionic Concentrations (mEq/L) Potassium Chloride in 5% Dextrose and 0.9% Sodium Chloride Injection, USP mEq Potassium Size (mL) Dextrose, Hydrous Sodium Chloride Potassium Chloride Calculated Osmolarity (mOsmol/L) pH Sodium (Na + ) Potassium (K + ) Chloride (Cl - ) Approximate Kcal/L 20 mEq 1000 50 9 1.49 600 4.2 (3.5 to 6.5) 154 20 174 170 40 mEq 1000 50 9 2.98 640 4.2 (3.5 to 6.5) 154 40 194 170 May contain HCl for pH adjustment. The solutions contain no bacteriostat, antimicrobial agent or added buffer and each is intended only for use as a single-dose injection. When smaller doses are required the unused portion should be discarded. These solutions are parenteral fluid, nutrient and/or electrolyte replenishers. Dextrose, USP is chemically designated D-glucose, monohydrate (C 6 H 12 O 6 • H 2 O), a hexose sugar freely soluble in water. It has the following structural formula: Potassium Chloride, USP is chemically designated KCl, a white granular powder freely soluble in water. Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water. Water for Injection, USP is chemically designated H 2 O. The flexible plastic container is fabricated from a specially formulated non-plasticized, film containing polypropylene and thermoplastic elastomers ( free flex ® bag) . Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in the moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. Figure

Intravenous solutions with potassium chloride (I.V. solutions with KCl) are sterile and nonpyrogenic solutions in water for injection. They are for administration by intravenous infusion only. See Tables for summary of content and characteristics of these solutions. The solutions contain no bacteriostat, antimicrobial agent or added buffer and each is intended only for use as a single-dose injection. When smaller doses are required the unused portion should be discarded. These solutions are parenteral fluid, nutrient and/or electrolyte replenishers. Dextrose, USP is chemically designated D-glucose, monohydrate (C 6 H 12 O 6 • H 2 O), a hexose sugar freely soluble in water. It has the following structural formula: Potassium Chloride, USP is chemically designated KCl, a white granular powder freely soluble in water. Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water. Water for Injection, USP is chemically designated H 2 O. The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in the moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. structural formula dextrose

Potassium Chloride in Dextrose and Sodium Chloride Injection, USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment and caloric supply in a single dose container for intravenous administration. It contains no antimicrobial agents. Composition, osmolarity, pH, ionic concentration and caloric content are shown in Table 1. Table 1 Table 1 mEq Potassium/container size Size (mL) Composition (g/L) pH Ionic Concentration (mEq/L) ** Dextrose Hydrous, USP Sodium Chloride, USP (NaCl) Potassium Chloride, USP (KCl) Normal physiologic osmolarity range is approximately 280 to 310 mOsmol/L. Osmolarity (mOsmol/L) (calc.) Sodium Potassium Chloride Caloric Content (kCal/L) Potassium Chloride in 5% Dextrose and 0.2% Sodium Chloride Injection, USP 20 mEq/L 1000 50 2 1.5 361 4.5 (3.5 to 6.5) 34 20 54 170 10 mEq/500 mL 500 50 2 1.5 361 4.5 (3.5 to 6.5) 34 20 54 170 Potassium Chloride in 5% Dextrose and 0.33% Sodium Chloride Injection, USP 10 mEq/500 mL 500 50 3.3 1.5 405 4.5 (3.5 to 6.5) 56 20 76 170 Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP 10 mEq/L 1000 50 4.5 0.75 426 4.5 (3.5 to 6.5) 77 10 87 170 20 mEq/L 1000 50 4.5 1.5 447 4.5 (3.5 to 6.5) 77 20 97 170 10 mEq/500 mL 500 50 4.5 1.5 447 4.5 (3.5 to 6.5) 77 20 97 170 30 mEq/L 1000 50 4.5 2.24 466 4.5 (3.5 to 6.5) 77 30 107 170 40 mEq/L 1000 50 4.5 3 487 4.5 (3.5 to 6.5) 77 40 117 170 Potassium Chloride in 5% Dextrose and 0.9% Sodium Chloride Injection, USP 20 mEq/L 1000 50 9 1.5 601 4.5 (3.5 to 6.5) 154 20 174 170 0.9% Sodium Chloride Injection, USP 40 mEq/L 1000 50 9 3 641 4.5 (3.5 to 6.5) 154 40 194 170 Dextrose is derived from corn. The VIAFLEX Plus plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). VIAFLEX Plus on the container indicates the presence of a drug additive in a drug vehicle. The VIAFLEX Plus plastic container system utilizes the same container as the VIAFLEX plastic container system. 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 5 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. Image of D-Glucose monohydrate Structural Formula

Intravenous solutions with potassium chloride (I.V. solutions with KCl) are sterile and nonpyrogenic solutions in water for injection. They are for administration by intravenous infusion only. See table below for summary of content and characteristics of these solutions. Table 1 COMPOSITION (g/L) Approx. Ionic Concentrations (mEq/L) Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP mEq Potassium Size (mL) Dextrose, Hydrous Sodium Chloride Potassium Chloride Calculated Osmolarity (mOsmol/L) pH Sodium (Na + ) Potassium (K + ) Chloride (Cl - ) Approximate Kcal/L 10 mEq 500 50 4.5 1.49 447 4.2 (3.5 to 6.5) 77 20 97 170 10 mEq 1000 50 4.5 0.745 426 4.2 (3.5 to 6.5) 77 10 87 170 20 mEq 1000 50 4.5 1.49 447 4.2 (3.5 to 6.5) 77 20 97 170 30 mEq 1000 50 4.5 2.24 467 4.2 (3.5 to 6.5) 77 30 107 170 40 mEq 1000 50 4.5 2.98 487 4.2 (3.5 to 6.5) 77 40 117 170 May contain HCl for pH adjustment. The solutions contain no bacteriostat, antimicrobial agent or added buffer and each is intended only for use as a single-dose injection. When smaller doses are required the unused portion should be discarded. These solutions are parenteral fluid, nutrient and/or electrolyte replenishers. Dextrose, USP is chemically designated D-glucose, monohydrate (C 6 H 12 O 6 • H 2 O), a hexose sugar freely soluble in water. It has the following structural formula: Potassium Chloride, USP is chemically designated KCl, a white granular powder freely soluble in water. Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water. Water for Injection, USP is chemically designated H 2 O. The flexible plastic container is fabricated from a specially formulated non-plasticized, film containing polypropylene and thermoplastic elastomers ( free flex ® bag) . Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in the moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. Figure

Intravenous solutions with potassium chloride (I.V. solutions with KCl) are sterile and nonpyrogenic solutions in water for injection. They are for administration by intravenous infusion only. See table below for summary of content and characteristics of these solutions. Table 1 COMPOSITION (g/L) Approx. Ionic Concentrations (mEq/L) Potassium Chloride in 5% Dextrose and 0.225% Sodium Chloride Injection, USP mEq Potassium Size (mL) Dextrose, Hydrous Sodium Chloride Potassium Chloride Calculated Osmolarity (mOsmol/L) pH Sodium (Na + ) Potassium (K + ) Chloride (Cl - ) Approximate Kcal/L 10 mEq 500 50 2.25 1.49 370 4.2 (3.5 to 6.5) 38.5 20 58.5 170 20 mEq 1000 50 2.25 1.49 370 4.2 (3.5 to 6.5) 38.5 20 58.5 170 May contain HCl for pH adjustment. The solutions contain no bacteriostat, antimicrobial agent or added buffer and each is intended only for use as a single-dose injection. When smaller doses are required the unused portion should be discarded. These solutions are parenteral fluid, nutrient and/or electrolyte replenishers. Dextrose, USP is chemically designated D-glucose, monohydrate (C 6 H 12 O 6 • H 2 O), a hexose sugar freely soluble in water. It has the following structural formula: Potassium Chloride, USP is chemically designated KCl, a white granular powder freely soluble in water. Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water. Water for Injection, USP is chemically designated H 2 O. The flexible plastic container is fabricated from a specially formulated non-plasticized, film containing polypropylene and thermoplastic elastomers ( free flex ® bag). Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in the moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. Structural Formula

Intravenous solution with potassium chloride (I.V. solutions with KCl) is a sterile and nonpyrogenic solution in water for injection. This solution is for administration by intravenous infusion only. See Table 1 below for summary of content and characteristics of this solution. Table 1 COMPOSITION (g/L) Calculated Osmolarity (mOsmol/L) Potassium Chloride in Lactated Ringer's and 5% Dextrose Injection, USP mEq Potassium Added Size (mL) Dextrose, Hydrous Potassium Chloride Sodium Chloride Sodium Lactate, Anhydrous Calcium Chloride Dihydrate 20 mEq 1000 50 1.79 6 3.1 0.2 563 pH Approx. Ionic Concentrations (mEq/L) Approx. kcal/L Calcium (Ca++) Sodium (Na+) Potassium (K+) Chloride (Cl-) Lactate 4.9 (3.5 to 6.5) 2.7 130 24 129 28 179 May contain HCl for pH adjustment. The solution contains no bacteriostat, antimicrobial agent or added buffer and each is intended only for use as a single-dose injection. When smaller doses are required the unused portion should be discarded. This solution is a parenteral fluid, nutrient and/or electrolyte replenisher. Dextrose, USP is chemically designated D-glucose, monohydrate (C 6 H 12 O 6 • H 2 O), a hexose sugar freely soluble in water. It has the following structural formula: Potassium Chloride, USP is chemically designated KCl, a white granular powder freely soluble in water. Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water. Calcium Chloride, USP is chemically designated calcium chloride dihydrate (CaCl 2 • 2H 2 O), white fragments or granules freely soluble in water. Sodium Lactate, USP is chemically designated monosodium lactate [CH 3 CH(OH)COONa], a 50% aqueous solution miscible in water. It has the following structural formula: Water for Injection, USP is chemically designated H 2 0. The flexible plastic container is fabricated from a specially formulated non-plasticized, film containing polypropylene and thermoplastic elastomers ( free flex ® bag). Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in the moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. Dextrose Structural Formula Calcium Chloride Structural Formula

Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection, USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment and caloric supply in a single dose container for intravenous administration. It contains no antimicrobial agents. Composition, osmolarity, pH, ionic concentration and caloric content are shown in Table 1 . Dextrose is derived from corn. Table 1 Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection, USP Size (mL) Composition (g/L) Normal physiologic osmolarity range is approximately 280 to 310 mOsmol/L. Osmolarity (mOsmol/L) (calc) pH Ionic Concentration (mEq/L) Caloric Content (kcal/L) Dextrose, USP Sodium Chloride, USP Sodium Lactate Potassium Chloride, USP Calcium Chloride, USP Sodium Potassium Calcium Chloride Lactate 20 mEq Potassium added 1000 50 6 3.1 1.79 0.2 565 5.0 (3.5 to 6.5) 130 24 3 129 28 170 The chemical name, structural formula, and molecular weight of the active ingredients are shown in Table 2 . Table 2 Chemical Name Structural Formula Molecular Weight Sodium Chloride, USP 58.44 Sodium Lactate 112.06 Potassium Chloride, USP 74.55 Calcium Chloride, USP 147.02 Dextrose, USP 198.17 The VIAFLEX plastic container is fabricated from polyvinyl chloride (PL 146 Plastic). Small amounts of its chemical components (e.g., di-2-ethylhexyl phthalate [DEHP]) may leach out within the expiration period. Animal tests, USP biological tests for plastic containers, and tissue culture toxicity studies have demonstrated that the container meets safety requirements. The container is overwrapped to provide protection from the physical environment and an additional moisture barrier. Sodium Chloride Structural Formula Sodium Lactate Structural Formula Potassium Chloride Structural Formula Calcium Chloride Structural Formula Dextrose Structural Formula

Intravenous solution with potassium chloride (I.V. solutions with KCl) is a sterile and nonpyrogenic solution in water for injection. This solution is for administration by intravenous infusion only. See Table for summary of content and characteristics of this solution. The solution contains no bacteriostat, antimicrobial agent or added buffer and is intended only for use as a single-dose injection. When smaller doses are required the unused portion should be discarded. This solution is a parenteral fluid, nutrient and/or electrolyte replenisher. Dextrose, USP is chemically designated D-glucose, monohydrate (C 6 H 12 O 6 • H 2 O), a hexose sugar freely soluble in water. It has the following structural formula: Potassium Chloride, USP is chemically designated KCl, a white granular powder freely soluble in water. Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water. Calcium Chloride, USP is chemically designated calcium chloride dihydrate (CaCl 2 • 2H 2 O), white fragments or granules freely soluble in water. Sodium Lactate, USP is chemically designated monosodium lactate [CH 3 CH(OH)COONa], a 60% aqueous solution miscible in water. It has the following structural formula: Water for Injection, USP is chemically designated H 2 0. The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. Structural Formula of Dextrose USP Structural Formula of Sodium Lactate USP

MACO BIOTECH Collection- Sterile Cord Blood Collection Unit (MSC123D) The MSC123D Sterile Cord Blood Collection Unit consists of 250 mL collection bag containing 35 mL of Anticoagulant Citrate Phosphate Dextrose Solution USP (CPD) and one 12 gauge needle with a protective shield (SECUVAM) for the used needle. Sterile, non-pyrogenic fluid path. Sterilized by steam. Rx only. This product is not made with natural rubber latex.

MACO BIOTECH Collection - Sterile Cord Blood Collection Unit (MSC127D) The MSC127D Sterile Cord Blood Collection Unit consists of 300 mL collection bag containing 27 mL of Anticoagulant Citrate Phosphate Dextrose Solution USP (CPD), a 40 mL rinsing bag containing 8 mL of CPD and two 12 gauge needles with a protective shield (SECUVAM) for the used needle. Sterile, non-pyrogenic fluid path. Sterilized by steam. Rx only . This product is not made with natural rubber latex.

MACO BIOTECH Collection - Sterile Cord Blood Collection Unit (MSC128D) The MSC128D Sterile Cord Blood Collection Unit consists of 300 mL collection bag containing 21 mL of Anticoagulant Citrate Phosphate Dextrose Solution USP (CPD), a 40 mL rinsing bag containing 8 mL of CPD and two 12 gauge needles with a protective shield (SECUVAM) for the used needle. Sterile, non-pyrogenic fluid path. Sterilized by steam. Rx only . This product is not made with natural rubber latex.

/ PRODUCT SPECIFICATIONS 11.1. This blood bag system includes a 16 gauge × 1 1/2 inch (1.60 × 38 mm) needle with needle cover and either a 450 mL or 500 mL (nominal capacity 600 mL) primary collection bag containing 63 mL or 70 mL, respectively, Citrate Phosphate Dextrose Adenine (CPDA-1) anticoagulant. The Triple blood bag set has one integrally attached empty satellite bag (nominal capacity 400 mL) and one empty XT-612 5 day Platelet bag (nominal capacity 500 mL). The Quadruple blood bag set has two integrally attached empty satellite bags (nominal capacity 400 mL) and one empty XT-612 5 day Platelet bag (nominal capacity 500 mL). 11.2. Blood bag codes ending in A2 are supplied with Integral Diversion Blood Sampling Arm intended to divert and obtain donor samples for laboratory testing prior to collection of the Whole Blood unit. 11.3. Blood bag codes ending in A2 also include a DonorCare Needle Guard pre-attached to the donor tubing. DonorCare Needle Guard device instructions are provided on the reverse side. 11.4. The blood bag collection set is made of PVC (polyvinyl chloride with DEHP plasticizer). 11.5. The blood bag has no components made of natural rubber latex. 11.6. Tubing internal diameter (ID) nominal 3.0 mm. 11.7. Tubing outer diameter (OD) nominal 4.4 mm. 11.8. Donor tubing line maximum 16 segments available.

/ PRODUCT SPECIFICATIONS 11.1. This blood bag system includes a 16 gauge × 1 1/2 inch (1.60 × 38 mm) needle with needle cover and either a 450 mL or 500 mL (nominal capacity 600 mL) primary collection bag containing 63 mL or 70 mL, respectively, Citrate Phosphate Dextrose Adenine (CPDA-1) anticoagulant. The Triple blood bag set has one integrally attached empty satellite bag (nominal capacity 400 mL) and one empty XT-612 5 day Platelet bag (nominal capacity 500 mL). The Quadruple blood bag set has two integrally attached empty satellite bags (nominal capacity 400 mL) and one empty XT-612 5 day Platelet bag (nominal capacity 500 mL). 11.2. Blood bag codes ending in A2 are supplied with Integral Diversion Blood Sampling Arm intended to divert and obtain donor samples for laboratory testing prior to collection of the Whole Blood unit. 11.3. Blood bag codes ending in A2 also include a DonorCare Needle Guard pre-attached to the donor tubing. DonorCare Needle Guard device instructions are provided on the reverse side. 11.4. The blood bag collection set is made of PVC (polyvinyl chloride with DEHP plasticizer). 11.5. The blood bag has no components made of natural rubber latex. 11.6. Tubing internal diameter (ID) nominal 3.0 mm. 11.7. Tubing outer diameter (OD) nominal 4.4 mm. 11.8. Donor tubing line maximum 16 segments available.

/ PRODUCT SPECIFICATIONS 11.1. This blood bag system includes a 16 gauge × 1 1/2 inch (1.60 × 38 mm) needle with needle cover and either a 450 mL or 500 mL (nominal capacity 600 mL) primary collection bag containing 63 mL or 70 mL, respectively, Citrate Phosphate Dextrose Adenine (CPDA-1) anticoagulant. The Triple blood bag set has one integrally attached empty satellite bag (nominal capacity 400 mL) and one empty XT-612 5 day Platelet bag (nominal capacity 500 mL). The Quadruple blood bag set has two integrally attached empty satellite bags (nominal capacity 400 mL) and one empty XT-612 5 day Platelet bag (nominal capacity 500 mL). 11.2. Blood bag codes ending in A2 are supplied with Integral Diversion Blood Sampling Arm intended to divert and obtain donor samples for laboratory testing prior to collection of the Whole Blood unit. 11.3. Blood bag codes ending in A2 also include a DonorCare Needle Guard pre-attached to the donor tubing. DonorCare Needle Guard device instructions are provided on the reverse side. 11.4. The blood bag collection set is made of PVC (polyvinyl chloride with DEHP plasticizer). 11.5. The blood bag has no components made of natural rubber latex. 11.6. Tubing internal diameter (ID) nominal 3.0 mm. 11.7. Tubing outer diameter (OD) nominal 4.4 mm. 11.8. Donor tubing line maximum 16 segments available.