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SOYBEAN OIL
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CLINOLIPID lipid injectable emulsion, USP is a sterile, non-pyrogenic, homogenous, white, milky lipid emulsion for intravenous infusion. The lipid content of CLINOLIPID is 0.2 g/mL and comprises a mixture of refined olive oil and refined soybean oil in an approximate ratio of 4:1 (olive:soy). The mean concentration of linoleic acid (an omega-6 essential fatty acid) is 35.8 mg/mL (range 27.6 to 44.0 mg/mL) and α-linolenic acid (an omega-3 essential fatty acid) is 4.7 mg/mL (range 1.0 to 8.4 mg/mL). The phospholipids provide 470 milligrams or 15 mmol of phosphorus per liter. The total energy content, including fat, phospholipids and glycerin is 2000 kcal/L. Each 100 mL of CLINOLIPID 20% contains approximately 16 g of Olive Oil NF and 4 g of Soybean Oil USP, 1.2 g Egg Phospholipids NF, 2.25 g Glycerin USP, 0.03 g Sodium Oleate, and Water for Injection USP. Sodium Hydroxide NF for pH adjustment, pH: 6.0 to 9.0. The olive and soybean oils are refined natural products consisting of a mixture of neutral triglycerides of predominantly unsaturated fatty acids with the following structure: The major component fatty acids are linoleic (13.8 to 22.0%), oleic (44.3 to 79.5%), palmitic (7.6 to 19.3%), linolenic (0.5 to 4.2%), palmitoleic (0.0 to 3.2%) and stearic (0.7 to 5.0%). These fatty acids have the following chemical and structural formulas: CLINOLIPID has an osmolality of approximately 340 mOsmol/kg water (which represents an osmolarity of 260 mOsmol/liter of emulsion). CLINOLIPID contains no more than 25 mcg/L of aluminum. Structural Formula 1 Structural Formula 2
Intralipid is a sterile, non-pyrogenic, white, homogenous lipid emulsion for intravenous infusion as a source of calories and essential fatty acids. The lipid content of Intralipid is 0.2 g/mL and comprises soybean oil. The phosphate content is 15 mmol/L. The total energy content, including fat, phospholipids, and glycerin is 2,000 kcal/L. Each 100 mL of Intralipid contains approximately 20 g soybean oil, 1.2 g egg yolk phospholipids, 2.25 g glycerin, water for injection, and sodium hydroxide for pH adjustment (pH 6 to 8.9). Intralipid has an osmolality of approximately 350 mOsmol/kg water (which represents an osmolarity of 260 mOsmoL/L). 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 in Intralipid are linoleic acid (44% to 62%), oleic acid (19% to 30%), palmitic acid (7% to 14%), alpha-linolenic acid (4% to 11%), and stearic acid (1.4% to 5.5%). These fatty acids have the following chemical and structural formulas: 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. R 3 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. Intralipid contains no more than 25 mcg/L of aluminum. The container is not made with natural rubber latex, PVC, or DEHP. intra-struc-01.jpg intra-struc-02.jpg intra-struc-03.jpg intra-struc-04.jpg intra-struc-05.jpg intra-struc-06.jpg intra-struc-07.jpg
Intralipid is a sterile, non-pyrogenic, white, homogenous lipid emulsion for intravenous infusion as a source of calories and essential fatty acids. The lipid content of Intralipid is 0.2 g/mL and comprises soybean oil. The phosphate content is 15 mmol/L. The total energy content, including fat, phospholipids, and glycerin is 2,000 kcal/L. Each 100 mL of Intralipid contains approximately 20 g soybean oil, 1.2 g egg yolk phospholipids, 2.25 g glycerin, water for injection, and sodium hydroxide for pH adjustment (pH 6 to 8.9). Intralipid has an osmolality of approximately 350 mOsmol/kg water (which represents an osmolarity of 260 mOsmoL/L). 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 in Intralipid are linoleic acid (44% to 62%), oleic acid (19% to 30%), palmitic acid (7% to 14%), alpha-linolenic acid (4% to 11%), and stearic acid (1.4% to 5.5%). These fatty acids have the following chemical and structural formulas: 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. R 3 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. Intralipid contains no more than 25 mcg/L of aluminum. The container is not made with natural rubber latex, PVC, or DEHP. intra-struc-01.jpg intra-struc-02.jpg intra-struc-03.jpg intra-struc-04.jpg intra-struc-05.jpg intra-struc-06.jpg intra-struc-07.jpg
Intralipid ® 10% (A 10% Intravenous Fat Emulsion) is a sterile, non-pyrogenic fat emulsion prepared for intravenous administration as a source of calories and essential fatty acids. It is made up of 10% 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 so that the final product pH is 8. pH range is 6 to 8.9. 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 acid (44-62%), oleic acid (19-30%), palmitic acid (7-14%), α-linolenic acid (4-11%) and stearic acid (1.4-5.5%) 1 . These fatty acids have the following chemical and structural formulas: 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. R 3 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: Intralipid 10% (A 10% Intravenous Fat Emulsion) has an osmolality of approximately 300 mOsmol/kg water (which represents 260 mOsmol/L of emulsion) and contains emulsified fat particles of approximately 0.5 micron size. The total caloric value, including fat, phospholipid and glycerin, is 1.1 kcal per mL of Intralipid 10%. The phospholipids present contribute 47 milligrams or approximately 1.5 mmol of phosphorus per 100 mL of the emulsion. The primary plastic container (Biofine TM ) is made from multilayered film specifically designed for parenteral nutrition drug products. The film is polypropylene based comprising three co-extruded layers. It contains no plasticizers and exhibits virtually no leachables. The container does not contain DEHP (di(2-ethylhexyl) phthalate), PVC. The container is nontoxic and biologically inert. This product is not made with natural rubber latex. The container-emulsion 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. Figure Figure Figure Figure Figure Figure Figure
Intralipid ® 30% (A 30% I.V. Fat Emulsion) Pharmacy Bulk Package is a sterile, non- pyrogenic fat emulsion intended as a source of calories and essential fatty acids for use in a pharmacy admixture program. It is made up of 30% Soybean Oil, 1.2% Egg Yolk Phospholipids, 1.7% Glycerin, and Water for Injection. In addition, sodium hydroxide has been added to adjust the pH so that the final product pH is 8. pH range is 6 to 8.9. Intralipid 30% Pharmacy Bulk Package is not intended for direct infusion. It is a sterile dosage form which contains several single doses for use in the preparation of three-in- one or total nutrient admixtures (TNAs) in a pharmacy admixture program. 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 acid (44-62%), oleic acid (19-30%), palmitic acid (7-14%), α-linolenic acid (4-11%) and stearic acid (1.4-5.5%) 1 . These fatty acids have the following chemical and structural formulas: 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. R 3 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: Intralipid 30% (A 30% I.V. Fat Emulsion) has an osmolality of approximately 310 mOsmoL/kg water (which represents 200 mOsmoL/L of emulsion) and contains emulsified fat particles of approximately 0.5 micron size. The total caloric value, including fat, phospholipid and glycerin, is 3.0 kcal per mL of Intralipid 30%. The phospholipids present contribute 47 milligrams or approximately 1.5 mmol of phosphorus per 100 mL of the emulsion. The primary plastic container (Biofine TM ) is made from multilayered film specifically designed for parenteral nutrition drug products. The film is polypropylene based comprising three co-extruded layers. It contains no plasticizers and exhibits virtually no leachables. The container does not contain DEHP (di(2-ethylhexyl) phthalate) or PVC. This product is not made with natural rubber latex. The container is nontoxic and biologically inert. The container-emulsion 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. Figure Figure Figure Figure Figure Figure Figure
Intralipid ® 20% (A 20% Intravenous Fat Emulsion) is a sterile, non-pyrogenic fat emulsion prepared for intravenous administration as a source of calories and essential fatty acids. It 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 so that the final product pH is 8. pH range is 6 to 8.9. 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 acid (44-62%), oleic acid (19-30%), palmitic acid (7-14%), α-linolenic acid (4-11%) and stearic acid (1.4-5.5%) 1 . These fatty acids have the following chemical and structural formulas: 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. R 3 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: Intralipid 20% (A 20% Intravenous Fat Emulsion) has an osmolality of approximately 350 mOsmol/kg water (which represents 260 mOsmoL/L of emulsion) and contains emulsified fat particles of approximately 0.5micron size. The total caloric value, including fat, phospholipid and glycerin, is 2.0 kcal per mL of Intralipid 20%. The phospholipids present contribute 47 milligrams or approximately 1.5 mmol of phosphorus per 100 mL of the emulsion. The primary plastic container (Biofine TM ) is made from multilayered film specifically designed for parenteral nutrition drug products. The film is polypropylene based comprising three co-extruded layers. It contains no plasticizers and exhibits virtually no leachables. The container does not contain DEHP (di(2-ethylhexyl) phthalate) or PVC. The container is nontoxic and biologically inert. This product is not made with natural rubber latex. The container-emulsion 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. Figure Figure Figure Figure Figure Figure Figure
Intralipid is a sterile, non-pyrogenic, white, homogenous lipid emulsion for intravenous infusion as a source of calories and essential fatty acids. The lipid content of Intralipid is 0.2 g/mL and comprises soybean oil. The phosphate content is 15 mmol/L. The total energy content, including fat, phospholipids, and glycerin is 2,000 kcal/L. Each 100 mL of Intralipid contains approximately 20 g soybean oil, 1.2 g egg yolk phospholipids, 2.25 g glycerin, water for injection, and sodium hydroxide for pH adjustment (pH 6 to 8.9). Intralipid has an osmolality of approximately 350 mOsmol/kg water (which represents an osmolarity of 260 mOsmoL/L). 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 in Intralipid are linoleic acid (44% to 62%), oleic acid (19% to 30%), palmitic acid (7% to 14%), alpha-linolenic acid (4% to 11%), and stearic acid (1.4% to 5.5%). These fatty acids have the following chemical and structural formulas: 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. R 3 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. Intralipid contains no more than 25 mcg/L of aluminum. The container is not made with natural rubber latex, PVC, or DEHP. Figure Figure Figure Figure Figure Figure Figure
Intralipid is a sterile, non-pyrogenic, white, homogenous lipid emulsion for intravenous infusion as a source of calories and essential fatty acids. The lipid content of Intralipid is 0.2 g/mL and comprises soybean oil. The phosphate content is 15 mmol/L. The total energy content, including fat, phospholipids, and glycerin is 2,000 kcal/L. Each 100 mL of Intralipid contains approximately 20 g soybean oil, 1.2 g egg yolk phospholipids, 2.25 g glycerin, water for injection, and sodium hydroxide for pH adjustment (pH 6 to 8.9). Intralipid has an osmolality of approximately 350 mOsmol/kg water (which represents an osmolarity of 260 mOsmoL/L). 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 in Intralipid are linoleic acid (44% to 62%), oleic acid (19% to 30%), palmitic acid (7% to 14%), alpha-linolenic acid (4% to 11%), and stearic acid (1.4% to 5.5%). These fatty acids have the following chemical and structural formulas: 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. R 3 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. Intralipid contains no more than 25 mcg/L of aluminum. The container is not made with natural rubber latex, PVC, or DEHP. intra-struc-01.jpg intra-struc-02.jpg intra-struc-03.jpg intra-struc-04.jpg intra-struc-05.jpg intra-struc-06.jpg intra-struc-07.jpg
Intralipid ® 20% (A 20% I.V. Fat Emulsion) Pharmacy Bulk Package is a sterile, non-pyrogenic fat emulsion intended as a source of calories and essential fatty acids for use in a pharmacy admixture program. It 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 so that the final product pH is 8. pH range is 6 to 8.9. Intralipid ® 20% Pharmacy Bulk Package is not intended for direct infusion. It is a sterile dosage form which contains several single doses for use in the preparation of three-in-one or total nutrient admixtures (TNAs) in a pharmacy admixture program. 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 (44-62%), oleic (19-30%), palmitic (7-14%), linolenic (4-11%) and stearic (1.4-5.5%) 1 . 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. R 3 is primarily either the choline or ethanolamine ester of phosphoric acid. Phosphatidylcholine Phosphatidylethanolamine Glycerin is chemically designated C 3 H 8 O 3 and is a clear colorless, hygroscopic syrupy liquid. It has the following structural formula: Intralipid ® 20% (A 20% I.V. Fat Emulsion) has an osmolality of approximately 350 mOsmol/kg water (which represents 260 mOsmol/liter of emulsion) and contains emulsified fat particles of approximately 0.5 micron size. The total caloric value, including fat, phospholipid and glycerin, is 2.0 kcal per mL of Intralipid ® 20%. The phospholipids present contribute 47 milligrams or approximately 1.5 mmol of phosphorus per 100 mL of the emulsion. The primary container is manufactured from Excel ® film, a polypropylene based material comprised of three co-extruded layers. The plastic container is made from multilayered film specifically designed 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. structure r1c r2c r3c structure structure structure structure structure structure structure figure stuct
Intralipid ® 20% (A 20% I.V. Fat Emulsion) is a sterile, non-pyrogenic fat emulsion intended as a source of calories and essential fatty acids for use in a pharmacy admixture program. It 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 so that the final product pH is 8. pH range is 6 to 8.9. Intralipid 20% Pharmacy Bulk Package is not intended for direct infusion. It is a sterile dosage form which contains several single doses for use in preparation of three-in-one or total nutrient admixtures (TNAs) in a pharmacy admixture program. 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 acid (44-62%), oleic acid (19-30%), palmitic acid (7-14%), α-linolenic acid (4-11%) and stearic acid (1.4-5.5%) 1 . These fatty acids have the following chemical and structural formulas: 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. R 3 is primarily either the choline or the 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: Intralipid 20% (A 20% I.V. Fat Emulsion) has an osmolality of approximately 350 mOsmol/kg water (which represents 260 mOsmol/L of emulsion) and contains emulsified fat particles of approximately 0.5 micron size. The total caloric value, including fat, phospholipid and glycerin, is 2.0 kcal per mL of Intralipid 20%. The phospholipids present contribute 47 milligrams or approximately 1.5 mmol of phosphorus per 100 mL of the emulsion. The primary plastic container (Biofine TM ) is made from multilayered film specifically designed for parenteral nutrition drug products. The film is polypropylene based comprising three co-extruded layers. It contains no plasticizers and exhibits virtually no leachables. The container does not contain DEHP (di(2-ethylhexyl) phthalate) or PVC. This product is not made with natural rubber latex. The container is nontoxic and biologically inert. The container-emulsion 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. Figure Figure Figure Figure Figure Figure Figure
Intralipid is a sterile, non-pyrogenic, white, homogenous lipid emulsion for intravenous infusion as a source of calories and essential fatty acids for use in a pharmacy admixture program. The lipid content of Intralipid 30% Pharmacy Bulk Package is 0.3 g/mL and comprises soybean oil. The phosphate content is 15 mmol/L. The total energy content, including fat, phospholipids, and glycerin is 3,000 kcal/L. Each 100 mL of Intralipid contains approximately 30 g soybean oil, 1.2 g egg yolk phospholipids, 1.7 g glycerin, water for injection, and sodium hydroxide for pH adjustment (pH 6 to 8.9). Intralipid has an osmolality of approximately 310 mOsm/kg water (which represents an osmolarity of 200 mOsm/L). 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 in Intralipid are linoleic acid (44% to 62%), oleic acid (19% to 30%), palmitic acid (7% to 14%), alpha-linolenic acid (4% to 11%), and stearic acid (1.4% to 5.5%). 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 α-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. R 3 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. Intralipid contains no more than 25 mcg/L of aluminum. The container is not made with natural rubber latex, PVC, or DEHP. intra-struc-01.jpg intra-struc-02.jpg intra-struc-03.jpg intra-struc-04.jpg intra-struc-05.jpg intra-struc-06.jpg intra-struc-07.jpg intra-struc-08.jpg intra-struc-09.jpg intra-struc-10.jpg intra-struc-11.jpg
KABIVEN is a sterile, hypertonic emulsion, for 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 KABIVEN 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 CH2CH(NH2)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 NH 2 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). KABIVEN 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
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
SMOFlipid is a sterile, nonpyrogenic, white, homogenous lipid emulsion for intravenous infusion. The lipid content of SMOFlipid is 0.2 g/mL, and comprises a mixture of soybean oil, MCTs, olive oil, and fish oil. The mean concentration of linoleic acid (an omega-6 essential fatty acid) is 35 mg/mL (range of 28 to 50 mg/mL), and alpha-linolenic acid (an omega-3 essential fatty acid) is 4.5 mg/mL (range of 3 to 7 mg/mL). The phosphate content is 15 mmol/L. The total energy content, including fat, phospholipids, and glycerol is 2,000 kcal/L. Each 100 mL of SMOFlipid contains approximately 6 g soybean oil, 6 g MCT, 5 g olive oil, 3 g fish oil, 1.2 g egg phospholipids, 2.5 g glycerin, 16.3 to 22.5 mg all-rac-alpha-tocopherol, 0.03 g sodium oleate, water for injection, and sodium hydroxide for pH adjustment (pH 6 to 9). SMOFlipid has an osmolality of approximately 380 mOsm/kg water (which represents an osmolarity of 270 mOsm/L). The oils included in SMOFlipid consist of a mixture of triglycerides of predominantly unsaturated fatty acids with the following structure: where , , and are saturated and unsaturated fatty acid residues. The major components of the fatty acids in SMOFlipid are oleic acid (23% to 35%), linoleic acid (14% to 25%), caprylic acid (13% to 24%), palmitic acid (7% to 12%), capric acid (5% to 15%), stearic acid (1.5% to 4%), alpha-linolenic acid (1.5% to 3.5%), eicosapentaenoic acid (EPA; 1% to 3.5%), and docosahexaenoic acid (DHA; 1% to 3.5%). Oleic Acid C 18 H 34 O 2 Linoleic Acid C 18 H 32 O 2 Caprylic Acid C 8 H 16 O 2 Capric Acid C 10 H 20 O 2 Stearic Acid C 18 H 36 O 2 Palmitic Acid C 16 H 32 O 2 Linolenic Acid C 18 H 30 O 2 EPA C 20 H 30 O 2 DHA C 22 H 32 O 2 SMOFlipid contains no more than 25 mcg/L of aluminum. The container is not made with natural rubber latex, PVC, or DEHP. smofl-struc-01.jpg Figure Figure Figure smofl-struc-02.jpg smofl-struc-03.jpg smofl-struc-04.jpg smofl-struc-05.jpg smofl-struc-06.jpg smofl-struc-07.jpg smofl-struc-08.jpg smofl-struc-09.jpg smofl-struc-10.jpg