Mastodon

SMOFKabiven® central (Emulsion) Instructions for Use

ATC Code

B05BA10 (Combined preparations for parenteral nutrition)

Clinical-Pharmacological Group

Drug for total parenteral nutrition – solution of amino acids, fats, carbohydrates, electrolytes

Pharmacotherapeutic Group

Parenteral nutrition agent

Pharmacological Action

Amino acid solutions for parenteral nutrition provide the body with substrates for protein synthesis.

The administration of all amino acids necessary for protein synthesis (including essential, conditionally essential, and non-essential amino acids) ensures high nutritional efficiency and reduces the metabolic burden on the body associated with protein synthesis.

In addition to amino acids, parenteral nutrition preparations may include minerals, Dextrose, xylitol, and lipids.

Minerals are necessary to maintain water-electrolyte and acid-base balance.

As an energy source, amino acid solutions for parenteral nutrition may contain dextrose, xylitol, sorbitol, which are involved in the processes of glycolysis and gluconeogenesis.

The fat emulsion is a source of energy and essential fatty acids.

Indications

For parenteral nutrition in inpatient and outpatient settings to cover the daily needs of patients for amino acids, electrolytes, and fluids during parenteral nutrition in patients with moderate to severe catabolism in cases where enteral nutrition is impossible, insufficient, or contraindicated, as well as in combination with it.

Parenteral nutrition agents should be used strictly in accordance with the indications in the instructions for medical use.

ICD codes

ICD-10 code Indication
E46 Unspecified protein-energy malnutrition
E63.8 Other specified types of nutritional deficiency
R63.3 Feeding difficulties and mismanagement of food intake
ICD-11 code Indication
5B50 Deficiency of weight in infants, children and adolescents
5B51 Exhaustion in infants, children and adolescents
5B52 Acute protein-energy malnutrition in infants, children and adolescents
5B53 Growth delay in infants, children and adolescents
5B54 Underweight in adults
5B71 Protein deficiency
5B7Z Malnutrition, unspecified
8D40.0 Encephalopathy due to nutritional deficiency
MG43.3Z Unspecified feeding difficulties

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Administer SMOFKabiven® central intravenously via a central venous catheter.

Determine the dosage individually based on the patient’s energy expenditure, nutritional status, clinical condition, and metabolic capacity.

Calculate the daily volume to meet the patient’s requirements for amino acids, electrolytes, and fluid.

Infuse the total daily dose over 12 to 24 hours.

Adjust the infusion rate gradually; do not exceed the recommended maximum infusion rate for lipids.

For adult patients, the typical dosage range is 20 to 40 ml/kg body weight per day.

Closely monitor serum triglycerides, blood glucose, and liver enzymes during therapy.

Regularly assess fluid balance, electrolytes, and acid-base status.

Discontinue infusion immediately if signs of lipid overload or intolerance occur.

Adverse Reactions

Immune system disorders allergic reactions.

Cardiovascular system disorders phlebitis, thrombosis.

Respiratory system disorders bronchospasm.

Digestive system disorders nausea, vomiting.

Urinary system disorders renal aminoacidosis.

General disorders chills, redness.

Contraindications

General for parenteral nutrition: severe circulatory disorders (collapse and shock); pronounced tissue hypoxia; overhydration; water-electrolyte balance disorders; pulmonary edema; decompensated heart failure, severe renal failure; acute period of traumatic brain injury; coma or brain function disorders that can cause a comatose state.

Before prescribing a parenteral nutrition drug, the contraindications for its use in a particular patient should be carefully studied.

With caution

Patients with increased plasma osmolarity, heart failure, hepatic and/or renal failure.

In children and adolescents under 18 years of age, only those parenteral nutrition drugs that are intended for the corresponding age category should be used.

Use in Pregnancy and Lactation

If it is necessary to prescribe a parenteral nutrition drug during pregnancy, the presence of contraindications for use and precautions in the current clinical situation should be taken into account.

The use of parenteral nutrition solutions during lactation (breastfeeding) is not recommended.

Pediatric Use

In children and adolescents under 18 years of age, only those parenteral nutrition drugs that are intended for the corresponding age category should be used.

Special Precautions

Intravenous administration of amino acid solutions is accompanied by increased urinary excretion of trace elements, especially copper and zinc. This must be taken into account when selecting doses of trace elements, especially during long-term therapy.

When administering a parenteral nutrition drug, regular monitoring of water-electrolyte balance and blood acid-base status, blood sugar concentration, and serum ionogram should be performed. During long-term therapy, monitoring of blood parameters (coagulogram, liver function indicators) is necessary.

Due to the risk of pseudoagglutination, it is not recommended to use the same infusion systems for the administration of blood products and multicomponent amino acid solutions.

Use in pediatrics

During parenteral nutrition of young children, the following indicators must be taken into account: urine nitrogen, ammonia, glucose, electrolytes, triglycerides (with additional administration of fat emulsions), liver enzymes, serum osmolarity, acid-base balance, and water-salt metabolism. Too rapid infusion can lead to the loss of amino acids through the kidneys, and consequently, to an amino acid imbalance.

In pediatrics, only those parenteral nutrition drugs that are intended for this category of patients should be used.

Drug Interactions

Parenteral nutrition drugs are multicomponent solutions. When adding other solutions or a lipid emulsion to the drug used, the compatibility of all ingredients must be taken into account.

Simultaneous administration of arginine with thiazide diuretics and aminophylline increases the insulin content in the blood.

Estrogens and oral contraceptives can increase the concentration of growth hormone caused by arginine and reduce the glucagon and insulin response to arginine.

With simultaneous use of arginine with spironolactone, the development of severe hyperkalemia is possible.

Storage Conditions

Store at 2°C (36°F) to 8°C (46°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

Fresenius Kabi Deutschland, GmbH (Germany)

Manufactured By

Fresenius Kabi, AB (Sweden)

Dosage Form

Bottle Rx Icon SMOFKabiven® central Emulsion for infusion 1477 ml: plastic three-chamber containers 4 pcs.

Dosage Form, Packaging, and Composition

SMOFKabiven® central is available in a three-chamber bag with a volume of 1477 ml.

The 1477 ml bag contains
Amino acid solution – 750 ml,
Dextrose 42% – 446 ml,
Fat emulsion – 281 ml.

Energy value 1600 kcal.

Amino acid solution – clear, colorless or with a yellowish tint.
Dextrose 42% – clear solution, colorless or with a yellowish tint.
Fat emulsion – white, homogeneous.
When the contents of the three chambers are mixed, a homogeneous white emulsion is formed.

Emulsion for infusion 1477 ml
L-alanine 10.5 g
L-arginine hydrochloride 9 g
Glycine 8.2 g
L-Histidine 2.2 g
L-Isoleucine 3.8 g
L-leucine 5.6 g
L-lysine (as acetate) 5 g
L-methionine 3.2 g
L-phenylalanine 3.8 g
L-proline 8.4 g
L-serine 4.9 g
Taurine 750 mg
L-threonine 3.3 g
L-tryptophan 1.5 g
L-tyrosine 300 mg
L-Valine 4.6 g
Calcium chloride (as dihydrate) 420 mg
Sodium glycerophosphate (as hydrate) 3.1 g
Magnesium sulfate (as heptahydrate) 900 mg
Potassium chloride 3.4 g
Sodium acetate (as trihydrate) 2.6 g
Zinc sulfate (as heptahydrate) 9.7 mg
Dextrose (as monohydrate) 187 g
Refined soybean oil 16.9 g
Medium-chain triglycerides 16.9 g
Olive oil (refined) 14.1 g
Fish oil (enriched with omega-3 fatty acids) 8.4 g
Including:
   carbohydrates (Dextrose) 187 g
   amino acids 75 g
   nitrogen 12 g
   fats 56 g
Energy value 1600 kcal
Non-protein energy value 1300 kcal
Electrolytes:
   sodium 60 mmol
   potassium 45 mmol
   magnesium 7.5 mmol
   calcium 3.8 mmol
   phosphate 19 mmol
   zinc 0.06 mmol
   sulfate 7.5 mmol
   chloride 52 mmol
   acetate 157 mmol
Osmolality about 1800 mOsmol/kg water
Theoretical osmolarity about 1500 mOsmol/l
PH after mixing about 5.6

Excipients : glycerol – 7 g, egg yolk phospholipids – 3.4 g, sodium oleate – 80 mg, racemic mixture of α-tocopherols – 45.8-63.2 mg, sodium hydroxide – q.s. for pH adjustment, hydrochloric acid – q.s. for pH adjustment, glacial acetic acid – q.s. for pH adjustment, water for injections – up to 1477 ml.

1477 ml – plastic three-chamber “Biofine” containers (1) with antioxidant – plastic bags (4) – cardboard boxes.

Marketing Authorization Holder

Fresenius Kabi Deutschland, GmbH (Germany)

Manufactured By

Fresenius Kabi, AB (Sweden)

Dosage Form

Bottle Rx Icon SMOFKabiven® central Emulsion for infusion 1970 ml: plastic three-chamber containers 4 pcs.

Dosage Form, Packaging, and Composition

SMOFKabiven® central is available in a three-chamber bag and is presented in a volume of 1970 ml.

The 1970 ml bag contains
Amino acid solution – 1000 ml,
Dextrose 42% – 595 ml,
Fat emulsion – 375 ml.

Energy value 2200 kcal.

Amino acid solution – clear, colorless or with a yellowish tint.
Dextrose 42% – clear solution, colorless or with a yellowish tint.
Fat emulsion – white, homogeneous.
When the contents of the three chambers are mixed, a homogeneous white emulsion is formed.

Emulsion for infusion 1970 ml
L-alanine 14 g
L-arginine hydrochloride 12 g
Glycine 11 g
L-Histidine 3 g
L-Isoleucine 5 g
L-leucine 7.4 g
L-lysine (as acetate) 6.6 g
L-methionine 4.3 g
L-phenylalanine 5.1 g
L-proline 11.2 g
L-serine 6.5 g
Taurine 1 g
L-threonine 4.4 g
L-tryptophan 2 g
L-tyrosine 400 mg
L-Valine 6.2 g
Calcium chloride (as dihydrate) 560 mg
Sodium glycerophosphate (as hydrate) 4.2 g
Magnesium sulfate (as heptahydrate) 1.2 g
Potassium chloride 4.5 g
Sodium acetate (as trihydrate) 3.4 g
Zinc sulfate (as heptahydrate) 13 mg
Dextrose (as monohydrate) 250 g
Refined soybean oil 22.5 g
Medium-chain triglycerides 22.5 g
Olive oil (refined) 18.8 g
Fish oil (enriched with omega-3 fatty acids) 11.3 g
Including:
   carbohydrates (Dextrose) 250 g
   amino acids 100 g
   nitrogen 16 g
   fats 75 g
Energy value 2200 kcal
Non-protein energy value 1800 kcal
Electrolytes:
   sodium 80 mmol
   potassium 60 mmol
   magnesium 10 mmol
   calcium 5 mmol
   phosphate 25 mmol
   zinc 0.08 mmol
   sulfate 10 mmol
   chloride 70 mmol
   acetate 209 mmol
Osmolality about 1800 mOsmol/kg water
Theoretical osmolarity about 1500 mOsmol/l
PH after mixing about 5.6

Excipients : glycerol – 9.4 g, egg yolk phospholipids – 4.5 g, sodium oleate – 110 mg, racemic mixture of α-tocopherols – 61.1-84.4 mg, sodium hydroxide – q.s. for pH adjustment, hydrochloric acid – q.s. for pH adjustment, glacial acetic acid – q.s. for pH adjustment, water for injections – up to 1970 ml.

1970 ml – plastic three-chamber “Biofine” containers (1) with antioxidant – plastic bags (4) – cardboard boxes.

Marketing Authorization Holder

Fresenius Kabi Deutschland, GmbH (Germany)

Manufactured By

Fresenius Kabi, AB (Sweden)

Dosage Form

Bottle Rx Icon SMOFKabiven® central Emulsion for infusion 2463 ml: plastic three-chamber containers 3 pcs.

Dosage Form, Packaging, and Composition

SMOFKabiven® central is available in a three-chamber bag and is presented in a volume of 2463 ml.

The 2463 ml bag contains
Amino acid solution – 1250 ml,
Dextrose 42% – 744 ml,
Fat emulsion – 469 ml.

Energy value 2700 kcal.

Amino acid solution – clear, colorless or with a yellowish tint.
Dextrose 42% – clear solution, colorless or with a yellowish tint.
Fat emulsion – white, homogeneous.
When the contents of the three chambers are mixed, a homogeneous white emulsion is formed.

Emulsion for infusion 2463 ml
L-alanine 17.5 g
L-arginine hydrochloride 15 g
Glycine 13.8 g
L-Histidine 3.7 g
L-Isoleucine 6.2 g
L-leucine 9.4 g
L-lysine (as acetate) 8.4 g
L-methionine 5.4 g
L-phenylalanine 6.4 g
L-proline 14 g
L-serine 8.1 g
Taurine 1.2 g
L-threonine 5.4 g
L-tryptophan 2.5 g
L-tyrosine 490 mg
L-Valine 7.6 g
Calcium chloride (as dihydrate) 690 mg
Sodium glycerophosphate (as hydrate) 5.2 g
Magnesium sulfate (as heptahydrate) 1.5 g
Potassium chloride 5.7 g
Sodium acetate (as trihydrate) 4.2 g
Zinc sulfate (as heptahydrate) 16 mg
Dextrose (as monohydrate) 313 g
Refined soybean oil 28.1 g
Medium-chain triglycerides 28.1 g
Olive oil (refined) 23.4 g
Fish oil (enriched with omega-3 fatty acids) 14 g
Including:
   carbohydrates (Dextrose) 313 g
   amino acids 125 g
   nitrogen 20 g
   fats 94 g
Energy value 2700 kcal
Non-protein energy value 2200 kcal
Electrolytes:
   sodium 100 mmol
   potassium 74 mmol
   magnesium 12 mmol
   calcium 6.2 mmol
   phosphate 31 mmol
   zinc 0.1 mmol
   sulfate 13 mmol
   chloride 89 mmol
   acetate 261 mmol
Osmolality about 1800 mOsmol/kg water
Theoretical osmolarity about 1500 mOsmol/l
PH after mixing about 5.6

Excipients: glycerol – 11.7 g, egg yolk phospholipids – 5.6 g, sodium oleate – 140 mg, racemic mixture of α-tocopherols – 76.4-105.5 mg, sodium hydroxide – q.s. for pH adjustment, hydrochloric acid – q.s. for pH adjustment, glacial acetic acid – q.s. for pH adjustment, water for injections – up to 2463 ml.

2463 ml – plastic three-chamber “Biofin” containers (1) with antioxidant – plastic bags (3) – cardboard boxes.

Marketing Authorization Holder

Fresenius Kabi Deutschland, GmbH (Germany)

Manufactured By

Fresenius Kabi, AB (Sweden)

Dosage Form

Bottle Rx Icon SMOFKabiven® central Emulsion for infusion 986 ml: plastic three-chamber containers 4 pcs.

Dosage Form, Packaging, and Composition

SMOFKabiven® central is supplied in a three-chamber bag with a volume of 986 ml.

The 986 ml bag contains
Amino acid solution – 500 ml,
Dextrose 42% – 298 ml,
Fat emulsion – 188 ml.

Energy value 1100 kcal.

Amino acid solution – clear, colorless or with a yellowish tint.
Dextrose 42% – clear solution, colorless or with a yellowish tint.
Fat emulsion – white, homogeneous.
When the contents of the three chambers are mixed, a homogeneous white emulsion is formed.

Emulsion for infusion 986 ml
L-alanine 7 g
L-arginine hydrochloride 6 g
Glycine 5.5 g
L-Histidine 1.5 g
L-Isoleucine 2.5 g
L-leucine 3.7 g
L-lysine (as acetate) 3.3 g
L-methionine 2.2 g
L-phenylalanine 2.6 g
L-proline 5.6 g
L-serine 3.2 g
Taurine 500 mg
L-threonine 2.2 g
L-tryptophan 1 g
L-tyrosine 200 mg
L-Valine 3.1 g
Calcium chloride (as dihydrate) 280 mg
Sodium glycerophosphate (as hydrate) 2.1 g
Magnesium sulfate (as heptahydrate) 600 mg
Potassium chloride 2.2 g
Sodium acetate (as trihydrate) 1.7 g
Zinc sulfate (as heptahydrate) 6.5 mg
Dextrose (as monohydrate) 125 g
Refined soybean oil 11.3 g
Medium-chain triglycerides 11.3 g
Olive oil (refined) 9.4 g
Fish oil (enriched with omega-3 fatty acids) 5.6 g
Including:
   carbohydrates (Dextrose) 125 g
   amino acids 50 g
   nitrogen 8 g
   fats 38 g
Energy value 1100 kcal
Non-protein energy value 900 kcal
Electrolytes:
   sodium 40 mmol
   potassium 30 mmol
   magnesium 5 mmol
   calcium 2.5 mmol
   phosphate 12 mmol
   zinc 0.04 mmol
   sulfate 5 mmol
   chloride 35 mmol
   acetate 104 mmol
Osmolality about 1800 mOsmol/kg water
Theoretical osmolarity about 1500 mOsmol/l
PH after mixing about 5.6

Excipients: glycerol – 4.7 g, egg yolk phospholipids – 2.3 g, sodium oleate – 60 mg, racemic mixture of α-tocopherols – 30.6-42.3 mg, sodium hydroxide – q.s. for pH adjustment, hydrochloric acid – q.s. for pH adjustment, glacial acetic acid – q.s. for pH adjustment, water for injections – up to 986 ml.

986 ml – plastic three-chamber “Biofin” containers (1) with antioxidant – plastic bags (4) – cardboard boxes.

Marketing Authorization Holder

Fresenius Kabi Deutschland, GmbH (Germany)

Manufactured By

Fresenius Kabi, AB (Sweden)

Dosage Form

Bottle Rx Icon SMOFKabiven® peripheral Emulsion for infusion 1206 ml: plastic three-chamber containers 4 pcs.

Dosage Form, Packaging, and Composition

SMOFKabiven® peripheral is supplied in a three-chamber bag with a volume of 1206 ml.

The 1206 ml bag contains
Amino acid solution – 656 ml,
Dextrose 13% – 380 ml,
Fat emulsion – 170 ml.

Energy value 800 kcal.

Amino acid solution – clear, colorless or with a yellowish tint.
Dextrose 13% – clear solution, colorless or with a yellowish tint.
Fat emulsion – white, homogeneous.
When the contents of the three chambers are mixed, a homogeneous white emulsion is formed.

Emulsion for infusion 1206 ml
L-alanine 5.3 g
L-arginine hydrochloride 4.6 g
Glycine 4.2 g
L-Histidine 1.1 g
L-Isoleucine 1.9 g
L-leucine 2.8 g
L-lysine (as acetate) 2.5 g
L-methionine 1.6 g
L-phenylalanine 1.9 g
L-proline 4.2 g
L-serine 2.5 g
Taurine 380 mg
L-threonine 1.7 g
L-tryptophan 760 mg
L-tyrosine 150 mg
L-Valine 2.4 g
Calcium chloride (as dihydrate) 210 mg
Sodium glycerophosphate (as hydrate) 1.6 g
Magnesium sulfate (as heptahydrate) 460 mg
Potassium chloride 1.7 g
Sodium acetate (as trihydrate) 1.3 g
Zinc sulfate (as heptahydrate) 5 mg
Dextrose (as monohydrate) 85 g
Refined soybean oil 10.2 g
Medium-chain triglycerides 10.2 g
Olive oil (refined) 8.5 g
Fish oil (enriched with omega-3 fatty acids) 5.1 g
Including:
   carbohydrates (Dextrose) 85 g
   amino acids 38 g
   nitrogen 6.2 g
   fats 34 g
Energy value 800 kcal
Non-protein energy value 700 kcal
Electrolytes:
   sodium 30 mmol
   potassium 23 mmol
   magnesium 3.8 mmol
   calcium 1.9 mmol
   phosphate 9.9 mmol
   zinc 0.03 mmol
   sulfate 3.8 mmol
   chloride 27 mmol
   acetate 79 mmol
Osmolality about 950 mOsmol/kg water
Theoretical osmolarity about 850 mOsmol/l
PH after mixing about 5.6

Excipients: glycerol – 4.3 g, egg yolk phospholipids – 2 g, sodium oleate – 51 mg, racemic mixture of α-tocopherols – 27.7-38.3 mg, sodium hydroxide – q.s. for pH adjustment, glacial acetic acid – q.s. for pH adjustment, water for injections – up to 1206 ml.

1206 ml – plastic three-chamber “Biofin” containers (1) with antioxidant – plastic bags (4) – cardboard boxes.

Marketing Authorization Holder

Fresenius Kabi Deutschland, GmbH (Germany)

Manufactured By

Fresenius Kabi, AB (Sweden)

Dosage Form

Bottle Rx Icon SMOFKabiven® peripheral Emulsion for infusion 1448 ml: plastic three-chamber containers 4 pcs.

Dosage Form, Packaging, and Composition

SMOFKabiven® peripheral is supplied in a three-chamber bag with a volume of 1448 ml.

SMOFKabiven® peripheral is supplied in a three-chamber bag and is available in four volumes (1206 ml, 1448 ml, 1904 ml).

The 1448 ml bag contains
Amino acid solution – 788 ml,
Dextrose 13% – 456 ml,
Fat emulsion – 204 ml.

Energy value 1000 kcal.

Amino acid solution – clear, colorless or with a yellowish tint.
Dextrose 13% – clear solution, colorless or with a yellowish tint.
Fat emulsion – white, homogeneous.
When the contents of the three chambers are mixed, a homogeneous white emulsion is formed.

Emulsion for infusion 1448 ml
L-alanine 6.4 g
L-arginine hydrochloride 5.5 g
Glycine 5.1 g
L-Histidine 1.3 g
L-Isoleucine 2.3 g
L-leucine 3.3 g
L-lysine (as acetate) 3 g
L-methionine 1.9 g
L-phenylalanine 2.3 g
L-proline 5.1 g
L-serine 3 g
Taurine 460 mg
L-threonine 2 g
L-tryptophan 910 mg
L-tyrosine 170 mg
L-Valine 2.9 g
Calcium chloride (as dihydrate) 260 mg
Sodium glycerophosphate (as hydrate) 1.9 g
Magnesium sulfate (as heptahydrate) 550 mg
Potassium chloride 2 g
Sodium acetate (as trihydrate) 1.6 g
Zinc sulfate (as heptahydrate) 6 mg
Dextrose (as monohydrate) 103 g
Refined soybean oil 12.3 g
Medium-chain triglycerides 12.3 g
Olive oil (refined) 10.1 g
Fish oil (enriched with omega-3 fatty acids) 6.1 g
Including:
   carbohydrates (Dextrose) 103 g
   amino acids 46 g
   nitrogen 7.4 g
   fats 41 g
Energy value 1000 kcal
Non-protein energy value 800 kcal
Electrolytes:
   sodium 36 mmol
   potassium 28 mmol
   magnesium 4.6 mmol
   calcium 2.3 mmol
   phosphate 11.9 mmol
   zinc 0.03 mmol
   sulfate 4.6 mmol
   chloride 32 mmol
   acetate 96 mmol
Osmolality about 950 mOsmol/kg water
Theoretical osmolarity about 850 mOsmol/l
PH after mixing about 5.6

Excipients: glycerol – 5.1 g, egg yolk phospholipids – 2.4 g, sodium oleate – 61 mg, racemic mixture of α-tocopherols – 33.3-45.9 mg, sodium hydroxide – q.s. for pH adjustment, glacial acetic acid – q.s. for pH adjustment, water for injections – up to 1448 ml.

1448 ml – plastic three-chamber “Biofin” containers (1) with antioxidant – plastic bags (4) – cardboard boxes.

Marketing Authorization Holder

Fresenius Kabi Deutschland, GmbH (Germany)

Manufactured By

Fresenius Kabi, AB (Sweden)

Dosage Form

Bottle Rx Icon SMOFKabiven® peripheral Emulsion for infusion 1904 ml: plastic three-chamber containers 4 pcs.

Dosage Form, Packaging, and Composition

SMOFKabiven® peripheral is supplied in a three-chamber bag with a volume of 1904 ml.

The 1904 ml bag contains
Amino acid solution – 1036 ml,
Dextrose 13% – 600 ml,
Fat emulsion – 268 ml.

Energy value 1300 kcal.

Amino acid solution – clear, colorless or with a yellowish tint.
Dextrose 13% – clear solution, colorless or with a yellowish tint.
Fat emulsion – white, homogeneous.
When the contents of the three chambers are mixed, a homogeneous white emulsion is formed.

Emulsion for infusion 1904 ml
L-alanine 8.4 g
L-arginine hydrochloride 7.2 g
Glycine 6.6 g
L-Histidine 1.8 g
L-Isoleucine 3 g
L-leucine 4.4 g
L-lysine (as acetate) 4 g
L-methionine 2.6 g
L-phenylalanine 3.1 g
L-proline 6.7 g
L-serine 3.9 g
Taurine 600 mg
L-threonine 2.6 g
L-tryptophan 1.2 g
L-tyrosine 240 mg
L-Valine 3.7 g
Calcium chloride (as dihydrate) 340 mg
Sodium glycerophosphate (as hydrate) 2.5 g
Magnesium sulfate (as heptahydrate) 720 mg
Potassium chloride 2.7 g
Sodium acetate (as trihydrate) 2 g
Zinc sulfate (as heptahydrate) 8 mg
Dextrose (as monohydrate) 135 g
Refined soybean oil 16.1 g
Medium-chain triglycerides 16.1 g
Olive oil (refined) 13.4 g
Fish oil (enriched with omega-3 fatty acids) 8 g
Including:
   carbohydrates (Dextrose) 135 g
   amino acids 60 g
   nitrogen 9.8 g
   fats 54 g
Energy value 1300 kcal
Non-protein energy value 1000 kcal
Electrolytes:
   sodium 48 mmol
   potassium 36 mmol
   magnesium 6 mmol
   calcium 3 mmol
   phosphate 15.6 mmol
   zinc 0.05 mmol
   sulfate 6.1 mmol
   chloride 42 mmol
   acetate 125 mmol
Osmolality about 950 mOsmol/kg water
Theoretical osmolarity about 850 mOsmol/l
PH after mixing about 5.6

Excipients: glycerol – 6.7 g, egg yolk phospholipids – 3.2 g, sodium oleate – 80 mg, racemic mixture of α-tocopherols – 43.7-60.3 mg, sodium hydroxide – q.s. for pH adjustment, glacial acetic acid – q.s. for pH adjustment, water for injections – up to 1904 ml.

1904 ml – plastic three-chamber “Biofin” containers (1) with antioxidant – plastic bags (4) – cardboard boxes.

Table of Contents

→ TABLE OF CONTENTS