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StructoKabiven[速立恩]-用于腸道外營養剂
Manufacturer：Fresenius Kabi
Contents：Per 1206 mL Purified structured triglyceride 34 g, glucose (as monohydrate) 85 g, alanine 5.3 g, arginine 4.6 g, glycine 4.2 g, histidine 1.1 g, isoleucine 1.9 g, leucine 2.8 g, lysine (as acetate) 2.5 g, methionine 1.6 g, phenylalanine 1.9 g, proline 4.2 g, serine 2.5 g, taurine 0.38 g, threonine 1.7 g, tryptophan 0.76 g, tyrosine 0.15 g, valine 2.4 g, CaCl2 (as dihydrate) 0.21 g, Na glycerophosphate (as hydrate) 1.6 g, Mg sulphate (as heptahydrate) 0.46 g, KCl 1.7 g, Na acetate (as trihydrate) 1.3 g, Zn sulphate (as heptahydrate) 0.005g.
Per 1904 mL Purified structured triglyceride 54 g, glucose (as monohydrate) 135 g, alanine 8.4 g, arginine 7.2 g, glycine 6.6g, histidine 1.8 g, isoleucine 3 g, leucine 4.4 g, lysine (as acetate) 4 g, methionine 2.6 g, phenylalanine 3.1 g, proline 6.7 g, serine 3.9 g, taurine 0.6 g, threonine 2.6 g, tryptophan 1.2 g, tyrosine 0.24 g, valine 3.7 g, CaCl2 (as dihydrate) 0.34 g, Na glycerophosphate (as hydrate) 2.5g, Mg sulphate (as heptahydrate) 0.72g, KCl 2.7g, Na acetate (as trihydrate) 2 g, Zn sulphate (as heptahydrate) 0.008g Indications：Parenteral nutrition for adult patients when oral or enteral nutrition is impossible, insufficient or contraindicated.
Dosage：For IV use, peripheral or central vein infusion.
The ability to eliminate fat and metabolise glucose should govern the dosage and infusion rate. (See Precautions.)
The dose should be individualised with regard to the patient's clinical condition, body weight and nutritional requirements.
The nitrogen requirements for maintenance of body protein mass depend on the patient's condition (eg, nutritional state and degree of catabolic stress). The requirements are nitrogen0.1-0.15 g/kg body weight/day in the normal nutritional state or in conditions with mild metabolic stress. In patients with moderate to high metabolic stress with or without malnutrition, the requirements are in the range of nitrogen0.15-0.25 g/kg body weight/day (amino acid 0.9-1.6 g/kg body weight/day).
The dosage range of nitrogen 0.1-0.2 g/kg body weight/day (amino acids 0.6-1.2 g/kg body weight/day) corresponds to StructoKabiven 20-40 mL/kg body weight/day. For a 60-kg patient, this is equivalent to StructoKabiven 1200-2400 mL/day.
The corresponding commonly accepted requirements are 2-6 g/kg body weight/day for glucose and 1-2g/kg body weight/day for fat. StructoKabiven 1000 mL contains nitrogen 5.1 g (amino acids 32 g), glucose 71 g, fat 28 g and non-protein calories 560 (total calories 688).
The total energy requirement depends on the patient's clinical condition and is most often between 20-30 kcal/kg body weight/day.
In obese patients, the dose should be based on the estimated ideal weight.
StructoKabiven is available in 2 pack sizes intended for patients with moderately increased or basal nutritional requirements. To provide total parenteral nutrition, trace elements and vitamins should be added to StructoKabiven according to the patient needs.
Infusion Rate: The maximum infusion rate for glucose is 0.25g/kg/hr, for amino acid 0.1 g/kg/hr and for fat 0.15 g/kg/hr.
The infusion rate should not exceed 3 mL/kg body weight/hr(corresponding to glucose 0.21 g, amino acid 0.1g and fat0.08 g/kg body weight/hr). The recommended infusion period is 14-24 hrs.
Maximum Daily Dose: The maximum daily dose varies with the clinical condition of the patient and may even change from day to day. The recommended maximum daily dose is 40 mL/kg/day.
Overdosage：See Fat Overload Syndrome, Excess of Amino Acid Infusion and Excess of Glucose Infusion under Adverse Reactions.
If symptoms of overdose of fat or amino acids occur, the infusion should be slowed down or discontinued.
There is no specific antidote for overdose. Emergency procedures should be general supportive measures, with particular attention to respiratory and cardiovascular systems. Close biochemical monitoring would be essential and specific abnormalities treated appropriately.
If hyperglycemia occurs, it should be treated according to the clinical situation either by appropriate insulin administration and/or adjustment of the infusion rate.
Additionally, overdose might cause fluid overload, electrolyte imbalances and hyperosmolarity.
In some rare serious cases, haemodialysis, haemofiltration or haemo-diafiltration may be considered.
Contraindications：Hypersensitivity to egg- or soya protein or to any of the active substances or excipients of StructoKabiven.
Severe hyperlipaemia; severe liver insufficiency; severe blood coagulation disorders; congenital errors of amino acid metabolism; severe renal insufficiency without access to hemofiltration or dialysis; acute shock; hyperglycemia, which requires >6 units of insulin/hr; pathologically elevated serum levels of any of the included electrolytes.
General Contraindications to Infusion Therapy: Acute pulmonary oedema, hyperhydration and decompensated cardiac insufficiency; hypotonic dehydration; hemophagocytotic syndrome.
Unstable conditions (eg, severe posttraumatic conditions, uncompensated diabetes mellitus, acute myocardial infarction, metabolic acidosis, severe sepsis and hyperosmolar coma).
Special Precautions：The ability to eliminate fat should be monitored.
It is recommended that this is done by measuring serum triglycerides after a fat-free period of 5-6 hrs.
The serum concentration of triglycerides should not exceed 4 mmol/L when starting the infusion.
To avoid risks associated with too rapid infusion rates, it is recommended to use a continuous and well-controlled infusion, if possible by using a volumetric pump.
Disturbances of the electrolyte and fluid balance (eg, abnormally high or low serum levels of the electrolytes) should be corrected before starting the infusion.
StructoKabiven should be given with caution to patients with a tendency towards electrolyte retention.
Special clinical monitoring is required at the beginning of any IV infusion. Should any abnormal sign occur, the infusion must be stopped.
Since an increased risk of infection is associated with the use of any central vein, strict aseptic precautions should be taken to avoid any contamination during catheter insertion and manipulation.
StructoKabiven should be given with caution in conditions of impaired lipid metabolism. Hypertriglyceridemia can occur in renal insufficiency, pancreatitis, impaired liver function, hypothyroidism and sepsis. If StructoKabiven is given to patients with these conditions, close monitoring of serum triglycerides is mandatory.
Serum glucose, electrolytes and osmolarity as well as fluid balance, acid-base status and liver enzyme tests (alkaline phosphatase, ALT, AST) should be monitored.
Blood cell count and coagulation should be monitored when fat is given for a longer period.
In patients with renal insufficiency, the phosphate and potassium intake should be carefully controlled to prevent hyperphosphatemia and hyperkalaemia.
The amount of individual electrolytes to be added is governed by the clinical condition of the patient and by frequent monitoring of serum levels.
Parenteral nutrition should be given with caution in lactic acidosis, insufficient cellular oxygen supply and increased serum osmolarity.
Any sign or symptom of anaphylactic reaction (eg, fever, shivering, rash or dyspnoea) should lead to immediate interruption of the infusion.
The fat content of StructoKabiven may interfere with certain laboratory measurements (eg, bilirubin, lactate dehydrogenase, oxygen saturation, hemoglobin) if blood is sampled before fat has been adequately cleared from the bloodstream. Fat is cleared after a fat-free interval of 5-6 hrs in most patients.
StructoKabiven contains soya oil (in the form of purified structured triglyceride), which may rarely cause severe allergic reactions.
IV infusion of amino acids is accompanied by increased urinary excretion of the trace elements, in particular copper and zinc. This should be considered in the dosing of trace elements, especially during long-term IV nutrition.
In malnourished patients, initiation of parenteral nutrition can precipitate fluid shifts resulting in pulmonary oedema and congestive heart failure as well as decrease in the serum concentration of potassium, phosphorus, magnesium and water soluble vitamins. These changes can occur within 24-48 hrs, therefore, careful and slow initiation of parenteral nutrition is recommended together with close monitoring and appropriate adjustments of fluid, electrolytes, minerals and vitamins.
StructoKabiven should not be given simultaneously with blood in the same infusion set due to the risk of pseudoagglutination.
In patients with hyperglycaemia, administration of exogenous insulin might be necessary.
Thrombophlebitis may occur if peripheral veins are used for infusions. The catheter insertion site should be evaluated daily for local signs of thrombophlebitis.
Effects on the Ability to Drive or Operate Machinery: Not relevant.
Use in pregnancy & lactation: For StructoKabiven, no clinical data on exposed pregnancies are available.
StructoKabiven has not been tested in animals for effects on the conceptus beyond the period of organogenesis. Evaluation of animal data has shown reproductive toxicity after administration of Structolipid (the fat emulsion in StructoKabiven) (see Toxicology under Actions). The clinical relevance of this data is unknown. StructoKabiven should be used during pregnancy only after special consideration.
No clinical experience of use during breastfeeding is available. Women treated with StructoKabiven should not breastfeed.
Use in children: StructoKabiven is not recommended in children. Due to composition of the amino acid solution, StructoKabiven is not suitable for the use in newborns or infants <2 years.
There is at present, no clinical experience of the use of StructoKabiven in children (2-11 years). Adverse Drug Reactions：Uncommon (>1/1000, <1/100): Nausea, headache, rise in body temperature, elevated plasma levels of liver enzymes, ketone bodies and triglycerides.
Rare (>1/10,000, <1/1000): Tachycardia, hypertension.
Very Rare (<1/10,000): Respiratory symptoms, rash, back pain, dizziness, diarrhoea.
Fat Overload Syndrome: An impaired capacity to eliminate Structolipid may lead to the fat overload syndrome as a result of overdosage, but also at recommended rates of infusion in association with a sudden change in the patient's clinical condition eg, renal function impairment or infection.
The fat overload syndrome is characterised by hyperlipaemia, fever, fat infiltration, hepatomegaly, splenomegaly, anaemia, leucopenia, thrombocytopenia, blood coagulation disorders and coma. All symptoms are usually reversible if the infusion is discontinued.
Excess of Amino Acid Infusion: As with other amino acid solutions, the Aminoven content in StructoKabiven may cause undesirable effects when the recommended infusion rate is exceeded.
These effects are nausea, vomiting, shivering and sweating. Amino acid infusion may also cause a rise in body temperature. With an impaired renal function, increased levels of nitrogen-containing products (eg, creatinine, urea) may occur.
Excess of Glucose Infusion: If the glucose clearance capacity of the patient is exceeded, hyperglycaemia will develop.
Drug Interactions：Some medicinal products, like insulin, may interfere with the body's lipase system. This kind of interaction seems, however, to be of limited clinical importance.
Heparin given in clinical doses causes a transient release of lipoprotein lipase into the circulation.
This may result initially in increased plasma lipolysis followed by a transient decrease in triglyceride clearance.
Purified structured triglycerides contain soya bean oil, which has a natural content of vitamin K1. However, the concentration in StructoKabiven is so low that it is not expected to significantly influence the coagulation process in patients treated with coumarin derivatives.
Incompatibilities: StructoKabiven may only be mixed with other medicinal products for which compatibility has been documented. (See Cautions for Usage.)Caution For Usage：Instructions for Use & Handling: Do not use if package is damaged. Use only if the amino acids and glucose solutions are clear and colourless or slightly yellow and the fat emulsion is white and homogenous. The contents of the 3 separate chambers have to be mixed before use.
After separation of the peelable seals, the bag should be inverted on a number of occasions to ensure a homogenous mixture, which does not show any evidence of phase separation.
After mixing of the 3 solutions, additions can be made via the additive port.
Compatibility: Only medicinal or nutrition solutions for which compatibility has been documented may be added to StructoKabiven. Compatibility for different additives and the storage time of the different admixtures will be available upon request.
Addition should be made aseptically.
For single use only. Any mixture remaining after infusion must be discarded.
Storage：Do not store above 25°C. Do not freeze. Store in overpouch.
Storage After Mixing with Additives: From a microbiological point of view, StructoKabiven should be used immediately when additions have been made. If not used immediately, the in-use storage time and conditions prior to use are the responsibility of the user and should normally not be longer than 24 hrs at 2-8°C.
Shelf-Life: 2 years.
Shelf-Life After Mixing: Chemical and physical in-use stability of the mixed 3-chamber bag has been demonstrated for 36 hrs at 25°C. From a microbiological point of view, StructoKabiven should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hrs at 2-8 C.
Shelf-Life After Mixing with Additives: Chemical and physical in-use stability, see Cautions for Usage. From a microbiological point of view, StructoKabiven should be used immediately when additions have been made.
If not used immediately, the in-use storage time and conditions prior to use are the responsibility of the user and should normally not be longer than 24 hrs at 2-8°C.
Description：StructoKabiven consists of a 3-chamber bag system.
Each bag contains the following partial volumes depending on the 2 pack sizes. See table.
StructoKabiven also contains the following excipients: Purified eggphospholipids, glycerol, sodium hydroxide (pH adjuster), glacial acetic acid (pH adjuster) and water for injections.
Glucose and amino acid solutions are clear and colourless to slightly yellow and free from particles. The fat emulsion is white and homogenous.
Mechanism of Action：Pharmacology: Pharmacodynamics: Fat Emulsion: Structolipid, the fat emulsion used in StructoKabiven, provides essential and non-essential long-chain fatty acids and medium-chain fatty acids which are important for energy metabolism and the structural integrity of cell membranes.
Structolipid in the recommended dosage does not cause haemodynamic changes. No clinically significant changes in pulmonary function have been described when Structolipid is used properly.
The transient increase in liver enzymes seen in some patients on parenteral nutrition is reversible and disappears when parenteral nutrition is discontinued. Similar changes are also seen in parenteral nutrition without fat emulsions.
Amino Acids and Electrolytes: The amino acids, constituents of protein in ordinary food, are utilised for tissue protein synthesis and any surplus is channeled to a number of metabolic pathways. Studies have shown a thermogenic effect of amino acid infusion.
Glucose: Glucose should have no pharmacodynamic effects apart from contributing to maintain or replete the normal nutritional status.
Pharmacokinetics: Fat Emulsion: Structolipid has biological properties similar to those of endogenous chylomicrons. Unlike chylomicrons, Structolipid does not contain cholesterol esters or apolipoproteins, while its phospholipid content is significantly higher.
Structolipid is eliminated from the circulation via a pathway similar to that of endogenous chylomicrons. The exogenous fat particle is primarily hydrolysed in the circulation and taken up by LDL receptors peripherally and by the liver.
The elimination rate is determined by the composition of the fat particles, the nutritional status, the disease and rate of infusion. In healthy volunteers, the maximum clearance rate of Structolipid after fasting overnight is faster than emulsions containing only triglycerides with long-chain fatty acid.
Both the elimination and the oxidation rates are dependent on the patient's clinical condition; elimination is faster and utilisation is increased in postoperative patients and in trauma, while patients with renal failure and hypertriglyceridaemia show lower utilisation of exogenous fat emulsions.
Amino Acids and Electrolytes: The principal pharmacokinetic properties of the infused amino acids and electrolytes are essentially the same as for amino acids and electrolytes
supplied by ordinary food. However, the amino acids of dietary protein first enter the portal vein and then the systemic circulation, while IV infused amino acids reach the systemic circulation directly.
Glucose: Then pharmacokinetic properties of infused glucose are essentially the same as those of glucose supplied by ordinary food.
Toxicology: Preclinical Safety Data: Preclinical safety studies with StructoKabiven have not been performed.
However, preclinical data for Structolipid as well as amino acids and glucose solutions of various compositions and concentrations reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated-dose toxicity and genotoxicity.
The carcinogenic potential of Structolipid has not been evaluated.
No teratogenic or embryotoxic potential was evident in rabbits after infusions of Structolipid at a dosage of triglycerides (TG) 3 g/kg/day (TG 0.75 g/kg/hr) over 4 hrs.
At a dosage of TG 4.5 g/kg/day (TG 1.12 g/kg/hr), a possible embryotoxic effect was evidenced by a slight increase in embryonic/fetal loss. The dosage and infusion rate were 3 and 7 times higher, respectively, than recommended for clinical use.
治療分類：腸道外營養品 - 經由注射營養品 (Parenteral Nutritional Products)
ATC Classification：A16AA - Amino acids and derivatives ; Used in treatment of alimentary tract and metabolism problems. Poison Schedule：NP Presentation/Packing：Emulsion for infusion 1206 mL, 1904 mL.
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Product trade name: StructoKabiven
Pharmaceutical active ingredients containing related brand and generic drugs, medications or other health care products:
Alanine
Arginine
Dextrose Monohydrate
Glycine
Histidine
Isoleucine
Leucine
Lysine Acetate
Methionine
Phenylalanine
Proline
Serine
Taurine
Threonine
Triglyceride Structured Purified (Soya Oil)
Tryptophan
Tyrosine
Valine
StructoKabiven available forms, composition, doses:Injectable; Injection; Alanine 7.1 g; Arginine 6.1 g; Dextrose Monohydrate 127 g; Glycine 5.6 g; Histidine 1.5 g; Isoleucine 2.5 g; Leucine 3.8 g; Lysine Acetate 3.4 g; Methionine 2.2 g; Phenylalanine 2.6 g; Proline 5.7 g; Serine 3.3 g; Taurine 500mg; Threonine 2.2 g; Triglyceride Structured Purified (SoyaOil) 38.5 g; Tryptophan 1 g; Tyrosine 200 mg; Valine 3.1 g / lStructoKabiven destination | category:
Human Indications and usages, anatomical therapeutic chemical and diseases classification codes:
ATC
ICD-10
Pharmaceutical companies, researchers, developers, manufacturers, distributors and suppliers:Fresenius。
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注：以下不同产品和不同价格，详细请以咨询为准！
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产地国家: 澳大利亚
原产地英文商品名:
STRUCTOKABIVEN 1970ml/bag 4bags/box
原产地英文药品名:
DEXTROSE/AMINO ACIDS/ELECTROLYTES/TRIGLYCERIDES
中文参考商品译名:
速立恩 1970毫升/袋 4袋/盒
中文参考药品译名:
葡萄糖/氨基酸类/电解质类/甘油三酯
生产厂家中文参考译名:
费森尤斯
生产厂家英文名:
Fresenius Kabi
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产地国家: 澳大利亚
原产地英文商品名:
STRUCTOKABIVEN Periph 1206ml/bag 4bags/box
原产地英文药品名:
DEXTROSE/AMINO ACIDS/ELECTROLYTES/TRIGLYCERIDES
中文参考商品译名:
速立恩Periph 1206毫升/袋 4袋/盒
中文参考药品译名:
葡萄糖/氨基酸类/电解质类/甘油三酯
生产厂家中文参考译名:
费森尤斯
生产厂家英文名:
Fresenius Kabi
-----------------------------------------------
产地国家: 澳大利亚
原产地英文商品名:
STRUCTOKABIVEN EF 1970ml/bag 4bags/box
原产地英文药品名:
DEXTROSE/AMINO ACIDS/ELECTROLYTES/TRIGLYCERIDES
中文参考商品译名:
速立恩EF 1970毫升/袋 4袋/盒
中文参考药品译名:
葡萄糖/氨基酸类/电解质类/甘油三酯
生产厂家中文参考译名:
费森尤斯
生产厂家英文名:
Fresenius Kabi
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产地国家: 澳大利亚
原产地英文商品名:
STRUCTOKABIVEN EF 1477ml/bag 4bags/box
原产地英文药品名:
DEXTROSE/AMINO ACIDS/ELECTROLYTES/TRIGLYCERIDES
中文参考商品译名:
速立恩EF 1477毫升/袋 4袋/盒
中文参考药品译名:
葡萄糖/氨基酸类/电解质类/甘油三酯
生产厂家中文参考译名:
费森尤斯
生产厂家英文名:
Fresenius Kabi
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产地国家: 澳大利亚
原产地英文商品名:
STRUCTOKABIVEN EF 986ml/bag 4bags/box
原产地英文药品名:
DEXTROSE/AMINO ACIDS/ELECTROLYTES/TRIGLYCERIDES
中文参考商品译名:
速立恩EF 986毫升/袋 4袋/盒
中文参考药品译名:
葡萄糖/氨基酸类/电解质类/甘油三酯
生产厂家中文参考译名:
费森尤斯
生产厂家英文名:
Fresenius Kabi
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