部份中文Liposyn®III处方资料（仅供参考）
Liposyn®III脂肪乳注射剂
通用名称：LIPOSYN III 20%
剂 型：注射液，乳液
规 格：20%
活性成份：SOYBEAN OIL
临床药理学
Liposyn III（静脉注射脂肪乳剂）提供必要的营养益处。（EFAD），并预防和逆转EFAD临床表现（如皮肤鳞屑，生长迟缓，伤口愈合不良和毛发生长发育不良）。
输注的脂肪颗粒以考虑清除乳糜微粒的方式从血液中清除。输注后，血浆甘油三酯有短暂的增加。甘油三酸酯通过酶脂蛋白脂肪酶水解成游离脂肪酸和甘油。游离脂肪酸进入组织（其中它们可被氧化或重新合成为甘油三酸酯并储存）或在等离子体中循环，结合到白蛋白上。在肝脏中，循环游离脂肪酸被氧化或转化成非常低密度的脂蛋白，其重新进入血流。
磷脂是膜的疏水组分，并提供电绝缘层。它们涉及膜结构的形成。胆碱可防止肝脏中脂肪的沉积。
甘油被代谢为二氧化碳和糖原，或用于合成身体脂肪。
适应症和用法
Liposyn III（静脉内脂肪乳剂）被指示为需要肠外营养的患者的卡路里来源。在脂质体的情况下，脂质体的脂质体的脂质体的脂质体的脂质体被还原EFAD的临床表现。
禁忌症
Liposyn III（静脉注射脂肪乳剂）的治疗禁忌证明正常脂肪代谢紊乱，如病理性高脂血症，脂质性肾病或伴有高脂血症的急性胰腺炎。
除了1至2单位/ mL脂肪乳剂的肝素外，Liposyn III瓶的添加剂是禁忌的。
相似的照片Liposyn III不能使用过滤器。不要使用任何有一瓶这似乎是在融化，乳液。
警告
输注静脉注射脂肪乳剂后早产儿的死亡率已在医学文献中有报道.1.2尸检结果包括肺部血管内脂肪积累。治疗早产儿和低出生体重婴儿静脉注射脂肪乳剂。严格遵守推荐的总日剂量是强制性的;在任何情况下，小时输液速率应尽可能缓慢。过早的和小的孕龄婴儿静脉注射脂肪乳清的清除率差，脂肪乳液输注后的游离脂肪酸血浆水平升高; （名词，女性）静脉注射脂肪过量（名词）（又名：这是您第一次能够监测血糖水平。每天输液之间必须清除血脂。
对于患有严重肝损伤，肺部疾病，贫血或血液凝固障碍或存在脂肪栓塞危险的患者，应注意使用Liposyn III（静脉注射脂肪乳剂）。除了上述之外，本发明还涉及一种用于施用脂蛋白III的方法。
警告：本产品含有可能有毒的铝。如果肾功能受损，铝可能会长期肠胃外给药达到毒性水平。早产新生儿至少3岁。
研究表明，肾功能受损的患者，包括早产新生儿，其接受肠胃外水平的大于4至5mcg / kg /天。组织加载。
注意事项
由于游离脂肪酸将胆红素置换为白蛋白，应谨慎使用黄疸或早产儿的脂质浸润液。
在Liposyn III（静脉内脂肪乳剂）给药期间，必须密切监测患者的血象，血液凝固，肝功能，血小板计数和血浆脂质谱。每天输液之间必须清除血脂。应停用Liposyn III应在任何这些参数中显着异常。
Liposyn II
Generic Name: safflower oil, soybean oil and egg phospholipids
Dosage Form: injection, emulsion
INTRAVENOUS FAT EMULSION
Rx only
Liposyn II Description
Liposyn II (Intravenous Fat Emulsion) is a sterile, nonpyrogenic fat emulsion for intravenous administration. It is supplied in both a 10% and 20% concentration.
Liposyn II 10% contains 5% safflower oil, 5% soybean oil, up to 1.2% egg phosphatides added as an emulsifier and 2.5% glycerin in water for injection. May contain sodium hydroxide for pH adjustment. pH 8.0 (6.0 − 9.0). Liposyn II 10% has an osmolarity of 276 mOsmol/liter (actual). The total caloric value of Liposyn II 10% including fat, phospholipid and glycerol is 1.1 kcal/mL. Of this total, approximately 0.6 kcal/mL is supplied by linoleic acid.
Liposyn II 20% contains 10% safflower oil, 10% soybean oil, 1.2% egg phosphatides and 2.5% glycerin in water for injection. May contain sodium hydroxide for pH adjustment. pH 8.3 (6.0 − 9.0). Liposyn II 20% has an osmolarity of 258 mOsmol/liter (actual). The total caloric value of Liposyn II 20% including fat, phospholipid and glycerol is 2 kcal/mL. Of this total, approximately 1.2 kcal/mL are supplied by linoleic acid.
Both Liposyn II 10% and Liposyn II 20% contain emulsified fat particles of approximately 0.4 micron in diameter, similar to naturally occurring chylomicrons.
Safflower oil and Soybean Oil, USP are mixtures of neutral triglycerides with the following structure:
and  are saturated and unsaturated fatty acid residues. The major component fatty acids of the 50/50 safflower/soybean oil mixture are approximately 65.8% linoleic, 17.7% oleic, 8.8% palmitic, 3.4% stearic, and 4.2% linolenic acid. These fatty acids have the following chemical and structural formulas:
Egg phosphatides, purified, are primarily a mixture of naturally occurring phospholipids which are isolated from the egg yolk. These phospholipids have the following general structure:
 and  are the same saturated and unsaturated fatty acid residues that abound in neutral fats. R3 is primarily either the choline [HOCH2CH2N(CH3)3OH] ester or ethanolamine (HOCH2CH2NH2) ester of phosphoric acid (H3PO4).
Glycerin, USP is chemically designated C3H803 and is a clear colorless, hygroscopic syrupy liquid. It has the following structural formula:
Liposyn II - Clinical Pharmacology
Liposyn II (Intravenous Fat Emulsion) provides the patient requiring parenteral nutrition with a source of calories and the essential fatty acids normally obtained from a nutritionally complete oral diet. The supplemental polyunsaturated fat prevents biochemical changes of essential fatty acid deficiency (EFAD) and prevents and reverses EFAD clinical manifestations (e.g., scaliness of skin, growth retardation, poor wound healing and sparse hair growth).
The infused fat particles are cleared from the bloodstream in a manner thought to be similar to the clearing of chylomicrons. Following infusion, there is a transient increase in plasma triglycerides. The triglycerides are hydrolyzed to free fatty acids and glycerol by the enzyme, lipoprotein lipase. The free fatty acids either enter the tissues (where they may be oxidized or resynthesized into triglycerides and stored) or circulate in the plasma, bound to albumin. In the liver, circulating free fatty acids are oxidized or converted to very low density lipoproteins that re-enter the bloodstream.
Phosphatides are the hydrophobic components of membranes and provide electrically insulated layers. They are involved in the formation of membrane structures. Choline prevents the deposition of fat in the liver.
Glycerol is metabolized to carbon dioxide and glycogen or is used in the synthesis of body fats.
Indications and Usage for Liposyn II
Liposyn II is indicated as a source of calories for patients requiring parenteral nutrition. Where such nutrition is required for extended periods of time (more than 5 days), Liposyn II is also indicated as a source of essential fatty acids to prevent or reverse biochemical changes in fatty acid composition of plasma lipids (elevated triene/tetraene ratio) and the clinical manifestations of EFAD.
Contraindications
The administration of Liposyn II (Intravenous Fat Emulsion) is contraindicated in patients demonstrating disturbances in normal fat metabolism such as pathologic hyperlipemia, lipoid nephrosis or acute pancreatitis if accompanied by hyperlipemia.
Warnings
Deaths in preterm infants after infusion of intravenous fat emulsions have been reported in the medical literature.1,2 Autopsy findings included intravascular fat accumulation in the lungs. Treatment of premature and low birth weight infants with intravenous fat emulsion must be based upon careful benefit-risk assessment. Strict adherence to the recommended total daily dose is mandatory; hourly infusion rate should be as slow as possible in each case and should not in any case exceed 1 g/kg in four hours. Premature and small for gestational age infants have poor clearance of intravenous fat emulsion and increased free fatty acid plasma levels following fat emulsion infusion; therefore, serious consideration must be given to administration of less than the maximum recommended doses in these patients in order to decrease the likelihood of intravenous fat overload. The infant’s ability to eliminate infused fat from the circulation must be carefully monitored (such as triglyceride and/or plasma free fatty acid levels). The lipemia must clear between daily infusions.
Caution should be exercised in administering Liposyn II (Intravenous Fat Emulsion) to patients with severe liver damage, pulmonary disease, anemia or blood coagulation disorders or when there is danger of fat embolism. The too rapid administration of Liposyn II can cause fluid and/or fat overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states, pulmonary edema, impaired pulmonary diffusion capacity or metabolic acidosis.
Caution should be exercised when admixing Liposyn II (Intravenous Fat Emulsion).
WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.
Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.
Precautions
Because free fatty acids displace bilirubin bound to albumin, the use of lipid infusions in jaundiced or premature infants should be undertaken with caution.
During Liposyn II administration, the patient’s hemogram, blood coagulation, liver function, platelet count and plasma lipid profile must be closely monitored. The lipemia must clear between daily infusions. Liposyn II should be discontinued should a significant abnormality in any one of these parameters be attributed to the infusion.
Pregnancy Category C. Animal reproduction studies have not been conducted with Liposyn II. It is also not known whether Liposyn II can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Liposyn II should be given to a pregnant woman only if clearly needed.
Nursing Mothers. It is not known whether the drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Liposyn II is administered to a nursing woman.
Frequent (some advise daily) platelet counts should be done in neonatal patients receiving parenteral nutrition with Liposyn II.
Liposyn II is supplied in single-dose containers. Partially used containers must be discarded and should not be stored or resterilized for later use. Do not administer the contents of any container in which the emulsion appears to be oiling out.
This product contains no more than 25 mcg/L of aluminum.
Adverse Reactions
Sepsis due to contamination of administration equipment and thrombophlebitis due to vein irritation from concurrently administered hypertonic solutions have been encountered. These are attributable to I.V. therapy in general or to the type of infusion administered.
Adverse reactions directly related to fat emulsions are of two types: (1) immediate (acute) and (2) long term (chronic). In studies of lipid products in general, the following immediate reactions have been noted: Allergic reactions, hyperlipemia, dyspnea, cyanosis, flushing, dizziness, headache, sleepiness, nausea, vomiting, hyperthermia, sweating, chest and back pain, thrombocytopenia (rarely in neonates), hypercoagulability and transient increases in liver enzymes.
The following reactions have been noted with long-term therapy with lipid infusions in general: Hepatomegaly, jaundice due to central lobular cholestasis, splenomegaly, thrombocytopenia, leucopenia, transient increases in liver function tests, overloading syndrome and deposition of brown pigment (“fat pigment”) in the reticuloendothelial tissue of the liver. The significance of this last occurrence and its cause are unknown.
Overdosage
In the event of fat overload during therapy, stop the infusion of Liposyn II (Intravenous Fat Emulsion) until visual inspection of the plasma, determination of triglyceride concentrations, or measurement of plasma light-scattering activity by nephelometry indicates the lipid has cleared. Re-eva luate the patient and institute appropriate corrective measures. See WARNINGS and PRECAUTIONS.
Liposyn II Dosage and Administration
Liposyn II (Intravenous Fat Emulsion) should be administered as part of an intravenous total nutrition program via peripheral vein or central venous catheter.
Adult Patients
Liposyn II can provide up to 60% of daily calories at a dose not to exceed 3 g/kg of body weight per day. The other 40% should be provided by carbohydrate and amino acids.
For the prevention of essential fatty acid deficiency, the recommended daily requirement is approximately 4% of the caloric intake as linoleate. In most adult patients, this can be supplied as 500 mL of Liposyn II 10% or 250 mL of Liposyn II 20% administered twice weekly.
The initial infusion rate for the first 15 minutes should be 1 mL/minute for Liposyn II 10% and 0.5 mL/minute for Liposyn II 20%. If no adverse effects are observed during this initial infusion, the rate can be increased to allow no more than 500 mL of Liposyn II 10% or 250 mL of Liposyn II 20% to be given over a period of four to six hours.
Pediatric Patients
Liposyn II can provide up to 60% of daily calories at a dose not to exceed 4 g/kg of body weight per day. The other 40% should be provided by carbohydrate and amino acids.
For the prevention of essential fatty acid deficiency, the recommended daily requirement is approximately 4% of the caloric intake as linoleate. The daily dosage of Liposyn II ranges from 5 mL to 10 mL per kilogram for the 10% emulsion and 2.5 mL to 5 mL per kilogram for the 20% emulsion, depending upon the size and maturity of the patient.
The infusion should be started at a rate of 0.1 mL/minute for the first 15 minutes. If no adverse effects are observed during this initial infusion, the rate can be increased to allow no more than 100 mL of Liposyn II 10% or 50 mL of Liposyn II 20% per hour.
Administration
With the exception of heparin at 1 to 2 units/mL of fat emulsion, additives to the Liposyn II bottle are contraindicated.
Partly used containers must not be stored for later use. Filters of less than 1.2 micron porosity must not be used with Liposyn II. Do not use any bottle in which there appears to be an oiling out of the emulsion.
See CONTRAINDICATIONS regarding mixing this emulsion with other I.V. fluids or additives.
Liposyn II can be infused into the same central or peripheral vein as the carbohydrate/amino acid solutions by means of a short Y-connector near the infusion site. This allows for mixing of the solutions immediately before entering the vein or for alternation of each solution. Flow rates of each solution should be controlled separately by infusion pumps, if these are used. Fat emulsion may also be infused through a separate peripheral site. If desired, heparin may be added to Liposyn II at a concentration of 1 to 2 units per mL prior to administration. Alternatively, studies have documented the stability of Liposyn® II 10% and 20%, necessary Hospira electrolytes, Hospira trace metals, and Hospira 10% through 70% Dextrose Injection, USP in a TPN admixture container with the following Hospira amino acid solutions:
Admixtures were compounded in either a nonphthalate polyvinylchloride (PVC) or an ethylene vinyl acetate (EVA) container. (See NOTE). SEE MIXING INSTRUCTIONS FOR COMBINED ADMINISTRATION. Compounded admixtures may be stored under refrigeration for up to 24 hours. Administration of admixtures should be completed within 24 hours after removal from refrigeration.
Conventional administration sets contain polyvinyl chloride (PVC) components that have DEHP (diethylhexyl phthalate) as a plasticizer. Fat-containing fluids such as Liposyn II extract DEHP from this PVC component, and it may be advisable to consider infusion of Liposyn II or the 3-in-1 admixture through a non-DEHP administration set.
A 1.2 micron air-eliminating filter can be used to deliver either a stable 3-in-1 admixture containing Liposyn II or the emulsion alone. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
MIXING INSTRUCTIONS FOR COMBINED ADMINISTRATION
Caution should be exercised when admixing Liposyn II (Intravenous Fat Emulsion).
It is absolutely essential that the admixture be prepared using strict aseptic techniques as this nutrient mixture is a good growth media for microorganisms.
Studies have documented the stability of Liposyn®II 10% and 20% with necessary Hospira electrolytes, Hospira trace metals, and Hospira 10% through 70% Dextrose Injection, USP in a TPN admixture container with the following Hospira amino acid solutions:
NOTE: The TPN admixture containers used in the stability studies were formulated to minimize lipid/container interactions. The principal bag materials were a nonphthalate polyvinylchloride (PVC) or ethylene vinyl acetate (EVA). The only significant leachable from EVA is acetate. Acetate is found in total parenteral nutrition (TPN) admixtures as acetic acid, used for adjusting the pH of amino acid solutions, and as lysine acetate. The level of leachable acetate from EVA is not sufficient to alter the final acetate concentration significantly. Compounded admixtures may be stored under refrigeration for up to 24 hours. Administration of admixtures should be completed within 24 hours after removal from refrigeration. Reference should be made to the individual package inserts for detailed information on each component.
The prime destabilizers of emulsions are excessive acidity (low pH) and inappropriate electrolyte content. Careful consideration should be given to the dosage levels of the divalent cations (Ca++ and Mg++) administered, as these have been shown to cause emulsion instability. Amino acid solutions exert a buffering effect, protecting the emulsion.
The following proper mixing sequence must be followed to minimize pH-related problems by ensuring that typically acidic dextrose injections are not mixed with lipid emulsion alone:
Transfer Liposyn®II (Intravenous Fat Emulsion) to the TPN admixture container.
Transfer Aminosyn®II (An Amino Acid Injection), Aminosyn II w/Electrolytes, or Aminosyn (pH 6).
Transfer Hospira Dextrose Injection, USP.
Perform addition of necessary Hospira electrolyte and Hospira trace metal additives.
Admixing should be accompanied by gentle agitation to avoid localized concentration effects. Simultaneous or sequential mixing of Liposyn II with other nutritional substrates using an automated, gravimetric pumping system is considered an acceptable method for admixture compounding, especially for institutions with a high volume of 3-in-1 admixtures.
How is Liposyn II Supplied
Liposyn II (Intravenous Fat Emulsion) 10% and 20% is a white to slightly off-white emulsion with no evidence of oiling out of the emulsion.
Liposyn II 10% (List No. 9786) is supplied in 200, 250 and 500 mL single-dose containers.
Liposyn II 20% (List No. 9789) is supplied in 200, 250 and 500 mL single-dose containers.
Store at 20 to 25ºC (68 to 77ºF). [See USP Controlled Room Temperature.] Protect from freezing