部分中文 Intralipid处方信息（仅供参考）

通用名：脂肪乳注射液
英文名：Fat Emulsion Injection, Intralipid
拼音名：Zhifangru Zhusheye
药品类别 营养治疗药
【别名】英脱利匹特、乳化脂肪。
【作用与用途】
本品是供静脉输注用的灭菌的脂肪乳剂，含有注射用大豆油和注射用卵磷脂，其中大约60％的脂肪酸是必需脂肪酸，其粒径大小和生物特性与天然乳糜微粒相似。
本品是静脉营养的组成部份之一，为机体提供能量和必需脂肪酸，用于胃肠外营养补充能量及必需脂肪酸，预防和治疗人体必需脂肪酸缺乏症，也为经口服途径不能维持和恢复正常必需脂肪酸水平的病人提供必需脂肪酸。提供热量和脂肪酸。用于消耗性疾病、烧伤、创伤、手术后补充营养。
【剂量与用法】
成人：静脉滴注，按脂肪量计，每天最大推荐剂量为3g(甘油三酯)/kg。本品提供的能量可占总能量的70％。10％、20％脂肪乳注射液500ml的输注时间不少于5小时；30％脂肪乳注射液250ml的输注时间不少于4小时。
新生儿和婴儿：10％、20％脂肪乳注射液每天使用剂量为0.5～4g(甘油三酯)／kg，输注速度不超过0.17g／kg／小时。每天最大用量不应超过4g／kg。只有在密切监测血清甘油三酯、肝功能、氧饱和度等指标的情况下输注剂量才可逐渐增加至每天4g／kg。早产儿及低体重新生儿，最好是24小时连续输注，开始时每天剂量为0.5～1g／kg，以后逐渐增加到每天2g／kg。
本品可单独输注或用于配制含葡萄糖、脂肪、氨基酸、电解质、维生素和微量元素等的“全合一”营养混合液。只有在可配伍性得到保证的前提下，才能将其它药品加入本品内。也可与葡萄糖注射液或氨基酸注射液通过Y型管道混合后输入体内。该法既适用于中心静脉也适用于外周静脉。
在无菌操作条件下，下列药品可加入本品内：
1．维他利匹特(成人)／维他利匹特(儿童)；
2．水乐维他(有关配制方法详见水乐维他说明书)。
【不良反应】
过敏反应：发热、体温升高、发冷、畏寒、过敏反应[4136]、高过敏反应(过敏反应[1545、1553]、皮疹、荨麻疹、过敏性休克[1547])，呼吸影响(如呼吸急促、困难)以及循环影响(如高血压、低血压)。
血液系统：
1.即刻和早期副作用：溶血、网状红细胞增多
2.迟发副作用：长期输注本品，婴儿可能发生血小板减少。另外，长期静脉营养时即使不用本品也会有短暂的肝功能指标的异常。偶可发生静脉炎，血管痛及出血倾向。
3．病人脂肪廓清能力减退时，尽管输注速度正常仍可能导致脂肪超载综合征。脂肪超载综合征偶尔也可发生于肾功能障碍和感染患者。脂肪超载综合征表现为：高脂血症、发热、脂肪浸润、脏器功能紊乱等，但一般只要停止输注，上述症状即可消退。
消化系统：恶心、呕吐、腹痛、肝功能损害。
神经系统：神经系反应[1546](头痛、疲倦、谵语，抓空动作，自行要求起立行走、浅昏迷)。致中枢神经系统不良反应[904]：表现为兴奋、躁动、谵语,自觉要求起立行走.立即停药后症状逐渐减轻,而后出现浅度昏迷。
其他：阴茎异常勃起。
【注意事项】
休克和血栓患者禁用。
本品慎用于脂肪代谢功能减退的患者，如肝、肾功能不全，糖尿病酮中毒、胰腺炎、甲状腺机能低下(伴有高脂血症)以及败血症患者慎用。这些患者输注本品时，应密切观察血清甘油三酯浓度，连续使用一周以上的患者，应检查患者的脂肪廓清能力。
对大豆蛋白过敏者慎用本品，使用前必须做过敏试验。
新生儿和未成熟儿伴有高胆红素血症或可疑肺动脉高压者应谨慎使用本品。新生儿，特别是未成熟儿，长期使用本品必须监测血小板数目、肝功能试验和血清甘油三酯浓度。因缺乏30％脂肪乳注射液用于婴儿和儿童的经验，所以暂不推荐给婴儿和儿童使用。
采血时，如本品还没有从血流中完全清除，则将干扰其它实验室检测项目(如胆红素、乳酸脱氢酶、氧饱和度、血红蛋白等)。绝大多数病人在本品输注后5～6小时，即可被完全清除。
孕妇：已有报道表明妊娠妇女使用10％和20％脂肪乳注射液是安全和成功的。理论上30％与10％和20％脂肪乳注射液一样，也能用于妊娠妇女，但尚缺乏动物生殖研究的证据。
使用本品一周以上必须做脂肪廓清试验。具体操作如下：输注前采血样，离心，如果血浆呈乳状，则原定的输注计划应延期实施(此法不适用于高脂血症的患者)；当发现病人脂肪廓清能力降低时，最好再查血清甘油三酯。对于婴儿和儿童，监测脂肪廓请能力的最可靠的办法是定期测定血清甘油三酯水平。
本品开瓶后一次未使用完的药液应予丢弃，不得再次使用。
【制剂规格】注射液：250ml:25g、500ml:50g、100ml:20g、250ml:50g、500ml:100g。
【贮藏】25℃以下，不得冰冻。有效期2年。

인트라리피드 20%주 (Intralipid 20% Inj.)

주성분 및 함량
이 약 100ml 중
정제대두유(EP) 20.0g

성상
유백색의 유탁액이 수액용 플라스틱 용기에 든 주사제

효능·효과
비경구 영양공급 처방의 일부로서 에너지 및 필수 지방산의 보급

용량·용법
1) 성인: 일반적으로 체중 kg당 정제대두유로서 1일 2g(20%는 10mL) 이내로 한다. 투여시간은 3시간 이상에 걸쳐 점적 정맥주사한다.
첫째 날 처음 주사에 한하여 체중 kg당 1g 이내로 투여한다.
2) 환자의 생리학적 물질대사 상태를 고려하여 필수 지방산과 칼로리의 요구량에 맞게 점적 정맥주사한다.

사용상 주의 사항
* 자세한 내용은 로그인을 하셔야 확인 하실 수 있습니다.

저장방법
밀봉용기, 25℃ 이하 실온 보관

사용기간
제조일로부터 24개월

포장단위
250ml/백

Intralipid
Generic Name: soybean oil
Dosage Form: intravenous emulsion
Intralipid® 20%
A 20% I.V. Fat Emulsion In Excel® Container
Intralipid Description
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 , and 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
C18H32O2 
Oleic acid
C18H34O2 
Palmitic acid
C16H32O2 
Linolenic acid
C18H30O2 
Stearic acid
C18H36O2 
Purified egg phosphatides are a mixture of naturally occurring phospholipids which are isolated from the egg yolk. These phospholipids have the following general structure:
and  contain saturated and unsaturated fatty acids that abound in neutral fats. R3 is primarily either the choline or ethanolamine ester of phosphoric acid.
Phosphatidylcholine   Phosphatidylethanolamine
Glycerin is chemically designated C3H8O3and 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.
Intralipid - Clinical Pharmacology
Intralipid® is metabolized and utilized as a source of energy causing an increase in heat production, decrease in respiratory quotient and increase in oxygen consumption. The infused fat particles are cleared from the blood stream in a manner thought to be comparable to the clearing of chylomicrons.
Intralipid® will prevent the biochemical lesions of essential fatty acid deficiency (EFAD), and correct the clinical manifestations of the EFAD syndrome.
Indications and Usage for Intralipid
Intralipid® 20% Pharmacy Bulk Package is indicated for use in a pharmacy admixture program for the preparation of three-inone or total nutrition admixtures (TNAs) to provide a source of calories and essential fatty acids for patients requiring parenteral nutrition for extended periods of time (usually for more than 5 days) and a source of essential fatty acids for prevention of EFAD.
Contraindications
The administration of Intralipid® is contraindicated in patients with disturbances of normal fat metabolism such as pathologic hyperlipemia, lipoid nephrosis or acute pancreatitis if accompanied by hyperlipidemia.
Intralipid® 20% PHARMACY BULK PACKAGE IS NOT INTENDED FOR DIRECT INTRAVENOUS ADMINISTRATION. DILUTING Intralipid ® 20% TO A 10% CONCENTRATION WITH INTRAVENOUS FLUID SUCH AS NORMAL SALINE OR OTHER DILUENTS DOES NOT PRODUCE A DILLITION THAT IS EQUIVALENT IN COMPOSITION TO Intralipid ® 10% I.V. FAT EMULSION, AND SUCH A DILUTION SHOULD NOT BE GIVEN BY DIRECT INTRAVENOUS ADMINISTRATION.
BOXED WARNING
Deaths in preterm infants after infusion of intravenous fat emulsion have been reported in the medical literature.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 fat/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 the infused fat from the circulation must be carefully monitored (such as serum triglycerides and/or plasma free fatty acid levels). The lipemia must clear between daily infusions.
Warnings
Caution should be exercised in administering of Intralipid® 20% (A 20% I.V. Fat Emulsion) to patients with severe liver damage, pulmonary disease, anemia or blood coagulation disorders, or when there is danger of fat embolism as occurs in post traumatic fractures of the pelvis and of long bones.
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
When Intralipid® is administered, the patients capacity to eliminate the infused fat from the circulation must be monitored by use of an appropriate laboratory determination of serum triglycerides. Overdosage must be avoided.
During long term intravenous nutrition with Intralipid®, liver function tests should be performed. If these tests indicate that liver function is impaired, the therapy should be withdrawn. Frequent (some advise daily) platelet counts should be done in neonatal patients receiving parenteral nutrition with Intralipid®.
Drug product contains no more than 25 mcg/L of aluminum.
Carcinogenesis, Mutagenesis, Impairment of Fertility. Studies with Intralipid® have not been performed to evaluate carcinogenic potential, mutagenic potential, or effects on fertility.
Pregnancy Category C: Animal reproduction studies have not been conducted with Intralipid®. It is also not known whether Intralipid® can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Intralipid® should be given to a pregnant woman only if clearly needed.
Nursing Mothers: Caution should be exercised when Intralipid® is administered to a nursing woman.
Pediatric Use: See DOSAGE AND ADMINISTRATION.
AVOID OVERDOSAGE ABSOLUTELY.
Adverse Reactions
The adverse reactions observed can be separated into two classes:
Those more frequently encountered are due either to a) contamination of the intravenous catheter and result in sepsis, or to b) vein irritation by concurrently infused hypertonic solutions and may result in thrombophlebitis. These adverse reactions are inseparable from the hyperalimentation procedure with or without Intralipid®.
Less frequent reactions more directly related to Intralipid® are: a) immediate or early adverse reactions, each of which has been reported to occur in clinical trials, in an incidence of less than 1%: dyspnea, cyanosis, allergic reactions, hyperlipemia, hypercoagulability, nausea, vomiting, headache, flush-ing, increase in temperature, sweating, sleepiness, pain in the chest and back, slight pressure over the eyes, dizziness, and irritation at the site of infusion, and, rarely, thrombocytopenia in neonates; b) delayed adverse reactions such as hepatomegaly, jaundice due to central lobular cholestasis, splenomegaly, thrombocytopenia, leukopenia, transient increases in liver function tests, and overloading syndrome (focal seizures, fever, leukocytosis, hepatomegaly. splenomegaly and shock).
The deposition of a brown pigmentation in the reticuloendothelial system, the so-called “intravenous fat pigment,” has been reported in patients infused with Intralipid®. The causes and significance of this phenomenon are unknown.
Overdosage
In the event of fat overload during therapy, stop the infusion containing Intralipid® 20% (A 20% I.V. 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-evaluate the patient and institute appropriate corrective measures. See WARNINGS and PRECAUTIONS.
Intralipid Dosage and Administration
Intralipid® 20% (A 20% I.V. Fat Emulsion) Pharmacy Bulk Package should be administered only as a part of a three-in-one or total nutrient admixture via peripheral vein or by central venous infusion.
Directions For Proper Use of Pharmacy Bulk Package.
Intralipid® 20% PHARMACY BULK PACKAGE IS NOT INTENDED FOR DIRECT INFUSION. The container closure may be penetrated only once using a suitable sterile transfer device or dispensing set which allows measured dispensing of the contents. The Pharmacy Bulk Package is to be used only in a suitable work area such as a laminar flow hood (or an equivalent clean air compounding area). Once the closure is penetrated, the contents should be dispensed as soon as possible; the transfer of contents to suitable TPN admixture containers must be completed within 4 hours of closure penetration. The bag should be stored below 25°C (77°F) after the closure has been entered. Date and time of container entry should be noted in the area designated on the container label.
Admixtures made using Intralipid® 20% should be used promptly. See MIXING GUIDELINES AND LIMITATIONS section for admixture storage recommendations.
Adult Patients
The initial infusion rate of the nutrient admixture in adults should be 0.1 g fat/minute for the first 15 to 30 minutes of infusion. If no untoward reactions occur (see ADVERSE. REACTIONS section), the infusion rate can be increased to 0.2 g fat/minute. For adults, the admixture should not contain more than 500 mL of Intralipid® 20% on the first day of therapy. If the patient has no untoward reactions, the dose can be increased on the following day. The daily dosage should not exceed 2.5 g of fat/kg of body weight (12.5 mL of Intralipid® 20% per kg). Intralipid® should make up no more than 60% of the total caloric input to the patient. Carbohydrate and a source of amino acids should comprise the remaining caloric input.
Pediatric Patients
The dosage for premature infants starts at 0.5 g fat/kg body weight/24 hours (2.5 mL Intralipid® 20%) and may be increased in relation to the infant’s ability to eliminate fat. The maximum dosage recommended by the American Academy of Pediatrics is 3 g fat/kg/24 hours3
The initial rate of infusion in older pediatric patients should be no more than 0.01 g fat/minute for the first 10 to 15 minutes. If no untoward reactions occur, the rate can be changed to permit infusion of 0.1 g of fat/kg/hour. The daily dosage should not exceed 3 g of fat/kg of body weight3 Intralipid® should make up no more than 60% of the total caloric input to the patient. Carbohydrate and a source of amino acids should comprise the remaining caloric input.
Essential Fatty Acid Deficiency
When Intralipid® is administered to correct essential fatty acid deficiency, eight to ten percent of the caloric input should be supplied by Intralipid® in order to provide adequate amounts of linoleic and linolenic acids. When EFAD occurs together with stress, the amount of Intralipid® needed to correct the deficiency may be increased.
Administration
See MIXING GUIDELINES AND LIMITATIONS section for information regarding mixing this fat emulsion with other parenteral fluids.
Intralipid® 20% (A 20% I.V. FAT EMULSION) PHARMACY BULK PACKAGE IS NOT INTENDED FOR DIRECT INFUSION. It must be infused as part of an admixture into a central or peripheral vein.
The flow rate of the admixture should be controlled with an infusion pump. Filters of less than 1.2 micron pore size must not be used with admixtures containing Intralipid® 20%. Conventional administration sets and TPN pooling bags contain polyvinyl chloride (PVC) components that have DEHP (diethyl hexyl phthalate) as a plasticizer. Fat-containing fluids such as Intralipid® extract DEHP from these PVC components. Therefore it may be advisable to use a non-DEHP administration set for infusing admixtures which contain Intralipid®.
Do not use any bag in which there appears to be an oiling out on the surface of the emulsion.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. whenever solution and container permit.
MIXING GUIDELINES AND LIMITATIONS
Investigations have been conducted which demonstrate the compatibility of Intralipid® 20% when properly mixed with either Novamine® (8.5%, 11.4% or 15%) or 8.5% Travasol® or 10% Travasol® Amino Acid Injections without Electrolytes for use in TPN therapy. Because of the potential for life threatening events, caution should be taken to ensure that precipitates have not formed in any parenteral nutrition mixture.
Perform all manipulations in a suitable work area, such as a laminar flow hood.
Failure to follow the Mixing Guidelines and Limitations below, including recommended storage temperature, storage time. order of mixing, etc., may result in an unstable admixture.
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 emulsions alone:
Transfer Dextrose Injection to the TPN (Total Parenteral Nutrition) Admixture Container
Transfer Amino Acid Injection
Transfer Intralipid® 20%
Note: Amino Acid Injection, (Novamine® 8.5, 11.4 or 15% or 8.5 Travasol® 8.5 or 15% without electrolytes), Dextrose Injection and Intralipid® 20% may be simultaneously transferred to the admixture container using an automatic mixer. Admixing should be accompanied by gentle agitation to avoid localized concentration effects.
These admixtures should be used promptly with storage under refrigeration (2-8°C) not to exceed 24 hours and must be completely used within 24 hours after removal from refrigeration.
It is essential that the admixture be prepared using strict aseptic techniques as this nutrient mixture is a good growth medium for microorganisms.
Additives other than those named above may be incompatible. Complete information is not available. Those additives known to be incompatible should not be used. Consult with pharmacist, if available. If, in the informed judgment of the physician, it is deemed advisable to introduce additives, use aseptic technique. Mix thoroughly when additives have been introduced. Do not store solutions containing additives (e.g., vitamins and minerals). Additives must not be added directly to Intralipid® 20% (A 20% I.V. Fat Emulsion) Pharmacy Bulk Package and in no case should Intralipid® 20% be added to the TPN container first. Bags should be shaken gently after each addition to minimize localized concentration.
Supplemental electrolytes, trace metals or multivitamins may be required in accordance with the prescription of the attending physician.
The prime destabilizers of emulsions are excessive acidity (low pH) and inappropriate electrolyte content. Careful consideration should be given to addition of divalent cations (Ca++ and Mg++) which have been shown to cause emulsion instability. Amino acid solutions exert a buffering effect protecting the emulsion.
The admixture should be inspected carefully for “breaking or oiling out” of the emulsion. “Breaking or oiling out” is described as the separation of the emulsion and can be visibly identified by a yellowish streaking or the accumulation of yellowish droplets in the admixed emulsion. The admixture should also be examined for particulates. The admixture must be discarded if any of the above is observed.
How is Intralipid Supplied
Intralipid® 20% is supplied as a sterile emulsion in 1000 mL Pharmacy Bulk Package.
1000 mL NDC 0338-0519-04
Intralipid® 20% is also available in the following fill sizes (see package insert 335 809).
100 mL
250 mL
500 mL
STORAGE
Intralipid® 20% should not be stored above 25°C (77°F). Do not freeze Intralipid® 20%. If accidentally frozen, discard the bag.