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Intralipid® 10% (10% I.V. Fat Emulsion)
In Excel® Container
DESCRIPTION
INTRALIPID® 10% (10% i.v fat emulsion) (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:
- 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:
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 PRIMARILY EITHER THE CHOLINE OR THE ETHANOLAMINE ESTER OF PHOSPHORIC ACID.
GLYCERIN IS CHEMICALLY DESIGNATED C3H8O3 AND IS A CLEAR COLORLESS, HYGROSCOPIC
SYRUPY LIQUID. IT HAS THE FOLLOWING STRUCTURAL FORMULA:
INTRALIPID® 10% (10% i.v fat emulsion) (A 10% INTRAVENOUS FAT EMULSION) HAS AN OSMOLALITY OF APPROXIMATELY
300 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 1.1 KCAL
PER ML OF INTRALIPID 10% (10% i.v fat emulsion) . 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.
1. PADLEY FB: “MAJOR VEGETABLE FATS,“ THE LIPID HANDBOOK
(GUNSTONE FD, HARWOOD JL, PADLEY FB, EDS.), CHAPMAN AND HALL LTD., CAMBRIDGE,
UK (1986), PP. 88-9.
Indications & Dosage
INDICATIONS
INTRALIPID® 10% (10% i.v fat emulsion) IS INDICATED AS 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 AS A SOURCE OF ESSENTIAL FATTY ACIDS FOR
PREVENTION OF EFAD.
DOSAGE AND ADMINISTRATION
INTRALIPID® 10% (10% i.v fat emulsion) SHOULD BE ADMINISTERED AS A PART OF INTRAVENOUS NUTRITION
VIA PERIPHERAL VEIN OR BY CENTRAL VENOUS INFUSION.
ADULT PATIENTS
THE INITIAL RATE OF INFUSION IN ADULTS SHOULD BE 1 ML/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 2 ML/MINUTE.
NOT MORE THAN 500 ML OF INTRALIPID® 10% (10% i.v fat emulsion) (A 10% INTRAVENOUS FAT EMULSION)
SHOULD BE INFUSED INTO ADULTS 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 (25 ML OF INTRALIPID®
10% PER KG). INTRALIPID® 10% (10% i.v fat emulsion) 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
(5 ML INTRALIPID® 10% (10% i.v fat emulsion) ) AND MAY BE INCREASED IN RELATION TO THE INFANTS
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 0.1 ML/MINUTE FOR THE FIRST
10 TO 15 MINUTES. IF NO UNTOWARD REACTIONS OCCUR, THE RATE CAN BE CHANGED TO
PERMIT INFUSION OF 1 ML OF INTRALIPID® 10% (10% i.v fat emulsion) /KG/HOUR. THE DAILY DOSAGE SHOULD
NOT EXCEED 3 G OF FAT/KG OF BODY WEIGHT3. INTRALIPID® 10% (10% i.v fat emulsion) 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® 10% (A 10% I.V. FAT EMULSION) IS ADMINISTERED TO CORRECT
ESSENTIAL FATTY ACID DEFICIENCY, EIGHT TO TEN PERCENT OF THE CALORIC INPUT SHOULD
BE SUPPLIED BY INTRALIPID® 10% (10% i.v fat emulsion) IN ORDER TO PROVIDE ADEQUATE AMOUNTS OF LINOLEIC
AND LINOLENIC ACIDS. WHEN EFAD OCCURS TOGETHER WITH STRESS, THE AMOUNT OF INTRALIPID®
10% 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® 10% (10% i.v fat emulsion) CAN BE INFUSED INTO THE SAME CENTRAL OR PERIPHERAL VEIN
AS CARBOHYDRATE/AMINO ACIDS SOLUTIONS BY MEANS OF A Y-CONNECTOR NEAR THE INFUSION
SITE. THIS ALLOWS FOR MIXING OF THE EMULSION IMMEDIATELY BEFORE ENTERING THE
VEIN OR FOR ALTERNATION OF EACH PARENTERAL FLUID. IF INFUSION PUMPS ARE USED,
FLOW RATES OF EACH PARENTERAL FLUID SHOULD BE CONTROLLED WITH A SEPARATE PUMP.
FAT EMULSION MAY ALSO BE INFUSED THROUGH A SEPARATE PERIPHERAL SITE. FILTERS
OF LESS THAN 1.2 MICRON PORE SIZE MUST NOT BE USED WITH INTRALIPID® 10% (10% i.v fat emulsion) .
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® 10% (10% i.v fat emulsion) EXTRACT DEHP FROM THESE PVC
COMPONENTS AND IT MAY BE ADVISABLE TO CONSIDER INFUSION OF INTRALIPID® 10% (10% i.v fat emulsion)
THROUGH A NON-DEHP ADMINISTRATION SET.
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®
10% WHEN PROPERLY MIXED WITH EITHER NOVAMINE® OR 8.5% TRAVASOL® OR 10%
TRAVASOL® AMINO ACID INJECTIONS WITHOUT ELECTROLYTES FOR USE IN TPN THERAPY.
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 ADMIXTURE CONTAINER
TRANSFER AMINO ACID INJECTION
TRANSFER INTRALIPID® 10% (10% i.v fat emulsion) (A 10% INTRAVENOUS FAT EMULSION)
NOTE: AMINO ACID INJECTION, DEXTROSE INJECTION AND INTRALIPID® 10% (10% i.v fat emulsion) MAY
BE SIMULTANEOUSLY TRANSFERRED TO THE ADMIXTURE CONTAINER. 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®
10% AND IN NO CASE SHOULD INTRALIPID® 10% (10% i.v fat emulsion) 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 ADDITIONS 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.
Instructions for Use - Intralipid® 10% (10% i.v fat emulsion) Container
1. The integrity indicator (Oxalert™) A should be
inspected before removing the overpouch.
If the indicator is black the overpouch is damaged and the product should
be discarded.
2. Remove the overwrap by tearing at the notch and pulling down along
the container. The Oxalert™sachet A and the oxygen absorber B should
be disposed.
3. Remove set port cover lifting ring with thumb and forefinger and
pulling upwards.
4. Use a non-vented infusion set or close the air vent on a vented
set. Follow the instructions for use for the infusion set. Use a spike
conforming to ISO 8536-4, diameter 5.6 ± 0.1 mm.
5. The bag should be port side up when the infusion set is attached.
Insert the spike straight into the set port. Twist and push the spike
through the diaphragm.
Do not spike bag while the bag is hanging on the IV pole.
6. The step of the spike (shown by the arrow) should not be inserted
into the port.
7. To hang the bag, invert and place hanger through container notch.
HOW SUPPLIED
INTRALIPID® 10% (10% i.v fat emulsion) IS SUPPLIED AS A STERILE EMULSION IN THE FOLLOWING FILL
SIZES: 100 ML, 250 ML, AND 500 ML.
INTRALIPID® 10% (10% i.v fat emulsion) SHOULD NOT BE STORED ABOVE 25°C (77°F). DO NOT
FREEZE INTRALIPID® 10% (10% i.v fat emulsion) . IF ACCIDENTALLY FROZEN, DISCARD THE BAG.
3. AMERICAN ACADEMY OF PEDIATRICS: USE OF INTRAVENOUS FAT
EMULSION IN PEDIATRIC PATIENTS. PEDIATRICS 1981; 68:5(NOV) 738-43.
(Rev June 2006) Manufactured for Baxter Healthcare Corporation
Clintec Nutrition Division Deerfield, IL 60015 USA Manufactured by Fresenius
Kabi, Uppsala, Sweden. Intralipid® is a registered trademark of Fresenius
Kabi AB. Novamine® is a registered trademark of Fresenius Kabi AB. Travasol®
is a registered trademark of Baxter Healthcare Corporation.
FDA rev date: 4/24/2007
QUESTION
According to the USDA, there is no difference between a “portion” and a “serving.”See Answer
Side Effects & Drug Interactions
SIDE EFFECTS
THE ADVERSE REACTIONS OBSERVED CAN BE SEPARATED INTO TWO CLASSES:
THOSE MORE FREQUENTLY ENCOUNTERED ARE DUE: EITHER TO CONTAMINATION OF THE
INTRAVENOUS CATHETER AND RESULT IN SEPSIS, OR TO VEIN IRRITATION BY CONCURRENTLY
INFUSED HYPERTONIC SOLUTIONS AND MAY RESULT IN THROMBOPHLEBITIS. THESE ADVERSE
REACTIONS ARE INSEPARABLE FROM THE HYPER-ALIMENTATION PROCEDURE WITH OR WITHOUT
INTRALIPID® 10% (A 10% I.V. FAT EMULSION).
LESS FREQUENT REACTIONS MORE DIRECTLY RELATED TO INTRALIPID® 10% (10% i.v fat emulsion) 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 RETICULOEN-DOTHELIAL SYSTEM,
THE SO-CALLED “INTRAVENOUS FAT PIGMENT,” HAS BEEN REPORTED
IN PATIENTS INFUSED WITH INTRALIPID® 10% (10% i.v fat emulsion) . THE CAUSES AND SIGNIFICANCE OF
THIS PHENOMENON ARE UNKNOWN.
DRUG INTERACTIONS
No information provided.
Warnings
WARNINGS
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 FAT 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 INFANTS 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.
CAUTION SHOULD BE EXERCISED IN ADMINISTERING INTRALIPID® 10% (10% i.v fat emulsion) (A 10% INTRAVENOUS
FAT EMULSION) TO PATIENTS WITH SEVERE LIVER DAMAGE, PULMONARY DISEASE, ANEMIA
OR BLOOD COAGULATION DISORDERS, OR WHEN THERE IS DANGER OF FAT EMBOLISM.
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
PRECAUTIONS
WHEN INTRALIPID® 10% (10% i.v fat emulsion) 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® 10% (10% i.v fat emulsion) , 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® 10% (10% i.v fat emulsion) .
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.
2. LEVENE MI, WIGGLESWORTH JS, DESAI R: PULMONARY FAT ACCUMULATION
AFTER INTRALIPID® INFUSION IN THE PRETERM INFANT. LANCET 1980; 2(8199):815-8.
Overdosage & Contraindications
OVERDOSE
IN THE EVENT OF FAT OVERLOAD DURING THERAPY, STOP THE INFUSION OF INTRALIPID®
10% 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.
CONTRAINDICATIONS
THE ADMINISTRATION OF INTRALIPID® 10% (10% i.v fat emulsion) IS CONTRAINDICATED IN PATIENTS WITH
DISTURBANCES OF NORMAL FAT METABOLISM SUCH AS PATHOLOGIC HYPERLIPEMIA, LIPOID
NEPHROSIS OR ACUTE PANCREATITIS IF ACCOMPANIED BY HYPERLIPIDEMIA.
Clinical Pharmacology
CLINICAL PHARMACOLOGY
INTRALIPID® 10% (10% i.v fat emulsion) 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® 10% (10% i.v fat emulsion) WILL PREVENT THE BIOCHEMICAL LESIONS OF ESSENTIAL FATTY
ACID DEFICIENCY (EFAD), AND CORRECT THE CLINICAL MANIFESTATIONS OF THE EFAD
SYNDROME.
Medication Guide
PATIENT INFORMATION
No information provided. Please refer to the WARNINGS
and PRECAUTIONS sections.