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Intralipid 10

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Intralipid 10%

Indications
Dosage
How Supplied

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 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 0.1 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:

  1. TRANSFER DEXTROSE INJECTION TO THE TPN ADMIXTURE CONTAINER
  2. TRANSFER AMINO ACID INJECTION
  3. 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.
Instructions for Use - illustration 1
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. Instructions for Use - illustration 2
3. Remove set port cover lifting ring with thumb and forefinger and pulling upwards. Instructions for Use - illustration 3
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. Instructions for Use - illustration 4
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.
Instructions for Use - illustration 5
6. The step of the spike (shown by the arrow) should not be inserted into the port. Instructions for Use - illustration 6
7. To hang the bag, invert and place hanger through container notch. Instructions for Use - illustration 7

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.

100 ML: 0338-0518-48
250 ML: 0338-0518-02
500 ML: 0338-0518-03

STORAGE

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

Last reviewed on RxList: 7/30/2007
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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