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Rx Item-Intralipid 30% Emulsion 12X500Ml By Baxter Pharma

NDC 00338-0520-13 UPC/GTIN No.3-03380-52013-8 Mfg.Part No.52013BRAND: INTRALIPID NDC: 00338-0520-13,338052013 UPC: 3-03380-52013-8,303380520138 Baxter Pharma USAOnly Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scopWant to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.comVisit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.

Rx Item-Intralipid 30% Emulsion 12X500Ml By Baxter Pharma

$894.77$889.00

Item No.:RX487199 NDC No.338052013 UPC No.:303380520138 NDC No. 00338-0520-13 UPC/GTIN No. 3-03380-52013-8 MPN 52013 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,ResearchCo.,Uni.,VA,Vet & Wholesalers in scope of practice can order this RX Item. Rx Item No. Rx487199 Intralipid 30% Emulsion 12X500ml by Baxter Med Item No. 3487199 NDC No. 338052013 UPC No. 303380520138 Other Name Intralipid

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INTRALIPID- soybean oil emulsion
Baxter Healthcare Corporation

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:

structure
where r1c r2c r3c 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
C18 H32 O2 structure
Oleic acid
C18 H34 O2 structure
Palmitic acid
C16 H32 O2 structure
Linolenic acid
C18 H30 O2
structure
(click image for full-size original)
Stearic acid
C18 H36 O2 structure
Purified egg phosphatides are a mixture of naturally occurring phospholipids which are isolated from the egg yolk. These phospholipids have the following general structure:

structure
structure contain saturated and unsaturated fatty acids that abound in neutral fats. R3 is primarily either the choline or ethanolamine ester of phosphoric acid.

figure
(click image for full-size original)
Phosphatidylcholine Phosphatidylethanolamine

Glycerin is chemically designated C3 H8 O3 and is a clear colorless, hygroscopic syrupy liquid. It has the following structural formula:

stuct
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.

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

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.

NDC 00338-0520-13 UPC/GTIN No.3-03380-52013-8 Mfg.Part No.52013
RX ITEM-Intralipid 30% Emulsion 12X500Ml
NDC 00338-0520-13 UPC/GTIN No.3-03380-52013-8 Mfg.Part No.52013

BRAND: INTRALIPID NDC: 00338-0520-13,338052013 UPC: 3-03380-52013-8,303380520138 Baxter Pharma USA
Intralipid 30% Emulsion 12X500Ml By Baxt
BRAND: INTRALIPID NDC: 00338-0520-13,338052013 UPC: 3-03380-52013-8,303380520138 Baxter Pharma USA

Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop
FAT EMULSIONS INTRAVEN EM
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

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Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.