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I.v. Fat Emulsion (Intralipid)

Trade Name : Intralipid

Baxter Healthcare Corporation

EMULSION

Strength 30 g/100mL

SOYBEAN OIL Lipid Emulsion [EPC],Lipids [CS]

Delivery Process

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of I.v. Fat Emulsion (Intralipid) which is also known as Intralipid and Manufactured by Baxter Healthcare Corporation. It is available in strength of 30 g/100mL per ml. Read more

I.v. Fat Emulsion (Intralipid) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • A 30% I.V. Fat Emulsion
  • Intralipidn n n u00a030% (A 30% 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 30% Soybean Oil, 1.2% Egg Yolk Phospholipids, 1.7% 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.n nn
  • Intralipidn- 30% 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 n n n u00a0 n n n andu00a0n n n are saturated and unsaturated fatty acid residues.n nn
  • The major component fatty acids are linoleic acid (44-62%), oleic acid (19-30%), palmitic acid (7-14%), u03b1-linolenic acid (4-11%) and stearic acid (1.4-5.5%).n n n These fatty acids have the following chemical and structural formulas:n nn
  • Purified egg phosphatides are a mixture of naturally occurring phospholipids which are isolated from the egg yolk. These phospholipids have the following general structure:
  • Glycerin is chemically designated Cn n n Hn n n On n n and is a clear colorless, hygroscopic syrupy liquid. It has the following structural formula:n nn
  • Intralipidn n n 30% (A 30% I.V. Fat Emulsion) has an osmolality of approximately 310 mOsmoL/kg water (which represents 200 mOsmol/L of emulsion) and contains emulsified fat particles of approximately 0.5 micron size.n nn
  • The total caloric value, including fat, phospholipid and glycerin, is 3.0 kcal per mL of Intralipidn n n 30%. The phospholipids present contribute 47 milligrams or approximately 1.5 mmol of phosphorus per 100 mL of the emulsion.n nn
  • The primary plastic container (Biofineu2122) is made from multilayered film specifically designed for parenteral nutrition drug products. The film is polypropylene based comprising three co-extruded layers. It contains no plasticizers and exhibits virtually no leachables. The container does not contain DEHP (di(2-ethylhexyl)phthalate) or PVC. This product is not made with natural rubber latex. The container is nontoxic and biologically inert.
  • The container-emulsion 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.
  • Intralipidn n n 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.n nn
  • Intralipidn n n will prevent the biochemical lesions of essential fatty acid deficiency (EFAD), and correct the clinical manifestations of the EFAD syndrome.n nn
  • Intralipidn n n u00a030% Pharmacy Bulk Package is indicated for use in a pharmacy admixture program for the preparation of three-in-one or total nutrient 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 as a source of essential fatty acids for prevention of EFAD.n nn
  • INTRALIPIDn n n u00a030% PHARMACY BULK PACKAGE IS NOT INTENDED FOR DIRECT INTRAVENOUS ADMINISTRATION. DILUTING INTRALIPIDn n n u00a030% TO A 10% OR 20% CONCENTRATION WITH AN INTRAVENOUS FLUID SUCH AS NORMAL SALINE OR OTHER DILUENT DOES NOT PRODUCE A DILUTION THAT IS EQUIVALENT IN COMPOSITION TO INTRALIPIDn n n 10% OR 20% I.V. FAT EMULSIONS, AND SUCH A DILUTION SHOULD NOT BE GIVEN BY DIRECT INTRAVENOUS ADMINISTRATION. (FOR EXAMPLE, THROUGH A Y-CONNECTOR).n nn
  • The administration of Intralipidn n n is contraindicated in patients with disturbances of normal fat metabolism such as pathologic hyperlipemia, lipoid nephrosis or acute pancreatitis if accompanied by hyperlipidemia. Intralipidn n n u00a030% (A 30% I.V. Fat Emulsion) is not intended for direct intravenous infusion.n nn
  • No data
  • When Intralipidn n n 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.n nn
  • During long term intravenous nutrition with Intralipidn n n , 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 Intralipidn n n .n nn
  • Drug product contains no more than 25 mcg/L of aluminum.
  • Carcinogenesis, Mutagenesis, Impairment of Fertility.
  • Studies with Intralipidn n n have not been performed to evaluate carcinogenic potential, mutagenic potential, or effects on fertility.n nn
  • Pregnancy Category C:n n n n
  • Nursing Mothers:n n n n
  • Pediatric Use:u00a0
  • AVOID OVERDOSAGE ABSOLUTELY.
  • The adverse reactions observed can be separated into two classes:
  • The deposition of a brown pigmentation in the reticuloendothelial system, the so-called u201cintravenous fat pigment,u201d has been reported in patients infused with Intralipidn n n . The causes and significance of this phenomenon are unknown.n nn
  • In the event of fat overload during therapy, stop the infusion containing Intralipidn n n u00a030% (A 30% 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 n n n and n n n .n nn
  • Intralipidn n n u00a030% (A 30% 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.n nn
  • Intralipidn n n u00a030% (A 30% I.V. Fat Emulsion) is supplied as a sterile emulsion in a Pharmacy Bulk Package in the following fill sizes:n nn
  • 500 mL: 0338-0520-13
  • Intralipidn n n u00a030% should not be stored above 25u00b0C (77u00b0F). Do not freeze Intralipidn n n u00a030%. If accidentally frozen, discard the bag.n nn
  • No data
  • (Revu00a0September 2016)
  • Manufactured forn n n n n Deerfield, IL 60015 USAn nn
  • Manufactured byn n n n n Uppsala, Swedenn nn
  • Intralipidn n n is a registered trademark of Freseniusu00a0Kabiu00a0AB.n nn
  • u00a0Instruction for Use - Intralipidu00ae 30% Pharmacy Bulk Package Containern n n n n n n n n n n n n n n
  • PACKAGE LABEL - PRINCIPAL DISPLAY - Intralipid 500 mL Container Label
  • NDC
  • Intrapilidn- 30%
  • A 30% I.V. Fat Emulsion
  • 500 mL n n n Rx onlyn nn
  • Pharmacy Bulk Package
  • Not For Direct Infusion
  • For Intravenous Use

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