Intralipid
Hf Acquisition Co Llc, Dba Healthfirst
Human Prescription Drug
NDC 51662-1333Intralipid is a human prescription drug labeled by 'Hf Acquisition Co Llc, Dba Healthfirst'. National Drug Code (NDC) number for Intralipid is 51662-1333. This drug is available in dosage form of Emulsion. The names of the active, medicinal ingredients in Intralipid drug includes Soybean Oil - 20 g/100mL . The currest status of Intralipid drug is Active.
Drug Information:
| Drug NDC: | 51662-1333 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Intralipid |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Intralipid |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Hf Acquisition Co Llc, Dba Healthfirst |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Emulsion |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | SOYBEAN OIL - 20 g/100mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | INTRAVENOUS
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | NDA |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 21 Dec, 2018 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 17 Jan, 2026 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | NDA018449 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | HF Acquisition Co LLC, DBA HealthFirst
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1799704
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| UPC: | 0303380519095
|
| UPC stands for Universal Product Code. |
| NUI: | N0000191261 M0012553
|
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). |
| UNII: | 241ATL177A
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class EPC: | Lipid Emulsion [EPC]
|
| Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`. |
| Pharmacologic Class CS: | Lipids [CS]
|
| Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient]. |
| Pharmacologic Class: | Lipid Emulsion [EPC] Lipids [CS]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 51662-1333-1 | 250 mL in 1 BAG (51662-1333-1) | 21 Dec, 2018 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Product Elements:
Intralipid intralipid egg phospholipids glycerin sodium hydroxide soybean oil soybean oil
Indications and Usage:
Indications & usage intralipid® 20% 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.
Warnings:
Warnings caution should be exercised in administering of intralipid® 20% (a 20% 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. warnings
Dosage and Administration:
Dosage & administration intralipid® 20% 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 0.5 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 1 ml/minute. not more than 500 ml of intralipid® 20% 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 (12.5 ml of intralipid® 20% per kg). intralipid® 20% (a 20% 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 (2.5 ml int
Read more...ralipid® 20%) and may be increased in relation to the infantâs ability to eliminate fat. the maximum dosage recommended by the american academy of pediatrics is 3 g fat/kg/24 hours.3 the initial rate of infusion in older pediatric patients should be no more than 0.05 ml/minute for the first 10 to 15 minutes. if no untoward reactions occur, the rate can be changed to permit infusion of 0.5 ml of intralipid® 20%/kg/hour. the daily dosage should not exceed 3 g of fat/kg of body weight.3 intralipid® 20% 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® 20% is administered to correct essential fatty acid deficiency, eight to ten percent of the caloric input should be supplied by intralipid® 20% in order to provide adequate amounts of linoleic and linolenic acids. when efad occurs together with stress, the amount of intralipid® 20% 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% 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. use a 1.2 micron filter with intralipid® 20%. filters of less than 1.2 micron pore size must not be used. conventional administration sets and tpn pooling bags contain polyvinyl chloride (pvc) components that have dehp (di(2-ethylhexyl) phthalate) as a plasticizer. fatâcontaining fluids such as intralipid® 20% extract dehp from these pvc components and it may be advisable to consider infusion of intralipid® 20% 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 intralipid® 20% (a 20% i.v. fat emulsion) may be mixed with amino acid and dextrose injections where compatibility have been demonstrated. additives known to be incompatible should not be used. please consult with pharmacist. 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). when being mixed 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® 20% (a 20% intravenous fat emulsion) note: amino acid injection, dextrose injection and intralipid® 20% may be simultaneously transferred to the admixture container. admixing should be accompanied by gentle agitation to avoid localized concentration effects. additives must not be added directly to intralipid® 20% 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. if the admixture is not used immediately, the in-use storage time and conditions prior to use are the responsibility of the user and should normally not be longer than 24 hours at 2-8°c. after removal from storage at 2-8°c, the admixture should be infused within 24 hours. it is essential that the admixture be prepared using strict aseptic techniques as this nutrient mixture is a good growth medium for microorganisms. 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 âbreaking or oiling outâ of the emulsion. âbreaking or oiling outâ 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.
Contraindications:
Contraindications the administration of intralipid® 20% is contraindicated in patients with disturbances of normal fat metabolism such as pathologic hyperlipemia, lipoid nephrosis or acute pancreatitis if accompanied by hyperlipidemia.
Adverse Reactions:
Adverse reactions 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 hyperalimentation procedure with or without intralipid® 20% (a 20% i.v. fat emulsion). less frequent reactions more directly related to intralipid® 20% 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, flushing, 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 h
Read more...epatomegaly, 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 âintravenous fat pigment,â has been reported in patients infused with intralipid® 20%. the causes and significance of this phenomenon are unknown.
Overdosage:
Overdosage in the event of fat overload during therapy, stop the infusion of intralipid® 20% 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 .
Description:
Description intralipid® 20% (a 20% 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 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. 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 acid (44-62%), oleic acid (19-30%), palmitic acid (7-14%), α-linolenic acid (4-11%) and stearic acid (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: and contain saturated and unsaturated fatty acids that abound in neutral fats. r3 is primarily either the choline or 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® 20% (a 20% intravenous fat emulsion) has an osmolality of approximately 350 mosmol/kg water (which represents 260 mosmol/l 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 plastic container (biofineâ¢), 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. the container is nontoxic and biologically inert. this product is not made with natural rubber latex. 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. stru 1 stru 2 stru 3 stru 4 desc 1 stru 5 stru 6 stru 7 desc 2 stru 8
Clinical Pharmacology:
Clinical pharmacology intralipid® 20% 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® 20% will prevent the biochemical lesions of essential fatty acid deficiency (efad), and correct the clinical manifestations of the efad syndrome.
How Supplied:
How supplied intralipid 20% is supplied in the following dosage forms. ndc 51662-1333-1 intralipid 20% 250ml bag hf acquisition co llc, dba healthfirst mukilteo, wa 98275 also supplied in the following manufacture supplied dosage forms intralipid® 20% is supplied as a sterile emulsion in the following fill sizes: 100 ml, 250 ml and 500 ml. 100 ml: 0338-0519-58 250 ml: 0338-0519-09 500 ml: 0338 0519-13 intralipid® 20% is also available as pharmacy bulk package in the following fill size. 1000 ml: 0338-0519-14
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