SPL UNCLASSIFIED SECTION.

IMPORTANT PRESCRIBING INFORMATION. Subject:Temporary importation of Vitalipid ADULT and Vitalipid INFANT to address drug shortage. The product is also labeled as Vitlipid ADULT and Vitlipid INFANT.Dear Healthcare Professional,Due to the critical shortage of parenteral multivitamins in the U.S. market, Fresenius Kabi USA, LLC (Fresenius Kabi USA) is coordinating with the U.S. Food and Drug Administration (FDA) to provide an alternative treatment option during this time. Fresenius Kabi USA has initiated temporary importation of Vitalipid Injection 10 mL Single Dose Glass Ampule into the U.S. market. The products imported into the U.S. may also be labeled with slight variation of the proprietary name, Vitlipid ADULT and Vitlipid INFANT, depending on which country the product was originally intended. Other than the slight variation in the proprietary name, the products are identical, and the products will be referred to as Vitalipid ADULT and Vitalipid INFANT for the remainder of this letter. Vitalipid ADULT and Vitalipid INFANT are sterile oil-in-water emulsions containing fat-soluble vitamins in the oil phase. This product is marketed in Europe and is manufactured in the Fresenius Kabi Uppsala, Sweden plant.At this time, no other entity except Fresenius Kabi USA is authorized by the FDA to import or distribute Vitalipid Injection 10 mL Single Dose Glass Ampules (One Point Cut) in the U.S. The FDA has not approved Fresenius Kabis Vitalipid product for marketing in the United States.This communication and product information is available on the Fresenius Kabi USA web site http://products.fresenius-kabi.us/product-323.html as well as on the FDA Drug Shortage web site. http://www.fda.gov/Drugs/DrugSafety/DrugShortages/default.htm.IMPORTANT DRUG INFORMATIONIt is important to note the following key differences between the Vitalipid and Infuvite:Product NameU.S. FDA-Approved Product (Infuvite Adult)1Imported Product (Vitalipid Adult)2,3U.S. FDA-Approved Product (Infuvite Pediatric)4Imported Product (Vitalipid Infant)5,6ManufacturerBaxterFresenius KabiBaxterFresenius KabiIndicationFor prevention of vitamin deficiency in adults and children aged 11 and older receiving parenteral nutritionIndicated in adult patients and children from 11 years of age as supplement in intravenous nutrition to meet the daily requirements of the fat-soluble vitamins A, D2, and K1.For the prevention of vitamin deficiency in pediatric patients up to 11 years of age receiving parenteral nutritionIndicated in infants and children up to 11 years of age as supplement in intravenous nutrition to meet the daily requirements of the fat-soluble vitamins A, D2, and K1.Product ingredients present13 vitamins present (water and fat soluble) Only fat-soluble vitamins13 vitamins present (water and fat soluble)Only fat-soluble vitaminsContraindicationsExisting hypervitaminosis or history of hypersensitivity due to any vitamins or excipients contained in the formulationEgg, soy, peanut allergy, hypersensitivity to ingredient/excipientExisting hypervitaminosis or history of hypersensitivity due to any vitamins or excipients contained in the formulationEgg, soy, peanut allergy, hypersensitivity to ingredient/excipientStorageMinimize exposure to light because vitamins A, and riboflavin are light sensitive. Store under refrigeration, 2-8C (36-46F).Between 2-25C (36-77F). Protect from light. Do not freezeMinimize exposure to light because vitamins A, and riboflavin are light sensitive. Store under refrigeration, 2-8C (36-46F).Between 2-25C (36-77F). Protect from light. Do not freezeBar code/NDC54643-5649-1NDC (Finished Product): 6521933582NDC (Unit of Use):652193351054643-5646-1NDC (Finished Product): 6521933762; 6521933964NDC (Unit of Use): 6521933710; 6521933910Vitalipid is packaged in glass ampules, so filter needles must always be used in conjunction with regular (nonfilter) needle during compounding to reduce the risk of introducing glass particles during administrationVitalipid provides fat-soluble vitamins (A, D, E, K) only; Infuvite contains fat-soluble vitamins as well as water-soluble vitamins (see Product Comparison Table below)Vitalipid ADULT and INFANT are contraindicated in patients with known hypersensitivity to any of the components (i.e., egg, soy, peanut protein, or any active substance or excipient)Any barcodes on the Vitalipid ADULT or Vitalipid INFANT products will not be appropriately recognized by scanning systems used in the United States and should NOT be used. Institutions should manually input the product into their systems to confirm that barcode systems do not provide incorrect information when the product is scanned. Alternative procedures should be followed to assure that the correct drug product is being prepared and administered to individual patients.Vitalipid ADULT and Vitalipid INFANT are available only by prescription in the U.S. However, the imported lots do not have the statement Rx only on their labeling.Effective immediately, and during this temporary period, Fresenius Kabi USA will offer the following presentation of adult and pediatric multivitamins:Product DescriptionVitalipid/Vitlipid ADULT 10 mL2,3DescriptionConcentrated Emulsion for InjectionDosage Form:10 mL Single Dose Glass AmpulePackage sizeBox contains 10 units of 10 mLFinished Product NDC6521933582Unit of Use NDC6521933510Lot Numbers/(Expiration Date)10SC1307/(2025.02.28); 10SD2190 (2025.03.31)VitaminActive Ingredients(per mL)Active Ingredients(per 10 mL)Retinol palmitate (Vitamin A)99 mcg (330 IU)990 mcg (3300 IU)Ergocalciferol (Vitamin D2)0.5 mcg (20 IU)5 mcg (200 IU)All-rac-alpha-tocopherol (Vitamin E)0.91 mg (1IU)9.1 mg (10 IU)Phytomenadione (Vitamin K1)15 mcg150 mcgExcipients (per mL)Excipients (per 10 mL)Egg Lecithin12 mg120 mgGlycerol anhydrous22 mg220 mgSoya oil100 mg1000 mgSodium hydroxideN/ATo pH 8Water for injectionN/ATo mLVitalipid/Vitlipid INFANT 10 mL5,6DescriptionConcentrated Emulsion for Injection Dosage Form:Single Dose Glass AmpulePackage Size:Box contains 10 units of 10 mLFinished Product NDC:6521933762; 6521933964Unit of Use NDC:6521933710; 6521933910Lot Numbers/(Expiration Date)10SB9030/(2025.01.31); 10SB9028/(2025.03.31)VitaminActive Ingredients(per mL)Active Ingredients(per 10 mL)Retinol palmitate (Vitamin A)69 mcg (230 IU)690 mcg (2300 IU)Ergocalciferol (Vitamin D2)1 mcg (40 IU)10 mcg (400 IU)All-rac-alpha-tocopherol (Vitamin E)0.64 mg (0.7 IU)6.4 mg (7 IU)Phytomenadione (Vitamin K1)20 mcg200 mcgExcipients (per mL)Excipients (per 10 mL)Purified egg phospholipids12 mg120 mgGlycerol anhydrous22 mg220 mgPurified egg phospholipids100 mg1000 mgSodium hydroxideN/ATo pH 8Water for injectionN/ATo mLPreparation/AdministrationVitalipid ADULT must be diluted before use and strict aseptic technique must always be maintained during handling. Because Vitalipid ADULT is packaged in glass ampule, filter needle must always be used in conjunction with regular (nonfilter) needle during compounding to reduce the risk of introducing glass particulates during administration.Both Vitalipid ADULT and Vitalipid INFANT are packaged in One Point Cut (OPC) ampules. OPC ampules are manufactured with colored dot on the bulbous part of the ampule indicating the position where the ampule should be broken. Please follow the recommended instructions below to open the OPC ampule easily and safely:Before an ampule is opened, any solution visible in the top portion (i.e., the head) should be moved to the bottom (i.e., body) by swirling the ampule in an upright position, tapping the ampule with ones finger, or inverting the ampule and then quickly swinging it into an upright position.To open an ampule properly, the head should be cleansed with an alcohol swab. The alcohol swab can be left in place or new alcohol-soaked gauze pad can be applied to prevent accidental cuts to the fingers as well as shattering of glass particles and aerosolized drug.Pick up the ampule and hold its lower part (body) between your thumb and index finger and position the ampule so that the colored dot faces you.Grasp the top of the ampule with your other hand. Place your thumb over the colored dot and index finger on the opposite side (back) of the bulbous part of the ampule.Hold the bottom of the ampule firmly in an upright position and push away from oneself in quick motion to snap open the ampule at the neck.Ampules should NOT be opened toward the HEPA filter in the compounding work area (to prevent spraying of liquid) or toward other sterile preparation within the hood. regular needle should be used to withdraw 10 mL from one ampule. The regular needle should be removed from the syringe and replaced with new filter needle to inject the 10 mL of Vitalipid into 500 mL of Intralipid (Fresenius Kabi). To ensure homogeneous admixture, the bag should be inverted couple of times immediately before the infusion. Vitalipid ADULT is also used as complement in parenteral nutrition (PN) formulations. Questions about compatibility may be directed to Fresenius Kabi USA, LLC Medical Affairs.Vitalipid ADULT should be added to an infusion within one hour of administration and the infusion should be completed within 24 hours from preparation to prevent microbiological contamination. Any remaining contents of opened ampules should be discarded.Vitalipid ADULT has been tested in PN formulations available outside of the U.S. containing lipid injectable emulsions under European standards and demonstrated compatibility with non-U.S. approved amino acids and other PN products. Branded U.S. PN products tested that have shown compatibility are SMOFlipid and Kabiven. Similar tests have not been conducted using U.S. amino acid products, thus caution should be taken when adding Vitalipid ADULT to adult PN formulations. Vitalipid has also demonstrated compatibility when added to Kabiven in combination with some US amino acid branded products (e.g., Travasol 10% [Baxter Healthcare], Aminosyn II 15% [Hospira, Inc], Clinisol 15% [Baxter Healthcare], Prosol 20% [Baxter Healthcare]).Vitalipid INFANT must be diluted before use in Intralipid 20% (Fresenius Kabi). The daily dose must not exceed 10 mL. Because Vitalipid INFANT is packaged in glass ampule, filter needle must always be used in conjunction with regular (nonfilter) needle during compounding to reduce the risk of introducing glass particulates during administration. regular needle should be used to withdraw up to 10 mL from ampule. The regular needle should be removed from the syringe and replaced with new filter needle to inject up to 10 mL of Vitalipid INFANT into Intralipid 20% (Fresenius Kabi). To ensure homogeneous admixture, the bag should be inverted couple of times immediately before the infusion. After mixing by gentle agitation, the emulsion is infused as described for Intralipid (Fresenius Kabi). Any remaining contents of opened ampules should be discarded.Vitalipid INFANT has been tested in PN formulations available outside of the U.S. containing lipid injectable emulsions under European standards and demonstrated compatibility with non-U.S. approved pediatric amino acids and other PN products. Similar tests have not been conducted using U.S. amino acid products, thus caution should be taken when adding Vitalipid INFANT to pediatric PN formulations. Branded U.S. PN products that have been tested and demonstrate compatibility include SMOFlipid, Intralipid (Fresenius Kabi).Results from stability studies show that unopened ampules of Vitalipid ADULT and Vitalipid INFANT can be stored both at +5+-3C and at +25C/60 RH for 24 months. Based on available data, the product is proposed to be stored between 2C 25C with shelf life of 24 months. Do not freeze. Protect the product from lightStorage with dilution and admixture: The admixing of Vitalipid ADULT and Vitalipid INFANT in PN formulations has been investigated according to standard methods, documenting the physicochemical stability of admixtures after storage times up to days. Vitalipid ADULT and Vitalipid INFANT have been tested with variety of PN products marketed in the US, including Kabiven, PeriKabiven, and Intralipid 20% (Fresenius Kabi). The storage time and conditions specifically investigated compatibility of these products for days, i.e., days storage at 2C -8C followed by 24 hours at 20C-25C (i.e., 6+1 conditions). The methods employed are measurement of mean droplet size, droplet size distribution, pH, visual inspection and investigations aiming to determine precipitation in the aqueous phase. The latter have been carried out by comparisons with the corresponding aqueous systems without added lipid emulsion. The experimental results demonstrate that all tested compositions are stable and compatible under 6+1 conditions. It is important to note that there is variability in the U.S. use of different PN components which may not have been tested. If HCPs have specific questions based on their PN admixtures, the Fresenius Kabi Medical Information department can provide them with the information on the specific admixtures tested.Consult Fresenius Kabi for further information on complete and balanced intravenous nutrition regimens.Product Comparison TableProduct NameU.S. FDA-Approved Product (Infuvite Adult)1Imported Product (Vitalipid Adult)2,3U.S. FDA-Approved Product (Infuvite Pediatric)4Imported Product (Vitalipid Infant)5,6ManufacturerBaxterFresenius KabiBaxterFresenius KabiMultivitamins active ingredient salt forms present13 vitamins present (water and fat soluble) These include:Thiamine (Vitamin B1)Riboflavin (Vitamin B2)Niacinamide (Vitamin B3)Dexpanthenol (Vitamin B5)Pyridoxine HCl (Vitamin B6)BiotinFolateCyanocobalamin (Vitamin B12)Ascorbic acid (Vitamin C)Vitamin (as palmitate)cholecalciferol (Vitamin D3)dl-Alpha-tocopherol acetate (Vitamin E)Vitamin K1 Only fat-soluble vitamins These include:Retinolpalmitate (vitamin A)Ergocalciferol (Vitamin D2)All-rac-Alpha-tocopherol (Vitamin E)Phytomenadione (Vitamin K1)13 vitamins present (water and fat soluble) These include:Thiamine (vitamin B1)Riboflavin (vitamin B2)Niacinamide (vitamin B3)Dexpanthenol (vitamin B5)Pyridoxine (vitamin B6)Biotin (B7)Folate (B9)Cyanocobalamin (B12)Ascorbic acid (Vitamin C)Vitamin (as palmitate)cholecalciferol (Vitamin D3)dl-Alpha-tocopherol acetate (Vitamin E)Vitamin K1 Only fat-soluble vitamins These include:Retinolpalmitate (vitamin A)Ergocalciferol (Vitamin D2)All-rac-Alpha-tocopherol (Vitamin E)Phytomenadione (Vitamin K1)Differences in the amount of vitamins present in each mLAscorbic acid: 20 mgVitamin A: 330 IUVitamin D3: 20 IUThiamine (vitamin B1): 0.6 mgRiboflavin (Vitamin B2): 0.36 mgPyridoxine (vitamin B6): 0.6 mgNiacinamide: mgDexpanthenol: 1.5 mgVitamin E: IUVitamin K1: 15 mcgFolic Acid: 60 mcgBiotin: mcgVitamin B12: 0.5 mcgAscorbic acid: 0Vitamin A: 330 IUVitamin D2: 20 IUThiamine: 0Riboflavin:0Pyridoxine: 0Niacinamide: 0Dexpanthenol: 0Vitamin E: IUVitamin K1: 15 mcgFolic Acid: 0Biotin: 0Vitamin B12: 0Ascorbic acid: 16 mgVitamin A: 460 IUVitamin D3: 80 IUThiamine: 0.24 mgRiboflavin: 0.28 mgPyridoxine: 0.2 mgNiacinamide: 3.4 mgDexpanthenol: mgVitamin E: 1.4 IUVitamin K1: 40 mcgFolic Acid: 28 mcgBiotin: mcgVitamin B12: 0.2 mcgAscorbic acid: 0Vitamin A: 230 IUVitamin D2: 40 IUThiamine: 0Riboflavin: 0Pyridoxine: 0Niacinamide: 0Dexpanthenol: 0Vitamin E: 0.7 IUVitamin K1: 20 mcgFolic Acid: 0Biotin: 0Vitamin B12: 0Package Container SizeSingle dose Vial 1: mL, Vial 2: mLPharmacy Bulk: Vial - 50 mL,Vial - 50 mL10 mL glass ampule, concentrated emulsion for injectionSingle dose: Vial 1: mL, Vial 2: mLPharmacy Bulk: Vial (40 mL Fill in 50 mL Vial) and Vial (10 mL). 10 mL glass ampule, concentrated emulsion for injectionStorageMinimize exposure of INFUVITE ADULT to light because vitamins A, and riboflavin are light sensitive.Store under refrigeration, 2-8C (36-46F).Between 2-25C (36-77F). Protect from light. Do not freezeMinimize exposure of INFUVITE PEDIATRIC to light because vitamins A, and riboflavin are light sensitive. Store under refrigeration 2-8C (36-46F).Between 2- 25C (36-77F). Protect from light. Do not freezeShelf LifeNot reported24 monthsNot reported24 monthsExcipientsVial 1: polysorbate 80, sodium hydroxide and/or hydrochloric acid for pH adjustment, water for injectionVial 2: Propylene glycol, citric acid +- sodium citrate for pH, water for injectionSoya oilEgg lecithinGlycerolSWFINaOH for pHpolysorbate 80, sodium hydroxide and/or hydrochloric acid for pH adjustment, and water for injection.Vial 2: mannitol, citric acid and/or sodium citrate for pH adjustment and water for injection.Soya oilEgg lecithinGlycerolSWFINaOH for pHAluminum<= 70 mcg/L (vials 1+2)Not reported<= 30 mcg/L (Vials + 2).Not reportedIndicationFor prevention of vitamin deficiency in adults andchildren aged 11 and older receiving parenteral nutritionIndicated in adult patients and children from 11 years of age as supplement in intravenous nutrition to meet the daily requirements of the fat-soluble vitamins A, D2, and K1.For the prevention of vitamin deficiency inpediatric patients up to 11 years of age receiving parenteral nutritionIndicated in infants and children up to 11 years of age as supplement in intravenous nutrition to meet the daily requirements of the fat-soluble vitamins A, D2, and K1.Dose10 mL10 mL<1 kg: 1.5 mL1 to <3 kg: 3.25 mL>=3 kg: mLPreterm and infants below 2.5 kg: mL/kg/dInfants and children >2.5 kg and up to 11 years: 10 mL/dContraindicationsAn existing hypervitaminosis, orA history of hypersensitivity due to any vitamins or excipients contained in thisformulation.Egg, soy, peanut allergy, hypersensitivity to ingredient/excipientAn existing hypervitaminosis, or history of hypersensitivity to any vitamins or excipients contained in thisformulation.Egg, soy, peanut allergy, hypersensitivity to ingredient/excipientThe following tables compare the content of Infuvite, Vitalipid and ASPEN Vitamin Recommendations for adult and pediatric patients.Daily Adult ASPEN Guideline Recommendations for Multivitamins and amount in Vitalipid Adult and Infuvite Adult ProductsAdult: Guideline Recommendations7Vitalipid Adult2,3(10 mL dose)Infuvite Adult1(10 mL dose)Thiamine (B1)6 mg6 mgRiboflavin (B2)3.6 mg3.6 mgNiacin (B3)40 mg40 mgPantothenic Acid (B5)5 mg15 mgPyridoxine (B6)6 mg6 mgBiotin60 mcg60 mcgFolate600 mcg600 mcgCyanocobalamin (B12)5 mcg5 mcgVitamin (ascorbic acid)200 mg200 mgVitamin A990 mcg (3300 IU)990 mcg (3300 IU)3300 IU (1 mg)Vitamin D5 mcg (200 IU)5 mcg (200 IU)200 IU (5 mcg)Vitamin E10 mg (10 IU)9.1 mg (10 IU)10 IU (10 mg)Vitamin K150 mcg150 mcg150 mcgDaily Pediatric ASPEN Guideline Recommendations for Parenteral Multivitamins and amount in Vitalipid Infant and Infuvite Pediatric ProductsPreterm Neonates: Guideline RecommendationsInfants: Guideline Recommendations7Children: Guideline Recommendations7Vitalipid Infant5,6(10 mL)Infuvite Pediatric(4 mL+ mL)4Pediatric DosingAmounts/kg/dAmounts/kg/dAmounts/dPreterm and <2.5 kg: mL/kg>2.5 kg to 11 years: 10 mL< kg: 1.5 mL1 kg <3 kg: 3.25 mL>= kg: mLThiamine (B1), mg200-350 mcg0.35 -0.51.21.2 mgRiboflavin (B2, mg)50-200 mcg0.15 0.21.41.4 mgNiacin (B3), mg4-6.84 6.81717 mgPantothenic Acid (B5), mg1-21 255 mgPyridoxine (B6), mg150-200 mcg0.15 0.211 mgBiotin mg5-8 mcg5 82020 mcgFolate, mcg56 mcg56140140 mcgCyanocobalamin (B12), mcg0.30.311 mcgVitamin (ascorbic acid), mg15-2515 258080 mgVitamin , mcg (IU)700-1500 IU150-300 (500 1000 IU)150 (500 IU)690 (2300 IU)700 mcg (2300 IU)Vitamin D, mcg (IU)40-160 IU0.8 (32 IU)10 (400 IU)10 mcg (400 IU)10 mcg (400 IU)Vitamin , mg2.8-3.5 IU2.8 3.576.4 mg (7 IU)7 mg (7 IU)Vitamin K1, mcg1010200200 mcg200 mcgRefer to the Vitalipid package insert for full prescribing informationREPORTING ADVERSE EVENTSTo report adverse events experienced with the use of this product, call Fresenius Kabi USA Vigilance at 1-800-551-7176, Monday Friday, between the hours of a.m. and p.m. (CST), or e-mail adverse.events.USAfresenius-kabi.comTo report product complaint with the use of this product, call (800) 551- 7176 or e-mail productcomplaint.USAfresenius-kabi.com.Fresenius Kabi USA CONTACT NUMBERS: Please use the following contact numbers as appropriate:Reason To CallDepartmentNumberADE ReportingVigilance Department1-800-551-7176Clinical/Technical Info. Or Product ComplaintMedical Affairs DepartmentProduct Availability OrderingCustomer Service Department1-888-386-1300Adverse reactions or quality problems experienced with the use of this product may be reported to the FDAs MedWatch Adverse Event Reporting program either online, by regular mail or by fax.Complete and submit the report Online: www.fda.gov/medwatch/report.htm Regular Mail or Fax: Download form www.fda.gov/medwatch/getforms.htm or call 1-800-332-1088 to request reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178 (1-800-332-0178).Sincerely,Gordon S. Sacks, PharmD, BCNSP, FASPEN, FCCPSenior Director, Medical AffairsFresenius Kabi USA, LLC. Vitalipid is packaged in glass ampules, so filter needles must always be used in conjunction with regular (nonfilter) needle during compounding to reduce the risk of introducing glass particles during administration. Vitalipid provides fat-soluble vitamins (A, D, E, K) only; Infuvite contains fat-soluble vitamins as well as water-soluble vitamins (see Product Comparison Table below). Vitalipid ADULT and INFANT are contraindicated in patients with known hypersensitivity to any of the components (i.e., egg, soy, peanut protein, or any active substance or excipient). Any barcodes on the Vitalipid ADULT or Vitalipid INFANT products will not be appropriately recognized by scanning systems used in the United States and should NOT be used. Institutions should manually input the product into their systems to confirm that barcode systems do not provide incorrect information when the product is scanned. Alternative procedures should be followed to assure that the correct drug product is being prepared and administered to individual patients.. Vitalipid ADULT and Vitalipid INFANT are available only by prescription in the U.S. However, the imported lots do not have the statement Rx only on their labeling.. Vitalipid ADULT must be diluted before use and strict aseptic technique must always be maintained during handling. Because Vitalipid ADULT is packaged in glass ampule, filter needle must always be used in conjunction with regular (nonfilter) needle during compounding to reduce the risk of introducing glass particulates during administration.. Both Vitalipid ADULT and Vitalipid INFANT are packaged in One Point Cut (OPC) ampules. OPC ampules are manufactured with colored dot on the bulbous part of the ampule indicating the position where the ampule should be broken. Please follow the recommended instructions below to open the OPC ampule easily and safely:Before an ampule is opened, any solution visible in the top portion (i.e., the head) should be moved to the bottom (i.e., body) by swirling the ampule in an upright position, tapping the ampule with ones finger, or inverting the ampule and then quickly swinging it into an upright position.To open an ampule properly, the head should be cleansed with an alcohol swab. The alcohol swab can be left in place or new alcohol-soaked gauze pad can be applied to prevent accidental cuts to the fingers as well as shattering of glass particles and aerosolized drug.Pick up the ampule and hold its lower part (body) between your thumb and index finger and position the ampule so that the colored dot faces you.Grasp the top of the ampule with your other hand. Place your thumb over the colored dot and index finger on the opposite side (back) of the bulbous part of the ampule.Hold the bottom of the ampule firmly in an upright position and push away from oneself in quick motion to snap open the ampule at the neck.Ampules should NOT be opened toward the HEPA filter in the compounding work area (to prevent spraying of liquid) or toward other sterile preparation within the hood. Before an ampule is opened, any solution visible in the top portion (i.e., the head) should be moved to the bottom (i.e., body) by swirling the ampule in an upright position, tapping the ampule with ones finger, or inverting the ampule and then quickly swinging it into an upright position.. To open an ampule properly, the head should be cleansed with an alcohol swab. The alcohol swab can be left in place or new alcohol-soaked gauze pad can be applied to prevent accidental cuts to the fingers as well as shattering of glass particles and aerosolized drug.. Pick up the ampule and hold its lower part (body) between your thumb and index finger and position the ampule so that the colored dot faces you.. Grasp the top of the ampule with your other hand. Place your thumb over the colored dot and index finger on the opposite side (back) of the bulbous part of the ampule.. Hold the bottom of the ampule firmly in an upright position and push away from oneself in quick motion to snap open the ampule at the neck.. Ampules should NOT be opened toward the HEPA filter in the compounding work area (to prevent spraying of liquid) or toward other sterile preparation within the hood.. regular needle should be used to withdraw 10 mL from one ampule. The regular needle should be removed from the syringe and replaced with new filter needle to inject the 10 mL of Vitalipid into 500 mL of Intralipid (Fresenius Kabi). To ensure homogeneous admixture, the bag should be inverted couple of times immediately before the infusion. Vitalipid ADULT is also used as complement in parenteral nutrition (PN) formulations. Questions about compatibility may be directed to Fresenius Kabi USA, LLC Medical Affairs.. Vitalipid ADULT should be added to an infusion within one hour of administration and the infusion should be completed within 24 hours from preparation to prevent microbiological contamination. Any remaining contents of opened ampules should be discarded.. Vitalipid ADULT has been tested in PN formulations available outside of the U.S. containing lipid injectable emulsions under European standards and demonstrated compatibility with non-U.S. approved amino acids and other PN products. Branded U.S. PN products tested that have shown compatibility are SMOFlipid and Kabiven. Similar tests have not been conducted using U.S. amino acid products, thus caution should be taken when adding Vitalipid ADULT to adult PN formulations. Vitalipid has also demonstrated compatibility when added to Kabiven in combination with some US amino acid branded products (e.g., Travasol 10% [Baxter Healthcare], Aminosyn II 15% [Hospira, Inc], Clinisol 15% [Baxter Healthcare], Prosol 20% [Baxter Healthcare]).. Vitalipid INFANT must be diluted before use in Intralipid 20% (Fresenius Kabi). The daily dose must not exceed 10 mL. Because Vitalipid INFANT is packaged in glass ampule, filter needle must always be used in conjunction with regular (nonfilter) needle during compounding to reduce the risk of introducing glass particulates during administration. regular needle should be used to withdraw up to 10 mL from ampule. The regular needle should be removed from the syringe and replaced with new filter needle to inject up to 10 mL of Vitalipid INFANT into Intralipid 20% (Fresenius Kabi). To ensure homogeneous admixture, the bag should be inverted couple of times immediately before the infusion. After mixing by gentle agitation, the emulsion is infused as described for Intralipid (Fresenius Kabi). Any remaining contents of opened ampules should be discarded.. Vitalipid INFANT has been tested in PN formulations available outside of the U.S. containing lipid injectable emulsions under European standards and demonstrated compatibility with non-U.S. approved pediatric amino acids and other PN products. Similar tests have not been conducted using U.S. amino acid products, thus caution should be taken when adding Vitalipid INFANT to pediatric PN formulations. Branded U.S. PN products that have been tested and demonstrate compatibility include SMOFlipid, Intralipid (Fresenius Kabi).. Results from stability studies show that unopened ampules of Vitalipid ADULT and Vitalipid INFANT can be stored both at +5+-3C and at +25C/60 RH for 24 months. Based on available data, the product is proposed to be stored between 2C 25C with shelf life of 24 months. Do not freeze. Protect the product from light. Storage with dilution and admixture: The admixing of Vitalipid ADULT and Vitalipid INFANT in PN formulations has been investigated according to standard methods, documenting the physicochemical stability of admixtures after storage times up to days. Vitalipid ADULT and Vitalipid INFANT have been tested with variety of PN products marketed in the US, including Kabiven, PeriKabiven, and Intralipid 20% (Fresenius Kabi). The storage time and conditions specifically investigated compatibility of these products for days, i.e., days storage at 2C -8C followed by 24 hours at 20C-25C (i.e., 6+1 conditions). The methods employed are measurement of mean droplet size, droplet size distribution, pH, visual inspection and investigations aiming to determine precipitation in the aqueous phase. The latter have been carried out by comparisons with the corresponding aqueous systems without added lipid emulsion. The experimental results demonstrate that all tested compositions are stable and compatible under 6+1 conditions. It is important to note that there is variability in the U.S. use of different PN components which may not have been tested. If HCPs have specific questions based on their PN admixtures, the Fresenius Kabi Medical Information department can provide them with the information on the specific admixtures tested.. Consult Fresenius Kabi for further information on complete and balanced intravenous nutrition regimens.. Complete and submit the report Online: www.fda.gov/medwatch/report.htm Regular Mail or Fax: Download form www.fda.gov/medwatch/getforms.htm or call 1-800-332-1088 to request reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178 (1-800-332-0178).. Figure.