Multiple Vitamins for Infusion

1 For intravenous Infusion after dilution Pediatricis a sterile product consisting of two vials: a 4 mL single-dose vial labeled Vial 1 and a 1 mL single-dose vial labeled Vial 2. Each 4 mL of Vial 1 contains:Ascorbic acid ( vitamin C) .. 80 mgVitamin A* (as palmitate) .. 2,300 IUVitamin D3* (cholecalciferol) .. 400 IUThiamine ( vitamin B1) (as the hydrochloride) .. mgRiboflavin ( vitamin B2) (as riboflavin 5-phosphate sodium) .. mgPyridoxine HCl ( vitamin B6) .. 1 mgNiacinamide .. 17 mgDexpanthenol (as d-pantothenyl alcohol) .. 5 mgVitamin E* (dl- -tocopheryl acetate) .. 7 IUVitamin K1*.. mgInactive ingredients: 50 mg polysorbate 80, sodiumhydroxide and/or hydrochloric acid for pH adjustment andwater for injection.* Polysorbate 80 is used to water solubilize the oil-solublevitamins A, D, E, and 1 mL of Vial 2 contains:Folic acid.

2 140 20 mcgVitamin B12(cyanocobalamin).. 1 mcgInactive ingredients: 75 mg mannitol, citric acid and/orsodium citrate for pH adjustment and water for A 2,300 IU equals mgVitamin D 400 IU equals 10 mcgVitamin E 7 IU equals 7 mgMultiple vitamin preparation for intravenous Infusion :INFUVITEP ediatric( Multiple Vitamins for Infusion ) makes available a combination of important oil-soluble and water-soluble Vitamins in an aqueous solution,formulated for incorporation into intravenoussolutions. The liposoluble Vitamins A, D, E, and Khave been solubilized in an aqueous medium withpolysorbate 80, permitting intravenous administrationof these no more than 30 mcg/L of aluminum (combinedvials 1 and 2).Indications and UsageINFUVITEP ediatricis indicated as a daily multivitaminmaintenance dosage for infants and children up to 11 years of age receiving parenteral also indicated in othersituations where administration by the intravenousroute is required.

3 Such situations include surgery,extensive burns, fractures and other trauma, severeinfectious diseases, and comatose states, which mayprovoke a stress situation with profound alterationsin the body s metabolic demands and consequent tissue depletion of physician should not await the development ofclinical signs of vitamin deficiency before initiatingvitamin therapy. INFUVITEP ediatric(administered in intravenous fluidsunder proper dilution) contributes intake of necessaryvitamins toward maintaining the body s normal resistanceand repair with Multiple vitamin deficiencies or withmarkedly increased requirements may be given multiplesof the daily dosage for two or more days, as indicated by the clinical status. Blood vitamin concentrations should be periodically monitored to ensure maintenance of adequate levels, particularly in patients receivingparenteral multivitamins as their sole source of vitaminsfor long periods of contraindicated where there is a preexisting hypervitaminosis, or a known hypersensitivity to any of the Vitamins or excipients in the reactions have been known to occur followingintravenous administration of thiamine and vitamin K.

4 The formulation is contraindicated prior to blood samplingfor detection of megaloblastic anemia, as the folic acid and the cyanocobalamin in the vitamin solution can maskserum should be exercised when administering INFUVITEP ediatricto patients on warfarin sodium-typeanticoagulant therapy. In such patients, vitamin K may antagonize the hypoprothrombinemic response to anticoagulant drugs. In such patients, periodicmonitoring of prothrombin time/INR response is essentialin determining the appropriate dosage of blood levels of vitamin E are achieved whenINFUVITEP ediatricis given to infants at the recommendeddosage. Larger doses or supplementation with oral orparenteral vitamin E are not recommended because elevated blood levels of vitamin E may have shown that vitamin A may adhere to plastic,resulting in inadequate vitamin A administration in the doses recommended with INFUVITEP ediatric.

5 Additionalvitamin A supplementation may be required, especially in low-birth-weight infants. Long-standing specific vitamin deficiencies may requireadditional therapeutic amounts of specific Vitamins to supplement the maintenance Vitamins provided by patients receiving parenteral multivitamins, blood vitamin concentrations should be periodically monitored to determine if vitamin deficiencies or excesses have been associated with the E-Ferolsyndrome (thrombocytopenia, renal dysfunction,hepatomagaly, cholestasis, ascites, hypotension andmetabolic acidosis) in low-birth-weight infants. However, no such adverse reports have been associated with the use of pediatric Multiple Vitamins for Infusion such be aseptically transferred to the Infusion InteractionsPhysical incompatibilities:INFUVITEP ediatric(MultipleVitamins for Infusion ) is not physically compatible withalkaline solutions or moderately alkaline drugs such asacetazolamide, and chlorothiazide sodium, aminopylline or sodium bicarbonate.

6 INFUVITEP ediatricis not physicallycompatible with ampicillin and it may not be physicallycompatible with tetracycline HCl. It has also been reportedthat folic acid is unstable in the presence of calcium saltssuch as calcium gluconate. Direct addition to intravenous fat emulsions is not recommended. Consult appropriatereferences for listings of physical compatibility of solutionsand drugs with the vitamin Infusion . In such circumstances,admixture or Y-site administration with vitamin solutionsshould be of the Vitamins in INFUVITEP ediatricmay react withvitamin K bisulfite or sodium bisulfite; if bisulfite solutionsare necessary, patients should be monitored for vitamin A,thiamine, and ascorbic acid Interactions:A number of interactions betweenvitamins and drugs have been reported which may affect the metabolism of either agent.

7 The following are examplesof these types of acid may lower the serum concentration of phenytoin resulting in increased seizure PediatricMultiple Vitamins for InfusionWarningsINFUVITEP ediatricis administered in intravenous solutions, which may contain aluminum that may be may reach toxic levels with prolonged parenteraladministration if kidney function is impaired. Prematureneonates are particularly at risk because their kidneys areimmature, and they require large amounts of calcium andphosphate solution, which contain indicates that patients with impaired kidney function,including premature neonates who receive parenteral levelsof aluminum at greater than 4 to 5 mcg/kg/day accumulatealuminum at levels associated with central nervous systemand bone toxicity. Tissue loading may occur at even lowerrates of Infuvite D1006224 10/29/07 1:05 PM Page 1 vitamin K may antagonize the hypoprothrombinemic effect of oral anticoagulants (see Precautions).

8 Consult appropriate references for additional specificvitamin-drug Test Interactions:Ascorbic acid in theurine may cause false negative urine glucose , Mutagenesis, and Impairment of Fertility:Carcinogenicity, mutagenicity, and fertility studies have notbeen ReactionsThere have been rare reports of anaphylactic reactionsfollowing parenteral multivitamin administration. Rarereports of anaphylactoid reactions have also been reportedafter large intravenous doses of thiamine. The risk, however,is negligible if thiamine is coadministered with othervitamins of the B group. There have been no reports of fatal anaphylactoid reactions associated with multivitaminpreparations for have been rare reports of the following types of reactions:Dermatologic rash, erythema, pruritisCNS headache, dizziness, agitation, anxietyOphthalmic diplopiaAllergic urticaria, shortness of breath, wheezing possibility of hypervitaminosis A or D should be borne in mind.

9 Clinical manifestations of hypervitaminosis A have been reported in patients with renal failure receiving mg/day retinol. Therefore, vitamin A supplementation of renal failure patients should be undertaken with and AdministrationINFUVITEP ediatricis ready for immediate use in infants and children up to 11 years of age when addedto intravenous Infusion not be given as a direct,undiluted intravenous injection as it may give rise todizziness, faintness and possible tissue daily dose of INFUVITEP ediatric(4 mL of Vial 1plus 1 mL of Vial 2) should be added directly to notless than 100 mL of intravenous dextrose, saline orsimilar Infusion administration to infants weighing < 1 kg:The daily dose is 30% of the contents of Vial 1 ( mL) and of Vial 2 ( mL). Do not exceed this daily dose. Supplemental vitamin A may berequired for low-birth-weight administration to infants weighing 1 kg and < 3 kg:The daily dose is 65% of thecontents of Vial 1 ( mL) and of Vial 2 ( mL).

10 Do not exceed this daily dose. Supplemental vitaminA may be required for low-birth-weight administration to infants and children weighing 3 kg up to 11 years of age:The daily dose is theentire contents of Vial 1 (4 mL) and of Vial 2 (1 mL), unless there is clinical or laboratory evidence for increasing or decreasing the drug products should be inspected visually forparticulate matter and discoloration prior to administration,whenever solution and container INFUVITEP ediatricis diluted in an intravenousinfusion, the resulting solution is ready for immediate of the Vitamins in this product, particularly A, D, andriboflavin, are light sensitive, therefore, exposure to lightshould be ANY UNUSED PORTIONHow SuppliedINFUVITEP ediatric NDC 54643-5646-0, is available inboxes containing 2 vials Vial 1 (4 mL) and Vial 2 (1 mL),both vials to be used for a single NDC 54643-5646-1, is available inboxes containing 10 vials 5 each of Vial 1 (4 mL)