ADVERSE REACTIONS SECTION.

6 ADVERSE REACTIONS. The following adverse reactions are discussed in greater detail in other sections of the labeling.oAllergic reactions to thiamine [see Warnings and Precautions (5.2)].oHypervitaminosis [see Warnings and Precautions (5.3)]The following adverse reactions have been identified during post-approval use of INFUVITE PEDIATRIC. Because these reactions are reported voluntarily from population of uncertain size, it is not always possible to reliably estimate their frequency or establish causal relationship to drug exposure. Dermatologic: rash, erythema, pruritis CNS: headache, dizziness, agitation, anxiety Ophthalmic: diplopia. oAllergic reactions to thiamine [see Warnings and Precautions (5.2)].. oHypervitaminosis [see Warnings and Precautions (5.3)]. Dermatologic: rash, erythema, pruritis. CNS: headache, dizziness, agitation, anxiety. Ophthalmic: diplopia. Adverse reactions have included anaphylaxis, rash, erythema, pruritis, headache, dizziness, agitation, anxiety, diplopia (6)To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION.

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility. Carcinogenicity, mutagenicity, and fertility studies have not been performed with INFUVITE PEDIATRIC.

CONTRAINDICATIONS SECTION.

4 CONTRAINDICATIONS. INFUVITE PEDIATRIC is contraindicated in patients who have:oAn existing hypervitaminosis, oroA history of hypersensitivity to any vitamins or excipients contained in this formulation.. oAn existing hypervitaminosis, or. oA history of hypersensitivity to any vitamins or excipients contained in this formulation.. oHypersensitivity to any of vitamins or excipients (4)oExisting hypervitaminosis (4). oHypersensitivity to any of vitamins or excipients (4). oExisting hypervitaminosis (4).

DESCRIPTION SECTION.

11 DESCRIPTION. INFUVITE PEDIATRIC (multiple vitamins injection) is sterile product consisting of two vials provided as single dose or as pharmacy bulk package for intravenous use intended for administration by intravenous infusion after dilution:INFUVITE PEDIATRIC (multiple vitamins injection) supplied as single dose consists of:(a) Vial (4 mL); and(b) Vial (1 mL).Vial will provide one daily dose of 1.2 mL, 2.6 mL or mL and Vial will provide one daily dose of 0.3 mL, 0.65 mL or mL [see Dosage and Administration (2.2)]. INFUVITE PEDIATRIC (multiple vitamins injection) supplied as pharmacy bulk package consists of:(a) Vial (40 mL Fill in 50 mL Vial); and(b) Vial (10 mL).The mixed solution will provide many single doses [see Dosage and Administration (2.2)]. Each mL of Vial contains 10 vitamins and each mL of Vial contains vitamins (see Table 3).Table 3: INGREDIENTS IN INFUVITE PEDIATRIC FORMULATIONVial 1Active IngredientQuantity per mLAscorbic acid (Vitamin C)80 mgVitamin (as palmitate)2,300 IU (equals 0.7 mg)Vitamin D3 (cholecalciferol)400 IU (equals 10 mcg)Thiamine (Vitamin B1) (as the hydrochloride)1.2 mgRiboflavin (Vitamin B2) (as riboflavin 5-phosphate sodium)1.4 mgPyridoxine HCl (Vitamin B6)1 mgNiacinamide17 mgDexpanthenol (as d-pantothenyl alcohol)5 mgVitamin (dl--tocopheryl acetate)7 IU (equals mg)Vitamin K10.2 mg Polysorbate 80 is used to water solubilize the oil-soluble vitamins A, D, E, and K.Inactive ingredients in mL of Vial 1: 50 mg polysorbate 80, sodium hydroxide and/or hydrochloric acid for pH adjustment, and water for injection.Vial 2Active IngredientQuantity per mLFolic acid140 mcgBiotin20 mcgVitamin B12 (cyanocobalamin) mcgInactive ingredients in mL of Vial 2: 75 mg mannitol, citric acid and/or sodium citrate for pH adjustment and water for injection.INFUVITE PEDIATRIC (multiple vitamins injection) makes available combination of oil-soluble and water-soluble vitamins in an aqueous solution, formulated for incorporation into intravenous solutions. The liposoluble vitamins A, D, E, and have been solubilized in an aqueous medium with polysorbate 80, permitting intravenous administration of these vitamins.INFUVITE PEDIATRIC contains no more than 30 mcg/L of aluminum (combined Vials and 2).

DOSAGE & ADMINISTRATION SECTION.

2 DOSAGE AND ADMINISTRATION. oINFUVITE PEDIATRIC is combination product that contains the following vitamins: ascorbic acid, vitamin A, vitamin D, thiamine, riboflavin, pyridoxine, niacinamide, dexpanthenol, vitamin E, vitamin K1, folic acid, biotin, and vitamin B12 (2.1)oINFUVITE PEDIATRIC is for administration by intravenous infusion after dilution (2.1)oRecommended daily dosage is based on patients actual weight (2.2):oINFUVITE PEDIATRIC Single Dose:oWeight less than kg: 1.2 mL of Vial and 0.3 mL of Vial 2oWeight kg to less than kg: 2.6 mL of Vial and 0.65 mL Vial 2oWeight kg or greater: mL of Vial and mL of Vial 2oINFUVITE PEDIATRIC Pharmacy Bulk Package:oWeight less than kg: 1.5 mL of combined content of Vials and 2oWeight kg to less than kg: 3.25 mL of combined content of Vials and 2oWeight kg or greater: mL of combined content of Vials and 2.oSupplemental vitamin may be required for low-birth weight infants (2.2)oINFUVITE PEDIATRIC is supplied as single dose and as pharmacy bulk package:oSingle Dose consists of two vials labeled Vial and Vial 2. Add one daily dose of Vial and one daily dose of Vial directly to at least 100 mL of intravenous dextrose or saline solution prior to intravenous use (2.3)oPharmacy Bulk Package consists of two vials labeled Vial and Vial 2.Transfer contents of Vial to contents of Vial 1. Then, take 1.5 mL, 3.25 mL, or mL from mixture and add to at least 100 mL of intravenous dextrose or saline solution prior to intravenous use (2.3)oAfter dilution in an intravenous infusion, refrigerate resulting solution unless used immediately. Use solution within 24 hours after dilution (2.3)oMonitor blood vitamin concentrations (2.4)oSee Full Prescribing Information for drug incompatibilities (2.5).. oINFUVITE PEDIATRIC is combination product that contains the following vitamins: ascorbic acid, vitamin A, vitamin D, thiamine, riboflavin, pyridoxine, niacinamide, dexpanthenol, vitamin E, vitamin K1, folic acid, biotin, and vitamin B12 (2.1). oINFUVITE PEDIATRIC is for administration by intravenous infusion after dilution (2.1). oRecommended daily dosage is based on patients actual weight (2.2):. oINFUVITE PEDIATRIC Single Dose:oWeight less than kg: 1.2 mL of Vial and 0.3 mL of Vial 2oWeight kg to less than kg: 2.6 mL of Vial and 0.65 mL Vial 2oWeight kg or greater: mL of Vial and mL of Vial 2. oWeight less than kg: 1.2 mL of Vial and 0.3 mL of Vial 2. oWeight kg to less than kg: 2.6 mL of Vial and 0.65 mL Vial 2. oWeight kg or greater: mL of Vial and mL of Vial 2. oINFUVITE PEDIATRIC Pharmacy Bulk Package:oWeight less than kg: 1.5 mL of combined content of Vials and 2oWeight kg to less than kg: 3.25 mL of combined content of Vials and 2oWeight kg or greater: mL of combined content of Vials and 2.. oWeight less than kg: 1.5 mL of combined content of Vials and 2. oWeight kg to less than kg: 3.25 mL of combined content of Vials and 2. oWeight kg or greater: mL of combined content of Vials and 2.. oSupplemental vitamin may be required for low-birth weight infants (2.2). oINFUVITE PEDIATRIC is supplied as single dose and as pharmacy bulk package:oSingle Dose consists of two vials labeled Vial and Vial 2. Add one daily dose of Vial and one daily dose of Vial directly to at least 100 mL of intravenous dextrose or saline solution prior to intravenous use (2.3)oPharmacy Bulk Package consists of two vials labeled Vial and Vial 2.Transfer contents of Vial to contents of Vial 1. Then, take 1.5 mL, 3.25 mL, or mL from mixture and add to at least 100 mL of intravenous dextrose or saline solution prior to intravenous use (2.3). oSingle Dose consists of two vials labeled Vial and Vial 2. Add one daily dose of Vial and one daily dose of Vial directly to at least 100 mL of intravenous dextrose or saline solution prior to intravenous use (2.3). oPharmacy Bulk Package consists of two vials labeled Vial and Vial 2.Transfer contents of Vial to contents of Vial 1. Then, take 1.5 mL, 3.25 mL, or mL from mixture and add to at least 100 mL of intravenous dextrose or saline solution prior to intravenous use (2.3). oAfter dilution in an intravenous infusion, refrigerate resulting solution unless used immediately. Use solution within 24 hours after dilution (2.3). oMonitor blood vitamin concentrations (2.4). oSee Full Prescribing Information for drug incompatibilities (2.5).. 2.1 Important Dosage and Administration Instructions. INFUVITE PEDIATRIC is combination product that contains the following vitamins: ascorbic acid, vitamin A, vitamin D, thiamine, riboflavin, pyridoxine, niacinamide, dexpanthenol, vitamin E, vitamin K1, folic acid, biotin, and vitamin B12.INFUVITE PEDIATRIC is supplied as single dose or as pharmacy bulk package for intravenous use intended for administration by intravenous infusion after dilution:oINFUVITE PEDIATRIC Single Dose consists of two vials. weightbased volume from each vial must be added directly to dextrose or saline solution prior to intravenous administration [see Dosage and Administration (2.2, 2.3)]. oINFUVITE PEDIATRIC Pharmacy Bulk Package consists of two pharmacy bulk vials which must be mixed prior to use. The mixed solution will provide multiple daily doses which must be diluted prior to intravenous administration. Pharmacy bulk package of INFUVITE PEDIATRIC is intended for dispensing of single doses to multiple patients in pharmacy admixture program and is restricted to the preparation of admixtures for infusion [see Dosage and Administration (2.2, 2.3)]. oINFUVITE PEDIATRIC Single Dose consists of two vials. weightbased volume from each vial must be added directly to dextrose or saline solution prior to intravenous administration [see Dosage and Administration (2.2, 2.3)]. oINFUVITE PEDIATRIC Pharmacy Bulk Package consists of two pharmacy bulk vials which must be mixed prior to use. The mixed solution will provide multiple daily doses which must be diluted prior to intravenous administration. Pharmacy bulk package of INFUVITE PEDIATRIC is intended for dispensing of single doses to multiple patients in pharmacy admixture program and is restricted to the preparation of admixtures for infusion [see Dosage and Administration (2.2, 2.3)]. 2.2 Dosage Information. The recommended daily dosage volume is based on the patients actual weight: less than kg, kg to less than kg, and kg or greater.Patients with multiple vitamin deficiencies or with increased vitamin requirements may need multiple daily dosages as indicated or additional doses of individual vitamins. Supplemental vitamin may be required for low-birth weight infants.Additional daily dosages of Vitamin in infants are not recommended [see Warnings and Precautions (5.8)]. INFUVITE PEDIATRIC Single Dose (see Table 1):One daily dose of Vial (1.2 mL, 2.6 mL or mL) and one daily dose of Vial (0.3 mL, 0.65 mL or mL) based on the patients weight are added directly to specified volume of an intravenous fluid [see Dosage and Administration (2.3)] (see Table 1).Table 1: Recommended Weight-Based Dosage of INFUVITE PEDIATRIC Single DoseLess than kg1 kg to less than kg3 kg or greaterDaily Dosage Volume -Vial 11.2 mL2.6 mL4 mLAscorbic acid (Vitamin C)24 mg52 mg80 mgVitamin (as palmitate)690 IU (equals 0.2 mg)1495 IU (equals 0.5 mg)2,300 IU (equals 0.7 mg)Vitamin D3 (cholecalciferol)120 IU (equals mcg)260 IU (equals mcg) 400 IU (equals 10 mcg)Thiamine (Vitamin B1) (as the hydrochloride)0.4 mg0.8 mg1.2 mgRiboflavin (Vitamin B2) (as riboflavin 5-phosphate sodium)0.4 mg0.9 mg1.4 mgPyridoxine HCl (Vitamin B6)0.3 mg0.7 mg1 mgNiacinamide5.1 mg11.1 mg17 mgDexpanthenol (as d-pantothenyl alcohol)1.5 mg3.3 mg5 mgVitamin (dl--tocopheryl acetate)2.1 IU (equals mg)4.6 IU (equals mg)7 IU (equals mg)Vitamin K1 0.1 mg0.1 mg0.2 mgDaily Dosage Volume Vial 20.3 mL0.65 mL1 mLFolic acid42 mcg91 mcg140 mcgBiotin6 mcg13 mcg20 mcgVitamin B12 (cyanocobalamin)0.3 mcg0.7 mcg1 mcgINFUVITE PEDIATRIC Pharmacy Bulk Package (see Table 2):The recommended daily dosage volume of combined content of vials and (1.5 mL, 3.25 mL or mL) is based on the patients weight and then added directly to the specific volume of an intravenous fluid [see Dosage and Administration (2.3)]. Table 2: Recommended Weight-Based Dosage of INFUVITE PEDIATRIC Pharmacy Bulk PackageLess than kg1 kg to less than kg3 kg or greaterDaily Dosage Volume(combined contents of Vial and Vial 2)1.5 mL3.25 mL5 mLAscorbic acid (Vitamin C)24 mg52 mg80 mgVitamin (as palmitate)690 IU (equals 0.2 mg)1495 IU (equals 0.5 mg)2,300 IU (equals 0.7 mg)Vitamin D3 (cholecalciferol)120 IU (equals mcg)260 IU (equals mcg)400 IU (equals 10 mcg)Thiamine (Vitamin B1) (as thehydrochloride)0.4 mg0.8 mg1.2 mgRiboflavin (Vitamin B2) (asriboflavin 5-phosphate sodium)0.4 mg0.9 mg1.4 mgPyridoxine HCl (Vitamin B6)0.3 mg0.7 mg1 mgNiacinamide5.1 mg11.1 mg17 mgDexpanthenol (as d-pantothenylalcohol)1.5 mg3.3 mg5 mgVitamin (dl--tocopherylacetate)2.1 IU (equals mg)4.6 IU (equals mg)7 IU (equals mg)Vitamin K1 0.1 mg0.1 mg0.2 mgFolic acid42 mcg91 mcg140 mcgBiotin6 mcg13 mcg20 mcgVitamin B12 (cyanocobalamin)0.3 mcg0.7 mcg1 mcg. 2.3 Preparation and Administration Instructions. Do not administer INFUVITE PEDIATRIC as direct, undiluted intravenous injection as it may cause dizziness, faintness, and possible tissue irritation.INFUVITE PEDIATRIC Single Dose:oUse only in suitable work area such as laminar flow hood (or an equivalent clean air compounding area). Add one weight-based dose of Vial (1.2 mL, 2.6 mL or mL) and one weight-based dose of Vial (0.3 mL, 0.65 mL or mL) directly to at least 100 mL of intravenous dextrose or saline solution.oDiscard unused portion.oVisually inspect for particulate matter and discoloration prior to administration.oAfter INFUVITE PEDIATRIC is diluted in an intravenous infusion, refrigerate the resulting solution unless it is to be used immediately, and use the solution within 24 hours after dilution.oMinimize exposure to light because some of the vitamins in INFUVITE PEDIATRIC, particularly A, and riboflavin, are light sensitive.INFUVITE PEDIATRIC Pharmacy Bulk Package:oUse only in suitable work area such as laminar flow hood (or an equivalent clean air compounding area).oTransfer the contents of Vial (10 mL of solution) into the contents of Vial (40 mL of solution). The mixed solution (50 mL) will provide thirty-three 1.5 mL single doses, fifteen 3.25 mL single doses or ten mL single doses.oEach bulk vial closure shall be penetrated only one time with suitable sterile transfer device or dispensing set that allows measured dispensing of the contents.oOnce the closure system has been penetrated, complete dispensing from the pharmacy bulk vial should be completed within hours.oThe mixed solution may be refrigerated and stored for up to hours.oDiscard unused portion.oVisually inspect for particulate matter and discoloration prior to administration.oAdd one dose directly to at least 100 mL of intravenous dextrose or saline solution for each patient.oAfter INFUVITE PEDIATRIC is diluted in an intravenous infusion, refrigerate the resulting solution unless it is to be used immediately, and use the solution within 24 hours after dilution.oMinimize exposure to light because some of the vitamins in INFUVITE PEDIATRIC, particularly A, and riboflavin, are light sensitive.. oUse only in suitable work area such as laminar flow hood (or an equivalent clean air compounding area).. Add one weight-based dose of Vial (1.2 mL, 2.6 mL or mL) and one weight-based dose of Vial (0.3 mL, 0.65 mL or mL) directly to at least 100 mL of intravenous dextrose or saline solution.. oDiscard unused portion.. oVisually inspect for particulate matter and discoloration prior to administration.. oAfter INFUVITE PEDIATRIC is diluted in an intravenous infusion, refrigerate the resulting solution unless it is to be used immediately, and use the solution within 24 hours after dilution.. oMinimize exposure to light because some of the vitamins in INFUVITE PEDIATRIC, particularly A, and riboflavin, are light sensitive.. oUse only in suitable work area such as laminar flow hood (or an equivalent clean air compounding area).. oTransfer the contents of Vial (10 mL of solution) into the contents of Vial (40 mL of solution). The mixed solution (50 mL) will provide thirty-three 1.5 mL single doses, fifteen 3.25 mL single doses or ten mL single doses.. oEach bulk vial closure shall be penetrated only one time with suitable sterile transfer device or dispensing set that allows measured dispensing of the contents.. oOnce the closure system has been penetrated, complete dispensing from the pharmacy bulk vial should be completed within hours.. oThe mixed solution may be refrigerated and stored for up to hours.. oDiscard unused portion.. oVisually inspect for particulate matter and discoloration prior to administration.. oAdd one dose directly to at least 100 mL of intravenous dextrose or saline solution for each patient.. oAfter INFUVITE PEDIATRIC is diluted in an intravenous infusion, refrigerate the resulting solution unless it is to be used immediately, and use the solution within 24 hours after dilution.. oMinimize exposure to light because some of the vitamins in INFUVITE PEDIATRIC, particularly A, and riboflavin, are light sensitive.. 2.4 Monitoring Vitamin Blood Levels. Blood vitamin concentrations should be monitored to ensure maintenance of adequate levels, particularly in patients receiving parenteral multivitamins as the only source of vitamins for long periods of time.. 2.5 Drug Incompatibilities. oINFUVITE PEDIATRIC is not physically compatible with moderately alkaline solutions such as sodium bicarbonate solution and other alkaline drugs such as acetazolamide sodium, aminophylline, ampicillin sodium, tetracycline HCl and chlorothiazide sodium.oFolic acid is unstable in the presence of calcium salts such as calcium gluconate.oVitamin and thiamine in INFUVITE PEDIATRIC may react with bisulfite solutions such as sodium bisulfite or vitamin bisulfite.oDo not add INFUVITE PEDIATRIC directly to intravenous fat emulsions.oConsult appropriate references for additional listings of physical and chemical compatibility of solutions and drugs with the vitamin infusion when needed. If incompatibilities are identified, avoid admixture or Y-site administration with vitamin solutions.. oINFUVITE PEDIATRIC is not physically compatible with moderately alkaline solutions such as sodium bicarbonate solution and other alkaline drugs such as acetazolamide sodium, aminophylline, ampicillin sodium, tetracycline HCl and chlorothiazide sodium.. oFolic acid is unstable in the presence of calcium salts such as calcium gluconate.. oVitamin and thiamine in INFUVITE PEDIATRIC may react with bisulfite solutions such as sodium bisulfite or vitamin bisulfite.. oDo not add INFUVITE PEDIATRIC directly to intravenous fat emulsions.. oConsult appropriate references for additional listings of physical and chemical compatibility of solutions and drugs with the vitamin infusion when needed. If incompatibilities are identified, avoid admixture or Y-site administration with vitamin solutions.

DOSAGE FORMS & STRENGTHS SECTION.

3 DOSAGE FORMS AND STRENGTHS. INFUVITE PEDIATRIC Single Dose is an injection consisting of two single-dose vials labeled Vial (4 mL) and Vial (1 mL). For the vitamin strengths [see Dosage and Administration (2.2) and Description (11)]. INFUVITE PEDIATRIC Pharmacy Bulk Package is an injection consisting of two vials labeled Vial (40 mL Fill in 50 mL Vial) and Vial (10 mL). The mixed solution (50 mL) will provide thirty-three 1.5 mL single doses, fifteen 3.25 mL single doses or ten mL single doses. For the vitamin strengths [see Dosage and Administration (2.2) and Description (11)]. oINFUVITE PEDIATRIC single dose is an injection consisting of two vials labeled Vial (4 mL) and Vial (1 mL) (3)oINFUVITE PEDIATRIC pharmacy bulk package is an injection consisting of two vials labeled Vial (50 mL) and Vial (10 mL) (3)oSee Full Prescribing Information for vitamin strengths (11). oINFUVITE PEDIATRIC single dose is an injection consisting of two vials labeled Vial (4 mL) and Vial (1 mL) (3). oINFUVITE PEDIATRIC pharmacy bulk package is an injection consisting of two vials labeled Vial (50 mL) and Vial (10 mL) (3). oSee Full Prescribing Information for vitamin strengths (11).

DRUG INTERACTIONS SECTION.

7 DRUG INTERACTIONS. Effect of INFUVITE PEDIATRIC on other drugs:oAntibiotics: Thiamine, riboflavin, pyridoxine, niacinamide, and ascorbic acid decrease activities of erythromycin, kanamycin, streptomycin, doxycycline, and lincomycin (7.1)oBleomycin: Ascorbic acid and riboflavin may reduce the activity of bleomycin (7.1)oLevodopa: Pyridoxine may decrease blood levels of levodopa and levodopa efficacy may decrease (7.1)oPhenytoin: Folic acid may decrease phenytoin blood levels and increase risk of seizure activity (7.1)oMethotrexate: Folic acid may decrease response to methotrexate (7.1)Effects of other drugs on INFUVITE PEDIATRIC:oHydralazine, Isoniazid: Concomitant administration of hydralazine or isoniazid may increase pyridoxine requirements (7.2).oPhenytoin: May decrease folic acid concentrations (7.2). oAntibiotics: Thiamine, riboflavin, pyridoxine, niacinamide, and ascorbic acid decrease activities of erythromycin, kanamycin, streptomycin, doxycycline, and lincomycin (7.1). oBleomycin: Ascorbic acid and riboflavin may reduce the activity of bleomycin (7.1). oLevodopa: Pyridoxine may decrease blood levels of levodopa and levodopa efficacy may decrease (7.1). oPhenytoin: Folic acid may decrease phenytoin blood levels and increase risk of seizure activity (7.1). oMethotrexate: Folic acid may decrease response to methotrexate (7.1). oHydralazine, Isoniazid: Concomitant administration of hydralazine or isoniazid may increase pyridoxine requirements (7.2).. oPhenytoin: May decrease folic acid concentrations (7.2). 7.1 Drug Interactions Affecting Co-administered Drugs. number of interactions between vitamins and drugs have been reported. The following are examples of these types of interactions: Warfarin: Vitamin K, component of INFUVITE PEDIATRIC, antagonizes the anticoagulant action of warfarin. In patients who are co-administered warfarin and INFUVITE PEDIATRIC, blood levels of prothrombin/INR should be monitored to determine if dose of warfarin needs to be adjusted [see Warnings and Precautions (5.4)]. Antibiotics: Thiamine, riboflavin, pyridoxine, niacinamide, and ascorbic acid decrease antibiotic activities of erythromycin, kanamycin, streptomycin, doxycycline, and lincomycin. Bleomycin: Ascorbic acid and riboflavin inactivate bleomycin in vitro, thus the activity of bleomycin may be reduced. Levodopa: Pyridoxine may increase the metabolism of levodopa (decrease blood levels of levodopa) and decrease its efficacy. Phenytoin: Folic acid may increase phenytoin metabolism and lower the serum concentration of phenytoin resulting in increased seizure activity. Methotrexate: Folic acid may decrease patients response to methotrexate therapy.. Warfarin: Vitamin K, component of INFUVITE PEDIATRIC, antagonizes the anticoagulant action of warfarin. In patients who are co-administered warfarin and INFUVITE PEDIATRIC, blood levels of prothrombin/INR should be monitored to determine if dose of warfarin needs to be adjusted [see Warnings and Precautions (5.4)].. Antibiotics: Thiamine, riboflavin, pyridoxine, niacinamide, and ascorbic acid decrease antibiotic activities of erythromycin, kanamycin, streptomycin, doxycycline, and lincomycin.. Bleomycin: Ascorbic acid and riboflavin inactivate bleomycin in vitro, thus the activity of bleomycin may be reduced.. Levodopa: Pyridoxine may increase the metabolism of levodopa (decrease blood levels of levodopa) and decrease its efficacy.. Phenytoin: Folic acid may increase phenytoin metabolism and lower the serum concentration of phenytoin resulting in increased seizure activity.. Methotrexate: Folic acid may decrease patients response to methotrexate therapy.. 7.2 Drug Interactions Affecting Vitamin Levels. Hydralazine, Isoniazid: Concomitant administration of hydralazine or isoniazid may increase pyridoxine requirements. Phenytoin: Phenytoin may decrease serum folic acid concentrations.. Hydralazine, Isoniazid:. Concomitant administration of hydralazine or isoniazid may increase pyridoxine requirements.. Phenytoin:. Phenytoin may decrease serum folic acid concentrations.

HOW SUPPLIED SECTION.

16 HOW SUPPLIED/STORAGE AND HANDLING. How Supplied:INFUVITE PEDIATRIC (multiple vitamins injection) is supplied as follows:INFUVITE PEDIATRIC (multiple vitamins injection) Single Dose:oNDC 54643-5646-1 Boxes containing ten single dose vials five each of Vial (4 mL) and five each of Vial (1 mL), one Vial plus one Vial to be used for single dose [see Dosage and Administration (2.2, 2.3)]. INFUVITE PEDIATRIC (multiple vitamins injection) Pharmacy Bulk Package:oNDC 54643-5647-0 Boxes containing two vials Vial (40 mL Fill in 50 mL Vial) and Vial (10 mL). Mixed contents of Vial with Vial provide thirty-three 1.5 mL single doses, fifteen 3.25 mL single doses or 10 single mL doses [see Dosage and Administration (2.2, 2.3)]. Storage and Handling:Minimize exposure of INFUVITE PEDIATRIC to light because vitamins A, and riboflavin are light sensitive.Store under refrigeration 2-8C (36-46F).. oNDC 54643-5646-1 Boxes containing ten single dose vials five each of Vial (4 mL) and five each of Vial (1 mL), one Vial plus one Vial to be used for single dose [see Dosage and Administration (2.2, 2.3)]. oNDC 54643-5647-0 Boxes containing two vials Vial (40 mL Fill in 50 mL Vial) and Vial (10 mL). Mixed contents of Vial with Vial provide thirty-three 1.5 mL single doses, fifteen 3.25 mL single doses or 10 single mL doses [see Dosage and Administration (2.2, 2.3)].

INDICATIONS & USAGE SECTION.

1 INDICATIONS AND USAGE. INFUVITE PEDIATRIC is combination of vitamins indicated for the prevention of vitamin deficiency in pediatric patients up to 11 years of age receiving parenteral nutrition.The physician should not await the development of clinical signs of vitamin deficiency before initiating vitamin therapy.. INFUVITE PEDIATRIC is combination of vitamins indicated for the prevention of vitamin deficiency in pediatric patients up to 11 years of age receiving parenteral nutrition (1).

INFORMATION FOR PATIENTS SECTION.

17 PATIENT COUNSELING INFORMATION. Instruct caregiver(s) and patients (if age appropriate):oTo watch for signs of allergic reactions such as urticaria, shortness of breath, wheezing and angioedema since hypersensitivity reactions may occur to any of the vitamins or excipients contained in INFUVITE PEDIATRIC.oTo watch for and immediately report nausea, vomiting, headache, dizziness, blurred vision, especially if patients have renal impairment, as these may be signs of hypervitaminosis A.oTo report other adverse reactions that patients may experience such as rash, erythema, pruritus, headache, dizziness, agitation, anxiety, and diplopia.oPatients on warfarin anticoagulant therapy will be monitored periodically with blood prothrombin/ INR levels to determine if the dose of warfarin needs to be adjusted.oAbout the significance of periodic monitoring of blood vitamin concentrations to determine if vitamin deficiencies or excesses are developing and the need to monitor renal function, calcium, phosphorus, aluminum and vitamin levels in patients with renal impairment.oThat INFUVITE PEDIATRIC should be avoided in patients with suspected or diagnosed megaloblastic anemia prior to blood sampling for the detection of the folic acid and cyanocobalamin deficiencies.oThat vitamin (ascorbic acid) contained in INFUVITE PEDIATRIC may cause false negative urine glucose results.Manufactured bySandoz Canada Inc.145 Jules-Leger StreetBoucherville, Qc, Canada, J4B 7K8Distributed byBaxter Healthcare CorporationClintec Nutrition DivisionDeerfield, IL 60015 USAPrinted in Canada(R) INFUVITE is registered trademark of Sandoz Canada Inc. D4614353303-2016M. oTo watch for signs of allergic reactions such as urticaria, shortness of breath, wheezing and angioedema since hypersensitivity reactions may occur to any of the vitamins or excipients contained in INFUVITE PEDIATRIC.. oTo watch for and immediately report nausea, vomiting, headache, dizziness, blurred vision, especially if patients have renal impairment, as these may be signs of hypervitaminosis A.. oTo report other adverse reactions that patients may experience such as rash, erythema, pruritus, headache, dizziness, agitation, anxiety, and diplopia.. oPatients on warfarin anticoagulant therapy will be monitored periodically with blood prothrombin/ INR levels to determine if the dose of warfarin needs to be adjusted.. oAbout the significance of periodic monitoring of blood vitamin concentrations to determine if vitamin deficiencies or excesses are developing and the need to monitor renal function, calcium, phosphorus, aluminum and vitamin levels in patients with renal impairment.. oThat INFUVITE PEDIATRIC should be avoided in patients with suspected or diagnosed megaloblastic anemia prior to blood sampling for the detection of the folic acid and cyanocobalamin deficiencies.. oThat vitamin (ascorbic acid) contained in INFUVITE PEDIATRIC may cause false negative urine glucose results.

NONCLINICAL TOXICOLOGY SECTION.

13 NONCLINICAL TOXICOLOGY. 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility. Carcinogenicity, mutagenicity, and fertility studies have not been performed with INFUVITE PEDIATRIC.

NURSING MOTHERS SECTION.

8.3 Nursing Mothers. INFUVITE PEDIATRIC has not been studied in nursing mothers. Lactating women may have vitamin requirements that exceed those of non-lactating women. Caution should be exercised when INFUVITE PEDIATRIC is administered to nursing mothers.

OVERDOSAGE SECTION.

10 OVERDOSAGE. Signs and symptoms of acute or chronic overdosage may be those of individual INFUVITE PEDIATRIC component toxicity. There is no clinical experience with INFUVITE PEDIATRIC overdosage.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

Carton. 2A9008 NDC 54643-5646-1BaxterINFUVITE(R) PEDiatric Multiple Vitamins InjectionFor intravenous infusion after dilution only.STERILE Rx onlyContains each of Vial (4 mL) and Vial (1 mL).One vial of each to be used for single dose.Store under refrigeration, 2-8C (36 46F).. Infuvite Pediatric Vial Carton.

PEDIATRIC USE SECTION.

8.4 Pediatric Use. INFUVITE PEDIATRIC is approved for the prevention of vitamin deficiency in pediatric patients up to 11 years old receiving parenteral nutrition. INFUVITE PEDIATRIC has not been studied in pediatric patients older than 11 years.INFUVITE PEDIATRIC contains aluminum that may be toxic for premature neonates. Aluminum levels should be monitored periodically during administration of INFUVITE PEDIATRIC to premature neonates [see Warnings and Precautions 5.1 )].Additional vitamin supplementations of infants receiving INFUVITE PEDIATRIC may result in elevated blood concentrations of vitamin and potential vitamin toxicity [see Warnings and Precautions 5.8 )].E-Ferol syndrome has been reported in low-birth weight infants following administration of polysorbates which are found in INFUVITE PEDIATRIC. No E-Ferol syndrome associated with INFUVITE PEDIATRIC has been reported [see Warnings and Precautions 5.10)].

PREGNANCY SECTION.

8.1 Pregnancy. Pregnancy Category C.. INFUVITE PEDIATRIC has not been studied in pregnant women. Pregnant women should follow the U.S. recommended daily allowances for pregnancy because their vitamin requirements may exceed those of non-pregnant women. Animal reproduction studies have not been conducted with INFUVITE PEDIATRIC (multiple vitamins injection).

SPL UNCLASSIFIED SECTION.

2.1 Important Dosage and Administration Instructions. INFUVITE PEDIATRIC is combination product that contains the following vitamins: ascorbic acid, vitamin A, vitamin D, thiamine, riboflavin, pyridoxine, niacinamide, dexpanthenol, vitamin E, vitamin K1, folic acid, biotin, and vitamin B12.INFUVITE PEDIATRIC is supplied as single dose or as pharmacy bulk package for intravenous use intended for administration by intravenous infusion after dilution:oINFUVITE PEDIATRIC Single Dose consists of two vials. weightbased volume from each vial must be added directly to dextrose or saline solution prior to intravenous administration [see Dosage and Administration (2.2, 2.3)]. oINFUVITE PEDIATRIC Pharmacy Bulk Package consists of two pharmacy bulk vials which must be mixed prior to use. The mixed solution will provide multiple daily doses which must be diluted prior to intravenous administration. Pharmacy bulk package of INFUVITE PEDIATRIC is intended for dispensing of single doses to multiple patients in pharmacy admixture program and is restricted to the preparation of admixtures for infusion [see Dosage and Administration (2.2, 2.3)]. oINFUVITE PEDIATRIC Single Dose consists of two vials. weightbased volume from each vial must be added directly to dextrose or saline solution prior to intravenous administration [see Dosage and Administration (2.2, 2.3)]. oINFUVITE PEDIATRIC Pharmacy Bulk Package consists of two pharmacy bulk vials which must be mixed prior to use. The mixed solution will provide multiple daily doses which must be diluted prior to intravenous administration. Pharmacy bulk package of INFUVITE PEDIATRIC is intended for dispensing of single doses to multiple patients in pharmacy admixture program and is restricted to the preparation of admixtures for infusion [see Dosage and Administration (2.2, 2.3)].

USE IN SPECIFIC POPULATIONS SECTION.

8 USE IN SPECIFIC POPULATIONS. oRenal Impairment: Monitor renal function, calcium, phosphorus and vitamin levels (8.6)oHepatic Impairment: Monitor vitamin levels (8.7). oRenal Impairment: Monitor renal function, calcium, phosphorus and vitamin levels (8.6). oHepatic Impairment: Monitor vitamin levels (8.7). 8.1 Pregnancy. Pregnancy Category C.. INFUVITE PEDIATRIC has not been studied in pregnant women. Pregnant women should follow the U.S. recommended daily allowances for pregnancy because their vitamin requirements may exceed those of non-pregnant women. Animal reproduction studies have not been conducted with INFUVITE PEDIATRIC (multiple vitamins injection).. 8.3 Nursing Mothers. INFUVITE PEDIATRIC has not been studied in nursing mothers. Lactating women may have vitamin requirements that exceed those of non-lactating women. Caution should be exercised when INFUVITE PEDIATRIC is administered to nursing mothers.. 8.4 Pediatric Use. INFUVITE PEDIATRIC is approved for the prevention of vitamin deficiency in pediatric patients up to 11 years old receiving parenteral nutrition. INFUVITE PEDIATRIC has not been studied in pediatric patients older than 11 years.INFUVITE PEDIATRIC contains aluminum that may be toxic for premature neonates. Aluminum levels should be monitored periodically during administration of INFUVITE PEDIATRIC to premature neonates [see Warnings and Precautions 5.1 )].Additional vitamin supplementations of infants receiving INFUVITE PEDIATRIC may result in elevated blood concentrations of vitamin and potential vitamin toxicity [see Warnings and Precautions 5.8 )].E-Ferol syndrome has been reported in low-birth weight infants following administration of polysorbates which are found in INFUVITE PEDIATRIC. No E-Ferol syndrome associated with INFUVITE PEDIATRIC has been reported [see Warnings and Precautions 5.10)].. 8.6 Renal Impairment. INFUVITE PEDIATRIC has not been studied in patients with renal impairment. Monitor renal function, calcium, phosphorus and vitamin levels in patients with renal impairment [see Warnings and Precautions (5.1, 5.3 )]. 8.7 Hepatic Impairment. INFUVITE PEDIATRIC has not been studied in patients with liver impairment. Monitor vitamin levels in patients with liver disease [see Warnings and Precautions 5.3 )].

WARNINGS AND PRECAUTIONS SECTION.

5 WARNINGS AND PRECAUTIONS. oRisk of Aluminum Toxicity: For at risk patients (renal failure or those with prolonged therapy), consider periodic monitoring of aluminum levels (5.1)oAllergic Reactions: To thiamine may occur (5.2)oHypervitaminosis A: Patients with renal failure or liver disease may be at higher risk (5.3)oDecreased Anticoagulant Effect of Warfarin: Monitor INR (5.4, 7.1)oInterferes with Megaloblastic Anemia Diagnosis: Avoid during testing for this disorder (5.5)oRisk of Vitamin Deficiencies or Excesses: Monitor blood vitamin concentrations (5.6)oFalse Negative Urine Glucose Tests: Due to vitamin (5.7)oRisk of Vitamin Toxicity: Additional oral and parenteral vitamin may result in elevated vitamin blood concentrations in infants (5.8)oLow Vitamin Levels: Monitor vitamin levels (5.9)oRisk of E-Ferol Syndrome: Due to polysorbates (5.10). oRisk of Aluminum Toxicity: For at risk patients (renal failure or those with prolonged therapy), consider periodic monitoring of aluminum levels (5.1). oAllergic Reactions: To thiamine may occur (5.2). oHypervitaminosis A: Patients with renal failure or liver disease may be at higher risk (5.3). oDecreased Anticoagulant Effect of Warfarin: Monitor INR (5.4, 7.1). oInterferes with Megaloblastic Anemia Diagnosis: Avoid during testing for this disorder (5.5). oRisk of Vitamin Deficiencies or Excesses: Monitor blood vitamin concentrations (5.6). oFalse Negative Urine Glucose Tests: Due to vitamin (5.7). oRisk of Vitamin Toxicity: Additional oral and parenteral vitamin may result in elevated vitamin blood concentrations in infants (5.8). oLow Vitamin Levels: Monitor vitamin levels (5.9). oRisk of E-Ferol Syndrome: Due to polysorbates (5.10). 5.1 Aluminum Toxicity. INFUVITE PEDIATRIC contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration in pediatric patients with renal impairment. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solution, which contain aluminum.Research indicates that patients with impaired kidney function, including premature neonates who receive parenteral levels of aluminum at greater than to 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. To prevent aluminum toxicity periodically monitor aluminum levels with prolonged parenteral administration of INFUVITE PEDIATRIC.. 5.2 Allergic Reactions to Thiamine. Allergic reactions such as urticaria, shortness of breath, wheezing and angioedema have been reported following intravenous administration of thiamine, which is found in INFUVITE PEDIATRIC. There have been rare reports of anaphylaxis following intravenous doses of thiamine. No fatal anaphylaxis associated with INFUVITE PEDIATRIC has been reported.. 5.3. Hypervitaminosis A. Hypervitaminosis A, manifested by nausea, vomiting, headache, dizziness, blurred vision has been reported in patients with renal failure receiving 1.5 mg/day retinol and in patients with liver disease. Therefore, supplementation of renal failure patients and patients with liver disease with vitamin A, an ingredient found in INFUVITE PEDIATRIC, should be undertaken with caution [See Use in Specific Populations 8.6 8.7 )]. Blood levels of Vitamin should be monitored periodically.. 5.4 Decreased Anticoagulant Effect of Warfarin INFUVITE PEDIATRIC contains Vitamin which may decrease the anticoagulant action of warfarin. In patients who are on warfarin anticoagulant therapy receiving INFUVITE PEDIATRIC monitor blood levels of prothrombin/INR to determine if dose of warfarin needs to be adjusted.. 5.5 Interference with Diagnosis of Megaloblastic Anemia. INFUVITE PEDIATRIC contains folic acid and cyanocobalamin which can mask serum deficiencies of folic acid and cyanocobalamin in patients with megaloblastic anemia. Avoid the use of INFUVITE PEDIATRICS in patients with suspected or diagnosed megaloblastic anemia prior to blood sampling for the detection of the folic acid and cyanocobalamin deficiencies.. 5.6 Potential to Develop Vitamin Deficiencies or Excesses. In patients receiving parenteral multivitamins such as with INFUVITE PEDIATRIC, blood vitamin concentrations should be periodically monitored to determine if vitamin deficiencies or excesses are developing. INFUVITE PEDIATRIC may not correct long-standing specific vitamin deficiencies. The administration of additional doses of specific vitamins may be required [see Dosage and Administration 2.2)].. 5.7 Interference with Urine Glucose Testing. INFUVITE PEDIATRIC contains vitamin which is also known as ascorbic acid. Ascorbic acid in the urine may cause false negative urine glucose results.. 5.8 Vitamin Overdose in Infants Receiving Additional Vitamin E. Additional vitamin supplementations of patients receiving INFUVITE PEDIATRIC may result in elevated blood concentrations of vitamin and potential vitamin toxicity in infants. Avoid additional oral or parental doses of vitamin in infants. Daily dose of INFUVITE PEDIATRIC contains adequate concentrations of vitamin required to achieve normal blood levels of vitamin E.. 5.9 Risk of Low Vitamin Levels. Lower vitamin concentrations may occur after administration of INFUVITE PEDIATRIC due to the adherence of Vitamin to plastic. Monitor blood vitamin concentrations periodically. Additional administration of therapeutic doses of vitamin may be required, especially in low-birth weight infants.. 5.10 Risk of E-Ferol Syndrome in Low-Birth Weight Infants. E-Ferol syndrome manifested by thrombocytopenia, renal dysfunction, hepatomegaly, cholestasis, ascites, hypotension and metabolic acidosis has been reported in low-birth weight infants following administration of polysorbates which are found in INFUVITE PEDIATRIC. No E-Ferol syndrome associated with INFUVITE PEDIATRIC has been reported.