2 ) • chloramphenicol : in patients with pernicious anemia, the hematologic response to vitamin b12 therapy may be inhibited ( 7.2 ) 7.1 drug interactions affecting co-administered drugs warfarin : vitamin k, a component of infuvite adult, antagonizes the anticoagulant action of warfarin. in patients who are co-administered warfarin and infuvite adult, 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 a patient’s 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. chloramphenicol: in patients with pernicious anemia, the hematologic response to vitamin b12 therapy may be inhibited by chloramphenicol.

te solution, 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. to prevent aluminum toxicity periodically monitor aluminum levels with prolonged parenteral administration of infuvite adult in patients with renal impairment. 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 adult. there have been rare reports of anaphylactoid reactions following intravenous doses of thiamine. no fatal anaphylactoid reactions associated with infuvite adult have 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 adult, should be undertaken with caution [ see use in specific populations ( 8.6 , 8.7 ) ]. 5.4 decreased anticoagulant effect of warfarin infuvite adult contains vitamin k, which may decrease the anticoagulant action of warfarin. in patients who are on warfarin anticoagulant therapy receiving infuvite adult 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 adult 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 adult 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 adult, blood concentration should be periodically monitored to determine if deficiencies or excesses are developing. infuvite adult may not correct long-standing specific vitamin deficiencies. the administration of additional therapeutic doses of specific vitamins may be required [ see dosage and administration ( 2.3 ) ]. 5.7 interference with urine glucose testing infuvite adult contains vitamin c which is also known as ascorbic acid. ascorbic acid in the urine may cause false negative urine glucose results.

ravenous infusion, refrigerate resulting solution unless used immediately. use solution within 24 hours after dilution ( 2.2 ) • monitor blood vitamin concentrations ( 2.3 ) • see full prescribing information for drug incompatibilities ( 2.4 ) 2.1 important dosage instructions infuvite adult is a 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 adult is supplied as a single dose or as a pharmacy bulk package for intravenous use intended for administration by intravenous infusion after dilution. infuvite adult single dose: • provides one daily dose of 10 ml (5 ml of vial 1 plus 5 ml of vial 2) which must be diluted prior to intravenous administration [see dosage and administration ( 2.2 )] . infuvite adult pharmacy bulk package: • provides ten 10 ml daily doses when the content of vial 1 is transferred into the content of vial 2. one 10 ml dose is then added directly to intravenous fluid. pharmacy bulk package of infuvite adult is intended for dispensing of single doses to multiple patients in a pharmacy admixture program and is restricted to the preparation of admixtures for infusion [ see dosage and administration ( 2.2 )]. patients with multiple vitamin deficiencies or with increased vitamin requirements may need multiple daily dosages as indicated. some patients do not maintain adequate levels of certain vitamins when this formulation in recommended amounts is the only source of vitamins. 2.2 preparation and administration instructions do not administer infuvite adult as a direct, undiluted intravenous injection as it may cause dizziness, faintness, and possible tissue irritation . infuvite adult single dose : • use only in a suitable work area such as a laminar flow hood (or an equivalent clean air compounding area). • add 5 ml of vial 1 and 5 ml of vial 2 to at least 500 ml to 1000 ml, of intravenous dextrose or saline solutions. • discard unused portion. • visually inspect for particulate matter and discoloration prior to administration. • after infuvite adult 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. • minimize exposure to light because some of the vitamins in infuvite adult, particularly a, d and riboflavin, are light sensitive. infuvite adult pharmacy bulk package : • use only in a suitable work area such as a laminar flow hood (or an equivalent clean air compounding area). • transfer the contents of vial 1 into the contents of vial 2 to provide ten 10 ml single doses. • each bulk vial closure shall be penetrated only one time with a suitable sterile transfer device or dispensing set that allows measured dispensing of the contents. • once the closure system has been penetrated, complete dispensing from the pharmacy bulk vial should be completed within 4 hours. the mixed solution may be refrigerated and stored for up to 4 hours. • discard unused portion. • visually inspect for particulate matter and discoloration prior to administration. • one daily 10 ml dose should be added directly to at least 500 ml to 1000 ml, of intravenous dextrose, saline or similar infusion solutions. • after infuvite adult 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. • minimize exposure to light because some of the vitamins in infuvite adult, particularly a, d and riboflavin, are light sensitive. 2.3 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. 2.4 drug incompatibilities • infuvite adult is not physically compatible with moderately alkaline solutions such as a sodium bicarbonate solution and other alkaline drugs such as acetazolamide sodium, aminophylline, ampicillin sodium, tetracycline hcl and chlorothiazide sodium. • folic acid is unstable in the presence of calcium salts such as calcium gluconate. • vitamin a and thiamine in infuvite adult may react with bisulfite solutions such as sodium bisulfite or vitamin k bisulfate. • do not add infuvite adult directly to intravenous fat emulsions. • consult 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.

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2 ) • chloramphenicol : in patients with pernicious anemia, the hematologic response to vitamin b12 therapy may be inhibited ( 7.2 ) 7.1 drug interactions affecting co-administered drugs warfarin : vitamin k, a component of infuvite adult, antagonizes the anticoagulant action of warfarin. in patients who are co-administered warfarin and infuvite adult, 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 a patient’s 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. chloramphenicol: in patients with pernicious anemia, the hematologic response to vitamin b12 therapy may be inhibited by chloramphenicol.

dult is administered to a nursing mother. 8.4 pediatric use safety and effectiveness in children below the age of 11 years have not been established. 8.5 geriatric use safety and effectiveness for geriatric use have not been established. 8.6 renal impairment infuvite adult has not been studied in patients with renal impairment. monitor renal function, calcium, phosphorus and vitamin a levels in patients with renal impairment [ see warnings and precautions ( 5.1 , 5.3 ) ] . 8.7 hepatic impairment infuvite adult has not been studied in patients with liver impairments. monitor vitamin a level in patients with liver disease, high alcohol consumption [ see warnings and precautions ( 5.3 ) ] .

on, calcium, phosphorus, aluminum and vitamin a levels in patients with renal impairment. • that infuvite adult 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. • that vitamin c (ascorbic acid) contained in infuvite adult may cause false negative urine glucose results. manufactured by sandoz canada inc. 145 jules-léger street boucherville, qc, canada, j4b 7k8 distributed by baxter healthcare corporation for novaplus ® clintec nutrition division deerfield, il 60015 usa printed in canada novaplus ® is a registered trademark of vizient, inc. ® infuvite is a registered trademark of sandoz canada inc. 46194734 10-2016