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INFUVITE Multiple Vitamins for Infusion Low aluminum. Zero preservatives. Readily available. See inside for Indications and Important Risk Information. INFUVITE Multiple Vitamins for Infusion A.S.P.E.N. suggests clinicians purchase product with the lowest aluminum content when possible.1 • Not more than 30 mcg/L for INFUVITE PEDiatric. Not more than 70 mcg/L for INFUVITE ADULT. (combined vials 1 and 2) • Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.) Full portfolio of injectable multivitamin formulations. • The only preservative-free option available. • The only pediatric pharmacy bulk package available. • Ready-to-use liquid formulas. Does not require reconstitution. • Latex free. Supplied in both single-dose and pharmacy bulk package configurations. • Adult and pediatric formulas available in convenient single-dose configurations. • Pharmacy bulk packages are well suited for use in high-volume pharmacy admixture programs, which allow you to: - Prepare up to 10 doses at once. - Reduce the number of physical manipulations, thereby helping to reduce the potential risk of contamination and improve compounding efficiency. • Pharmacy bulk package is not for direct infusion. • Consistent intake of vitamin K is recommended for patients on anticoagulation therapy. - INFUVITE ADULT Multiple Vitamins for Infusion provide a consistent daily supply of vitamin K for these patients. - Vitamin K is essential for the activation of vitamin-K dependent proteins, which are involved not only in blood coagulation but in bone metabolism and inhibition of arterial calcification.2 Options deliver flexibility and simplicity. Product Configuration NDC Baxter Code INFUVITE ADULT Multiple Vitamins for Infusion 54643-5649-1 2A9018 INFUVITE ADULT Multiple Vitamins for Infusion — Pharmacy Bulk Package 54643-5649-2 2A9019 INFUVITE PEDIATRIC Multiple Vitamins for Infusion 54643-5646-1 2A9008 INFUVITE PEDIATRIC Multiple Vitamins for Infusion — Pharmacy Bulk Package 54643-5647-0 2A9061 Indications: • INFUVITE Multiple Vitamins for Infusion are for intravenous infusion after dilution only. • INFUVITE ADULT Multiple Vitamins for Infusion are indicated as a daily multivitamin maintenance supplement for adults and children aged 11 and older receiving parenteral nutrition. • INFUVITE PEDiatric Multiple Vitamins for Infusion are indicated as a daily multivitamin maintenance dosage for infants and children up to 11 years of age receiving parenteral nutrition. • Caution should be exercised when administering INFUVITE Multiple Vitamins for Infusion to patients on warfarin sodium-type anticoagulation therapy. Periodic monitoring of prothrombin time/INR response is essential in determining the appropriate dosage of anticoagulant therapy. • If this formulation is the only source of vitamins for a long period of time, blood concentrations of each of the vitamins should be monitored, particularly vitamins A, C, D, and folic acid, to determine if deficiencies are occurring. •T here have been rare reports of anaphylactoid reactions Important Risk Information: • INFUVITE Multiple Vitamins for Infusion are contraindicated where there is a pre-existing hypervitaminosis or known hypersensitivity to any of the vitamins or excipients in the product. • Allergic reactions have been known to occur following intravenous administration of thiamine and vitamin K. The formulation is contraindicated prior to blood sampling for detection of megaloblastic anemia. following parenteral multivitamin administration. Rare reports of anaphylactoid reactions have also been reported following large intravenous doses of thiamine. However, the risk is negligible if thiamine is coadministered with other vitamins in the B group. • INFUVITE Multiple Vitamins for Infusion contain aluminum that may be toxic. • See enclosed for complete prescribing information. Reference 1. Koo WWk, McLaughlin K, Saba M. The A.S.P.E.N. Nutrition Support Practice Manual. 2005:301-314. 2. A dams J, Pepping J. Vitamin K in the treatment and prevention of osteoporosis and arterial calcification. Am J Health Syst Pharm. 2005;62(15):1574-1581. Move Ahead with streamlined parental nutrition. With our 70-plus years in developing solutions that work together to improve patient outcomes, Baxter offers you the broadest portfolio of parenteral nutrition products and technologies available. Our complete line includes premix formulations, injectable multiple vitamins, compounding solutions and technologies, micronutrients, and ongoing support. More options mean that you can efficiently meet the nutritional needs of each and every patient. For more information on INFUVITE Multiple Vitamins for Infusion or our other nutrition products, please contact your local Baxter representative. To order product, please call the Baxter Center for Service at 1-888-229-0001. Medication Delivery Baxter is a trademark of Baxter International Inc. Infuvite is a trademark of Sandoz Canada Inc. Any other trademarks, brands or images that appear herein are the property of their respective owners. Baxter Healthcare Corporation, Route 120 and Wilson Road, Round Lake, IL 60073 www.baxter.com 801400 5K 8/11 22582•Baxter Inf. 1006224 1/7/08 1:08 PM Page 1 For intravenous infusion after dilution only. function is impaired. 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 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. Description Precautions INFUVITE® Pediatric Multiple Vitamins for Infusion INFUVITE Pediatric is 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 mg Vitamin A* (as palmitate) ................................................. 2,300 IU Vitamin D3* (cholecalciferol) ................................................ 400 IU Thiamine (Vitamin B1) (as the hydrochloride) ...................... 1.2 mg Riboflavin (Vitamin B2) (as riboflavin 5-phosphate sodium) 1.4 mg Pyridoxine HCl (Vitamin B6) ................................................... 1 mg Niacinamide ........................................................................ 17 mg Dexpanthenol (as d-pantothenyl alcohol) .............................. 5 mg Vitamin E* (dl-α-tocopheryl acetate) ....................................... 7 IU Vitamin K1* ........................................................................ 0.2 mg Inactive ingredients: 50 mg polysorbate 80, sodium hydroxide and/or hydrochloric acid for pH adjustment and water for injection. * Polysorbate 80 is used to water solubilize the oil-soluble vitamins A, D, E, and K. Each 1 mL of Vial 2 contains: Folic acid ........................................................................ 140 mcg Biotin ................................................................................ 20 mcg Vitamin B12 (cyanocobalamin) ............................................. 1 mcg Inactive ingredients: 75 mg mannitol, citric acid and/or sodium citrate for pH adjustment and water for injection. Vitamin A 2,300 IU equals 0.7 mg Vitamin D 400 IU equals 10 mcg Vitamin E 7 IU equals 7 mg Multiple vitamin preparation for intravenous infusion: INFUVITE Pediatric (Multiple Vitamins for Infusion) makes available a combination of important oil-soluble and water-soluble vitamins in an aqueous solution, formulated for incorporation into intravenous solutions. The liposoluble vitamins A, D, E, and K have been solubilized in an aqueous medium with polysorbate 80, permitting intravenous administration of these vitamins. Contains no more than 30 mcg/L of aluminum (combined vials 1 and 2). Indications and Usage INFUVITE Pediatric is indicated as a daily multivitamin maintenance dosage for infants and children up to 11 years of age receiving parenteral nutrition. INFUVITE Pediatric is also indicated in other situations where administration by the intravenous route is required. Such situations include surgery, extensive burns, fractures and other trauma, severe infectious diseases, and comatose states, which may provoke a “stress” situation with profound alterations in the body’s metabolic demands and consequent tissue depletion of nutrients. The physician should not await the development of clinical signs of vitamin deficiency before initiating vitamin therapy. INFUVITE Pediatric (administered in intravenous fluids under proper dilution) contributes intake of necessary vitamins toward maintaining the body’s normal resistance and repair processes. Patients with multiple vitamin deficiencies or with markedly increased requirements may be given multiples of 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 receiving parenteral multivitamins as their sole source of vitamins for long periods of time. Contraindications INFUVITE Pediatric is contraindicated where there is a preexisting hypervitaminosis, or a known hypersensitivity to any of the vitamins or excipients in the product. Allergic reactions have been known to occur following intravenous administration of thiamine and vitamin K. The formulation is contraindicated prior to blood sampling for detection of megaloblastic anemia, as the folic acid and the cyanocobalamin in the vitamin solution can mask serum deficits. Warnings INFUVITE Pediatric is administered in intravenous solutions, which may contain aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney Caution should be exercised when administering INFUVITE Pediatric to patients on warfarin sodium-type anticoagulant therapy. In such patients, vitamin K may antagonize the hypoprothrombinemic response to anticoagulant drugs. In such patients, periodic monitoring of prothrombin time/INR response is essential in determining the appropriate dosage of anticoagulant therapy. Adequate blood levels of vitamin E are achieved when INFUVITE Pediatric is given to infants at the recommended dosage. Larger doses or supplementation with oral or parenteral vitamin E are not recommended because elevated blood levels of vitamin E may result. Studies have shown that vitamin A may adhere to plastic, resulting in inadequate vitamin A administration in the doses recommended with INFUVITE Pediatric. Additional vitamin A supplementation may be required, especially in low-birth-weight infants. Long-standing specific vitamin deficiencies may require additional therapeutic amounts of specific vitamins to supplement the maintenance vitamins provided by INFUVITE Pediatric. In patients receiving parenteral multivitamins, blood vitamin concentrations should be periodically monitored to determine if vitamin deficiencies or excesses are developing. Polysorbates have been associated with the E-Ferol syndrome (thrombocytopenia, renal dysfunction, hepatomagaly, cholestasis, ascites, hypotension and metabolic acidosis) in low-birth-weight infants. However, no such adverse reports have been associated with the use of pediatric multiple vitamins for infusion such as INFUVITE Pediatric. INFUVITE Pediatric should be aseptically transferred to the infusion fluid. Drug-Drug Interactions Physical incompatibilities: INFUVITE Pediatric (Multiple Vitamins for Infusion) is not physically compatible with alkaline solutions or moderately alkaline drugs such as acetazolamide, and chlorothiazide sodium, aminopylline or sodium bicarbonate. INFUVITE Pediatric is not physically compatible with ampicillin and it may not be physically compatible with tetracycline HCl. It has also been reported that folic acid is unstable in the presence of calcium salts such as calcium gluconate. Direct addition to intravenous fat emulsions is not recommended. Consult appropriate references for listings of physical compatibility of solutions and drugs with the vitamin infusion. In such circumstances, admixture or Y-site administration with vitamin solutions should be avoided. Some of the vitamins in INFUVITE Pediatric may react with vitamin K bisulfite or sodium bisulfite; if bisulfite solutions are necessary, patients should be monitored for Vitamin A, thiamine, and ascorbic acid deficiencies. Clinical Interactions: A number of interactions between vitamins and drugs have been reported which may affect the metabolism of either agent. The following are examples of these types of interactions. Folic acid may lower the serum concentration of phenytoin resulting in increased seizure frequency. Conversely, phenytoin may decrease serum folic acid concentrations and, therefore, should be avoided in pregnancy. Folic acid may decrease the patient’s response to methotrexate therapy. Pyridoxine may decrease the efficacy of levodopa by increasing its metabolism. Concomitant administration of hydralazine or isoniazid may increase pyridoxine requirements. In patients with pernicious anemia, the hematological response to vitamin B12 therapy may be inhibited by concomitant administration of chloramphenicol. Several vitamins have been reported to decrease the activity of certain antibiotics. Thiamine, riboflavin, pyridoxine, niacinamide, and ascorbic acid have been reported to decrease the antibiotic activity of erythromycin, kanamycin, streptomycin, doxycycline, and lincomycin. Bleomycin is inactivated in vitro by ascorbic acid and riboflavin. Vitamin K may antagonize the hypoprothrombinemic effect of oral anticoagulants (see Precautions). Consult appropriate references for additional specific vitamin-drug interactions. Drug-Laboratory Test Interactions: Ascorbic acid in the urine may cause false negative urine glucose determinations. anemia, as the folic acid and the cyanocobalamin in the vitamin solution can mask serum deficits. ® INFUVITE PEDIATRIC PHARMACY BULK PACKAGE Multiple Vitamins for Infusion Rx only For intravenous infusion after dilution only. Pharmacy Bulk Package Not for Direct Infusion Description INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE) is a sterile product consisting of two vials: 1 each of Vial 1 (40 mL fill in 50 mL) and Vial 2 (10 mL), provided as a pharmacy bulk package. A pharmacy bulk package is a container of a sterile preparation for parenteral use that contains many single doses. The contents are intended for use in a pharmacy admixture program and are restricted to the preparation of admixtures for intravenous infusion. Each 4 mL of Vial 1 contains: Ascorbic acid (Vitamin C).............................................................. 80 mg Vitamin A* (as palmitate) ........................................................... 2 300 IU Vitamin D3* (cholecalciferol) ......................................................... 400 IU Thiamine (Vitamin B1) (as the hydrochloride) ............................... 1.2 mg Riboflavin (Vitamin B2) (as riboflavin 5-phosphate sodium) .......... 1.4 mg Pyridoxine HCl (Vitamin B6)............................................................. 1 mg Niacinamide ................................................................................. 17 mg Dexpanthenol (as d-pantothenyl alcohol) ........................................ 5 mg Vitamin E* (dl-α-tocopheryl acetate) ................................................ 7 IU Vitamin K1*.................................................................................. 0.2 mg Inactive ingredients: 50 mg polysorbate 80, sodium hydroxide and/or hydrochloric acid for pH adjustment and water for injection. * Polysorbate 80 is used to water solubilize the oil-soluble vitamins A, D, E and K. Each 1 mL of Vial 2 contains: Folic acid .................................................................................. 140 mcg Biotin.......................................................................................... 20 mcg Vitamin B12 (cyanocobalamin) ....................................................... 1 mcg Inactive ingredients: 75 mg mannitol, citric acid and/or sodium citrate for pH adjustment and water for injection. Vitamin A 2,300 IU equals 0.7 mg Vitamin D 400 IU equals 10 mcg Vitamin E 7 IU equals 7 mg Multiple vitamin preparation for intravenous infusion: INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE) (Multiple Vitamins for Infusion) makes available a combination of important oil-soluble and water-soluble vitamins in an aqueous solution, formulated for incorporation into intravenous solutions. The liposoluble vitamins A, D, E and K have been solubilized in an aqueous medium with polysorbate 80, permitting intravenous administration of these vitamins. Contains no more than 30 mcg/L of aluminum (combined vials 1 and 2). Indications and Usage INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE) is indicated as a daily multivitamin maintenance dosage for infants and children up to 11 years of age receiving parenteral nutrition. INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE) is also indicated in other situations where administration by the intravenous route is required. Such situations include surgery, extensive burns, fractures and other trauma, severe infectious diseases, and comatose states, which may provoke a “stress” situation with profound alterations in the body’s metabolic demands and consequent tissue depletion of nutrients. The physician should not await the development of clinical signs of vitamin deficiency before initiating vitamin therapy. INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE) (administered in intravenous fluids under proper dilution) contributes intake of necessary vitamins toward maintaining the body’s normal resistance and repair processes. Patients with multiple vitamin deficiencies or with markedly increased requirements may be given multiples of 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 receiving parenteral multivitamins as their sole source of vitamins for long periods of time. Contraindications INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE) is contraindicated where there is a preexisting hypervitaminosis, or a known hypersensitivity to any of the vitamins or excipients in the product. Allergic reactions have been known to occur following intravenous administration of thiamine and vitamin K. The formulation is contraindicated prior to blood sampling for detection of megaloblastic Warnings INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE) is administered in intravenous solutions, which may contain aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate 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. Precautions Caution should be exercised when administering INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE) to patients on warfarin sodium-type anticoagulant therapy. In such patients, vitamin K may antagonize the hypoprothrombinemic response to anticoagulant drugs. In such patients, periodic monitoring of prothrombin time/INR response is essential in determining the appropriate dosage of anticoagulant therapy. Adequate blood levels of vitamin E are achieved when INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE) is given to infants at the recommended dosage. Larger doses or supplementation with oral or parenteral vitamin E are not recommended because elevated blood levels of vitamin E may result. Studies have shown that vitamin A may adhere to plastic, resulting in inadequate vitamin A administration in the doses recommended with INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE). Additional vitamin A supplementation may be required, especially in low-birth-weight infants. Long-standing specific vitamin deficiencies may require additional therapeutic amounts of specific vitamins to supplement the maintenance vitamins provided by INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE). In patients receiving parenteral multivitamins, blood vitamin concentrations should be periodically monitored to determine if vitamin deficiencies or excesses are developing. Polysorbates have been associated with the E-Ferol syndrome (thrombocytopenia, renal dysfunction, hepatomegaly, cholestasis, ascites, hypotension and metabolic acidosis) in low-birth-weight infants. However, no such adverse reports have been associated with the use of pediatric multiple vitamins for infusion such as INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE). INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE) should be aseptically transferred to the infusion fluid. Drug-Drug Interactions Physical incompatibilities: INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE) (Multiple Vitamins for Infusion) is not physically compatible with alkaline solutions or moderately alkaline drugs such as acetazolamide, and chlorothiazide sodium, aminophylline or sodium bicarbonate. INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE) is not physically compatible with ampicillin and it may not be physically compatible with tetracycline HCl. It has also been reported that folic acid is unstable in the presence of calcium salts such as calcium gluconate. Direct addition to intravenous fat emulsions is not recommended. Consult appropriate references for listings of physical compatibility of solutions and drugs with the vitamin infusion. In such circumstances, admixture or Y-site administration with vitamin solutions should be avoided. Some of the vitamins in INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE) may react with vitamin K bisulfite or sodium bisulfite; if bisulfite solutions are necessary, patients should be monitored for Vitamin A, thiamine and ascorbic acid deficiencies. Clinical Interactions: A number of interactions between vitamins and drugs have been reported which may affect the metabolism of either agent. The following are examples of these types of interactions. Folic acid may lower the serum concentration of phenytoin resulting in increased seizure frequency. Conversely, phenytoin may decrease serum folic acid concentrations and, therefore, should be avoided in pregnancy. Folic acid may decrease the patient’s response to methotrexate therapy. Pyridoxine may decrease the efficacy of levodopa by increasing its metabolism. Concomitant administration of hydralazine or isoniazid may increase pryridoxine requirements. In patients with pernicious anemia, the hematological response to vitamin B12 therapy may be inhibited by concomitant administration of chloramphenicol. Several vitamins have been reported to decrease the activity of certain antibiotics. Thiamine, riboflavin, pyridoxine, niacinamide, and ascorbic acid have been reported to decrease the antibiotic activity of erythromycin, kanamycin, streptomycin, doxycycline, and lincomycin. Bleomycin is inactivated in vitro by ascorbic acid and riboflavin. Vitamin K may antagonize the hypoprothrombinemic effect of oral anticoagulants (see PRECAUTIONS). Consult appropriate references for additional specific vitamin-drug interactions. Drug-Laboratory Test Interactions: Ascorbic acid in the urine may cause false negative urine glucose determinations. Carcinogenesis, Mutagenesis, and Impairment of Fertility: Carcinogenicity, mutagenicity and fertility studies have not been performed. Carcinogenesis, Mutagenesis, and Impairment of Fertility: Carcinogenicity, mutagenicity, and fertility studies have not been performed. Adverse Reactions There have been rare reports of anaphylactic reactions following parenteral multivitamin administration. Rare reports of anaphylactoid reactions have also been reported after large intravenous doses of thiamine. The risk, however, is negligible if thiamine is coadministered with other vitamins of the B group. There have been no reports of fatal anaphylactoid reactions associated with multivitamin preparations for infusion. There have been rare reports of the following types of reactions: Dermatologic – rash, erythema, pruritis CNS – headache, dizziness, agitation, anxiety Ophthalmic – diplopia Allergic – urticaria, shortness of breath, wheezing and angioedema. Overdosage The possibility of hypervitaminosis A or D should be borne in mind. Clinical manifestations of hypervitaminosis A have been reported in patients with renal failure receiving 1.5 mg/day retinol. Therefore, vitamin A supplementation of renal failure patients should be undertaken with caution. Dosage and Administration INFUVITE Pediatric is ready for immediate use in infants and children up to 11 years of age when added to intravenous infusion fluids. INFUVITE Pediatric should not be given as a direct, undiluted intravenous injection as it may give rise to dizziness, faintness and possible tissue irritation. A daily dose of INFUVITE Pediatric (4 mL of Vial 1 plus 1 mL of Vial 2) should be added directly to not less than 100 mL of intravenous dextrose, saline or similar infusion solutions. For administration to infants weighing < 1 kg: The daily dose is 30% of the contents of Vial 1 (1.2 mL) and of Vial 2 (0.3 mL). Do not exceed this daily dose. Supplemental vitamin A may be required for low-birth-weight infants. For administration to infants weighing ≥ 1 kg and < 3 kg: The daily dose is 65% of the contents of Vial 1 (2.6 mL) and of Vial 2 (0.65 mL). Do not exceed this daily dose. Supplemental vitamin A may be required for low-birth-weight infants. For administration to infants and children weighing ≥ 3 kg up to 11 years of age: The daily dose is the entire contents of Vial 1 (4 mL) and of Vial 2 (1 mL), unless there is clinical or laboratory evidence for increasing or decreasing the dosage. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. After INFUVITE Pediatric is diluted in an intravenous infusion, the resulting solution is ready for immediate use. Some of the vitamins in this product, particularly A, D, and riboflavin, are light sensitive, therefore, exposure to light should be minimized. DISCARD ANY UNUSED PORTION How Supplied INFUVITE Pediatric – NDC 54643-5646-0, is available in boxes containing 2 vials – Vial 1 (4 mL) and Vial 2 (1 mL), both vials to be used for a single dose. INFUVITE Pediatric – NDC 54643-5646-1, is available in boxes containing 10 vials – 5 each of Vial 1 (4 mL) and 5 each of Vial 2 (1 mL), one Vial 1 plus one Vial 2 to be used for a single dose. Store under refrigeration 2-8°C (36-46°F). Rx only Manufactured by Sandoz Canada Inc. 145 Jules-Leger Street Boucherville, QC, Canada J4B 7K8 Distributed by Baxter Healthcare Corporation Clintec Nutrition Division Deerfield, IL 60015 USA Printed in Canada D1006224 Rev. September 2007 ® INFUVITE is a registered trademark of Sandoz Canada Inc. Adverse Reactions There have been rare reports of anaphylactic reactions following parenteral multivitamin administration. Rare reports of anaphylactoid reactions have also been reported after large intravenous doses of thiamine. The risk, however, is negligible if thiamine is coadministered with other vitamins of the B group. There have been no reports of fatal anaphylactoid reactions associated with multivitamin preparations for infusion. There have been rare reports of the following types of reactions: Dermatologic – rash, erythema, pruritis CNS – headache, dizziness, agitation, anxiety Ophthalmic – diplopia Allergic – urticaria, shortness of breath, wheezing and angioedema. Overdosage The possibility of hypervitaminosis A or D should be borne in mind. Clinical manifestations of hypervitaminosis A have been reported in patients with renal failure receiving 1.5 mg/day retinol. Therefore, vitamin A supplementation of renal failure patients should be undertaken with caution. Dosage and Administration INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE) is ready for immediate use in infants and children up to 11 years of age when added to intravenous infusion fluids. INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE) should not be given as a direct, undiluted intravenous injection as it may give rise to dizziness, faintness and possible tissue irritation. Preparation of INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE) for intravenous feeding should be done by transferring the contents of Vial 2 into the contents of Vial 1 to provide ten 5 mL single doses. One daily dose of INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE) should be added directly to not less than 100 mL of intravenous dextrose, saline or similar solutions. Discard any unused portion. Daily doses in pediatric patients are determined as follows: For administration to infants weighing < 1 kg: The daily dose is 30% of the contents of a 5 mL single dose (1.5 mL of combined vials 1 and 2). Do not exceed this daily dose. Supplemental vitamin A may be required for low-birth-weight infants. For administration to infants weighing ≥ 1 kg and < 3 kg: The daily dose is 65% of the contents of a 5 mL single dose (3.25 mL of combined vials 1 and 2). Do not exceed this daily dose. Supplemental vitamin A may be required for low-birth-weight infants. For administration to infants and children weighing ≥ 3 kg up to 11 years of age: The daily dose is an entire 5 mL single dose of combined vials 1 and 2, unless there is clinical or laboratory evidence for increasing or decreasing the dosage. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. After INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE) is diluted in an intravenous infusion, the resulting solution should be refrigerated unless it is to be used immediately. The solution should be used within 24 hours after dilution. Some of the vitamins in this product, particularly A, D and riboflavin, are light sensitive, therefore, exposure to light should be minimized. Once closure system has been compromised, withdrawal of container contents should be completed within 4 hours. INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE) IS A PHARMACY BULK PACKAGE. IT IS NOT INTENDED FOR DIRECT INFUSION. DISCARD UNUSED PORTION. Directions For Dispensing From Pharmacy Bulk Vial The Pharmacy Bulk Vial is intended for single puncture, multiple dispensing and for intravenous use only. The contents are intended for use in a pharmacy admixture program and are restricted to the preparation of admixtures for infusion. The Pharmacy bulk package is to be used only in a suitable work area such as a laminar flow hood (or an equivalent clean air compounding area). Dispensing from Pharmacy Bulk Vial should be completed as soon as possible after initial entry. How Supplied INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE) NDC 54643-5647-0, is available in boxes containing 2 vials – 1 each of Vial 1 (40 mL Fill in 50 mL Vial) and Vial 2 (10 mL). Mix contents of Vial 2 with Vial 1 to provide 10 single 5 mL doses. Store under refrigeration, 2-8 °C (36-46 °F). Manufactured by Sandoz Canada Inc. 145 Jules-Léger Street Boucherville, Qc, Canada, J4B 7K8 Distributed by Baxter Healthcare Corporation Clintec Nutrition Division Deerfield, IL 60015 USA Printed in Canada 1006227 Rev. September 2007 ® INFUVITE is a registered trademark of Sandoz Canada Inc. Feuillet Infuvite Adult Baxter-D46082006__ 12-03-16 10:30 Page1 INFUVITE® ADULT PHARMACY BULK PACKAGE Multiple Vitamins for Infusion Rx Only For intravenous infusion after dilution only. Pharmacy Bulk Package Not for Direct Infusion Description INFUVITE ADULT (PHARMACY BULK PACKAGE) is a sterile product consisting of 2 vials – 1 each of Vial 1 (50 mL) and Vial 2 (50 mL Fill in 100 mL Vial), provided as a pharmacy bulk package. A pharmacy bulk package is a container of a sterile preparation for parenteral use that contains many single doses. The contents are intended for use in a pharmacy admixture program and are restricted to the preparation of admixtures for intravenous infusion. Each 5 mL of Vial 1 contains: Ascorbic acid (Vitamin C) . . . . . . . . . . . . . . . . . . . . . . . . . . .200 mg Vitamin A* (as palmitate) . . . . . . . . . . . . . . . . . . . . . . . . . .3,300 IU Vitamin D3* (cholecalciferol) . . . . . . . . . . . . . . . . . . . . . . . . .200 IU Thiamine (Vitamin B1) (as the hydrochloride) . . . . . . . . . . . . . .6 mg INFUVITE ADULT (PHARMACY BULK PACKAGE) (administered in intravenous fluids under proper dilution) contributes intake of necessary vitamins toward maintaining the body’s normal resistance and repair processes. Patients with multiple vitamin deficiencies or with markedly increased requirements may be given multiples of the daily dosage for two or more days, as indicated by the clinical status. Some patients do not maintain adequate levels of certain vitamins when a multiple vitamin preparation, such as INFUVITE ADULT (PHARMACY BULK PACKAGE), in recommended amounts, is the sole source of vitamins. Blood levels of vitamins A, C, D, and folic acid may decline in patients receiving parenteral multivitamins as their sole source of vitamins for 4 to 6 months. Therefore, in patients for whom total parenteral nutrition will be continued for long periods of time blood vitamin concentrations should be monitored to ensure maintenance of adequate levels. If deficiencies appear to be developing, multiples of the formulation (1.5 to 3 times) may be needed for a period of time. When multiples of the formulation are used for more than a few weeks, vitamins A and D should be monitored occasionally to be certain that an excess accumulation of these vitamins is not occurring. Contraindications INFUVITE ADULT (PHARMACY BULK PACKAGE) is contraindicated where there is a preexisting hypervitaminosis, or a known hypersensitivity to any of the vitamins or excipients in the product. Allergic reactions have been known to occur following intravenous administration of thiamine and vitamin K. The formulation is contraindicated prior to blood sampling for detection of megaloblastic anemia, as the folic acid and the cyanocobalamin in the vitamin solution can mask serum deficits. Warnings This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate 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. Riboflavin (Vitamin B2) (as riboflavin 5-phosphate sodium) . . . . . . . . . . . . . . . . . . .3.6 mg Precautions Pyridoxine HCl (Vitamin B6) . . . . . . . . . . . . . . . . . . . . . . . . . . .6 mg If this formulation is the only source of vitamins for long periods of time, blood concentration of each of the vitamins should be monitored, particularly vitamins A, C, D, and folic acid, to determine if deficiencies are occurring. If deficiencies are developing or when long-standing vitamin deficiencies are present, it may be necessary to add therapeutic amounts of certain vitamins to supplement the maintenance vitamins provided in INFUVITE ADULT (PHARMACY BULK PACKAGE). Niacinamide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .40 mg Dexpanthenol (as d-pantothenyl alcohol) . . . . . . . . . . . . . . . . . . . . . . . . . .15 mg Vitamin E* (dl-α-tocopheryl acetate) . . . . . . . . . . . . . . . . . . . .10 IU Vitamin K1* . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .150 mcg Inactive ingredients: 1.4% polysorbate 80, sodium hydroxide and/or hydrochloric acid for pH adjustment, and water for injection. * Polysorbate 80 is used to water solubilize the oil-soluble vitamins A, D, E, and K. Each 5 mL of Vial 2 contains: Folic acid . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .600 mcg Biotin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .60 mcg Vitamin B12 (cyanocobalamin) . . . . . . . . . . . . . . . . . . .5 mcg FPO Inactive ingredients: 30% propylene glycol, citric acid and/or sodium citrate for pH adjustment, and water for injection. “Aqueous” multiple vitamin preparation for intravenous infusion: INFUVITE ADULT (PHARMACY BULK PACKAGE) (Multiple Vitamins for Infusion) makes available a combination of important oil-soluble and water-soluble vitamins in an aqueous solution, formulated for incorporation into intravenous solutions. The liposoluble vitamins A, D, E, and K have been solubilized in an aqueous medium with polysorbate 80, permitting intravenous administration of these vitamins. Contains no more than 70 mcg/L of aluminum (combined Vials 1 and 2). Indications and Usage INFUVITE ADULT (PHARMACY BULK PACKAGE) is indicated as a daily multivitamin maintenance supplement for adults and children aged 11 and older receiving parenteral nutrition. INFUVITE ADULT (PHARMACY BULK PACKAGE) is also indicated in other situations where administration by the intravenous route is required. Such situations include surgery, extensive burns, fractures and other trauma, severe infectious diseases, and comatose states, which may provoke a “stress” situation with profound alterations in the body’s metabolic demands and consequent tissue depletion of nutrients. The physician should not await the development of clinical signs of vitamin deficiency before initiating vitamin therapy. Drug – Drug/Solution Interactions: Caution should be exercised when administering INFUVITE ADULT (PHARMACY BULK PACKAGE) to patients on warfarin sodium-type anticoagulant therapy. In such patients, vitamin K may antagonize the hypoprothrombinemic response to anticoagulant drugs, such as warfarin and its congeners. Therefore, periodic monitoring of prothrombin/INR response is essential in determining the appropriate dosage of anticoagulant therapy. INFUVITE ADULT (PHARMACY BULK PACKAGE) (Multiple Vitamins for Infusion) is not physically compatible with alkaline solutions or moderately alkaline drugs such as acetazolamide, chlorothiazide sodium, aminophylline or sodium bicarbonate. Tetracycline HCl and ampicillin may not be physically compatible with INFUVITE ADULT (PHARMACY BULK PACKAGE). Also, it has been reported that folic acid is unstable in the presence of calcium salts such as calcium gluconate. Direct addition to intravenous fat emulsions is not recommended. Consult appropriate references for listings of physical compatibility of solutions and drugs with the vitamin infusion. In such circumstances, admixture or Y-site administration with vitamin solutions should be avoided. A number of interactions between vitamins and drugs have been reported which may affect the metabolism of either agent. The following are examples of these types of interactions. Folic acid may lower the serum concentration of phenytoin resulting in increased seizure activity. Conversely, phenytoin may decrease serum folic acid concentrations and, therefore, should be avoided in pregnancy. Folic acid may decrease the patient’s response to methotrexate therapy. Pyridoxine may decrease the efficacy of levodopa by increasing its metabolism. Concomitant administration of hydralazine or isoniazid may increase pyridoxine requirements. In patients with pernicious anemia, the hematologic response to vitamin B12 therapy may be inhibited by concomitant administration of chloramphenicol. Feuillet Infuvite Adult Baxter-D46082006__ 12-03-16 10:30 Page2 Several vitamins have been reported to decrease the activity of certain antibiotics. Thiamine, riboflavin, pyridoxine, niacinamide, and ascorbic acid have been reported to decrease the antibiotic activity of erythromycin, kanamycin, streptomycin, doxycycline, and lincomycin. Bleomycin is inactivated in vitro by ascorbic acid and riboflavin. Vitamin K may antagonize the hypoprothrombinemic effect of oral anticoagulants (see bolded statement above). Consult appropriate references for additional specific vitamin-drug interactions. Some of the vitamins in INFUVITE ADULT (PHARMACY BULK PACKAGE) may react with vitamin K bisulfite or sodium bisulfite; if bisulfite solutions are necessary, patients should be monitored for vitamin A and thiamine deficiencies. Drug-Laboratory Test Interactions: Ascorbic acid in the urine may cause false negative urine glucose determinations. Carcinogenesis, Mutagenesis, and Impairment of Fertility: Carcinogenicity, mutagenicity, and fertility studies have not been performed with INFUVITE ADULT (PHARMACY BULK PACKAGE). Directions For Dispensing From Pharmacy Bulk Vial The Pharmacy Bulk Vial is intended for single puncture, multiple dispensing and for intravenous use only. The contents are intended for use in a pharmacy admixture program and are restricted to the preparation of admixtures for infusion. The Pharmacy Bulk Package is to be used only in a suitable work area such as a laminar flow hood (or an equivalent clean air compounding area). Dispensing from Pharmacy Bulk Vial should be completed as soon as possible after initial entry. How Supplied INFUVITE ADULT (PHARMACY BULK PACKAGE) – NDC 54643-5650-2, is available in boxes containing 2 vials – 1 each of Vial 1 (50 mL) and Vial 2 (50 mL Fill in 100 mL Vial). Mix contents of Vial 1 with Vial 2 to provide 10 single doses. Store under refrigeration, 2-8°C (36-46°F). Pregnancy: Pregnancy Category C: Animal reproduction studies have not been conducted with INFUVITE ADULT (PHARMACY BULK PACKAGE) (Multiple Vitamins for Infusion). INFUVITE ADULT (PHARMACY BULK PACKAGE) should be given to a pregnant woman only if clearly needed. Pregnant women should follow the U.S. Recommended Daily Allowances for their condition, because their vitamin requirements may exceed those of nonpregnant women. The use of INFUVITE ADULT (PHARMACY BULK PACKAGE) has not been studied in human pregnancy. Nursing Mothers: Lactating women should follow the U.S. Recommended Daily Allowances for their condition, because their vitamin requirement may exceed those of nonlactating women. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when INFUVITE ADULT (PHARMACY BULK PACKAGE) is administered to a nursing mother. Pediatric Use: Safety and effectiveness in children below the age of 11 years have not been established. Adverse Reactions There have been rare reports of anaphylactic reactions following parenteral multivitamin administration. Rare reports of anaphylactoid reactions have also been reported following large intravenous doses of thiamine. However, the risk is negligible if thiamine is coadministered with other vitamins of the B group. There have been rare reports of the following types of reactions: Dermatologic – rash, erythema, pruritis CNS – headache, dizziness, agitation, anxiety Ophthalmic – diplopia Allergic – urticaria, shortness of breath, wheezing and angioedema. Overdosage The fat-soluble vitamins A, D, and E can accumulate to harmful levels. The possibility of hypervitaminosis A or D should be borne in mind. Clinical manifestations of hypervitaminosis A have been reported in patients with renal failure receiving 1.5 mg/day retinol. Therefore, vitamin A supplementation of renal failure patients should be undertaken with caution. Water-soluble vitamins are readily excreted in the urine. Treatment of vitamin overdosage usually consists of withdrawal of the vitamin. Dosage and Administration INFUVITE ADULT (PHARMACY BULK PACKAGE) is ready for immediate use in adults and children aged 11 years and older when added to intravenous infusion fluids. FPO INFUVITE ADULT (PHARMACY BULK PACKAGE) should not be given as a direct, undiluted intravenous injection as it may give rise to dizziness, faintness, and possible tissue irritation. Preparation of INFUVITE ADULT (PHARMACY BULK PACKAGE) for intravenous feeding should be done by transferring the contents of Vial 1 into the contents of Vial 2 to provide ten 10 mL single doses. One daily 10 mL dose should be added directly to not less than 500 mL, and preferably 1000 mL, of intravenous dextrose, saline or similar infusion solutions. Discard any unused portion. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. After INFUVITE ADULT (PHARMACY BULK PACKAGE) is diluted in an intravenous infusion, the resulting solution should be refrigerated unless it is to be used immediately. The solution should be used within 24 hours after dilution. Some of the vitamins in this product, particularly A, D and riboflavin, are light sensitive; therefore, exposure to light should be minimized. Once closure system has been compromised, withdrawal of container contents should be completed within 4 hours. INFUVITE ADULT (PHARMACY BULK PACKAGE) IS A PHARMACY BULK PACKAGE. IT IS NOT INTENDED FOR DIRECT INFUSION. DISCARD UNUSED PORTION. Manufactured by Sandoz Canada Inc. 145 Jules-Léger Street Boucherville, Qc, Canada, J4B 7K8 Distributed by Baxter Healthcare Corporation Clintec Nutrition Division Deerfield, IL 60015 USA Printed in Canada D46082006 Rev. March 2012 ® Parmacode: 8153 INFUVITE is a registered trademark of Sandoz Canada Inc. 22582•Baxter Inf. 1006224 1/7/08 1:08 PM Page 2 megaloblastic anemia, as the folic acid and the cyanocobalamin in the vitamin solution can mask serum deficits. INFUVITE® ADULT Multiple Vitamins for Infusion For intravenous infusion after dilution only. Description INFUVITE ADULT is a sterile product consisting of two 5 mL singledose vials labeled Vial 1 and Vial 2. Each 5 mL of Vial 1 contains: Ascorbic acid (Vitamin C) .................................................... 200 mg Vitamin A* (as palmitate) ................................................... 3,300 IU Vitamin D3* (cholecalciferol) ................................................. 200 IU Thiamine (Vitamin B1) (as the hydrochloride) .......................... 6 mg Riboflavin (Vitamin B2) (as riboflavin 5-phosphate sodium) .. 3.6 mg Pyridoxine HCl (Vitamin B6) ..................................................... 6 mg Niacinamide ......................................................................... 40 mg Dexpanthenol (as d-pantothenyl alcohol ............................... 15 mg Vitamin E* (dl-α-tocopheryl acetate) ...................................... 10 IU Vitamin K1* ....................................................................... 150 mcg Inactive ingredients: 1.4% polysorbate 80, sodium hydroxide and/or hydrochloric acid for pH adjustment, and water for injection. * Polysorbate 80 is used to water solubilize the oil-soluble vitamins A, D, E, and K. Each 5 mL of Vial 2 contains: Folic acid .......................................................................... 600 mcg Biotin .................................................................................. 60 mcg Vitamin B12 (cyanocobalamin) ............................................... 5 mcg Inactive ingredients: 30% propylene glycol, citric acid and/or sodium citrate for pH adjustment, and water for injection. “Aqueous” multiple vitamin preparation for intravenous infusion: INFUVITE ADULT (Multiple Vitamins for Infusion) makes available a combination of important oil-soluble and water-soluble vitamins in an aqueous solution, formulated for incorporation into intravenous solutions. The liposoluble vitamins A, D, E, and K have been solubilized in an aqueous medium with polysorbate 80, permitting intravenous administration of these vitamins. Contains no more than 70 mcg/L of aluminum (combined Vials 1 and 2). Indications and Usage INFUVITE ADULT is indicated as a daily multivitamin maintenance supplement for adults and children aged 11 and older receiving parenteral nutrition. INFUVITE ADULT is also indicated in other situations where administration by the intravenous route is required. Such situations include surgery, extensive burns, fractures and other trauma, severe infectious diseases, and comatose states, which may provoke a “stress” situation with profound alterations in the body’s metabolic demands and consequent tissue depletion of nutrients. The physician should not await the development of clinical signs of vitamin deficiency before initiating vitamin therapy. INFUVITE ADULT (administered in intravenous fluids under proper dilution) contributes intake of necessary vitamins toward maintaining the body’s normal resistance and repair processes. Patients with multiple vitamin deficiencies or with markedly increased requirements may be given multiples of the daily dosage for two or more days, as indicated by the clinical status. Some patients do not maintain adequate levels of certain vitamins when a multiple vitamin preparation, such as INFUVITE ADULT, in recommended amounts, is the sole source of vitamins. Blood levels of vitamins A, C, D, and folic acid may decline in patients receiving parenteral multivitamins as their sole source of vitamins for 4 to 6 months. Therefore, in patients for whom total parenteral nutrition will be continued for long periods of time blood vitamin concentrations should be monitored to ensure maintenance of adequate levels. If deficiencies appear to be developing, multiples of the formulation (1.5 to 3 times) may be needed for a period of time. When multiples of the formulation are used for more than a few weeks, vitamins A and D should be monitored occasionally to be certain that an excess accumulation of these vitamins is not occurring. Contraindications INFUVITE ADULT is contraindicated where there is a preexisting hypervitaminosis, or a known hypersensitivity to any of the vitamins or excipients in the product. Allergic reactions have been known to occur following intravenous administration of thiamine and vitamin K. The formulation is contraindicated prior to blood sampling for detection of Warnings This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate 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. Precautions If this formulation is the only source of vitamins for long periods of time, blood concentration of each of the vitamins should be monitored, particularly vitamins A, C, D, and folic acid, to determine if deficiencies are occurring. If deficiencies are developing or when long-standing vitamin deficiencies are present, it may be necessary to add therapeutic amounts of certain vitamins to supplement the maintenance vitamins provided in INFUVITE ADULT. Drug – Drug/Solution Interactions: Caution should be exercised when administering INFUVITE ADULT to patients on warfarin sodium-type anticoagulant therapy. In such patients, vitamin K may antagonize the hypoprothrombinemic response to anticoagulant drugs, such as warfarin and its congeners. Therefore, periodic monitoring of prothrombin/INR response is essential in determining the appropriate dosage of anticoagulant therapy. INFUVITE ADULT (Multiple Vitamins for Infusion) is not physically compatible with alkaline solutions or moderately alkaline drugs such as acetazolamide, chlorothiazide sodium, aminophylline or sodium bicarbonate. Tetracycline HCl and ampicillin may not be physically compatible with INFUVITE ADULT. Also, it has been reported that folic acid is unstable in the presence of calcium salts such as calcium gluconate. Direct addition to intravenous fat emulsions is not recommended. Consult appropriate references for listings of physical compatibility of solutions and drugs with the vitamin infusion. In such circumstances, admixture or Y-site administration with vitamin solutions should be avoided. A number of interactions between vitamins and drugs have been reported which may affect the metabolism of either agent. The following are examples of these types of interactions. Folic acid may lower the serum concentration of phenytoin resulting in increased seizure activity. Conversely, phenytoin may decrease serum folic acid concentrations and, therefore, should be avoided in pregnancy. Folic acid may decrease the patient’s response to methotrexate therapy. Pyridoxine may decrease the efficacy of levodopa by increasing its metabolism. Concomitant administration of hydralazine or isoniazid may increase pyridoxine requirements. In patients with pernicious anemia, the hematologic response to vitamin B12 therapy may be inhibited by concomitant administration of chloramphenicol. Several vitamins have been reported to decrease the activity of certain antibiotics. Thiamine, riboflavin, pyridoxine, niacinamide, and ascorbic acid have been reported to decrease the antibiotic activity of erythromycin, kanamycin, streptomycin, doxycycline, and lincomycin. Bleomycin is inactivated in vitro by ascorbic acid and riboflavin. Vitamin K may antagonize the hypoprothrombinemic effect of oral anticoagulants (see bolded statement above). Consult appropriate references for additional specific vitamin-drug interactions. Some of the vitamins in INFUVITE ADULT may react with vitamin K bisulfite or sodium bisulfite; if bisulfite solutions are necessary, patients should be monitored for vitamin A and thiamine deficiencies. Drug-Laboratory Test Interactions: Ascorbic acid in the urine may cause false negative urine glucose determinations. Carcinogenesis, Mutagenesis, and Impairment of Fertility: Carcinogenicity, mutagenicity, and fertility studies have not been performed with INFUVITE ADULT. Pregnancy: Pregnancy Category C: Animal reproduction studies have not been conducted with INFUVITE ADULT (Multiple Vitamins for Infusion). INFUVITE ADULT should be given to a pregnant woman only if clearly needed. Pregnant women should follow the U.S. Recommended Daily Allowances for their condition, because their vitamin requirements may exceed those of nonpregnant women. The use of INFUVITE ADULT has not been studied in human pregnancy. Multiple Vitamins for Infusion Rx only For intravenous infusion after dilution only. Pharmacy Bulk Package Not for Direct Infusion Description INFUVITE ADULT (PHARMACY BULK PACKAGE) is a sterile product consisting of 2 vials – 1 each of Vial 1 (50 mL) and Vial 2 (50 mL Fill in 100 mL Vial), provided as a pharmacy bulk package. A pharmacy bulk package is a container of a sterile preparation for parenteral use that contains many single doses. The contents are intended for use in a pharmacy admixture program and are restricted to the preparation of admixtures for intravenous infusion. Each 5 mL of Vial 1 contains: Ascorbic acid (Vitamin C) ......................................................... 200 mg Vitamin A* (as palmitate) ........................................................ 3,300 IU Vitamin D3* (cholecalciferol) ...................................................... 200 IU Thiamine (Vitamin B1) (as the hydrochloride)................................ 6 mg Riboflavin (Vitamin B2) (as riboflavin 5-phosphate sodium) ....... 3.6 mg Pyridoxine HCl (Vitamin B6) .......................................................... 6 mg Niacinamide............................................................................... 40 mg Dexpanthenol (as d-pantothenyl alcohol) ................................... 15 mg Vitamin E* (dl-α-tocopheryl acetate)............................................ 10 IU Vitamin K1* ............................................................................ 150 mcg Inactive ingredients: 1.4% polysorbate 80, sodium hydroxide and/or hydrochloric acid for pH adjustment, and water for injection. * Polysorbate 80 is used to water solubilize the oil-soluble vitamins A, D, E, and K. Each 5 mL of Vial 2 contains: Folic acid ............................................................................... 600 mcg Biotin ....................................................................................... 60 mcg Vitamin B12 (cyanocobalamin)..................................................... 5 mcg Inactive ingredients: 30% propylene glycol, citric acid and/or sodium citrate for pH adjustment, and water for injection. “Aqueous” multiple vitamin preparation for intravenous infusion: INFUVITE ADULT (PHARMACY BULK PACKAGE) (Multiple Vitamins for Infusion) makes available a combination of important oil-soluble and water-soluble vitamins in an aqueous solution, formulated for incorporation into intravenous solutions. The liposoluble vitamins A, D, E, and K have been solubilized in an aqueous medium with polysorbate 80, permitting intravenous administration of these vitamins. Contains no more than 70 mcg/L of aluminum (combined Vials 1 and 2). Indications and Usage INFUVITE ADULT (PHARMACY BULK PACKAGE) is indicated as a daily multivitamin maintenance supplement for adults and children aged 11 and older receiving parenteral nutrition. INFUVITE ADULT (PHARMACY BULK PACKAGE) is also indicated in other situations where administration by the intravenous route is required. Such situations include surgery, extensive burns, fractures and other trauma, severe infectious diseases, and comatose states, which may provoke a “stress” situation with profound alterations in the body’s metabolic demands and consequent tissue depletion of nutrients. The physician should not await the development of clinical signs of vitamin deficiency before initiating vitamin therapy. INFUVITE ADULT (PHARMACY BULK PACKAGE) (administered in intravenous fluids under proper dilution) contributes intake of necessary vitamins toward maintaining the body’s normal resistance and repair processes. Patients with multiple vitamin deficiencies or with markedly increased requirements may be given multiples of the daily dosage for two or more days, as indicated by the clinical status. Some patients do not maintain adequate levels of certain vitamins when a multiple vitamin preparation, such as INFUVITE ADULT (PHARMACY BULK PACKAGE), in recommended amounts, is the sole source of vitamins. Blood levels of vitamins A, C, D, and folic acid may decline in patients receiving parenteral multivitamins as their sole source of vitamins for 4 to 6 months. Therefore, in patients for whom total parenteral nutrition will be continued for long periods of time blood vitamin concentrations should be monitored to ensure maintenance of adequate levels. If deficiencies appear to be developing, multiples of the formulation (1.5 to 3 times) may be needed for a period of time. When multiples of the formulation are used for more than a few weeks, vitamins A and D should be monitored occasionally to be certain that an excess accumulation of these vitamins is not occurring. Adverse Reactions There have been rare reports of anaphylactic reactions following parenteral multivitamin administration. Rare reports of anaphylactoid reactions have also been reported following large intravenous doses of thiamine. However, the risk is negligible if thiamine is coadministered with other vitamins of the B group. There have been rare reports of the following types of reactions: Dermatologic – rash, erythema, pruritis CNS – headache, dizziness, agitation, anxiety Ophthalmic – diplopia Allergic – urticaria, shortness of breath, wheezing and angioedema. Overdosage The fat-soluble vitamins A, D, and E can accumulate to harmful levels. The possibility of hypervitaminosis A or D should be borne in mind. Clinical manifestations of hypervitaminosis A have been reported in patients with renal failure receiving 1.5 mg/day retinol. Therefore, vitamin A supplementation of renal failure patients should be undertaken with caution. Water-soluble vitamins are readily excreted in the urine. Treatment of vitamin overdosage usually consists of withdrawal of the vitamin. Dosage and Administration INFUVITE ADULT is ready for immediate use in adults and children aged 11 years and older when added to intravenous infusion fluids. INFUVITE ADULT should not be given as a direct, undiluted intravenous injection as it may give rise to dizziness, faintness, and possible tissue irritation. For intravenous feeding, one daily dose of INFUVITE ADULT (5 mL of Vial 1 plus 5 mL of Vial 2) added directly to not less than 500 mL, and preferably 1,000 mL, of intravenous dextrose, saline or similar infusion solutions. Discard any unused portion. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. After INFUVITE ADULT is diluted in an intravenous infusion, the resulting solution should be refrigerated unless it is to be used immediately. The solution should be used within 24 hours after dilution. Some of the vitamins in this product, particularly A, D, and riboflavin, are light sensitive, therefore, exposure to light should be minimized. How Supplied INFUVITE ADULT – NDC 54643-5649-1, is available in boxes containing 10 vials - 5 each of Vial 1 (5 mL) and Vial 2 (5 mL), one Vial 1 plus one Vial 2 to be used for a single dose. Store under refrigeration, 2-8°C (36-46°F). Rx only Manufactured by Sandoz Canada Inc. 145 Jules-Leger Street Boucherville, QC, Canada J4B 7K8 Distributed by Baxter Healthcare Corporation Clintec Nutrition Division Deerfield, IL 60015 USA Printed in Canada D1006230 Rev. September 2007 ® INFUVITE is a registered trademark of Sandoz Canada Inc. INFUVITE ADULT (PHARMACY BULK PACKAGE) is contraindicated where there is a preexisting hypervitaminosis, or a known hypersensitivity to any of the vitamins or excipients in the product. Allergic reactions have been known to occur following intravenous administration of thiamine and vitamin K. The formulation is contraindicated prior to blood sampling for detection of megaloblastic anemia, as the folic acid and the cyanocobalamin in the vitamin solution can mask serum deficits. Nursing Mothers: Lactating women should follow the U.S. Recommended Daily Allowances for their condition, because their vitamin requirement may exceed those of nonlactating women. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when INFUVITE ADULT (PHARMACY BULK PACKAGE) is administered to a nursing mother. Pediatric Use: Safety and effectiveness in children below the age of 11 years have not been established. Warnings Adverse Reactions Contraindications INFUVITE® ADULT PHARMACY BULK PACKAGE Nursing Mothers: Lactating women should follow the U.S. Recommended Daily Allowances for their condition, because their vitamin requirement may exceed those of nonlactating women. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when INFUVITE ADULT is administered to a nursing mother. Pediatric Use: Safety and effectiveness in children below the age of 11 years have not been established. This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate 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. There have been rare reports of anaphylactic reactions following parenteral multivitamin administration. Rare reports of anaphylactoid reactions have also been reported following large intravenous doses of thiamine. However, the risk is negligible if thiamine is coadministered with other vitamins of the B group. There have been rare reports of the following types of reactions: Dermatologic – rash, erythema, pruritis CNS – headache, dizziness, agitation, anxiety Ophthalmic – diplopia Allergic – urticaria, shortness of breath, wheezing and angioedema. Precautions Overdosage If this formulation is the only source of vitamins for long periods of time, blood concentration of each of the vitamins should be monitored, particularly vitamins A, C, D, and folic acid, to determine if deficiencies are occurring. If deficiencies are developing or when long-standing vitamin deficiencies are present, it may be necessary to add therapeutic amounts of certain vitamins to supplement the maintenance vitamins provided in INFUVITE ADULT (PHARMACY BULK PACKAGE). Drug – Drug/Solution Interactions: Caution should be exercised when administering INFUVITE ADULT (PHARMACY BULK PACKAGE) to patients on warfarin sodium-type anticoagulant therapy. In such patients, vitamin K may antagonize the hypoprothrombinemic response to anticoagulant drugs, such as warfarin and its congeners. Therefore, periodic monitoring of prothrombin/INR response is essential in determining the appropriate dosage of anticoagulant therapy. INFUVITE ADULT (PHARMACY BULK PACKAGE) (Multiple Vitamins for Infusion) is not physically compatible with alkaline solutions or moderately alkaline drugs such as acetazolamide, chlorothiazide sodium, aminophylline or sodium bicarbonate. Tetracycline HCl and ampicillin may not be physically compatible with INFUVITE ADULT (PHARMACY BULK PACKAGE). Also, it has been reported that folic acid is unstable in the presence of calcium salts such as calcium gluconate. Direct addition to intravenous fat emulsions is not recommended. Consult appropriate references for listings of physical compatibility of solutions and drugs with the vitamin infusion. In such circumstances, admixture or Y-site administration with vitamin solutions should be avoided. A number of interactions between vitamins and drugs have been reported which may affect the metabolism of either agent. The following are examples of these types of interactions. Folic acid may lower the serum concentration of phenytoin resulting in increased seizure activity. Conversely, phenytoin may decrease serum folic acid concentrations and, therefore, should be avoided in pregnancy. Folic acid may decrease the patient’s response to methotrexate therapy. Pyridoxine may decrease the efficacy of levodopa by increasing its metabolism. Concomitant administration of hydralazine or isoniazid may increase pyridoxine requirements. In patients with pernicious anemia, the hematologic response to vitamin B12 therapy may be inhibited by concomitant administration of chloramphenicol. Several vitamins have been reported to decrease the activity of certain antibiotics. Thiamine, riboflavin, pyridoxine, niacinamide, and ascorbic acid have been reported to decrease the antibiotic activity of erythromycin, kanamycin, streptomycin, doxycycline, and lincomycin. Bleomycin is inactivated in vitro by ascorbic acid and riboflavin. Vitamin K may antagonize the hypoprothrombinemic effect of oral anticoagulants (see bolded statement above). Consult appropriate references for additional specific vitamin-drug interactions. Some of the vitamins in INFUVITE ADULT (PHARMACY BULK PACKAGE) may react with vitamin K bisulfite or sodium bisulfite; if bisulfite solutions are necessary, patients should be monitored for vitamin A and thiamine deficiencies. Drug-Laboratory Test Interactions: Ascorbic acid in the urine may cause false negative urine glucose determinations. Carcinogenesis, Mutagenesis, and Impairment of Fertility: Carcinogenicity, mutagenicity, and fertility studies have not been performed with INFUVITE ADULT (PHARMACY BULK PACKAGE). Pregnancy: Pregnancy Category C: Animal reproduction studies have not been conducted with INFUVITE ADULT (PHARMACY BULK PACKAGE) (Multiple Vitamins for Infusion). INFUVITE ADULT (PHARMACY BULK PACKAGE) should be given to a pregnant woman only if clearly needed. Pregnant women should follow the U.S. Recommended Daily Allowances for their condition, because their vitamin requirements may exceed those of nonpregnant women. The use of INFUVITE ADULT (PHARMACY BULK PACKAGE) has not been studied in human pregnancy. The fat-soluble vitamins A, D, and E can accumulate to harmful levels. The possibility of hypervitaminosis A or D should be borne in mind. Clinical manifestations of hypervitaminosis A have been reported in patients with renal failure receiving 1.5 mg/day retinol. Therefore, vitamin A supplementation of renal failure patients should be undertaken with caution. Water-soluble vitamins are readily excreted in the urine. Treatment of vitamin overdosage usually consists of withdrawal of the vitamin. Dosage and Administration INFUVITE ADULT (PHARMACY BULK PACKAGE) is ready for immediate use in adults and children aged 11 years and older when added to intravenous infusion fluids. INFUVITE ADULT (PHARMACY BULK PACKAGE) should not be given as a direct, undiluted intravenous injection as it may give rise to dizziness, faintness, and possible tissue irritation. Preparation of INFUVITE ADULT (PHARMACY BULK PACKAGE) for intravenous feeding should be done by transferring the contents of Vial 1 into the contents of Vial 2 to provide ten 10 mL single doses. One daily 10 mL dose should be added directly to not less than 500 mL, and preferably 1000 mL, of intravenous dextrose, saline or similar infusion solutions. Discard any unused portion. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. After INFUVITE ADULT (PHARMACY BULK PACKAGE) is diluted in an intravenous infusion, the resulting solution should be refrigerated unless it is to be used immediately. The solution should be used within 24 hours after dilution. Some of the vitamins in this product, particularly A, D and riboflavin, are light sensitive; therefore, exposure to light should be minimized. Once closure system has been compromised, withdrawal of container contents should be completed within 4 hours. INFUVITE ADULT (PHARMACY BULK PACKAGE) IS A PHARMACY BULK PACKAGE. IT IS NOT INTENDED FOR DIRECT INFUSION. DISCARD UNUSED PORTION. Directions For Dispensing From Pharmacy Bulk Vial The Pharmacy Bulk Vial is intended for single puncture, multiple dispensing and for intravenous use only. The contents are intended for use in a pharmacy admixture program and are restricted to the preparation of admixtures for infusion. The Pharmacy Bulk Package is to be used only in a suitable work area such as a laminar flow hood (or an equivalent clean air compounding area). Dispensing from Pharmacy Bulk Vial should be completed as soon as possible after initial entry. How Supplied INFUVITE ADULT (PHARMACY BULK PACKAGE) NDC 54643-5649-2, is available in boxes containing 2 vials – 1 each of Vial 1 (50 mL) and Vial 2 (50 mL Fill in 100 mL Vial). Mix contents of Vial 1 with Vial 2 to provide 10 single doses. Store under refrigeration, 2-8°C (36-46°F). Manufactured by Sandoz Canada Inc. 145 Jules-Léger Street Boucherville, Qc, Canada, J4B 7K8 Distributed by Baxter Healthcare Corporation Clintec Nutrition Division Deerfield, IL 60015 USA Printed in Canada 1006234 Rev. September 2007 ® INFUVITE is a registered trademark of Sandoz Canada Inc.
