Multiple Vitamins Injection

1 INDICATIONS AND USAGE INFUVITE PEDIATRIC is a 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 a combination of vitamins indicated for the prevention of vitamin deficiency in pediatric patients up to 11 years of age receiving parenteral nutrition ( 1 )

6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling. • Allergic reactions to thiamine [see Warnings and Precautions ( 5.2 )] . • Hypervitaminosis A [see Warnings and Precautions ( 5.3 )] The following adverse reactions have been identified during postapproval use of INFUVITE PEDIATRIC. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

8.1 Pregnancy Risk Summary Administration of the approved recommended dose of INFUVITE PEDIATRIC in parental nutrition is not expected to cause major birth defects, miscarriage, or adverse maternal or fetal outcomes. Pregnant patients should follow the U.S. Recommended Daily Allowances for pregnancy because their vitamin requirements may exceed those of nonpregnant patients. Deficiency of essential vitamins may result in adverse pregnancy outcomes (see Clinical Considerations) . Animal reproduction studies have not been conducted with INFUVITE PEDIATRIC.

5 WARNINGS AND PRECAUTIONS • Risk of Aluminum Toxicity : For at risk patients (renal failure or those with prolonged therapy), consider periodic monitoring of aluminum levels ( 5.1 ) • Allergic Reactions : To thiamine may occur ( 5.2 ) • Hypervitaminosis A : Patients with renal failure or liver disease may be at higher risk ( 5.3 ) • Decreased Anticoagulant Effect of Warfarin : Monitor INR ( 5.4 , 7.1 ) • Interferes with Megaloblastic Anemia Diagnosis : Avoid during testing for this disorder ( 5.5 ) • Risk of Vitamin Deficiencies or Excesses : Monitor blood vitamin concentrations ( 5.6 ) • False Negative Urine Glucose Tests : Due to vitamin C ( 5.7 ) • Risk of Vitamin E Toxicity : Additional oral and parenteral vitamin E may result in elevated vitamin E blood concentrations in infants ( 5.... 4 CONTRAINDICATIONS INFUVITE PEDIATRIC is contraindicated in patients who have: • An existing hypervitaminosis, or • A history of hypersensitivity to any vitamins or excipients contained in this formulation. • Hypersensitivity to any of vitamins or excipients ( 4 ) • Existing hypervitaminosis ( 4 )