Infuvite Pediatric

• If your child has an allergy to Infuvite Pediatric (vitamins (multiple/injectable)) or any part of this medicine.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have too many vitamins in the body.

This is not a list of all drugs or health problems that interact with Infuvite Pediatric.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as an infusion into a vein over a period of time after being added to fluids.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if you have any side effects that bother you or do not go away.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

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.

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 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 Pediatric.

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.

. 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 A should be monitored periodically.

Decreased Anticoagulant Effect of Warfarin

Infuvite Pediatric contains Vitamin K 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.

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.

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)].

Interference with Urine Glucose Testing

Infuvite Pediatric contains vitamin C which is also known as ascorbic acid. Ascorbic acid in the urine may cause false negative urine glucose results.

Vitamin E Overdose in Infants Receiving Additional Vitamin E

Additional vitamin E supplementations of patients receiving Infuvite Pediatric may result in elevated blood concentrations of vitamin E and potential vitamin E toxicity in infants. Avoid additional oral or parental doses of vitamin E in infants. Daily dose of Infuvite Pediatric contains adequate concentrations of vitamin E required to achieve normal blood levels of vitamin E.

Risk of Low Vitamin A Levels

Lower vitamin A concentrations may occur after administration of Infuvite Pediatric due to the adherence of Vitamin A to plastic. Monitor blood vitamin A concentrations periodically. Additional administration of therapeutic doses of vitamin A may be required, especially in low-birth weight infants.

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.

The following adverse reactions are discussed in greater detail in other sections of the labeling.

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.

Infuvite Pediatric (multiple vitamins injection) is a sterile product consisting of two vials provided as a single dose or as a 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:

Vial 1 will provide one daily dose of 1.2 mL, 2.6 mL or 4 mL and Vial 2 will provide one daily dose of 0.3 mL, 0.65 mL or 1 mL [see Dosage and Administration (2.2)].

Infuvite Pediatric (multiple vitamins injection) supplied as pharmacy bulk package consists of:

The mixed solution will provide many single doses [see Dosage and Administration (2.2)].

Each 4 mL of Vial 1 contains 10 vitamins and each 1 mL of Vial 2 contains 3 vitamins (see Table 3).

Infuvite Pediatric (multiple vitamins injection) makes available a 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 K 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 1 and 2).