Rx only

For intravenous infusion after dilution only.

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.

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.

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 (PHARMACY BULK PACKAGE).

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.

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 BULKPACKAGE) 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 54643-5650-2, 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).

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

46082006
Rev. March 2012

® INFUVITE is a registered trademark of Sandoz Canada Inc.

Infuvite Adult Pharmacy Bulk Package Carton

2A9019 NDC 54643-5650-2

Baxter

INFUVITE® ADULT

PHARMACY BULK PACKAGE

Multiple Vitamins for Infusion

PHARMACY BULK PACKAGE

NOT FOR DIRECT INFUSION

For intravenous infusion after dilution only.

Sterile Rx only

Contents: Vial 1 (50 mL) and

Vial 2 (50 mL Fill in 100 mL Vial).

Both vials combined produce 10 single doses.

Store under refrigeration, 2-8°C (36-46°F).