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Infuvite Pediatric Pharmacy Bulk Package

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Infuvite Pediatric Pharmacy Bulk Package

Indications
Dosage
How Supplied

INDICATIONS

INFUVITE (multiple vitamins for infusion pharmacy bulk package) 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 (multiple vitamins for infusion pharmacy bulk package) 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 (multiple vitamins for infusion pharmacy bulk package) 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.

DOSAGE AND ADMINISTRATION

INFUVITE (multiple vitamins for infusion pharmacy bulk package) 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 (multiple vitamins for infusion pharmacy bulk package) 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 (multiple vitamins for infusion pharmacy bulk package) 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 (multiple vitamins for infusion pharmacy bulk package) 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 (multiple vitamins for infusion pharmacy bulk package) 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 (multiple vitamins for infusion pharmacy bulk package) 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 (multiple vitamins for infusion pharmacy bulk package) 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. Rev. September 2007. FDA revision date: n/a

Last reviewed on RxList: 2/13/2009
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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