FDA records indicate that there are no current recalls for this drug.
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Adult Infuvite Multiple Vitamins For Infusion Recall
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Questions & Answers
Side Effects & Adverse Reactions
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.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
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.
History
There is currently no drug history available for this drug.
Other Information
INFUVITE ADULT is a sterile product consisting of two 5 mL single-dose 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).
Sources
Adult Infuvite Multiple Vitamins For Infusion Manufacturers
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Sandoz Canada Inc
Adult Infuvite Multiple Vitamins For Infusion | Sandoz Canada Inc
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.
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