Adult Infuvite Multiple Vitamins For Infusion

Adult Infuvite Multiple Vitamins For Infusion

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).

Adult Infuvite Multiple Vitamins For Infusion Manufacturers


  • Sandoz Canada Inc
    Adult Infuvite Multiple Vitamins For Infusion (Asorbic Acid, Vitamin A Palmitate, Cholecalciferol, Thiamine Hydrochloride, Riboflavin 5-phosphate Sodium, Pyridoxine Hydrochloride, Niacinamide, Dexpanthenol, Alpha-tocopherol Acetate, Vitamin K1, Folic Acid, Biotin, Cyanocobalamin) Injection, Solution [Sandoz Canada Inc]

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