Pediatric Infuvite Multiple Vitamins For Infusion
Loading...Pediatric Infuvite Multiple Vitamins For Infusion Recall
Get an alert when a recall is issued.
Questions & Answers
Side Effects & Adverse Reactions
INFUVITE Pediatric is administered in intravenous solutions, which may contain 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 Pediatric is indicated as a daily multivitamin maintenance dosage for infants and children up to 11 years of age receiving parenteral nutrition.
INFUVITE Pediatric 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 Pediatric (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.
History
There is currently no drug history available for this drug.
Other Information
INFUVITE Pediatric is a sterile product consisting of two vials: a 4 mL single-dose vial labeled Vial 1 and a 1 mL single-dose vial labeled Vial 2.
Each 4 mL of Vial 1 contains:
Ascorbic acid (Vitamin C) ......................................... 80 mg
Vitamin A1 (as palmitate)...................................... 2,300 IU
Vitamin D31 (cholecalciferol) ................................... 400 IU
Thiamine (Vitamin B1)
(as the hydrochloride)............................................ 1.2 mg
Riboflavin (Vitamin B2)
(as riboflavin 5-phosphate sodium) ....................... 1.4 mg
Pyridoxine HCl (Vitamin B6) ....................................... 1 mg
Niacinamide .............................................................. 17 mg
Dexpanthenol
(as d-pantothenyl alcohol) ........................................ 5 mg
Vitamin E1 (dl-α-tocopheryl acetate)........................... 7 IU
Vitamin K11.............................................................. 0.2 mg
Inactive ingredients: 50 mg polysorbate 80, sodium hydroxide and/or hydrochloric acid for pH adjustment and water for injection.
1Polysorbate 80 is used to water solubilize the oil-soluble vitamins A, D, E, and K.
Each 1 mL of Vial 2 contains:
Folic acid............................................................... 140 mcg
Biotin....................................................................... 20 mcg
Vitamin B12 (cyanocobalamin).................................. 1 mcg
Inactive ingredients: 75 mg mannitol, citric acid and/or sodium citrate for pH adjustment and water for injection.
Vitamin A 2,300 IU equals 0.7 mg
Vitamin D 400 IU equals 10 mcg
Vitamin E 7 IU equals 7 mg
Multiple vitamin preparation for intravenous infusion: INFUVITE Pediatric (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 30 mcg/L of aluminum (combined vials 1 and 2).
Sources
Pediatric Infuvite Multiple Vitamins For Infusion Manufacturers
-
Sandoz Canada Inc
![Pediatric 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]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Pediatric Infuvite Multiple Vitamins For Infusion | Sandoz Canada Inc
INFUVITE Pediatric is ready for immediate use in infants and children up to 11 years of age when added to intravenous infusion fluids.
INFUVITE Pediatric should not be given as a direct, undiluted intravenous injection as it may give rise to dizziness, faintness and possible tissue irritation.
A daily dose of INFUVITE Pediatric (4 mL of Vial 1 plus 1 mL of Vial 2) should be added directly to not less than 100 mL of intravenous dextrose, saline or similar infusion solutions.
For administration to infants weighing < 1 kg:
The daily dose is 30% of the contents of Vial 1 (1.2 mL) and of Vial 2 (0.3 mL). 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 Vial 1 (2.6 mL) and of Vial 2 (0.65 mL). 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 the entire contents of Vial 1 (4 mL) and of Vial 2 (1 mL), 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 Pediatric is diluted in an intravenous infusion, the resulting solution is ready for immediate use. Some of the vitamins in this product, particularly A, D, and riboflavin, are light sensitive, therefore, exposure to light should be minimized. DISCARD ANY UNUSED PORTION
Login To Your Free Account