INFUVITE ADULT (Pharmacy Bulk Package) is indicated for the prevention of vitamin deficiency in adults and
children aged 11 and older receiving parenteral nutrition
The physician should not await
the development of clinical signs of vitamin deficiency before initiating
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. Do not administer INFUVITE
ADULT (Pharmacy Bulk Package) as a direct, undiluted intravenous injection as
it may give rise to dizziness, faintness, and possible tissue irritation.
Starting Dose, Dose Range and
Route of Administration
The starting dose is one 10 mL
daily dose that is prepared by transferring the content of vial 1 into the
content of vial 2 to provide 10 single doses. One 10 mL dose is then added
directly to the intravenous fluid. Patients
with multiple vitamin deficiencies or with increased vitamin requirements may
need multiple daily dosages as indicated. Some patients do not maintain
adequate levels of certain vitamins when this formulation in recommended
amounts is the only source of vitamins
Blood vitamin concentrations
should be monitored to ensure maintenance of adequate levels, particularly in
patients receiving parenteral multivitamins as the only source of vitamins for
long periods of time.
Instructions for Intravenous
The solution must be prepared
prior to intravenous administration. Preparation of INFUVITE ADULT (Pharmacy Bulk Package) 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.
INFUVITE ADULT (Pharmacy Bulk Package) is not physically compatible with moderately alkaline solutions such
as a sodium bicarbonate solution and other alkaline drugs such as acetazolamide
sodium, aminophylline, ampicillin sodium, tetracycline HCl and chlorothiazide
Folic acid is unstable in the
presence of calcium salts such as calcium gluconate.
Vitamin A and thiamine in
INFUVITE ADULT (Pharmacy Bulk Package) may react with bisulfite solutions such
as sodium bisulfite or vitamin K bisulfate. Patients should be monitored for
vitamin A and thiamine deficiencies.
Consult appropriate references
for listings of physical and chemical compatibility of solutions and drugs with
the vitamin infusion. In such circumstances, admixture or Y-site administration
with vitamin solutions should be avoided.
Dosage Forms And Strengths
INFUVITE ADULT (Pharmacy Bulk Package) is an injection for intravenous administration and is a sterile
product consisting of two vials labeled Vial 1 (50 mL) and Vial 2 (50 mL Fill
in 100 mL Vial). The mixed solution (100 ml) will provide ten 10 mL single
Storage And Handling
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,
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. Revised: 12/2012