[Vial-1 (5ml) + Vial-2 (5ml) -10ml total ] [500 - 1000 ml ] [Range: 40 to 500 ml/hr]
Note: 1000 ml is the preferred infusion volume.
Label: Refrigerate.
Infusion rate: Maximum infusion rate not listed. Based on the possiblitity of an infusion related adverse reaction [e.g. urticaria, shortness of breath, wheezing and angioedema.] the maximum rate should probably not exceed 500 ml/hr (or 250 ml/hr max if a 500ml bag is used). [slower infusions reduce overall exposure and allow for prompt corrective action if an adverse effect is observed]
Allergic reactions have been known to occur following intravenous administration of thiamine, and vitamin K. The formulation is contraindicated prior to blood sampling for detection of megaloblastic anemia, as the folic acid and the cyanocobalamin in the vitamin solution can mask serum deficits. |
| WARNINGS: 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 µg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.
Caution should be exercised when administering INFUVITE ADULT ® to patients on warfarin sodium-type anticoagulant therapy. In such patients, vitamin K may antagonize the hypothrombinemic response to anticoagulant drugs, such as warfarin and its congeners. Therefore, periodic monitoring of prothrombin/INR response is essential in determining the appropriate dosage of anticoagulant therapy. |
INFUVITE ADULT - Multiple Vitamins for Infusion
| 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-a-tocopheryl acetate)..........................................10 IU
Vitamin K**..................................................................……….150 mcg
* with 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
† with 30 % propylene glycol, citric acid and/or sodium citrate for pH adjustment and water for injection. |
DOSAGE AND ADMINISTRATION:
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.
Preparation of INFUVITE ADULT for intravenous feeding should be done by transferring the contents of Vial 1 into the contents of Vial 2 (10 mL total). One daily 10 mL dose should be 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. Once closure system has been compromised, withdrawal of container contents should be completed within 4 hours.
Store under refrigeration, 2-8 °C (36-46 °F).
Reference:
Multiple Vitamins for Infusion - INFUVITE® [package insert]. Boucherville, QC, Canada: Sab-Pharma Inc., May 21, 2003
Source: [package insert] |
