Adult Infuvite Multiple Vitamins For Infusion Pharmacy Bulk

ADULT INFUVITE MULTIPLE VITAMINS FOR INFUSION PHARMACY BULK- ascorbic acid, vitamin a palmitate, cholecalciferol, thiamine hydrochloride, riboflavin 5′-phosphate sodium, pyridoxine hydrochloride, niacinamide, dexpanthenol, .alpha.-tocopherol acetate, phytonadione, folic acid, biotin and cyanocobalamin injection, solution
Sandoz Canada Inc

1 INDICATIONS AND USAGE

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 vitamin therapy.

2 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.

2.1 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 [see Dosage and Administration (2.3)]. 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

2.2 Monitoring

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.

2.3 Instructions for Intravenous Administration

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.

2.4 Drug Incompatibilities

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 sodium.

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.

3 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 doses.

4 CONTRAINDICATIONS

INFUVITE ADULT (PHARMACY BULK PACKAGE)is contraindicated in patients who have an existing hypervitaminosis, or a history of hypersensitivity due to any vitamins or excipients contained in this formulation.

Allergic reactions have been known to occur following intravenous administration of thiamine and vitamin K.

5 WARNINGS AND PRECAUTIONS

5.1 Aluminum Toxicity

INFUVITE ADULT (PHARMACY BULK PACKAGE)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.

5.2 Allergic Reactions to Thiamine

Allergic reactions such as urticaria, shortness of breath, wheezing and angioedema have been reported following intravenous administration of thiamine, which is found in INFUVITE ADULT (PHARMACY BULK PACKAGE). There have been rare reports of anaphylactoid reactions following intravenous doses of thiamine. No fatal anaphylactoid reactions associated with INFUVITE ADULT (PHARMACY BULK PACKAGE) have been reported.

5.3. Hypervitaminosis A

Hypervitaminosis A, manifested by nausea, vomiting, headache, dizziness, blurred vision has been reported in patients with renal failure receiving 1.5 mg/day retinol and in patients with liver disease, Therefore, supplementation of renal failure patients and patients with liver disease with vitamin A, an ingredient found in INFUVITE ADULT, should be undertaken with caution [See Use in Specific Populations (8.5 and 8.6)].

5.4 Vitamin K Antagonizes the Anticoagulant Action of Warfarin

Vitamin K, which is found in INFUVITE ADULT (PHARMACY BULK PACKAGE) antagonizes the anticoagulant action of warfarin. In patients who are on warfarin anticoagulant therapy receiving parenteral multivitamins such as with INFUVITE ADULT (PHARMACY BULK PACKAGE) blood levels of prothrombin/INR should be periodically monitored to determine if dose of warfarin needs to be adjusted.

5.5 Interferes with Diagnosis of Megaloblastic Anemia

Do not administer INFUVITE ADULT (PHARMACY BULK PACKAGE) to patients with suspected or diagnosed megaloblastic anemia prior to blood sampling for the detection of the folic acid and cyanocobalamin deficiencies. The folic acid and the cyanocobalamin in the INFUVITE ADULT (PHARMACY BULK PACKAGE) solution can mask serum deficits of folic acid and cyanocobalamin in these patients.

5.6 Monitor Blood Vitamin Concentrations to Determine if Deficiencies or Excesses are Developing

In patients receiving parenteral multivitamins such as with INFUVITE ADULT (PHARMACY BULK PACKAGE) , blood concentration should be periodically monitored to determine if deficiencies or excesses are developing. INFUVITE ADULT (PHARMACY BULK PACKAGE) may not correct long-standing specific vitamin deficiencies. The administration of additional therapeutic doses of specific vitamins may be required [see Dosage and Administration ( 2.2)].

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