Adult Infuvite Multiple Vitamins

ADULT INFUVITE MULTIPLE VITAMINS- 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 Inc

1 INDICATIONS AND USAGE

INFUVITE ADULT is a combination of vitamins 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

2.1 Important Dosage Instructions

INFUVITE ADULT is a combination product that contains the following vitamins: ascorbic acid, vitamin A, vitamin D, thiamine, riboflavin, pyridoxine, niacinamide, dexpanthenol, vitamin E, vitamin K1, folic acid, biotin, and vitamin B12.

INFUVITE ADULT is supplied as a single dose or as a pharmacy bulk package for intravenous use intended for administration by intravenous infusion after dilution.

INFUVITE ADULT Single Dose:

Provides one daily dose of 10 mL (5 mL of Vial 1 plus 5 mL of Vial 2) which must be diluted prior to intravenous administration [see Dosage and Administration (2.2)].

INFUVITE ADULT Pharmacy Bulk Package:

Provides ten 10 mL daily doses when the content of vial 1 is transferred into the content of vial 2. One 10 mL dose is then added directly to intravenous fluid. Pharmacy bulk package of INFUVITE ADULT is intended for dispensing of single doses to multiple patients in a pharmacy admixture program and is restricted to the preparation of admixtures for infusion [see Dosage and Administration ( 2.2)].

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 Preparation and Administration Instructions

Do not administer INFUVITE ADULT as a direct, undiluted intravenous injection as it may cause dizziness, faintness, and possible tissue irritation.

INFUVITE ADULT Single Dose:

Use only in a suitable work area such as a laminar flow hood (or an equivalent clean air compounding area).
Add 5 mL of Vial 1 and 5 mL of Vial 2 to at least 500 mL to 1000 mL, of intravenous dextrose or saline solutions.
Discard unused portion.
Visually inspect for particulate matter and discoloration prior to administration.
After INFUVITE ADULT is diluted in an intravenous infusion, refrigerate the resulting solution unless it is to be used immediately, and use the solution within 24 hours after dilution.
Minimize exposure to light because some of the vitamins in INFUVITE ADULT, particularly A, D and riboflavin, are light sensitive.

INFUVITE ADULT Pharmacy Bulk Package:

Use only in a suitable work area such as a laminar flow hood (or an equivalent clean air compounding area).
Transfer the contents of Vial 1 into the contents of Vial 2 to provide ten 10 mL single doses.
Each bulk vial closure shall be penetrated only one time with a suitable sterile transfer device or dispensing set that allows measured dispensing of the contents.
Once the closure system has been penetrated, complete dispensing from the pharmacy bulk vial should be completed within 4 hours. The mixed solution may be refrigerated and stored for up to 4 hours.
Discard unused portion.
Visually inspect for particulate matter and discoloration prior to administration.
One daily 10 mL dose should be added directly to at least 500 mL to 1000 mL, of intravenous dextrose, saline or similar infusion solutions.
After INFUVITE ADULT is diluted in an intravenous infusion, refrigerate the resulting solution unless it is to be used immediately, and use the solution within 24 hours after dilution.
Minimize exposure to light because some of the vitamins in INFUVITE ADULT, particularly A, D and riboflavin, are light sensitive.

2.3 Monitoring Vitamin Blood Levels

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.

2.4 Drug Incompatibilities

INFUVITE ADULT 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 may react with bisulfite solutions such as sodium bisulfite or vitamin K bisulfate.
Do not add INFUVITE ADULT directly to intravenous fat emulsions.
Consult appropriate references for additional listings of physical and chemical compatibility of solutions and drugs with the vitamin infusion when needed. If incompatibilities are identified, avoid admixture or Y-site administration with vitamin solutions.

3 DOSAGE FORMS AND STRENGTHS

INFUVITE ADULT Single Dose: is an injection for intravenous administration consisting of two vials labeled Vial 1 (5 mL) and Vial 2 (5 mL). For the vitamin strengths [see Description (11)].

INFUVITE ADULT Pharmacy Bulk Package: is an injection for intravenous administration 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. For the vitamin strengths [see Description ( 11)].

4 CONTRAINDICATIONS

INFUVITE ADULT is contraindicated in patients who have

An existing hypervitaminosis, or
A history of hypersensitivity due to any vitamins or excipients contained in this formulation.

5 WARNINGS AND PRECAUTIONS

5.1 Aluminum Toxicity

INFUVITE ADULT 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. To prevent aluminum toxicity periodically monitor aluminum levels with prolonged parenteral administration of INFUVITE ADULT in patients with renal impairment.

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. There have been rare reports of anaphylactoid reactions following intravenous doses of thiamine. No fatal anaphylactoid reactions associated with INFUVITE ADULT 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 (8.6, 8.7)].

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