This IV preparation is indicated as a daily multivitamin maintenance dose for infants and children up to 11 years of age who are receiving parenteral nutrition. It is also used in conditions where intravenous administration is necessary, such as during surgery, in extensive burns, fractures, and other traumatic injuries, severe infections, and comatose states. These conditions can create stress that significantly increases metabolic demand and leads to depletion of essential nutrients in body tissues.

This is a sterile, lyophilized powder for infusion containing both water-soluble and fat-soluble vitamins. Each vial contains:

• Vitamin A 2300 IU
• Vitamin D3 400 IU
• Vitamin E 7 mg
• Vitamin C 80 mg
• Vitamin B1 1.2 mg
• Vitamin B2 1.4 mg
• Vitamin B6 1 mg
• Vitamin B12 0.001 mg
• Folic acid 0.14 mg
• Dexpanthenol 5 mg
• Biotin 0.02 mg
• Nicotinamide 17 mg
• Vitamin K1 0.2 mg

This IV formulation is a sterile, lyophilized powder/cake designed for infusion and contains nine water-soluble and four fat-soluble vitamins. Mixed micelles are used as a solubilizing agent to enhance stability and absorption. It appears as an orange-yellow sterile powder cake, which must be reconstituted with 5 ml of Water for Injection or other suitable parenteral fluids (such as 0.9% Sodium Chloride or 5% Dextrose solution) before intravenous administration.

Infants weighing less than 1 kg: The daily dose is 30% (1.5 ml) of a single full dose (5 ml). Do not exceed this daily dose.

Infants weighing 1 to 3 kg: The daily dose is 65% (3.25 ml) of a single full dose (5 ml). A supplemental Vitamin A may be required for low birth weight infants.

Infants and children weighing 3 kg or more up to 11 years of age: The daily dose is 5 ml.

The single dose vial of This IV is reconstituted by adding 5 ml of sterile Water for injection or other intravenous fluids like 0.9% Sodium Chloride injection or 5% dextrose injection. 5 ml of diluent should be added by means of sterile syringe into the vial and gently mixed to dissolve the lyophilized powder/cake. The product will form a clear and yellow color solution after reconstitution. The reconstituted solution is ready within three minutes for immediate use. After This IV is reconstituted it should be immediately diluted into the intravenous solution. The resulting solution should be administered immediately. Some of the vitamins in this product, particularly vitamins A, D and riboflavin are lightsensitive and exposure to light should be minimized. The reconstituted This IV should not be given as a direct, undiluted intravenous injection as it may give rise to dizziness, faintness and possible tissue irritation. For a single dose, 5 ml of reconstituted This IV should be added directly to not less than 100 ml of intravenous dextrose, saline or similar infusion solutions.

This IV is not physically compatible with alkaline or moderately alkaline solutions such as Acetazolamide, Chlorothiazide sodium, Aminophylline, sodium bicarbonate, and Tetracycline HCl. Folic acid is unstable in the presence of calcium salts like calcium gluconate. Direct mixing with intravenous fat emulsions is not recommended. Vitamins such as thiamine, riboflavin, pyridoxine, niacinamide, and ascorbic acid may reduce the antibacterial activity of erythromycin, doxycycline, and lincomycin. Folic acid may reduce serum levels of phenytoin, increasing seizure risk, and may also reduce response to methotrexate therapy.

Rare anaphylactic reactions have been reported after parenteral multivitamin use. High-dose intravenous thiamine may also rarely cause anaphylaxis, though risk is low when given with other B vitamins. Other rare effects include rash, erythema, pruritus, headache, dizziness, agitation, anxiety, diplopia, urticaria, shortness of breath, wheezing, and angioedema.

Not recommended.

Use with caution in patients receiving warfarin due to Vitamin K content. Excess Vitamin E supplementation is not recommended. Additional Vitamin A may be needed in low birth weight infants. Polysorbates may cause E-Ferol syndrome in premature infants. The product contains aluminum, which may accumulate to toxic levels in patients with renal impairment, especially in premature neonates.

Hypervitaminosis A or D may occur in overdose. Vitamin A toxicity has been reported, especially in patients with renal failure receiving high doses of retinol.

Multi-vitamin & Multi-mineral combined preparations

Before reconstitution: Store in a cool, dry place away from light. After reconstitution: Use immediately or store at 2°C–8°C for up to 24 hours. Discard any unused portion.