Arovital IV Injection or Infusion

This is intended as a supplement for intravenous nutrition in order to meet the daily requirements of the water soluble vitamins of NPO (nothing by mouth) or surgery patients.

Each vial contains:

• Vitamin B1 (as Thiamine Mononitrate USP) 2.5 mg
• Vitamin B2 (as Riboflavin Sodium Phosphate BP) 3.6 mg
• Nicotinamide BP 40 mg
• Pantothenic Acid (as Dexpanthenol USP) 15 mg
• Vitamin B6 (as Pyridoxine Hydrochloride BP) 4 mg
• Biotin BP 0.06 mg
• Folic Acid BP 0.4 mg
• Vitamin B12 (as Cyanocobalamin BP) 0.005 mg
• Ascorbic Acid (as Sodium Ascorbate USP) 100 mg

This is a sterile, lyophilized powder of water-soluble vitamins for infusion. It contains balanced amount of all the important water soluble vitamins which act as coenzymes of vital enzymes associated with crucial physiological processes, energy metabolism, cell growth and replenishment especially in brain and nerve cells. Vitamin C acts as an antioxidant and helps in collagen formation. Intravenous administration of this combination gives prompt action.

Adults and children weighing 10 kg or more: 1 vial (10 ml) daily.
Children weighing less than 10 kg: should be given 1 ml of the dissolved mixture per kg body weight/day.

The contents of one vial are dissolved by the aseptic addition of 10 ml of one of the following:

• Water for injection
• Fat emulsion 10%
• Glucose solution for infusion (5% to 60%)
• Normal saline (0.9% Sodium Chloride)

IV Injection may be added to parenteral nutrition admixtures containing carbohydrates, lipids, amino acids, electrolytes and trace elements provided that compatibility and stability have been confirmed.

Method of IV Injection Preparation:

• Take 10 ml WFI from provided ampoule by a sterile syringe.
• Transfer it into the vial & mix gently to dissolve the lyophilized powder.
• Pull back all the reconstituted solution by the syringe.
• Administer the solution by slow IV injection (at least over 10 minutes).

Vitamin B6 can reduce the effect of Levodopa. Folic Acid may lower the serum concentration of Phenytoin.

Known hypersensitivity to any of the components, e.g. Thiamine.

Allergic reactions may occur in patients hypersensitive to any component of the preparation, e.g. Thiamine.

Animal reproduction studies or clinical investigations during pregnancy have not been carried out with this preparation. However, there are published reports on safe administration of water soluble vitamins in this patient group.

When Lyophilized Powder for Infusion is diluted with water-based solutions, the admixture sould be protected from light. This is not necessary if lyophilized powder for infusion is diluted with intralipid because of the protective effect of the fat emulsion.

No adverse effects of an overdose of water soluble multivitamin have been reported, with exception of cases of extremely high parenteral doses. The possibility of hypervitaminosis A and D should be considered if lyophilized powder for infusion is dissolved in another multivitamin injection.

Multi-vitamin & Multi-mineral combined preparations

Before reconstitution: Store at below 25°C in a dry place, protected from light. Keep out of reach of children. After reconstitution: The reconstituted preparation should be added to the infusion solution aseptically immediately before the start of the infusion & used within 24 hours.