This is intended as a supplement for nutrition in order to meet the daily requirements of the water-soluble vitamins in infants, children and adults.

Specific combined vitamin preparations

Vitamin-B complex & Vitamin C act as coenzymes of vital enzymes associated with crucial physiological processes, energy metabolism, cell growth and replenishment especially in brain and nerve cells and gives better synergistic action.

Vitamin C acts as an antioxidant and helps in collagen formation. Intravenous administration of this combination gives prompt action with fine pharmacological properties in body in terms of efficacy and tolerability.

Adults: For adult patients and children weighing 10 kg or more, the recommended daily doses are the content of 1 vial (10 ml).

Children: Children weighing less than 10 kg should be given 1/10 of the content of one vial i.e. 1 ml per kg body weight per day.

Instructions for use or handling: Adults and children weighing 10 kg or more: 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, electrolyte-free (5% to 60%)

Children below 10 kg: The contents of one vial are dissolved by aseptic addition of 10 ml of one of the above 3 solutions. But the dose should be given as 1 ml of the dissolved mixture per kg body weight per day. This 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.

Instructions for use or handling-

Adults and children weighing 10 kg or more: The contents of one vial are dissolved by the aseptic addition of 10 ml of one of the following: 1. Water for injection. 2. Fat emulsion (10%). 3. Glucose solution, electrolyte-free (5% to 60%)

Children below 10 kg: The contents of one vial are dissolved by aseptic addition of 10 ml of one of the above 3 solutions. But the dose should be given as 1 ml of the dissolved mixture per kg body weight per day. This 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.

Vitamin B6 can reduce the effect of levodopa. Folic acid may lower the serum concentration of phenytoin. Other drugs should not be added to this IV Injection mixed with fat-soluble vitamins, due to the possibility of physical incompatibilities.

Hypersensitivity to any of the ingredients of the preparation.

Since this Injection has to be diluted with other nutrient solutions, it may cause unwanted effects in some people. The unwanted effects of nutrient solutions are a rise in the body temperature, shivering, chills and nausea and vomiting. Other rare unwanted effects include: allergic reactions; breathing difficulties (rapid breathing, shortness of breath); effects on blood pressure, abdominal pain, tiredness, headaches, flushing, slight pressure over the eyes and dizziness.

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.

Administering folic acid may obscure pernicious anemia. This IV Injection doses recommended are insufficient to correct severe vitamin deficiency states and may be insufficient in patients with markedly increased vitamin requirements. In patients receiving total parenteral nutrition (TPN), routine supplementation with both fat-soluble and water-soluble vitamins is recommended to prevent deficiency states and to obviate the need to speculate on individual vitamin status. Daily vitamin requirements must be calculated to avoid over dosage and toxic effects, especially with regards to vitamins A & D and particularly in pediatric patients. In patients for whom total parenteral nutrition is continued for prolonged periods (months or years), periodic monitoring of blood vitamin levels should be considered. To prevent excessive excretion of water-soluble vitamins and for reasons of safety, daily dosage should be administered over a number of hours.

Before reconstitution: Store below 25 °C, protected from light.

After reconstitution: The reconstituted this IV should be added to the infusion solution aseptically immediately before the start of the infusion and used within 24 hours.