DESCRIPTION

Presentation

Each 10 ml vial contains: Vitamin B1 BP 2.5 mg, Vitamin B2 BP 3.6 mg, Nicotinamide BP 40 mg, Vitamin B6 BP 4 mg, Pantothenic acid BP 15 mg, Folic acid BP 0.4 mg, Vitamin B12 BP 0.005 mg, Ascorbic acid BP 100 mg, Biotin BP 0.06 mg

Description

Aritone IV is a lyophilized, sterile, yellow colored porous cake or powder of water-soluble vitamins for intravenous infusion. It contains balanced amount of all the important water soluble vitamins. It is a sterile lyophilized mixture of Vitamin B1, Vitamin B2, Nicotinamide, Vitamin B6, Pantothenic Acid, Ascorbic Acid, Biotin, Folic Acid and Vitamin B12.

Indications

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

Dosage & Administration

Adults and children age 11 years and above: One vial (10 ml) daily.

Children below 11 years of age: Children weighing less than 10 kg should be given 1 ml of the dissolved mixture per kg body weight /day.

Children weighing 10 kg or more should be given 10 ml (one vial) of the dissolved mixture /day.

Instruction for use

The content of each vial of Aritone IV should be dissolved first and then diluted for infusion only. The content of each vial are dissolved by the aseptic addition of-

1. Water for injections

2. Glucose solution for infusion (5%-50%) or

3. Fat emulsion (10%)

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

Side Effects

Allergic reactions may occur in patients hypersensitive to any component in the preparation, for example, methyl parahydroxybenzoate or thiamine. There have been rare reports of anaphylactoid reactions following repeated injection of preparations containing thiamine. Flushing, itching or burning of the skin may occur in patients susceptible to the effects of nicotinamide. Adverse reactions that may be expected based on experience with other water-soluble vitamin compounds administered intravenously include: allergic reactions, including anaphylaxis; dermatological reactions including flushing, erythema and pruritus and CNS reactions including headache, dizziness and agitation etc.

Precautions

Aritone IV must not be given undiluted. When Aritone IV is diluted with water based solutions, the admixture should be protected from light.

Use in Pregnancy & Lactation

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.

Drug Interaction

Folic acid may lower the serum concentration of phenytoin. Vitamin B6 can reduce the effect of levodopa.

Over Dose

No adverse effects of an overdose of water soluble vitamins have been reported, with exception of cases of extremly high parenteral doses. The possibility of hypervitaminosis A and D should be considered if the content of the Aritone IV vial is dissolved in another multivitamin injection.

Storage

Before reconstitution: Store below 25 °C, protected from light. After reconstitution: The reconstituted Aritone IV should be added to the infusion solution aseptically immediately before the start of the infusion and used within 24 hours.

Commercial Pack

Aritone IV for infusion: Each box contains 1 vial of multivitamin injections, one 10 ml syringe & 1 ampoule of 10 ml water for injections BP as solvent.