Composition

Each 100 ml contains:

i) Active ingredients Specification Quantity

L-Isoleucine USP 0.352 gm

L-Leucine USP 0.490 gm

L-Lysine Hydrochloride USP 0.430 gm

L-Methionine USP 0.225 gm

L-Phenylalanine USP 0.533 gm

L-Threonine USP 0.250 gm

L-Tryptophan USP 0.090 gm

L-Valine USP 0.360 gm

L-Arginine Hydrochloride USP 0.500 gm

L-Histidine Hydrochloride Monohydrate BP 0.250 gm

L-Aspartic Acid USP 0.250 gm

L - Glutamic Acid BP 0.075 gm

L-Alanine USP 0.200 gm

L-Cystine BP 0.010 gm

Glycine (2-Amino Acetic Acid) BP 0.760 gm

L-Proline USP 0.100 gm

L-Serine USP 0.100 gm

L-Tyrosine USP 0.025 gm

ii) Excipients

D-Sorbitol BP 5.000 gm

Water for injection BP q.s

Electrolytes (mmol/l)

Sodium 40.0

Potassium 25.0

Magnesium 2.5

Chloride 43.5

Acetate 25.0

Energy content: 155 Kj/L (371.14 Kcal/L)

Nitrogen content: 7.2 gm/L

Prosol IV consists of 18 essential and non-essential amino acids which are needed for protein synthesis as well as body build up. The amino acid composition is such that positive nitrogen balance can be achieved in the post-operative period and during extended periods of intravenous nutrition.

Prosol IV is indicated as a source of amino acids for protein synthesis in patients needing intravenous nutrition. It is particularly suitable for a patient with basal amino acid requirements. Prosol IV is also indicated in faster recovery in surgery, burns, renal insufficiency, hepatic insufficiency and effective management of Cancer.

Adults:

The nitrogen requirement for maintenance of body protein mass depends on the patient's condition (nutritional state and degree of metabolic stress).
No or minor metabolic stress and normal nutritional state: 0.10-0.15 g nitrogen/kg/day,
Moderate metabolic stress with or without malnutrition: 0.15-0.20 g nitrogen/kg/day,
Severe catabolism as in burns, sepsis and trauma: up to 0.20-0.25 g nitrogen/kg/day.

The dosage range 0.10-0.25 g nitrogen/kg/day corresponds to 15-35 ml Prosol IV/kg/day.
In obese patients, the dose should be based on the estimated ideal weight. Depending upon patients requirements, 1000-2000 ml Prosol IV may be infused intravenously per 24 hours. Prosol IV should be infused slowly, at rates 1.4-2.8 ml (30-60 drops) per minute.

Infants and Children:
In children and infants, the rate of infusion is 28-35 ml/kg body wt/day is recommended, with a stepwise increment in the rate of administration during the first week of treatment.

Prosol IV is usually well tolerated. Yet nausea, vomiting, flushing and sweating have been observed during infusion of Prosol IV at rates exceeding the recommended maximal rate. Hypersensitivity reactions have been reported. Like all hypertonic infusion solution, thrombophlebitis may occur when peripheral veins are used. The incidence may be reduced by the simultaneous infusion of 10% fat emulsion. If it is infused to severely ill patients, premature infants, hyperphenylalaninemia may occur.

Hyperphenylalaninemia has been noted in severely ill, premature infants. In these patients, monitoring of the phenylalanine levels is recommended and the infusion rate adjusted as needed.
Do not use if the solution is turbid or contains particles. Discard any unused portion.

Prosol IV is contraindicated in patients with inborn errors of amino acids metabolism. Moreover, Prosol IV should not be used in patients with hepatic coma or metabolic disorders involving impaired nitrogen utilization.

Successful and safe administration of amino acid solutions during pregnancy in the human has been reported. Animal reproduction studies have not been carried out with Prosol IV.

Protect from light and store between 15-25 °C temperature. Avoid freezing. Keep medicaments out of reach of children.

Prosol IV : Each box contains 500 ml of 5% composite amino acid solution with D-Sorbitol in glass bottle.