Refusan

Amino Acid.

Each 1000 mL contains: L-Threonine 10.4 g, L-Serine 4.4 g, L-Asparagine 5.7 g, L-Proline 3.9 g, Glycine 6.7 g, L-Valine 5.3 g, L-Methionine 1.5 g, L-Isoleucine 3.0 g, L-Leucine 5.4 g, N-Acetyl -L- Tyrosine 6.9 g Free base (5.60 g), L-Phenylalanine 2.7 g, L-Lysine Acetate 25.6 g Free base (18.15 g), L-Histidine HCl 6.0 g Free base (4.44 g), L-Arginine 10.6 g, L- Tryptophan 1.7 g In water for injection, Total free amino acids 89.49 g, Indispensable (essential) amino acids 48.15 g, Dispensable (non essential) amino acids 41.34, Essential/non essential ratio 1.2, Chloride 28.62 mEq/L, Acetate 124.13 mEq/L, Total Nitrogen 15.2 g, Branched Chain Amino Acids (BCAA) 15.3%.
pH: ± 7
Osmolarity: ± 860 mOsm/L

Pharmacology: Amino acids have primary functions as prior element in protein biosynthesis. REFUSAN is an amino acids solution containing 8 essential amino acids enriched formulas and 7 non essential amino acids.
Essential amino acids enriched formula has been proposed as an alternative protein source for patients with renal failure. This formula reduce urea production by recycling nitrogen for the synthesis of non essential amino acid.
But non essential amino acids are also required to maintain nitrogen balance and to optimize protein synthesis since patients with renal failure may have an impaired ability to synthesize some of the non essential amino acids. REFUSAN is equipped with Glycine which has a cytoprotective effect to the damage of glomerolus cell.

REFUSAN is indicated to patients with hypoproteinemia e.g. malnutrition and trauma or injury (before and after surgery) and particularly for acute and chronic renal failure including Intradialytic Parenteral Nutrition (IDPN).

Dosage is given according to metabolic requirement, energy expenditure and clinical status of patients.
Usual daily dosage: For renal failure condition without dialysis: 0.4-0.6 g/Kg Body Weight/Day.
For renal failure condition with dialysis: 0.8 -1.2 g/Kg Body Weight/Day.
Route of administration: Slow intravenous infusion. Slow infusion rate is recommended according to dosing schedule.

REFUSAN is contraindicated to patient with: Abnormal amino acids metabolism. Hepatic coma or risk or hepatic coma. Hyperammonemia. Untreated severe renal disorder or azotemia.

Administration of amino acid solutions to a patient with hepatic insufficiency may result imbalances, hyperammonaemia, stupor and coma.
Jaundice in children has been reported in association with administration of some parenteral nutrients containing amino acids. The jaundice appeared to be cholestatic in type, was easily reversed, and there was no evidence of long-term toxicity.
Amino acids intravenous infusions have not been approved for use in pregnant women and breastfeeding mother.
Strong hypertonic nutrient solutions should be administered through an indwelling i.v catheter with the tip located in the superior vena cava.
It is recommended to check fluid and electrolyte balances and serum urea concentration.
For total parenteral nutrition in patients with renal insufficiency supplement this solution with a simultaneous supply of carbohydrate compound solutions.
Use only clear solution in condition of intact container.

Hypersensitivity reaction: Skin eruption. Nausea, vomiting. Chest discomfort, palpitation. Increase of SGPT, SGOT and total bilirubin. Increase of blood urea nitrogen. Acidosis, after large and acute infusion. Fever, chills, headache.

Store at temperature below 30°C, do not cool or freeze. Away from light.

Parenteral Nutritional Products

B05BA01 - amino acids ; Belongs to the class of solutions for parenteral nutrition used in I.V. solutions.

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