2/22/2017 AminofusinHeparInfusionDrugsInformation

Aminofusin Hepar Infusion

ObatInfo asho 12:33 AM Cholagogues; Cholelitholytics and Hepatic Protectors

Aminofusin Hepar
5% Amino acids with carbohydrates and electrolytes

Composition

1000 ml infusion solution contains :

L-Isoleucine 7.60 g

L-Leucine 8.50 g

L-Lysine monomalate 7.86 g

L-Methionine 0.50 g

L-Phenylalanine 0.25 g

L-Threonine 1.20 g

L-Tryptophan 0.10 g

L-Valine 6.40 g

L-Arginine 4.90 g

L-Histidine 0.60 g

L-Ornithine-L-aspartate 8.03 g

L-Alanine 2.10 g

N-Acetyl-L-cysteine 0.20 g

L-Glutamic acid 1.00 g

Glycine 0.70 g

L-Proline 1.20 g

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L-Serine 2.75 g

Sorbitol 25.00 g

Xylitol 25.00 g

Sodium glycero-phosphate-5-hydrate 4.592 g

Magnesium chloride 1.017 g

Potassium chloride 1.342 g

In water for injection

Electrolytes mEq/l mmol/l mg/l

Na + 30 30 690

K+ 18 18 704

Mg ++ 10 5 122

Cl - 28 28 993

Malate - 28 28 3732

P 15 465

Description
Parenteral nutrient solution with an amino acid (AA) pattern adjusted to the altered AA
metabolism of patients with hepatic insuciency. The high content of branched-chain amino
acids (isoleucine, leucine, valine) and the low content of methionine, phenylalanine and
tryptophan take the altered inuences on CNS function into account. This in particular
counteracts the risk of neurological deterioration which was previously present in patients with
serious liver disease receiving parenteral nutrition in the form of standard amino acid
solutions. Use of this preparation may bring about increased mental alertness in cases where
sensory disorders due to hepatic insuciency are present.

Other factors contributing to this objective are the use of reliable substances which back up
the detoxication functions of the diseased liver e.g. ornithine aspartate, arginine, malate (malic
acid) and adjustments of the electrolyte pattern to the specic requirements of. patients with
liver disease, for example, reduced Na+, average K+ and increased Mg++ content.

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The solution contains 50 g AA, 7.59 g nitrogen and 1750 kJ (approx. 400 kcal) per litre.
Osmolarity of approx. 800 mOsm/l allows the solution to be applied via peripheral venous
network.

Indications
Essential parenteral nutrition in patients with severe chronic hepatic insuciency, e.g.
decompensated liver cirrhosis, shunt patients with liver cirrhosis, hepatic insuency resulting
from other causes (e.g. metastatic liver); possibly also in cases of chronic hepatitis.

Dosage Instructions
For intravenous infusion.
Dosage unless otherwise prescribed, 0.7-1 g AA/kg BW/day. In special cases a reduced dosage
(approx. 0.5 g AA/kg BW/day) or with considerably increased requirements, up to 1.4 g AA/kg
BW/day. This yields 14-20 ml (10-28 ml)/kg BW/day or approx. 1000-1500 ml (700-2000 ml)/day
for patient weighing 70 kg.
The infusion rate under normal circumstances is 0.10 g AA/kg BW/h equivalent to 2 ml/kg BW/h
or 2.3 ml/min (45 drops/min. or 500 ml in approx. 3 h) in 70 kg patient. A rate of 0.15 g AA/kg
BW/h (approx. 3.5 ml or 70 drops/min. in a 70 kg patient) should not be exceeded.

Adverse Reactions and Side Eects

There are no known adverse reactions or side eects. Reactions which may occur because of
the solution or the technique of administration include brile response, infection at the site of
injection, venous thrombosis or phlebitis extending from the site of injection, extra vasation
and hyper volemia. If an adverse reaction occurs, discontinue infusion. Initiate appropriate
treatment and retain the remainder of the uid for examination if deemed necessary.

Contraindications
This preparation is contraindicated in patients with coma due to liver atrophy (so-called
endogenous hepatic coma, acute liver atrophy) occuring as a result of hepatitis or severe
poisoning, for example: chronic renal disease with serious restriction of renal performance,
hyperkalaemia, shock decompensated, cardiac insuciency, fructose or sorbitol intolerance,
fructose-l-6-diphosphatase deciency, methanol poisoning, metabolic anomalies in connection
with the amino acids contained in this preparation.

Presentation and Pack Sizes

Infusion solution in bottles containing 500 ml.
Clinic pack available with 10 bottles.

Notes
Energy in the form of non-protein nutrients should be given separately at a rate approx. 100-
150 kJ (approx. 25-35 kcal)/kg BW/day, or in spesial cases where required 170 kJ (40kcal)/kg
BW/day, preferably via either the parenteral or the enteral (with feeding tube if necessary)
route, or a combination of the two methods. Vitamin supply must also be ensured. If ascites
develops increased diuretic therapy should be considered. Parenteral nutrition should not be
applied for periods of more than two to three weeks without control of protein synthesis (i.e.

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assessment of plasma proteins, coagulation factors etc.) Little practical experience has so far
been gained in cases of acute poisoning where comatose states are imminent. No denite
guidelines can be given regarding the use of this product in children as their requirements vary
during the growth phase.
Ensure adequate renal function.
Use only clear solutions in condition of intact containers.
Protect from light. Store below 25C.

Reg. No. DKL0411637249A1

HARUS DENGAN RESEP DOKTER

Manufactured by:
PT Finusolprima Farma Internasional, Bekasi - Indonesia
For: PT KALBE FARMA Tbk., Bekasi - Indonesia
Under license from: Baxter Deutschland GMBH, Germany

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