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 | ||
| 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 | |
DescriptionParenteral nutrient solution with an amino acid (AA) pattern adjusted to the altered AA metabolism of patients with hepatic insufficiency. The high content of branched-chain amino acids (isoleucine, leucine, valine) and the low content of methionine, phenylalanine and tryptophan take the altered influences 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 insufficiency 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 specific requirements of. patients with liver disease, for example, reduced Na+, average K+ and increased Mg++ content.
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.
IndicationsEssential parenteral nutrition in patients with severe chronic hepatic insufficiency, e.g. decompensated liver cirrhosis, shunt patients with liver cirrhosis, hepatic insuffiency resulting from other causes (e.g. metastatic liver); possibly also in cases of chronic hepatitis.
Dosage InstructionsFor 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. 3¾ 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 Effects
There are no known adverse reactions or side effects. Reactions which may occur because of the solution or the technique of administration include fibrile 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 fluid for examination if deemed necessary.
ContraindicationsThis 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 insufficiency, fructose or sorbitol intolerance,
fructose-l-6-diphosphatase deficiency, methanol poisoning, metabolic anomalies in connection with the amino acids contained in this preparation.
Presentation and Pack SizesInfusion solution in bottles containing 500 ml.
Clinic pack available with 10 bottles.
NotesEnergy 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. 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 definite 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 25°C.
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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