AMINOSTERIL N HEPA 8% 500 ml. FRESENIUS
AMINOSTERIL N - HEPA 8% 500 ml. FRESENIUS
1000 ml (1 liter) containing: Active substance:
L-isoIeucine 10.40 g
L-leucine 13.09 g
L-lysine monoacetate 9.71 g (corresponding to L-Iysine 6.88 g)
L-methionine 1.10 g
N-acetyl-L-cysteine 0.70 g (corresponding to L-Cysteine 0.52 g)
L-phenylalanine 0.88 g
L-threonine 4.40 g
L-tryptophan 0.70 g
L-valine 10.08 g
L-arginine 10.72 g
L-histidine 2.80 g
Glycine 5.82 g
L-alanine 4.64 g
L-proline 5.73 g
L-serine 2.24 g
Glacial acetic acid 4.42 g
Excipient: water for injections.
Total amino acids 80 g / l
Total nitrogen 12.9 g / l
Total energy 1340 kJ / l = 320 kcal / l
Theoretical osmolarity 770 mosm / l
Titration acidity 12-25 mmol NaOH / l
Clear colorless solution.
Delivery of amino acids as part of a regime of parenteral nutrition in severe hepatic insufficiency with or without hepatic encephalopathy, when oral or enteral nutrition is impossible or insufficient or contraindicated.
Like all solutions containing amino acids Aminosteril-N-Xena 8% is contraindicated in:
• Metabolism of amino acids
• Metabolic acidosis;
• Burden of liquids;
• Renal failure;
• Decompensated heart failure;
Pregnancy and lactation
No specific studies in pregnant and lactating women, demonstrating the safe use of Aminosteril-N-Xena 8% in these categories of persons. The accumulated clinical experience with the use of parenteral solutions with similar amino acid composition showed no evidence of risk to health in pregnant and lactating women.
The physician should consider the benefit / risk before prescribing the use of Aminosteril-N-Xena 8% in pregnant and lactating women.
Effects on ability to drive and use machines
Aminosteril-N-Xena 8% did not affect the ability to drive and use machines.
Not observed in correct administration of the medicinal product.
Special warnings and special precautions for use
Should be monitored and serum electrolytes, water balance and acid-base sastoyanie.Elektrolitite and carbohydrates should be applied in balanced quantities and infused if necessary via a bypass or a combination All-in-One bag.
Based on special composition of this product, its use in indications other than those recommended may lead to amino acid imbalance and severe metabolic narusheniya.Izborat of vein - peripheral or central depending on the final osmolality of the solution. It is assumed that by means of peripheral venous routes may be used to dissolve an osmolality of no greater than 800 mosml / l, while it was taken into account the general condition of the patient, the age and condition of the peripheral veins.
No evidence of adverse drug interactions.
Interactions with other medicinal products and other possible interactions
Due to the risk of microbiological contamination and incompatibilities amino acid solutions should not be mixed with other medicinal products except products for parenteral hranene.Smesvaneto with other products for parenteral nutrition can be done only documented compatibility of products. See "instructions for use".
Dosage and method of administration
For intravenous administration. The solution is intended for intravenous administration via a peripheral vein or a central.
Unless otherwise prescribed recommended doses are as follows: 1.0 to 1.25 ml / kg body weight (bw) per hour = 0.08 - 0.1 g amino acids / kg body weight per hour.
Maximum infusion rate
1.25 ml / kg body weight per hour (equivalent to 0.1 g amino acid / kg body weight per hour).
Maximum daily dose
1.5 g amino acids / kg body weight equivalent to 18.75 ml / kg body weight equivalent to 1300 ml for a patient weighing 70 kg.
Aminosteril-N-Xena 8% is applicable as part of the regime of total parenteral nutrition in combination with adequate energy carriers in the body (carbohydrate solutions, fat emulsions), electrolytes, vitamins and trace elements. In order to achieve optimum satisfaction of the needs required the simultaneous infusion of infusion solutions containing carbohydrates and emulsions containing lipids. Medicinal product can be used as long as required by the clinical condition of the patient or as amino acid metabolism of the patient to normal.
Aminosteril-N-Xena 8% is an amino acid solution for parenteral nutrition. Acute intoxication when properly administering the medicinal product is not poznata.Visokata infusion rate in a peripheral line may cause thrombophlebitis (due osmolarity of the solution).
In relation to existing or pre-induced pathological dysregulation or abnormal liver capacity in some patients may experience nausea, vomiting, chills and increased loss of amino acids through the kidneys as symptoms of overdose. If symptoms of overdose, the infusion should be slowed or stopped.
Keep in places protected from light. Store at a temperature lower than 25 ° C. Do not freeze!
Medicinal product should be used immediately.
Any unused portion should not be reused and should be discarded. Normally, when the solution is added to the pulp, storage should not be longer than 24 h at a temperature of from 2 ° C to 8 ° C.
Instructions for use
For intravenous use only.
Used immediately after opening the bottle.
For single use only.
The product is not used after the expiry date stated on opakovkata.Neupotrebenoto amount of solution should be discarded. All matter in the completion of infusion should be discarded.
Due to the risk of microbial contamination and compatibility is necessary to avoid mixing with other medicinal products. If necessary Dobjani carbohydrate solutions, fat emulsions, electrolytes, vitamins and trace elements for the realization of the full total parenteral nutrition, as these procedures are performed using aseptic techniques and conditions for savmestimost.Upotrebyavat Only clear solutions, free of impurities and particles if the bottle is intact.
Keep out of reach of children.
Bottles x 250 ml and 500 ml.
For the patient: Aminosteril-N-Xena infusion solution is a medicine which is used for delivery of amino acids as part of a parenteral feeding mode in severe hepatic failure, with or without hepatic encephalopathy, when oral or enteral nutrition is impossible or insufficient or ???????????????.?????????? only on prescription and under medical supervision. For more information, contact your doctor.