Aminosteril N-Hepa 8%

Aminosteril N-Hepa 8%

Manufacturer:

Fresenius Kabi Austria

Distributor:

Fresenius Kabi
Full Prescribing Info
Contents
Amino acids.
Description
Each 1000 mL contains: L-Isoleucine 10.40 g, L-Leucine 13.09 g, L-Lysine monoacetate 9.71 g = L-Lysine 6.88 g, L-Methionine 1.10 g, N-Acetyl-L-cysteine 700 mg = L-Cysteine 520 mg, L-Phenylalanine 880 mg, L-Threonine 4.40 g, L-Tryptophan 700 mg, 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.
Total nitrogen content 12.9 g/L.
Theor. Osmolarity 770 mOsm/L.
Total energy 320 kcal.
Indications/Uses
Parenteral amino acid supply in severe forms of hepatic failure (liver insufficiency) with and without encephalopathy.
Dosage/Direction for Use
For intravenous infusion.
1.0 to 1.25 mL/kg b.w./h.
Maximum dosage: 1.5 g amino acids/kg b.w./day = 1,300 mL/day at 70 kg b.w.
Remark: Constant checking of serum electrolytes, fluid balance and acid-base balance is mandatory.
Length of Application: The product is used as long as required by therapy.
Contraindications
Disturbance of amino acid metabolism, metabolic acidosis, fluid overload, hyponatremia, hypokalemia, renal insufficiency, decompensated cardiac insufficiency, shock, hypoxia.
Use in Pregnancy & Lactation: See USE IN PREGNANCY & LACTATION section for further information.
Use In Pregnancy & Lactation
Remark: No specific studies have been performed to assess the safety of the product in pregnancy and lactation.
Adverse Reactions
Remark: Due to the special composition of this preparation, use in indications other than those recommended may result in amino acid imbalances and severe metabolic disorders.
Drug Interactions
Because of the increased risk of microbiological contamination and incompatibilities, amino acid solutions should not be mixed with other drugs. Should it become necessary to add other nutrients like carbohydrates, lipid emulsions, electrolytes, vitamins or trace elements to the product for complete nutrition, care should be given to hygienic admixing, good blending and, in particular, to compatibility.
The product should not be stored after the addition of other components.
Storage
Store at temperatures not exceeding 30°C. Do not freeze. Protect from light. Do not use the product if the solution is cloudy or if the container is damaged.
MIMS Class
Parenteral Nutritional Products
ATC Classification
B05BA01 - amino acids ; Belongs to the class of solutions for parenteral nutrition used in I.V. solutions.
Presentation/Packing
Form
Aminosteril N-Hepa 8% soln for IV infusion 80 g/L (8% w/v)
Packing/Price
500 mL x 1's