Each 1000 mL of solution contains isoleucine 8.8 g, leucine 13.6 g, lysine acetate 10.6 g (equivalent to lysine 7.51 g), methionine 1.2 g, phenylalanine 1.6 g, threonine 4.6 g, tryptophan 1.5 g, valine 10.6 g, arginine 8.8 g, histidine 4.7 g, glycine (aminoacetic acid) 6.3 g, alanine 8.3 g, proline 7.1 g, aspartic acid 2.5 g, asparagine monohydrate 0.55 g (equivalent to asparagine 0.48 g), acetylcysteine 0.8 g (equivalent to cysteine 0.59 g), glutamic acid 5.7 g, ornithine HCl 1.66 g (equivalent to ornithine 1.3 g), serine 3.7 g and acetyltyrosine 0.86 g (equivalent to tyrosine 0.7 g). It also contains the following excipients: Disodium edetate dihydrate 0.05 g, hydrochloric acid or sodium hydroxide for pH adjustment and water for injections.
Total Amino Acids: 100 g/L. Total Nitrogen: 15.3 g/L. α-Amino Nitrogen: 11.2 g. Caloric Value: 1675 kJ/L=400 kcal/L. Osmolarity: 875 mOsmol/L.
Electrolyte Concentrations: Acetate: 51 mmol/L; chloride: 10 mmol/L.
Supply of amino acids in the setting of parenteral nutrition of patients with severe liver insufficiency and imminent or manifest hepatic encephalopathy.
Depending on individual requirements.
Normal Dose: 7-10 mL/kg body weight/day, corresponding to 0.7-1 g of amino acids/kg body weight/day.
Maximum Dose: 15 mL/kg body weight/day, corresponding to 1.5 g of amino acids/kg body weight/day.
Flow Rate: Treatment of Hepatic Coma: In hepatic encephalopathy, it is recommended to start the infusion of Aminoplasmal Hepa-10% at an increased rate, until onset of the effect, eg for a patient weighing 70 kg:
1st-2nd hr: 150 mL/hr (2 mL/kg body weight/hr), corresponding to approximately 50 drops/min; 3rd-4th hr: 75 mL/hr (1 mL/kg body weight/hr), corresponding to approximately 25 drops/min; from 5th hr: 45 mL/hr (0.6 mL/kg body weight/hr), corresponding to approximately 15 drops/min.
Maintenance Requirements/Parenteral Nutrition: 45-75 mL/hr, corresponding to 15-25 drops/min (0.6-1 mL/kg body weight/hr).
Duration of Use: Aminoplasmal Hepa-10% may be administered as long as there is a risk of manifestation of hepatic encephalopathy.
Administration: IV infusion into the vena cava.
Symptoms: Overdosage or a too rapid infusion rate may manifest in the form of nausea, shivering, vomiting and renal amino acid losses.
Treatment: In such cases, the infusion should be interrupted and later continued at a lower infusion rate.
Disorders of amino acid metabolism of other than hepatic origin; life-endangering unstable circulation (shock); acidosis; hyperhydration; hypokalaemia; hyponatraemia.
Because of the particulars of its composition, Aminoplasmal Hepa 10% may cause marked metabolic disturbances if given for other reasons than stated under Indications. Unindicated use must strictly be avoided.
Use in children: No data are available on the use of Aminoplasmal Hepa 10% in children <2 years. Therefore, administration of the solution to such patients cannot be recommended until relevant data become available.
Because of its composition, Aminoplasmal Hepa 10% should be administered to patients with concomitant renal insufficiency only after individual benefit/risk assessment.
The dose should be adjusted according to the serum urea and creatinine concentrations.
Caution is also to be exercised in patients with increased serum osmolarity.
Amino acid therapy is not a substitute for established therapeutic measures, eg purging, administration of lactulose and/or gut-sterilising antibiotics, in the treatment of hepatic encephalopathy.
Infusion of Aminoplasmal Hepa 10% should be accompanied by appropriate carbohydrate supply.
Clinical supervision should include regular checks of fluid balance and serum electrolytes.
Electrolytes are to be supplemented as required.
No data are available on the use of Aminoplasmal Hepa 10% during pregnancy and lactation.
Provided contraindications, dosage recommendations and precautions are observed, side effects are not anticipated.
Because of the risk of microbial contamination and physicochemical incompatibility, it is not recommended that any additives should be incorporated into Aminoplasmal Hepa 10% solution, but should preferably be given in standard carbohydrate or electrolyte solutions. However, if admixture with Aminoplasmal Hepa 10% is essential, then the compatibility of the additives must be checked before administration.
Instructions for Use: Aminoplasmal Hepa 10% is supplied in single-dose containers. Unused contents must be discarded and should not be stored for later use.
The solution should not be administered if it is not clear or if the container or its closure show visible sign of damage.
Do not store above 25°C. Protect from light.
B05BA01 - amino acids ; Belongs to the class of solutions for parenteral nutrition used in I.V. solutions.