Aminoplasmal HEPA 10% 500 ml System

AMINOPLAZMAL HEPA, solution for infusion 10%

AMINOPLAZMAL HEPA composition

Active substances: In 1000 ml of solution there are 8.80 g of isoleucine, 13.60 g of leucine, 10.60 g of lysine acetate (corresponding to 7.51 g of lysine), 1.20 g of methionine, 1.60 g of phenylalanine, 4.60 g of threonine, 1.50 g of tryptophan, 10.60 g of valine, 8.80 g of arginine, 4.70 g of histidine, 6.30 g of glycine, 8.30 g of alanine, 7.10 g of proline, 2.50 g of aspartic acid, 0.55 g of asparagine monohydrate (corresponding to 0.48 g of asparagine), 0.80 g of acetylcysteine (corresponding to 0.59 g of cysteine) 5.70 g of glutamic acid, 1.66 g of ornithine hydrochloride (corresponding to 1.30 g of ornithine), 3.70 g of serine, 0.86 g of acetyltyrosine (corresponding to 0.70 g of tyrosine).

Indications for use

Provision of amino acids as part of parenteral nutrition for patients with hepatic encephalopathy from mild to severe, or with severe impairment of liver function due to acute or subacute liver failure. Used in adults, adolescents, and children over 2 years of age.

Contraindications

- Hypersensitivity to any component of the product; - congenital disorder of amino acid metabolism; - life-threatening severe circulatory disturbance (e.g., shock); - hypoxia; - metabolic acidosis; - severe renal failure without replacement renal therapy; - decompensated heart failure; - acute pulmonary edema; - disturbance of water-electrolyte balance. This medicinal product must not be used in newborns, premature infants, and children under 2 years of age, because its amino acid composition does not fully meet the specific needs of this patient group. Due to the characteristics of the composition of the Aminoplasmal Hepa 10% product, if it is not used according to indications, it may cause pronounced metabolic disturbances.

Effect on the ability to drive vehicles and operate other potentially dangerous machinery

No specific effects.

How to use and dosage of AMINOPLAZMAL HEPA

Dosage The dose should be selected taking into account the patient’s individual requirements for amino acids and fluid, as well as the patient’s clinical condition (the level of nitrogen catabolism related to nutritional status and/or the underlying disease). Adults Daily dose 0.8–1.5 g amino acids/kg body weight ≙ 8–15 ml/kg body weight ≙ 560–1050 ml for a patient with 70 kg body weight Maximum infusion rate 0.1 g amino acids/kg body weight/hour ≙ 1 ml/kg body weight/hour ≙ 1.17 ml/min for a patient with 70 kg body weight Children and adolescents Newborns, premature infants and children under 2 years of age The use of Aminoplasmal Hepa 10% is contraindicated in newborns, premature infants, and children under 2 years of age. The safety and efficacy of Aminoplasmal Hepa 10% in children have not been established. The information available to date has been provided, but there are no recommendations regarding dosage.

Duration of use The duration of administration of this solution is selected according to the patient’s clinical condition until the disturbance of the amino acid balance is resolved. Method of administration For intravenous use. Intended only for infusion into a central vein.