Aminosteril N-Hepa 8% Injection

AMINOSTERIL N-HEPA 8 % is indicated as a source of amino acids as part of total parenteral nutrition regimens to provide protein in patients with hepatic insufficiencies.

The recommended dosage is 1,0 to 1,25 mL/kg body weight/hour = 0,08 u2013 0,1 g amino acids per kg body weight and hour. Maximum infusion rate 1,25 mL/kg body weight/hour corresponding to 0,1 g amino acids/kg body weight/hour. Maximum daily dose 1,5 g amino acids/kg body weight corresponding to 18,75 mL/kg body weight corresponding to 1 300 mL at 70 kg body weight. AMINOSTERIL N-HEPA 8 % is applicable as part of total parenteral nutrition regimen in combination with adequate amounts of energy supplements (carbohydrate solutions, fat emulsions), electrolytes, vitamins and trace elements. For an optimal administration, carbohydrate solutions and/or fat emulsions should be given simultaneously. The preparation may be used for as long as required by the patientu2018s clinical condition or until the amino acid metabolism of the patient has normalised.

Paediatric population There is no experience in children. Method of administration For intravenous infusion only. For administration via a peripheral or central vein See section 6.6 for Special Precautions for Disposal and Handling.

• Hypersensitivity to any of the active ingredients listed in section 2 or to any of the excipients listed in section 6.1.
• Disturbed amino acid metabolism, metabolic acidosis, fluid overload, hyperhydration conditions, hyponatraemia, hypokalaemia, hyperkalaemia, renal insufficiency, serious cardiac function disorders, shock and hypoxia.
• Safety during pregnancy and in children has not been established.

It is necessary to monitor serum electrolytes, the water balance and the acid-base status. Laboratory monitoring should also include blood glucose, serum protein, creatinine, and liver function tests. Electrolytes and energy sources should be added in balanced portions, and infused, as necessary, using a bypass or mixed in an All-in-One bag. 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. The choice of a peripheral or central vein depends on the final osmolarity of the mixture. The general accepted limit for peripheral infusions is about 800 mosm/L, but it varies considerably with the age and the general condition of the patient and the characteristics of the peripheral veins. In order to minimise the risk of thrombophlebitis while using a peripheral application, frequent checks of the infusion site are recommended.

No interactions are known to date. Please refer to section 6.2 u201cIncompatibilitiesu201d.

Safety during pregnancy and lactation has not been established (see section 4.3).

AMINOSTERIL N-HEPA 8 % has no influence on the ability to drive and use machines.

Thrombophlebitis may occur if peripheral veins are used. No other undesirable effects are known when the solution is correctly administered. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Health care providers are asked to report any suspected adverse reactions to SAHPRA via Med Safety APP (Medsafety X SAHPRA) or via the eReporting platform (who-umc.org) found on the SAHPRA website. Healthcare providers are asked to report any suspected adverse drug reactions to the Holder of the Certificate of Registration at the following email address: [email protected] and to the relevant medicineu2019s regulatory authority in the country where the product is marketed.

AMINOSTERIL N-HEPA 8 % is an amino acid solution for parenteral nutrition. Acute intoxication is unlikely if the solution is used as recommended. A too rapid infusion via peripheral veins can cause thrombophlebitis (osmolarity of the solution). Depending on the extent of any pre-existing, pathologically-induced dysregulation and impairment of hepatic capacity, nausea, vomiting, chills and renal amino acid losses may occur in some patients after overdosage. If symptoms of overdose occur, the infusion should be slowed down or discontinued. The treatment of overdosage is symptomatic and supportive.