Aminoven Inection

AMINOVEN 5 %, 10 % and 15 %: For supply of amino acids as part of a parenteral nutrition regimen.

AMINOVEN 15 % is mainly indicated if, during parenteral nutrition therapy, the fluid volume needs to be restricted.

Posology

The daily requirement of amino acids depends on the body weight and the metabolic conditions of the patient. The maximum daily dose varies with the clinical condition of the patient and may even change from day to day. The recommended infusion period is to provide a continuous infusion for at least 14 hours up to 24 hours, depending on the clinical situation. Bolus administration is not recommended. The solution is administered as long as a parenteral nutrition is required.

Adult dose:

• AMINOVEN 5 %: 16 u2013 20 ml of AMINOVEN 5 % per kg body weight/day (equivalent to 0,8 u2013 1,0 g amino acids per kg body weight), corresponding to 1 120 u2013 1 400 ml AMINOVEN 5 % at 70 kg body weight/day.
• AMINOVEN 10 %: 10 u2013 20 ml of AMINOVEN 10 % per kg body weight/day (equivalent to 1,0 u2013 2,0 g amino acids per kg body weight), corresponding to 700 u2013 1 400 ml AMINOVEN 10 % at 70 kg body weight/day.
• AMINOVEN 15 %: 6,7 u2013 13,3 ml of AMINOVEN 15 % per kg body weight/day (equivalent to 1,0 u2013 2,0 g amino acids per kg body weight), corresponding to 470 u2013 930 ml AMINOVEN 15 % at 70 kg body weight/day.

Maximum infusion rate:

• AMINOVEN 5 %: 2,0 ml of AMINOVEN 5 % per kg body weight/hour (equivalent to 0,1 g amino acids per kg body weight/hour).
• AMINOVEN 10 %: 1,0 ml of AMINOVEN 10 % per kg body weight/hour (equivalent to 0,1 g amino acids per kg body weight/hour).
• AMINOVEN 15 %: 0,67 ml of AMINOVEN 15 % per kg body weight/hour (equivalent to 0,1 g amino acids per kg body weight/hour).

Maximum daily dose:

• AMINOVEN 5 %: 20 ml of AMINOVEN 5 % per kg body weight/day (equivalent to 1,0 g amino acids per kg body weight/day) corresponding to 70 g amino acids at 70 kg body weight.
• AMINOVEN 10 %: 20 ml of AMINOVEN 10 % per kg body weight/day (equivalent to 2,0 g amino acids per kg body weight/day) corresponding to 1 400 ml AMINOVEN 10 % or 140 g amino acids at 70 kg body weight.
• AMINOVEN 15 %: 13,3 ml of AMINOVEN 15 % per kg body weight/day (equivalent to 2,0 g amino acids per kg body weight/day) corresponding to 140 g amino acids at 70 kg body weight.

The solution is administered as long as parenteral nutrition is required.

Paediatric population

No studies have been performed in the paediatric population.

• AMINOVEN 15 % is contraindicated in children (see section 4.3).
• AMINOVEN 5 % and 10 % are contraindicated in children less than 2 year of age (see section 4.3).

Children and adolescents (2-18 years)

The dose should be adjusted to hydration status, biological development and body weight.

Maximum infusion rate: Same as for adults, see information above.

Maximum daily dose:

• AMINOVEN 5 %: 40 ml per kg body weight/day (equivalent to 2,0 g amino acids per kg body weight/day) but total daily fluid intake must be considered.
• AMINOVEN 10 %: Same as for adults; see information above.

Method of administration

For administration only via a central vein as a continuous infusion. AMINOVEN 5 %, 10 % and 15 % should be used with sterile transfer equipment immediately after opening. Any unused solution should be discarded. Only clear, particle-free solutions in undamaged containers should be used. AMINOVEN 5 %, 10 % and 15 % may be aseptically mixed with other nutrients such as fat emulsions, carbohydrates and electrolytes. TPN admixtures compounded in uncontrolled or unvalidated conditions should be used immediately (in-use storage should be no longer than 24 hours at 2-8 u00b0C).

• The administration of AMINOVEN 5 % and 10 %, is contraindicated in children less than 2 years of age.
• The administration of AMINOVEN 15 % is contraindicated in children.
• Disturbances of amino acid metabolism, metabolic acidosis, renal insufficiency without haemodialysis or haemofiltration treatment, advanced liver insufficiency, fluid overload, shock, hypoxia, decompensated heart failure.

Serum electrolytes, fluid balance and renal function should be monitored. In cases of hypokalaemia and/or hyponatraemia adequate amounts of potassium and/or sodium should be administered simultaneously. Amino acid solutions such as AMINOVEN 5 %, 10 % and 15 % may precipitate acute folate deficiency; folic acid should therefore be given daily. Care should be taken if large volumes are infused in patients with cardiac insufficiency. Infusion via peripheral veins in general can cause irritation of the vein wall and thrombophlebitis. Therefore, AMINOVEN 5 %, 10 % or 15 % should not be infused via peripheral vein. If adjunction of lipid emulsions is indicated it should be administered where possible as a mixture with AMINOVEN 5 %, in order to minimise the risk of vein irritation. Strict asepsis should be maintained, particularly when inserting a central vein catheter. AMINOVEN 5 %, 10 % and 15 % are applicable as part of a total parenteral nutrition in combination with adequate amounts of energy supplements (carbohydrate solutions, lipid emulsions), electrolytes, vitamins and trace elements.

No interactions are known to date. Due to the increased risk of microbiological contamination and incompatibilities, amino acid solutions should not be mixed with other medicines. Should it become necessary to add other nutrients, like carbohydrates, lipid emulsions, electrolytes, vitamins or trace elements to AMINOVEN 5 %, 10 % or 15 % for complete parenteral nutrition, care should be given to aseptic techniques, thorough mixing and, in particular, to compatibility.

No specific studies have been performed to assess the safety of AMINOVEN 5 %, 10 % or 15 % in pregnancy, fertility or lactation. The risk/benefit relationship should be considered before administering AMINOVEN 5 %, 10 % or 15 % during pregnancy or lactation.

Not Applicable

None known when correctly administered. Those that occur during overdose (see section 4.9) are usually reversible and regress when therapy is discontinued. Infusion via peripheral veins in general can cause irritation of the vein wall and thrombophlebitis, and should therefore be avoided.

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 the u201c6.04 Adverse Drug Reactions Reporting Formu201d, found online under SAHPRAu2019s publications: https://www.sahpra.org.za/Publications/Index/8.

Shivering, vomiting, nausea and increased renal amino acid losses can occur when AMINOVEN 5 %, 10 % or 15 % is given in overdose or the infusion rate is exceeded. Infusion should be stopped immediately in this case. It may be possible to continue with a reduced dosage. A too rapid infusion can cause fluid overload and electrolyte disturbances. There is no specific antidote for overdose. Emergency procedures should be supportive general measures, with particular attention to respiratory and cardiovascular systems. Close biochemical monitoring is essential and specific abnormalities should be treated appropriately.