Brand name: Aminoven
Active ingredient ( generic name):Amino-Acid Infusion
Manufacturer: Fresenius-Kabi
Importer: Darmanyab Darou
Pharmacotherapeutic group: Nutrition
Pharmaceutical form: 5% and 10% solution for infusion
Pharmacodynamic:
The amino acids contained in Aminoven 10% are all naturally occurring physiological compounds. As with amino acids derived from the ingestion and assimilation of food proteins, parenterally administered amino acids enter the body pool of free amino acids and all subsequent metabolic pathways.
Pharmacokinetic:
The amino acids in Aminoven enter the plasma pool of corresponding free amino acids. From the intravascular space, amino acids distribute to the interstitial fluid and are individually regulated for each single amino acid, into the intracellular space of different tissues as required.
Only a small proportion of the infused amino acids is eliminated by the kidneys. For the majority of amino acids plasma half lives between 10 and 30 minutes have been reported.
Therapeutic indication:
For supply of amino acids as part of parenteral nutrition regimen.
Amino acid solutions should be administered generally in combination with adequate amount of energy supplement.
Dosage and administration:
For administration via a central vein as a continuous infusion.
Dosage depends on the severity of the catabolic state and on the amino acid requirement.
A max. daily dose of 2 g amino acid /kg body weight should not be exceeded in parenteral nutrition.
· Daily dose: 10-20 ml of Aminoven 10% per kg body weight ( equivalent to 1.0 to 2.0 g amino acids per kg body weight) corresponding to 700-1400 ml Aminoven 10% at 70kg body weight.
· Maximum infusion rate: 1.0ml of Aminoven 10% per kg body weight per hour ( equivalent to 0.1g amino acid per kg body weight and hour).
· Maximum daily dose: 20ml of Aminoven 10% per kg body weight (equivalent to 2.0 g amino acids per kg body weight) corresponding to 1400 ml Aminoven 10% or 140g amino acids at 70 kg body weight).
The solution is administered as long as parenteral nutrition is required.
Contraindication:
As for all amino acid solutions the administration of Aminoven is contraindicated in the following conditions:
Disturbances of amino acid metabolism, metabolic acidosis, renal insufficiency, without haemodialysis or haemofiltration treatment, advanced liver insufficiency, fluid overload, shock, hypoxia, decompensated heart failure.
The administration of Aminoven is contra-indicated in neonants. For parenteral nutrition of infants and small children and children paediatric amino acid preparations should be used, which are formulated to meet the different metabolic needs of children. No clinical studies have been conducted with Aminoven solution in newborn, infants or children.
Adverse reaction:
None known when correctly administered. Those that occur during overdose are usually reversible and regress when therapy is discontinued. Infusion via peripheral veins in general can cause irritation of the vein wall and thrombophlebitis.
Interactions:
No interactions are known to date. Tetracycline may decrease the efficacy of Aminoven.
Due to the increased risk of microbiological contamination and incompatibilities, amino acid solutions should not be mixed with other drugs.
Special warning:
Serum electrolytes, fluid balance and renal function should be monitored.
In case of Hypokalemia and/or hyponatremia adequate amounts of potassium and/or sodium should be supplied simultaneously.
Amino acid solutions may precipitate acute folate deficiency, folic acid should therefore be given daily.
Care should be exercised in the administration of large volume infusion fluids to patients with cardiac insufficiency.
The choice of a peripheral or central vein depends on the final osmolarity of the mixture. The general accepted limit for peripheral infusion 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 vein.
Strict asepsis should be maintained, particularly when inserting a central vein catheter.
Aminoven is applicable as a part of total parenteral nutrition regimen in combination with adequate amounts of energy supplements (carbohydrate solutions, fat emulsions), electrolytes, vitamins and trace elements.
Pregnancy and lactation:
No specific studies have been performed to assess the safety of Aminoven in pregnancy and lactation. However, clinical experiences with similar parenteral amino acid solutions have shown no evidence of risk during pregnancy or breast feeding. The risk/benefit relationship should be considered before administering Aminoven during pregnancy or breastfeeding.
Storage temperature:
Keep container in the outer cartoon.
Do not freeze.
Room temperature ( 15-25 C).
From a microbiological point of View, TPN admixtures compounded in uncontrolled or unvalidated conditions should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and should normally be no longer than 24 hours at 2-8 C, unless mixing has taken place in controlled and validated aseptic conditions.
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