Aminoven 10%

Aminoven 10%

Manufacturer:

Fresenius Kabi

Distributor:

Zuellig Pharma
Full Prescribing Info
Contents
Amino acids without electrolytes and carbohydrates.
Description
Each 1000 mL solution for infusion contains iso-leucine 5 g, leucine 7.4 g, lysine acetate 9.31 g (equivalent to lysine 6.6 g), methionine 4.3 g, phenylalanine 5.1 g, threonine 4.4 g, tryptophan 2 g, valine 6.2 g, arginine 12 g, histidine 3 g, alanine 14 g, glycine 11 g, proline 11.2 g, serine 6.5 g, tyrosine 0.4 g, taurine 1 g. It also contains glacial acetic acid and water for injections as excipients.
Total amino acids: 100 g/L. Total nitrogen: 16.2 g/L. Total energy content: 1680 kJ/L = 400 kcal/L. pH value: 5.5-6.5. Titration acidity after mixing: 22 mmol NaOH/L. Theoretical osmolarity: 990 mOsmol/L.
Indications/Uses
For supply of amino acids as part of a parenteral nutrition regimen.
Amino acid solutions should be administered generally in combination with adequate amount of energy supplements.
Dosage/Direction for Use
Dosage depends on the severity of the catabolic state and on the amino acid requirement.
A maximum daily dosage of 2 g amino acids/kg body weight should not be exceeded in parenteral nutrition.
Daily Dose: 10-20 mL/kg body weight (equivalent to 1-2 g amino acids/kg body weight) corresponding to 700-1400 mL Aminoven 10% at 70 kg body weight.
Maximum Infusion Rate: 1 mL/kg body weight/hr (equivalent to 0.1 g amino acids/kg body weight/hr).
Maximum Daily Dose: 20 mL/kg body weight (equivalent to 2 g amino acids/kg body weight) corresponding to 1400 mL Aminoven 10% or 140 g amino acids at 70 kg body weight.
The solution is administered as long as a parenteral nutrition is required.
Administration: For administration via central vein as a continuous infusion.
Overdosage
Symptoms: As with other amino acid solutions, shivering, vomiting, nausea and increased renal amino acid losses can occur when Aminoven 10% 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 hyperhydration or electrolyte disturbances due to relatively high fluid load.
Treatment: There is no specific antidote for overdose. Emergency procedures should be general supportive measures, with particular attention to respiratory and cardiovascular systems. Close biochemical monitoring would be essential and specific abnormalities treated appropriately.
Contraindications
As for all amino acid solutions, the administration of Aminoven 10% 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.
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.
Use in children: The administration of Aminoven 10% is contraindicated in neonates.
No clinical studies have been conducted with Aminoven 10% solution in newborns, infants or children.
Special Precautions
Serum electrolytes, fluid balance and renal function should be monitored.
In cases 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.
Infusion via peripheral veins in general can cause irritation of the vein wall and thrombophlebitis. Therefore, daily inspections of the insertion site are recommended.
The choice of peripheral or central vein depends on the final osmolarity of the mixture. The general accepted limit for peripheral infusion is about 800 mOsmol/L, but it varies considerably with the age and the general condition of the patient and the characteristics of the peripheral veins.
Strict asepsis should be maintained, particularly when inserting a central vein catheter.
Aminoven 10% is applicable as part of total parenteral nutrition (TPN) regimen in combination with adequate amounts of energy supplements (carbohydrate solutions; fat emulsions), electrolytes, vitamins and trace elements.
Use in pregnancy & lactation: No specific studies have been performed to assess the safety of Aminoven 10% in pregnancy or lactation. Thus, the risk/benefit relationship should be considered before administering Aminoven 10% during pregnancy or breastfeeding.
Use In Pregnancy & Lactation
Use in pregnancy & lactation: No specific studies have been performed to assess the safety of Aminoven 10% in pregnancy or lactation. Thus, the risk/benefit relationship should be considered before administering Aminoven 10% during pregnancy or breastfeeding.
Adverse Reactions
None known when correctly administered.
Those that occur during overdose (see Overdosage) are usually reversible and regress when therapy is discontinued. Infusion via peripheral veins in general can cause irritation of the vein wall and thrombophlebitis.
No other adverse events have been reported than these that can be seen in connection with parenteral nutrition in general.
Drug Interactions
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 drugs. Should it become necessary to add other nutrients eg, carbohydrates, lipid emulsions, electrolytes, vitamins or trace elements to Aminoven 10% for complete parenteral nutrition, care should be given to aseptic techniques, thorough mixing and, in particular, to compatibility.
Caution For Usage
Aminoven 10% should be used with sterile transfer equipment immediately after opening. Any unused solution should be discarded.
For single use only.
Use only clear, particle-free solutions and undamaged containers.
Aminoven 10% may be aseptically admixed with other nutrients eg, fat emulsions, carbohydrates and electrolytes. Chemical and physical stability data for a number of admixtures stored at 4°C for up to 9 days are available from the manufacturer upon request.
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 hrs at 2-8°C, unless mixing has taken place in controlled and validated aseptic conditions.
Storage
Do not freeze.
ATC Classification
B05BA01 - amino acids ; Belongs to the class of solutions for parenteral nutrition used in I.V. solutions.
Presentation/Packing
Soln 10% x 500 mL.
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Sign up for free
Already a member? Sign in