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 has to be restricted.
Amino acid solutions should be administered generally in combination with adequate amount of energy supplements.

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.
Adults
Dosage:
6.7 – 13.3 ml of Aminoven 15% per kg body weight/day (equivalent to 1.0 - 2.0 g amino acids per kg body weight/day) e.g. corresponding to 470 - 930 ml Aminoven 15% at 70 kg body weight/day.
Maximum infusion rate:
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:
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.
Paediatric population
No studies have been performed in the paediatric population.
Aminoven 15% is contraindicated in children (see section 4.3).
Children and adolescents (2-18 years of age) are recommended to receive Aminoven 5% or Aminoven 10%.
For children under 2 years, paediatric amino acid preparations which are formulated to meet their different
metabolic needs should be used.
Method of administration
For administration via a central vein as a continuous infusion

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. Therefore folic acid should be given daily.
Care given if large volumes infused in 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 approx. 800 mosm/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 15% is for use as part of 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.
Concerning incompatibilities, see Section 6.2.

No specific studies have been performed to assess the safety of Aminoven 15% in fertility, pregnancy or lactation. However, clinical experiences with similar parenteral amino acid solutions have shown no evidence of risk during pregnancy or breastfeeding. The risk/benefit relationship should be considered before administering Aminoven 15% during pregnancy or breastfeeding.

Not relevant.

None known when correctly administered.
Undesirable effects which 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.
Clinical experience is very limited.
Reporting suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system below list:
Saudi Arabia:
Other GCC States:
The National Pharmacovigilance and Drug Safety Centre (NPC)
Fax: +966-11-205-7662
Call NPC at +966-11-2038222, Exts: 2317-2356-2353-2354-2334-2340.
Toll free phone: 8002490000
E-mail: npc.drug@sfda.gov.sa
Website: www.sfda.gov.sa/npc
Please contact the relevant competent authority.

As with other amino acid solutions shivering, vomiting, nausea, and increased renal amino acid losses can occur when Aminoven 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.

Pharmacotherapeutic group: Amino acids - solution for parenteral nutrition, ATC code: B05B A01
The amino acids contained in Aminoven 15% are all naturally occuring physiological compounds. As with the 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.

The amino acids in Aminoven 15% enter the plasma pool of corresponding free amino acids. From the intravascular space, amino acids reach the interstitial fluid and the intracellular space of different tissues.
Plasma and intracellular free amino acid concentrations are endogenously regulated for each single amino acid within narrow ranges, depending on the age, nutritional status and pathological condition of the patient.
Balanced amino acid solutions such as Aminoven 15% do not significantly alter the physiologic amino acid pool of essential and non-essential amino acids when infused at a constant and slow infusion rate.
Characteristic changes in the physiologic plasma amino acid pool are only foreseeable when the regulative function of essential organs as liver and kidneys is seriously impaired. In such cases special formulated amino acid solutions may be recommended for restoring homeostasis.
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.

Preclinical toxicity data are available for single amino acids but are not relevant to mixtures of amino acids in solutions such as Aminoven 15%. No preclinical toxicity studies with Aminoven 15% have been carried out. Studies with comparable amino acid solutions have shown no toxic effect.

Glacial acetic acid
Water for injections
Malic acid

Due to the increased risk of microbiological contamination and incompatibilities, amino acid solutions should not be mixed with other medicinal products.
Should it become necessary to add other nutrients, see sections 6.3 c), 6.4, 6.6

Keep container in the outer carton.
Do not freeze.
Storage precautions after mixing with other components:
Aminoven 15% may be aseptically admixed with other nutrients as lipid 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 hours at 2 to 8°C, unless mixing has taken place in controlled and validated aseptic conditions.

Glass bottles, 250 ml, 500 ml and 1000 ml.
Type II, colourless glass, rubber closure/aluminium cap and outer carton.
Bottle sizes: 10x250 ml glass bottle
10 x 500 ml glass bottle
6 x 1000 ml glass bottle
1 x 250 ml glass bottle (sample package).
Infusion bags consisting of an inner bag and an overpouch. The inner bag is made of polypropylene-based polymer. An oxygen absorber is placed between the inner bag and the overpouch.
Bag size: 500 ml, 12 x 500 ml
1000 ml, 6 x 1000 ml
Not all pack sizes may be marketed.

To be used immediately after the container is opened.
For single use only.
Do not use Aminoven 15% after expiry date.
Use only clear, particle-free solutions and undamaged containers.
Discard unused solutions. Any admixture remaining after infusion must be discarded.
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, like carbohydrates, lipid emulsions, electrolytes, vitamins or trace elements to Aminoven 15% for complete parenteral nutrition, care should be given to aseptic techniques, thorough mixing and, in particular, to compatibility.
Compatibility data are available from the manufacturer for a number of mixtures.