Aminoven 16
1. NAME OF THE MEDICINAL PRODUCT
Aminoven 16, solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1000 ml solution for infusion contains:
5.00 g
7.40 g 9.31 g
6.60 g
4.30 g 5.10 g
6.50 g 0.40 g
Isoleucine
Leucine
Lysine acetate
= Lysine
Methionine
Phenylalanine
Threonine
Tryptophan
Valine
Arginine
Histidine
Alanine
Glycine
Proline
Serine
Tyrosine
Taurine
Total amino acids: 100.0 g/l
Total nitrogen: 16.2 g/l
Total energy: 1680 kJ/l (= 400 kcal/l)
Titratable acidity: 22 mmol NaOH/l
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Solution for infusion
The solution is clear and colourless to slightly yellow.
pH : 5.5 - 6.3
Theoretical osmolarity : 990 mosm/l
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
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.
4.2 Posology and method of administration
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:
10 - 20 ml of Aminoven 16 per kg body weight/day (equivalent to 1.0 - 2.0 g amino acids per kg body weight/day), e.g. corresponding to 700 - 1400 ml Aminoven 16 at 70 kg body weight/day.
Maximum infusion rate:
1.0 ml of Aminoven 16 per kg body weight/ hour (equivalent to 0.1 g amino acids per kg body weight/ hour). Maximum daily dose:
20 ml of Aminoven 16 per kg body weight/day (equivalent to 2.0 g amino acids per kg body weight/day) corresponding to 1400 ml Aminoven 16 or 140 g amino acids at 70 kg body weight.
Paediatric population
No studies have been performed in the paediatric population.
Aminoven 16 is contraindicated in children less than 2 years of age (see section 4.3). For children under 2 years, paediatric amino acid preparations which are formulated to meet their different metabolic needs should be used.
Children and adolescents (2-18 years)
Dosage:
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:
Same as for adults, see information above.
Method of administration
For administration via a central vein as a continuous infusion.
4.3 Contraindications
The administration of Aminoven 16 is contraindicated in children less than 2 years of age.
As for all amino acid solutions the administration of Aminoven 16 is contra-indicated 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.
4.4 Special warnings and precautions for use
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 should be given if large volumes are 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 16 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.
4.5 Interaction with other medicinal products and other forms of interaction
No interactions are known to date.
Concerning incompatibilities, see Section 6.2.
4.6 Fertility, pregnancy and lactation
No specific studies have been performed to assess the safety of Aminoven 16 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 16 during pregnancy or breastfeeding.
4.7 Effects on ability to drive and use machines
Not relevant.
4.8 Undesirable effects
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.
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
4.9 Overdose
As with other amino acid solutions shivering, vomiting, nausea, and increased renal amino acid losses can occur when Aminoven 16 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.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Amino acids - solution for parenteral nutrition ATC code: B05B A01
The amino acids contained in Aminoven 16 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.
5.2 Pharmacokinetic properties
The amino acids in Aminoven 16 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 16 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.
5.3 Preclinical safety data
Preclinical toxicity data are available for single amino acids but are not relevant to mixtures of amino acids in solutions such as Aminoven 10%. No preclinical toxicity studies with Aminoven 16 have been carried out. Studies with comparable amino acid solutions have shown no toxic effect
6. PHARMACEUTICAL PARTICULARS
6.1. List of excipients
Glacial acetic acid Water for injections
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.
6.3. Shelf life
a) Shelf-life of the medicinal product as packaged for sale
Glass bottle: 2 years Infusion bag: 18 months
b) Shelf life after first opening the container
Aminoven 16 should be used with sterile transfer equipment immediately after opening. Any unused solution should be discarded.
c) Shelf-life after mixing with other components
In general, TPN admixtures may be stored for a maximum period of 24 hours at 2 to 8°C, unless a longer storage period has been proven. See Section 6.4.
6.4 Special precautions for storage
Keep container in the outer carton.
Do not freeze.
Storage precautions after mixing with other components:
Aminoven 16 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.
6.5. Nature and contents of container
Glass bottles, 500 ml and 1000 ml
Type II, colourless glass, rubber closure/aluminium cap and outer carton.
Package sizes: 10 x 500 ml glass bottle 6 x 1000 ml glass bottle 1 x 500 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
To be used immediately after the bottle is opened.
For single use only.
Do not use Aminoven 16 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 16 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.
7. MARKETING AUTHORISATION HOLDER
Fresenius Kabi Limited Cestrian Court Eastgate Way Manor Park Runcorn Chesire WA7 1NT United Kingdom
8. MARKETING AUTHORISATION NUMBER
PL 08828/0128
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
06/01/2009
10 DATE OF REVISION OF THE TEXT
16/03/2013