Supply of amino acids for parenteral nutrition, when oral or enteral
nutrition is impossible, insufficient or contraindicated.

Posology
The dosage has to be adjusted according to the individual need of
amino acids and fluid, depending on the clinical condition of the
patient (nutritional status and/or degree of nitrogen catabolism due to
underlying disease).
Adults
Daily dose:
6.7 � 13.3 ml/kg body weight  1.0 � 2.0 g amino acids/kg body
weight
 469 � 931 ml for a 70 kg patient
Maximum infusion rate:
0.67 ml/kg body weight/h  0.1 g amino acids/kg body weight/h
 0.78 ml/min for a 70 kg patient
Paediatric population
Aminoplasmal 15% is contraindicated in children under 2 years old
(see section 4.3).
The dosages for the age group stated below are average values for
guidance. The exact dosage should be adjusted individually according
to age, developmental stage and prevailing disease.
Daily dose for children 2 to 17 years old:
6.7 � 13.3 ml/kg body weight  1.0 � 2.0 g amino acids/kg body
weight
Critically ill children:
For critically ill patients the advisable amino acid intake may be higher
(up to 3.0 g amino acids/kg body weight per day).
Maximum infusion rate:
0.67 ml/kg body weight /h  0.1 g amino acids/kg body weight /h
Patients with renal/hepatic impairment
The doses should be adjusted individually in patients with hepatic or
renal insufficiency (see also section 4.4). Aminoplasmal 15% is contraindicated
in severe hepatic insufficiency and severe renal insufficiency
(see section 4.3).
Duration of use
This solution can be administered as long as parenteral nutrition is
indicated.
Method of administration
Intravenous use.
For central venous infusion only.

� Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. � Inborn errors of amino acid metabolism � Severe circulation disorders with vital risk (e.g. shock) � Hypoxia � Metabolic acidosis � Severe hepatic insufficiency � Severe renal insufficiency without treatment with haemofiltration or haemodialysis � Decompensated cardiac insufficiency � Acute pulmonary oedema � Hyperhydration The medicinal product must not be administered to neonates, infants, and children under 2 years old, because the nutrient ratios do not properly meet the special paediatric requirements.

The medicinal product should only be administered after careful benefit-
risk assessment in the presence of disorders of amino acid metabolism
of other origin than stated under section 4.3.
Care should be exercised in the administration of large volume infusion
fluids to patients with cardiac insufficiency.
Caution should be exercised in patients with increased serum osmolarity.
Disturbances of fluid and electrolyte balance (e.g. hypotonic dehydration, hyponatraemia, hypokalaemia) should be corrected prior to the
administration of parenteral nutrition.
Serum electrolytes, blood glucose, fluid balance, acid-base balance
and renal function should be monitored regularly.
Monitoring should also include serum protein and liver function tests.
In patients with renal insufficiency, the dose must be carefully adjusted
according to individual needs, severity of organ insufficiency and
the kind of instituted renal replacement therapy (haemodialysis,
haemofiltration etc.).
In patients with hepatic insufficiency, the dose must be carefully
adjusted according to individual needs and severity of organ insufficiency.
Amino acid solutions are only one component of parenteral nutrition.
For complete parenteral nutrition, substrates for energy supply, essential
fatty acids, electrolytes, vitamins, fluids and trace elements must
be administered together with amino acids.

None known

Pregnancy
There are no or limited amount of data from the use of Aminoplasmal
15% in pregnant women. The use of Aminoplasmal 15% may be considered
during pregnancy, if necessary.

Breast-feeding
Amino acids/metabolites are excreted in human milk, but at therapeutic
doses of Aminoplasmal 15% no effects on the breastfed newborns/
infants are anticipated.
Nevertheless, breast-feeding is not recommended for mothers on parenteral
nutrition.

Fertility
No data available.

Not relevant.

If used according to the directions given, undesirable effects are not
to be expected.

Reporting of side effects

National Pharmacovigilance & Drug Safety Center (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

By reporting side effects you can help provide more information on
the safety of this medicine.

Symptoms
Overdose or too high infusion rates may lead to intolerance reactions
manifesting in the form of nausea, vomiting, shivering, headache,
metabolic acidosis and renal amino acid losses.

Treatment
If intolerance reactions occur, the amino acid infusion should be interrupted
temporarily and resumed later on at a lower infusion rate.19aE1E7

Pharmacotherapeutic group: Solutions for parenteral nutrition, amino
acids
ATC-Code: B05B A01

Mechanism of action
The aim of parenteral nutrition is the supply of all nutrients necessary
for the growth, maintenance and regeneration of body tissues etc.
Amino acids are of special importance as they partly are essential for
protein synthesis. Intravenously administered amino acids are incorporated
in the respective intravascular and intracellular amino acid
pools. Both endogenous and exogenous amino acids serve as substrate
for the synthesis of functional and structural proteins.
To prevent the metabolisation of amino acids for energy production,
and also to fuel the other energy-consuming processes in the organism,
simultaneous energy supply (in the form of carbohydrates or fats)
is necessary.

Absorption
Because this medicinal product is infused intravenously, the bio-availability
of the amino acids contained in the solution is 100%.
Distribution
Amino acids are incorporated in a variety of proteins in different tissues
of the body. In addition each amino acid is present as free amino
acid in the blood and inside cells.
The composition of the amino acid solution is based upon the results
of clinical investigations of the metabolism of intravenously administered
amino acids. The quantities of the amino acids contained in the
solution have been chosen so that a homogenous increase of the concentrations
of all plasma amino acids is achieved. The physiological
ratios of plasma amino acids, i.e. the amino acid homeostasis, are thus
maintained during infusion of the medicinal product.
Normal foetal growth and development depend on a continuous supply
of amino acids from the mother to the foetus. The placenta is
responsible for the transfer of amino acids between the two circulations.
Biotransformation
Amino acids that do not enter protein synthesis are metabolised as
follows: The amino group is separated from the carbon skeleton by
transamination. The carbon chain is either oxidised directly to CO2 or
utilised as substrate for gluconeogenesis in the liver. The amino group
is also metabolised in the liver to urea.
Elimination
Only minor amounts of amino acids are excreted unchanged in the
urinen

Non-clinical data available for the single components of the medicinal
product reveal at common dosages no special hazard for humans
based on conventional data of safety pharmacology, repeated dose
toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction
and development.
Therefore, no toxic reactions are expected to occur as long as the indications,
contraindications and dosage recommendations are duly
observed.

Sodium hydroxide
Citric acid monohydrate (for pH-adjustment)
Water for injections 

This medicinal product must not be mixed with other medicinal products
except those mentioned in section 6.6.

Unopened 3 years After first opening The medicinal product should be used immediately. After admixture of additives Chemical and physical in-use stability after mixture with other components of parenteral nutrition has been demonstrated for 7 days at 2-8�C plus 2 days at 25�C. Detailed information on tested components (e.g. glucose, lipids, electrolytes, trace elements, vitamins) and shelf life can be provided on demand by the manufacturer. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.

Do not store above 25 C.
Keep the bottles in the outer carton in order to protect from light.
Do not freeze.
Cool storage of the solution, below 15 C, may lead to formation of
crystals and should therefore be avoided.

Bottles of colourless glass (type II), sealed with halogen butyl rubber
stoppers, containing 500 ml or 1000 ml of solution.
Pack sizes: 10 x 500 ml, 6 x 1000 ml
Not all pack sizes may be marketed.

No special requirements for disposal.
Containers are for single use only. Discard container and any unused
content after use.

Only to be used if the solution is clear and colourless or faintly strawcoloured
and the bottle and its closure are undamaged.
Use a sterile giving set for administration.
Aminoplasmal 15% should only be mixed with other iv solutions, if
compatibility has been proven in advance. Compatibility data for different
additives (e.g. glucose, lipids, electrolytes, trace elements, vitamins)
and the corresponding shelf-life of such admixtures can be provided
on demand by the manufacturer.
It is essential that any admixture be prepared using strict aseptic
techniques as this nutrient mixture supports microbial growth.