Aminoplasmal 10% Solution For Infusion
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT
Aminoplasmal 10% solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
The solution for infusion contains
|
Amino acids: |
per 1 ml |
per 250 ml |
per 500 ml |
per 1000 ml |
|
Isoleucine |
5.00 mg |
1.25 g |
2.50 g |
5.00 g |
|
Leucine |
8.90 mg |
2.23 g |
4.45 g |
8.90 g |
|
Lysine acetate |
5.74 mg |
1.44 g |
2.87 g |
5.74 g |
|
(equivalent to lysine) |
(4.07 mg) |
(102 g) |
(2.04 g) |
(4.07 g) |
|
Lysine monohydrate |
3.12 mg |
0.78 g |
1.56 g |
3.12 g |
|
(equivalent to lysine) |
(2.78 mg) |
(0.70 g) |
(139 g) |
(2.78 g) |
|
Methionine |
4.40 mg |
1.10 g |
2.20 g |
4.40 g |
|
Phenylalanine |
4.70 mg |
1.18 g |
2.35 g |
4.70 g |
|
Threonine |
4.20 mg |
1.05 g |
2.10 g |
4.20 g |
|
Tryptophan |
1.60 mg |
0.40 g |
0.80 g |
1.60 g |
|
Valine |
6.20 mg |
1.55 g |
3.10 g |
6.20 g |
|
Arginine |
11.50 mg |
2.88 g |
5.75 g |
11.50 g |
|
Histidine |
3.00 mg |
0.75 g |
1.50 g |
3.00 g |
|
Alanine |
10.50 mg |
2.63 g |
5.25 g |
10.50 g |
|
Glycine |
12.00 mg |
3.00 g |
6.00 g |
12.00 g |
|
Aspartic acid |
5.60 mg |
1.40 g |
2.80 g |
5.60 g |
|
Glutamic acid |
7.20 mg |
1.80 g |
3.60 g |
7.20 g |
|
Proline |
5.50 mg |
1.38 g |
2.75 g |
5.50 g |
|
Serine |
2.30 mg |
0.58 g |
1.15 g |
2.30 g |
|
Tyrosine |
0.40 mg |
0.10 g |
0.20 g |
0.40 g |
Total nitrogen 15.8 g/l
Caloric value: 1675 kJ/l = 400 kcal/l
Theoretical osmolarity: 864 mOsm/l
Titration acidity (to pH 7.4): approx. 20 mmol/l pH: 5.7 - 6.3
Electrolyte concentrations: mmol/l Acetate 28
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for infusion
Clear, colourless up to faintly straw-coloured solution
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Supply of amino acids for parenteral nutrition, when oral or enteral nutrition is impossible, insufficient or contra-indicated. For adults, adolescents and children over 2 years of age.
In parenteral nutrition, amino acid infusions should always be combined with adequate calorie supply, e.g. in the form of carbohydrate infusions.
4.2 Posology and method of administration
Posology
The dosage is 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 and adolescents from 14 to 17 years:
Average daily dose:
10 - 20 ml /kg body weight (BW)= 1.0-2.0 g amino acids/kg BW
= 700-1400 ml for a 70 kg patient
Maximum daily dose:
20 ml/kg BW = 2.0 g amino acids/kg BW
= 140 g amino acids for a 70 kg patient = 1400 ml for a 70 kg patient
Maximum infusion and drop rates, respectively:
1 ml/kg BW/h = 0.1 g amino acids/kg BW/h
= 25 drops/min for a 70 kg patient = 1.17 ml/min for a 70 kg patient
Children and adolescents 2 to 13 years:
The dosages for this age group as 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 from 2 to 4 years:
15 ml/kg BW = 1.5 g amino acids/kg BW
Daily dose for children from 5 to 13 years:
10 ml/kg BW = 1.0 g amino acids/kg BW
Maximum infusion rate:
1 ml/kg BW/h = 0.1 g amino acids/kg BW/h
Duration of use
It can be administered as long as there is an indication for parenteral nutrition. Method of administration
Intravenous use (central venous infusion).
Aminoplasmal 10% is only one component of parenteral nutrition. In parenteral nutrition, amino acid supply must be combined with supply of calorie sources, essential fatty acids, electrolytes, vitamins, and trace elements.
4.3 Contraindications
• Hypersensitivity to the active substances or to any of the excipients listed in section 6.1
• Congenital abnormalities of amino acid metabolism
• Severe circulation disorders with vital risk (e.g. shock)
• Hypoxia
• Metabolic acidosis
• Advanced liver disease
• Severe renal insufficiency without access to haemofiltration or haemodialysis
• Children under 2 years of age because the nutrient ratios do not properly meet the special paediatric requirements
• General contraindications of infusion therapy:
- uncompensated cardiac insufficiency
- acute pulmonary oedema
- hyperhydration
4.4 Special warnings and precautions for use
Aminoplasmal 10% 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.
Hypotonic dehydration should be corrected by adequate supply of fluid and electrolytes prior to parenteral nutrition.
In cases of hypokalaemia and/or hyponatraemia adequate amounts of potassium and/or sodium should be supplied.
In patients with liver or renal insufficiency, the dose must be adjusted according to individual requirements.
Caution should be exercised in patients with increased serum osmolarity.
Serum electrolytes, blood glucose, fluid balance, acid-base balance and renal function (BUN, creatinine) should be monitored regularly.
Monitoring should also include serum protein and liver function tests.
Care should be exercised in the administration of large volume infusion fluids to patients with cardiac insufficiency.
Aminoplasmal 10% is applicable as part of a total parenteral nutrition regimen in combination with adequate amounts of energy supplements (carbohydrate solutions, fat emulsions), vitamins, trace elements and electrolytes.
The site of infusion should be checked daily for signs of inflammation or infection.
4.5 Interaction with other medicinal products and other forms of interaction
None known
4.6 Fertility, pregnancy and lactation
Studies in pregnant or breast-feeding women have not been conducted with this medicinal product. There are no pre-clinical data regarding the administration of Aminoplasmal 10% during pregnancy. Aminoplasmal 10% should therefore be administered with caution during pregnancy and lactation and only if deemed clearly indicated after assessment of its benefits and possible risks.
4.7 Effects on ability to drive and use machines
Not applicable
4.8 Undesirable effects
Undesirable effects that, however, are not specifically related to the product but to parenteral nutrition in general may occur, especially at the beginning of parenteral nutrition.
Listing of undesirable effects
Undesirable effects are listed according to their frequencies as follows:
Very common (> 1/10)
Common (> 1/100 to < 1/10)
(> 1/1,000 to < 1/100)
Uncommon Rare Very rare Not known
(> 1/10,000 to < 1/1,000)
(< 1/10,000)
(frequency cannot be estimated from the available data)
Immune system disorders Not known: Allergic reactions
Gastrointestinal disorders
Uncommon: Nausea, vomiting
General disorders and administration site conditions
Uncommon: Headache, shivering, fever
Reporting of 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 via the MHRA Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
4.9 Overdose
Symptoms
Overdose or too high infusion rates may lead to intolerance reactions manifesting in the form of shivering, nausea, vomiting, 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
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Blood substitutes and perfusion solutions, i.v. solutions, solutions for parenteral nutrition, ATC code: B05BA01.
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 carbohydrate or fat) is necessary.
5.2 Pharmacokinetic properties
Because Aminoplasmal 10% is infused intravenously, the bio-availability of the amino acids contained in the solution is 100 %.
The composition of Aminoplasmal 10% is based upon the results of clinical investigations of the metabolism of intravenously administered amino acids. The quantities of the amino acids contained in Aminoplasmal 10% have been chosen so that a homogenous increase of the concentrations of all plasma amino acids is achieved. The physiological relations of plasma amino acids, i. e. the amino acid homeostasis is thus maintained during infusion of Aminoplasmal 10%.
Amino acids, that do not enter protein synthesis, are metabolized as follows. The amino group is separated from the carbon skeleton by transamination. The carbon chain is either oxidized directly to CO2 or utilized as substrate for gluconeogenesis in the liver. The amino group is also metabolized in the liver to urea.
5.3 Preclinical safety data
Preclinical studies have not been performed with this medicinal product.
Aminoplasmal 10% only contains amino acids that are substrates of human metabolism.
Therefore, no toxic reactions are expected to occur as long as the indications, contraindications and dosage recommendations are duly observed.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Acetylcysteine
Citric acid monohydrate (for pH-adjustment)
Water for injections
6.2 Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
6.3 Shelf life
Shelf life in the unopened container 3 years
Shelf life after first opening the container
The medicinal product should be used immediately.
Shelf life after mixing with other components
From the microbiological point of view, mixtures should be administered immediately after preparation. If not administered immediately, storage times and conditions of mixtures prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 °C - 8 °C, unless mixing has taken place under controlled and validated aseptic conditions.
6.4 Special precautions for storage
Keep the container 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, that can, however, be easily dissolved by gentle warming at 25 °C until dissolution is complete. Shake container gently to ensure homogeneity.
6.5 Nature and contents of container
Bottles of colourless glass (type II), sealed with chlorobutyl-rubber stoppers.
Contents: 250 ml, available in packs of 10 bottles
500 ml, available in packs of 10 bottles 1000 ml, available in packs of 6 bottles
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
No special requirements for disposal.
Containers are for single use only. Discard any unused contents remaining after the end of the infusion.
The solution should only be used if the closure of the container is not damaged and if the solution is clear.
Use a sterile giving set for administration.
If in the setting of complete parenteral nutrition it is necessary to add other nutrients such as carbohydrates, lipids, vitamins and trace elements to this medicinal product, admixing must be performed under strict aseptic conditions. Mix well after admixture of any additive. Pay special attention to compatibility.
7 MARKETING AUTHORISATION HOLDER
B. Braun Melsungen AG Carl-Braun-StraBe 1 34212 Melsungen Germany
Postal address B. Braun Melsungen AG 34209 Melsungen Germany
Phone: +49-5661-71-0
Fax: +49-5661-4567
8 MARKETING AUTHORISATION NUMBER(S)
PL 03551/0104
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
22/10/2009