AMINOPLASMAL 5% E WITHOUT CARBOHYDRATES SOLUTION F
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
25-04-2024
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Active ingredient:
ISOLEUCINE LEUCINE LYSINE HYDROCHLORIDE DL-METHIONINE PHENYLALANINE THREONINE TRYPTOPHAN, L- VALINE ARGININE HISTIDINE AMINOACETIC ACID ALANINE PROLINE ASPARTIC ACID ASPARGINE MONOHYDRATE ACETYLCYSTEINE GLUTAMIC ACID ORNITHINE HYDROCHLORIDE SERINE TYROSINE SODIUM ACETATE TRIHYDRATE POTASSIUM ACETATE MAGNESIUM ACETATE TETRAHYDRATE SODIUM DIHYDROGEN PHOSPHATE DIHYDRATE MALIC ACID N-ACETYLTYROSINE PH. EUR.
Available from:
B. Braun Medical Limited
Dosage:
5 %w/v
Pharmaceutical form:
Solution for Infusion
Authorization date:
1987-04-08
Summary of Product characteristics
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Aminoplasmal 5% E without Carbohydrates Solution for Infusion.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
_1000 ml of solution contains:_
Isoleucine
2.55
g
Leucine
4.45
g
Lysine Hydrochloride
3.50
g
_(equivalent to lysine 2.80g)_
Methionine
1.90
g
Phenylalanine
2.55
g
Threonine
2.05
g
Tryptophan
0.90
g
Valine
2.40
g
Arginine
4.60
g
Histidine
2.60
g
Glycine
3.95
g
Alanine
6.85
g
Proline
4.45
g
Aspartic Acid
0.65
g
Asparagine monohydrate
1.86
g
_(equivalent to asparagine 1.64 g)_
Acetylcysteine
0.34
g
_(equivalent to cysteine 0.25 g)_
Glutamic acid
2.30
g
Ornithine hydrochloride
1.60
g
_(equivalent to ornithine 1.25 g)_
Serine
1.20
g
Tyrosine
0.30
g
Acetyltyrosine
0.43
g
_(equivalent to tyrosine 0.35 g)_
Sodium acetate trihydrate
3.95
g
Potassium acetate
2.45
g
Magnesium acetate tetrahydrate
0.56
g
Sodium dihydrogen phosphate dihydrate 1.40
g
Sodium hydroxide
0.20
g
Malic acid
1.01
g
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 11/11/2008_
_CRN 2058197_
_page number: 1_
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Solution for infusion
A clear, colourless or faintly straw-coloured aqueous solution
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Supply of amino acids as a substrate for protein synthesis in parenteral nutrition, when oral or enteral nutrition is
impossible, insufficient or contraindicated.
In parenteral nutrition, amino acid infusions should always be combined with adequate calorie supply, e. g. in the form
of carbohydrate solutions.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The dosage is adjusted according to the individual need of amino acids, electrolytes and fluid, depending on the
patient’s clinical condition (nutritional status and/or
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