AMINOPLASMAL 10% E WITHOUT CARBOHYDRATES SOLUTION 10 %w/v Solution for Infusion

País: Irlanda

Língua: inglês

Origem: HPRA (Health Products Regulatory Authority)

Ingredientes ativos:

LEUCINE ISOLEUCINE 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 PHOSPHATE MONOBASIC MALIC ACID N-ACETYLTYROSINE PH. EUR.

Disponível em:

B. Braun Medical Limited

DCI (Denominação Comum Internacional):

LEUCINE ISOLEUCINE LYSINE HYDROCHLORIDE DL-METHIONINE PHENYLALANINE THREONINE TRYPTOPHAN, L- VALINE ARGININE HISTIDINE

Dosagem:

10 %w/v

Forma farmacêutica:

Solution for Infusion

Tipo de prescrição:

Product subject to prescription which may not be renewed (A)

Status de autorização:

Withdrawn

Data de autorização:

0000-00-00

Características técnicas

PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Aminoplasmal 10% E without Carbohydrates Solution for Infusion.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
_1000 ml of solution contains_
Isoleucine
5.10
g
Leucine
8.90
g
Lysine Hydrochloride
7.00
g
_(equivalent to lysine 5.60 g)_
Methionine
3.80
g
Phenylalanine
5.10
g
Threonine
4.10g
Tryptophan
1.80g
Valine
4.80g
Arginine
9.20
g
Histidine
5.20
g
Glycine
7.90
g
Alanine
13.70 g
Proline
8.90
g
Aspartic Acid
1.30
g
Asparagine Monohydrate
3.72
g
_(equivalent to asparagine 3.27 g)_
Acetylcysteine
0.68
g
_(equivalent to cysteine 0.50 g)_
Glutamic Acid
4.60
g
Ornithine Hydrochloride
3.20
g
_(equivalent to ornithine 2.51 g)_
Serine
2.40
g
Tyrosine
0.30
g
Acetyltyrosine
1.23
g
_(equivalent to tyrosine 1.0 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
Electrolyte concentrations:
Sodium
43.0
mmol/l
Potassium
25.0
mmol/l
Magnesium
2.6
mmol/l
Acetate
59.0
mmol/l
Chloride
57.0
mmol/l
Dihydrogen phosphate
9.0
mmol/l
L-Malate
7.5
mmol/l
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 11/11/2008_
_CRN 2058214_
_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 dos