INTRAFUSIN 22 500 Unknown Solution for Infusion
Land: Irland
Sprog: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Produktets egenskaber
(SPC)
13-06-2024
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Aktiv bestanddel:
ISOLEUCINE LEUCINE L-LYSINE-L-GLUTAMATE DIHYDRATE L-METHIONINE PHENYLALANINE THREONINE TRYPTOPHAN, L- VALINE ARGININE HISTIDINE ACETYLCYSTEINE AMINOACETIC ACID ALANINE GLUTAMIC ACID PROLINE SERINE N-ACETYLTYROSINE PH. EUR.
Tilgængelig fra:
Fresenius Kabi Limited
INN (International Name):
ISOLEUCINE LEUCINE L-LYSINE-L-GLUTAMATE DIHYDRATE L-METHIONINE PHENYLALANINE THREONINE TRYPTOPHAN, L- VALINE ARGININE H
Dosering:
500 Unknown
Lægemiddelform:
Solution for Infusion
Recept type:
Product subject to prescription which may not be renewed (A)
Autorisation status:
Withdrawn
Autorisation dato:
2013-02-15
Produktets egenskaber
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Intrafusin 22 Solution for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1000 ml bottle of Intrafusin 22 contains:
PRODUCT PROPERTIES
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for infusion.
Clear, colourless to pale yellow solution.
Isoleucine Ph. Eur.
4.2
g
Leucine Ph. Eur.
5.7
g
L-Lysine-L-Glutamate.2H
2
O
(equivalent to
Lysine and
Glutamic acid)
15.15
g
6.75
g
6.75
g
Methionine Ph. Eur.
5.4
g
Phenylalanine Ph. Eur.
4.1
g
Threonine Ph. Eur.
5.4
g
Tryptophan Ph. Eur.
2.1
g
Valine Ph. Eur.
4.7
g
Arginine Ph. Eur.
14.0
g
Histidine Ph. Eur.
3.5
g
N-Acetyl-L-Cysteine Ph. Eur.
0.7
g
Glycine Ph. Eur.
15.6
g
Alanine Ph. Eur.
26.0
g
Glutamic Acid Ph. Eur.
15.3
g
Proline Ph. Eur.
14.1
g
Serine Ph. Eur.
14.1
g
N-Acetyl-L-tyrosine Ph. Eur.
2.25
g
TOTAL AMINO ACIDS
152.3
G
Energy content/litre
600 kcal
Nitrogen content/litre
22.8 g
Osmolality
1440 mosmol/kg water
pH
5.2
Titratable acidity (pH 7.4) approx.
45.5 mmol/l
Acetate
Nil
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 28/09/2012_
_CRN 2116164_
_page number: 1_
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
To be used as part of an intravenous parenteral nutrition regimen, which is indicated whenever oral feeding is
impossible or inadequate.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For intravenous use only.
DOSAGE AND ADMINISTRATION
The amount of Intrafusin 22 to be administered daily is calculated according to individual patients’ requirement of
nitrogen, fluid etc.
RECOMMENDED DOSAGE FOR ADULTS (INCLUDING THE ELDERLY)
Adults should receive 1.0-2.0 g amino acids/kg body weight/day, which equates to approximately 6.5-13 ml/kg body
weight/day of Intrafusin 22. In a 70 kg pat
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