CLINIMIX N12G20

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Aktiivinen ainesosa:

LEUCINE PHENYLALANINE L-METHIONINE L-LYSINE ISOLEUCINE VALINE HISTIDINE THREONINE TRYPTOPHAN, L- ALANINE ARGININE AMINOACETIC ACID PROLINE SERINE TYROSINE GLUCOSE

Saatavilla:

Baxter Healthcare Limited

Annos:

7/20 %v/v

Lääkemuoto:

Solution for Infusion

Valtuutus päivämäärä:

1996-04-30

Valmisteyhteenveto

PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
CLINIMIX
®
N12G20, solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
CLINIMIX
®
N12G20 is packaged in a dual compartment plastic bag containing respectively an amino acid solution
without electrolytes and a glucose solution without calcium.
The injectable amino acid solution contains 15 L-amino acids (8 essential amino acids) needed for the protein
synthesis.
The amino acid profile is the following:
o
Essential amino acids/Total amino acids = 41.3%
o
Essential amino acids/Total nitrogen = 2.83
o
Branched chain amino acids/Total amino acids = 19 %
The quantitative composition of CLINIMIX
®
N12G20 is the following:
For excipients, see section 6.1
7% Amino acid solution
without electrolytes
20% Glucose solution without
calcium
ACTIVE INGREDIENTS
L-Leucine
L-Phenylalanine
L-Methionine
L-Lysine
(as L-Lysine chlorhydrate)
L-Isoleucine
L-Valine
L-Histidine
L-Threonine
L-Tryptophan
L-Alanine
L-Arginine
Glycine
L-Proline
L-Serine
L-Tyrosine
Glucose
(as monohydrate glucose)
5.11 g/l
3.92 g/l
2.80 g/l
4.06 g/l
(5.07 g/l)
4.20 g/l
4.06 g/l
3.36 g/l
2.94 g/l
1.26 g/l
14.49 g/l
8.05 g/l
7.21 g/l
4.76 g/l
3.50 g/l
0.28 g/l
200 g/l
(220 g/l)
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 09/03/2009_
_CRN 2062633_
_page number: 1_
After mixing of the contents of both compartments, the composition of the binary mixture_, _for all the available bag
sizes, is the following:
3 PHARMACEUTICAL FORM
Solution for infusion.
Appearance prior to reconstitution: The aminoacid and glucose solutions are clear and colourless or slightly yellow
Appearance after reconstitution: Clear and colourless or slightly yellow solution
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Pa