CLINIMIX N14G30
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
25-04-2024
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Active ingredient:
LEUCINE PHENYLALANINE L-METHIONINE L-LYSINE ISOLEUCINE VALINE HISTIDINE THREONINE TRYPTOPHAN, L- ALANINE ARGININE AMINOACETIC ACID PROLINE SERINE TYROSINE GLUCOSE
Available from:
Baxter Healthcare Limited
Dosage:
8.5/30 %v/v
Pharmaceutical form:
Solution for Infusion
Authorization date:
1996-04-30
Summary of Product characteristics
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
CLINIMIX
®
N14G30E, solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
CLINIMIX
®
N14G30E is packaged in a dual compartment plastic bag containing respectively an amino acid solution
with electrolytes and a glucose solution with 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
®
N14G30E is the following:
For excipients, see section 6.1
8.5% Amino acid
solution with electrolytes
30% Glucose
solution
with 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
Sodium acetate, 3H
2
O
Dibasic potassium phosphate
Sodium chloride
Magnesium chloride 6H
2
0
Glucose
(as monohydrate glucose)
Calcium chloride, 2H
2
0
6.20 g/l
4.76 g/l
3.40 g/l
4.93 g/l
(6.16 g/l)
5.10 g/l
4.93 g/l
4.08 g/l
3.57 g/l
1.53 g/l
17.6 g/l
9.78 g/l
8.76 g/l
5.78 g/l
4.25 g/l
0.34 g/l
5.94 g/l
5.22 g/l
1.54 g/l
1.02 g/l
300 g/l
(330 g/l)
0.66 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
Appearance prior to reconstitution: The aminoacid and glucose solutions are clear and colourless or slightly yellow
Appea
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