CLINIMIX N17G35 10/35 %v/v Solution for Infusion

国家: 爱尔兰

语言: 英文

来源: HPRA (Health Products Regulatory Authority)

有效成分:

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

可用日期:

Baxter Healthcare Limited

INN（国际名称）:

LEUCINE PHENYLALANINE L-METHIONINE L-LYSINE ISOLEUCINE VALINE HISTIDINE THREONINE TRYPTOPHAN, L- ALANINE ARGININE AMI

剂量:

10/35 %v/v

药物剂型:

Solution for Infusion

处方类型:

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

授权状态:

Withdrawn

授权日期:

2009-12-11

产品特点

PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
CLINIMIX
®
N17G35, solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
CLINIMIX
®
N17G35 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
®
N17G35 is the following:
For excipients , see section 6.1
10% Amino acid
solution without
electrolytes
35% 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)
7.30 g/l
5.60 g/l
4.00 g/l
5.80 g/l
(7.25 g/l)
6.00 g/l
5.80 g/l
4.80 g/l
4.20 g/l
1.80 g/l
20.70 g/l
11.50 g/l
10.30 g/l
6.80 g/l
5.00 g/l
0.40 g/l
350 g/l
(385 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