CLINIMIX N14G30E, solution for infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

L-leucine; L-phenylalanine; L-methionine; L-lysine; L-isoleucine; L-valine; L-histidine; L-threonine; L-tryptophan; L-alanine; L-arginine; Glycine; L-proline; L-serine; L-tyrosine; Sodium acetate trihydrate ; Dibasic potassium phosphate ; Sodium chloride; Magnesium chloride hexahydrate; Glucose; Calcium chloride dihydrate

Available from:

Baxter Holding B.V.

ATC code:

B05BA; B05BA01

INN (International Name):

L-leucine; L-phenylalanine; L-methionine; L-lysine; L-isoleucine; L-valine; L-histidine; L-threonine; L-tryptophan; L-alanine; L-arginine; Glycine; L-proline; L-serine; L-tyrosine; Sodium acetate trihydrate ; Dibasic potassium phosphate ; Sodium chloride; Magnesium chloride hexahydrate; Glucose; Calcium chloride dihydrate

Pharmaceutical form:

Solution for infusion

Therapeutic area:

Solutions for parenteral nutrition; amino acids

Authorization status:

Marketed

Authorization date:

1996-04-30

Patient Information leaflet

BAXTER CONFIDENTIAL - INTERNAL USE ONLY
Part Number: BE-30-03-500
Date: 09 SEPT 2021 Proofread No.: 04
Designer: DFO
Page: 1 of 06
Colour Reference:
BLACK
BE-30-03-500
1
Read all of this leaflet carefully before this medicine is
administered, because it
contains important information for you.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctoror nurse.
•
If you get any side effects, talk to your doctor or nurse. This
includes any
possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1.
What CLINIMIX is and what it is administered for
2.
What you need to know before CLINIMIX is administered
3.
How CLINIMIX is administered
4.
Possible side effects
5.
How to store CLINIMIX
6.
Contents of the pack and other information
1.
WHAT CLINIMIX IS AND WHAT IT IS ADMINISTERED FOR
CLINIMIX is a solution for infusion. It is supplied in a bag with 2
chambers. One
chamber contains an amino acid solution with electrolytes and the
second contains
a glucose solution with calcium chloride. The chambers are separated
by a non-
permanent seal. Just before administration, the contents of the
chambers are mixed
together by rolling the top of the bag to open the seals.
CLINIMIX is administered to provide nutrition in adults and children
by a tube into a
vein when normal feeding by mouth is not suitable.
CLINIMIX must only be administered under medical supervision.
2.
WHAT YOU NEED TO KNOW BEFORE CLINIMIX IS ADMINISTERED
CLINIMIX shall not be administered if
•
you are allergic to any of the ingredients of this medicine (listed in
section 6).
•
your body has problems using certain amino acids.
•
you have too much sugar in your blood (severe hyperglycaemia),
•
your blood is excessively acid (metabolic acidosis due to an excess of
lactate),
•
your blood level of sodium, potassium, magnesium, calcium and/or
phosphorus is too high (hypernatraemia, hyperkalemia, hypermagnesemia,
hypercalcemia and/or hyperphosphatemia),
•
In children less tha

Summary of Product characteristics

Health Products Regulatory Authority
03 December 2021
CRN009SMZ
Page 1 of 12
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:
- Essential amino acids/Total amino acids = 41.3 %
- Essential amino acids/Total nitrogen = 2.83
- Branched chain amino acids/Total amino acids = 19 %
The quantitative composition of CLINIMIX N14G30Eis the following:
8.5% AMINO ACID SOLUTION WITH
ELECTROLYTES
30% GLUCOSE SOLUTIONWITH CALCIUM
ACTIVE INGREDIENTS
L-Leucine
L-Phenylalanine
L-Methionine
L-Lysine
(as L-Lysine hydrochloride) L-Isoleucine
L-Valine
L-Histidine
L-Threonine
L-Tryptophan
L-Alanine
L-Arginine
Glycine
L-Proline
L-Serine
L-Tyrosine
Sodium acetate, 3H2O Dibasic potassium
phosphate Sodium chloride
Magnesium chloride, 6H2O
Glucose
(as monohydrate glucose)
Calcium chloride, 2H2O
6.21 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
17.60 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
For the full list of excipients, see section 6.1.
After mixing of the contents of both compartments, the composition of
the binary mixture, for all the available bag sizes, is the
following:
N14G30E
1 L
N14G30E
1.5 L
N14G30E
2 L
Nitrogen (g)
Amino acids (g) Glucose (g)
7.0
43
10.5
64
14.0
85
Health Products Regulatory Authority
03 December 2021
CRN009SMZ
Page 2 of 12
150
225
300
Total calories (kcal)
Glucose calories (kcal)
770
600
1155
900
1540
1200
Sodium (mmol)
Potassium (mmol) Magnesium (mmol)
Calcium (mmol)
Acetate (mmol) Chloride (mmol)
Phosphate as HPO4
2-
(mmol)
35
30
2.5
2.3
70
40
15
53
45
3.8
3.4
105
60
23
70
60
5.