CLINIMIX N14G30E

Kraj: Irlandia

Język: angielski

Źródło: HPRA (Health Products Regulatory Authority)

Składnik aktywny:

LEUCINE ; PHENYLALANINE ; L-METHIONINE ; L-LYSINE ; ISOLEUCINE ; VALINE ; HISTIDINE ; THREONINE ; TRYPTOPHAN, L- ; ALANINE ; ARGININE ; AMINOACETIC ACID ; PROLINE ; SERINE ; TYROSINE ; SODIUM ACETATE TRIHYDRATE ; POTASSIUM PHOSPHATE DIBASIC ; SODIUM CHLORIDE ; MAGNESIUM CHLORIDE HEXAHYDRATE ; GLUCOSE ; CALCIUM CHLORIDE DIHYDRATE

Dostępny od:

Baxter Healthcare Limited

Kod ATC:

B05BA01

INN (International Nazwa):

LEUCINE ; PHENYLALANINE ; L-METHIONINE ; L-LYSINE ; ISOLEUCINE ; VALINE ; HISTIDINE ; THREONINE ; TRYPTOPHAN, L- ; ALANINE ; ARGININE ; AMINOACETIC ACID ; PROLINE ; SERINE ; TYROSINE ; SODIUM ACETATE TRIHYDRATE ; POTASSIUM PHOSPHATE DIBASIC ; SODIUM CHLORI

Dawkowanie:

8.5/30 %v/v

Forma farmaceutyczna:

Solution for Infusion

Typ recepty:

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

Dziedzina terapeutyczna:

amino acids

Status autoryzacji:

Marketed

Data autoryzacji:

1996-04-30

Ulotka dla pacjenta

Package leaflet: Information for the patient
CLINIMIX N14G30E, SOLUTION FOR INFUSION
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 doctor or 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 than 28 days of age
,
ceftriaxone must not be co-administered with calcium-
containing IV solutions, becaus

Charakterystyka produktu

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 N14G30E is the following:
For the full list of excipients, see section 6.1.
8.5% Amino acid solution with
electrolytes
30% Glucose solution
with calcium
ACTIVE INGREDIENTS
L-Leucine
6.20 g/l
L-Phenylalanine
4.76 g/l
L-Methionine
3.40 g/l
L-Lysine
4.93 g/l
(as L-Lysine hydrochloride)
(6.16 g/l)
L-Isoleucine
5.10 g/l
L-Valine
4.93 g/l
L-Histidine
4.08 g/l
L-Threonine
3.57 g/l
L-Tryptophan
1.53 g/l
L-Alanine
17.6 g/l
L-Arginine
9.78 g/l
Glycine
8.76 g/l
L-Proline
5.78 g/l
L-Serine
4.25 g/l
L-Tyrosine
0.34 g/l
Sodium acetate, 3H
2
O
5.94 g/l
Dibasic potassium phosphate
5.22 g/l
Sodium chloride
1.54 g/l
Magnesium chloride.6H
2
0
1.02 g/l
Glucose
300 g/l
(as monohydrate glucose)
(330 g/l)
Calcium chloride, 2H
2
0
0.66 g/l
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