NuTRIflex Lipid special without Electrolytes Emulsion for infusion

Negara: Irlandia

Bahasa: Inggris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Glucose monohydrate; Soya bean oil; Medium chain triglycerides; Isoleucine; Leucine; Lysine monohydrate; Methionine; Phenylalanine; Threonine; Tryptophan; Valine; Arginine; Histidine; Alanine; Aspartic acid; Glutamic acid; GLYCINE; Proline; Serine

Tersedia dari:

B. Braun Melsungen AG

Kode ATC:

B05BA; B05BA10

INN (Nama Internasional):

Glucose monohydrate; Soya bean oil; Medium chain triglycerides; Isoleucine; Leucine; Lysine monohydrate; Methionine; Phenylalanine; Threonine; Tryptophan; Valine; Arginine; Histidine; Alanine; Aspartic acid; Glutamic acid; GLYCINE; Proline; Serine

Dosis:

N/A

Bentuk farmasi:

Emulsion for infusion

Jenis Resep:

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

Area terapi:

Solutions for parenteral nutrition; combinations

Status otorisasi:

Marketed

Tanggal Otorisasi:

1999-11-26

Selebaran informasi

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
NUTRIFLEX LIPID SPECIAL WITHOUT ELECTROLYTES
EMULSION FOR INFUSION
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE 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, pharmacist or
nurse.

This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What NuTRIflex Lipid special without Electrolytes is and what it is
used for
2.
What you need to know before you use NuTRIflex Lipid special without
Electrolytes
3.
How to use NuTRIflex Lipid special without Electrolytes
4.
Possible side effects
5.
How to store NuTRIflex Lipid special without Electrolytes
6.
Contents of the pack and other information
1.
WHAT NUTRIFLEX LIPID SPECIAL WITHOUT ELECTROLYTES IS AND WHAT IT IS
USED FOR
NuTRIflex Lipid special without Electrolytes contains fluids and
substances called amino acids and fatty
acids that
are essential for the body to grow or to recover. It also contains
calories in the form of
carbohydrates
and fats.
You are given NuTRIflex Lipid special without Electrolytes when you
are unable to eat food normally.
There are many situations when this might be the case, for example
when you are recovering from
surgery, injuries or burns, or when you are unable to absorb food from
your stomach and gut.
This solution can be given to adults, adolescents and children over 2
years of age.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE NUTRIFLEX LIPID SPECIAL WITHOUT
ELECTROLYTES
DO NOT USE NUTRIFLEX LIPID SPECIAL WITHOUT ELECTROLYTES

If you are allergic to any of the active substances, to egg, peanut or
soybean or to any of
the other ingredients of this medicine
(listed in section 6).

This

Karakteristik produk

Health Products Regulatory Authority
27 August 2019
CRN008LK3
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
NuTRIflex Lipid special without Electrolytes Emulsion for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
The ready-for-use emulsion for intravenous infusion contains after
mixing the chamber contents:
_FROM THE UPPER, LEFT-HAND CHAMBER_
_(GLUCOSE SOLUTION)_
in 1000 ml
in 1250 ml
in 1875 ml
in 2500 ml
Glucose monohydrate
equivalent to glucose
158.4g
144.0 g
198.0 g
180.0 g
297.0 g
270.0 g
396.0 g
360.0 g
_FROM THE UPPER, RIGHT-HAND_
_CHAMBER (FAT EMULSION)_
in 1000 ml
in 1250 ml
in 1875 ml
in 2500 ml
Soya-bean oil, refined
20.0 g
25.0 g
37.5 g
50.0 g
Medium-chain triglycerides
20.0 g
25.0 g
37.5 g
50.0 g
_FROM THE LOWER CHAMBER_
_(AMINO ACID SOLUTION)_
in 1000 ml
in 1250 ml
in 1875 ml
in 2500 ml
Isoleucine
3.28 g
4.11 g
6.16 g
8.21 g
Leucine
4.38 g
5.48g
8.22 g
10.96 g
Lysine monohydrate equivalent to lysine
3.58 g
3.18 g
4.47 g
3.98 g
6.71 g
5.97 g
8.94 g
7.96 g
Methionine
2.74 g
3.42 g
5.13 g
6.84 g
Phenylalanine
4.92 g
6.15 g
9.22 g
12.29 g
Threonine
2.54 g
3.18 g
4.76 g
6.35 g
Tryptophan
0.80 g
1.00 g
1.50 g
2.00 g
Valine
3.60 g
4.51 g
6.76 g
9.01 g
Arginine
3.78 g
4.73 g
7.09 g
9.45 g
Histidine
1.75 g
2.19 g
3.28 g
4.38 g
Alanine
6.79 g
8.49 g
12.73 g
16.98 g
Aspartic acid
2.10 g
2.63 g
3.94 g
5.25 g
Glutamic acid
4.91 g
6.14 g
9.20 g
12.27 g
Glycine
2.31 g
2.89 g
4.33 g
5.78 g
Proline
4.76 g
5.95 g
8.93 g
11.90 g
Serine
4.20 g
5.25 g
7.88 g
10.50 g
Amino acid content [g]
56.0
70.1
105.1
140.1
Nitrogen content [g]
8
10
15
20
Carbohydrate content [g]
144
180
270
360
Lipid content [g]
40
50
75
100
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Emulsion for infusion
Amino acids and glucose solutions: clear, colourless up to
straw-coloured solutions
Fat emulsion: oil-in-water emulsion, milky white
in 1000 ml
in 1250 ml
in 1875 ml
in 2500 ml
Health Products Regulatory Authority
27 August 2019
CRN008LK3
Page 2 of 11
Energy in the form of lipids
[