NuTRIflex Lipid peri Emulsion for infusion

Country: Իռլանդիա

language: անգլերեն

source: HPRA (Health Products Regulatory Authority)

active_ingredient:

Glucose monohydrate; Sodium dihydrogen phosphate dihydrate; Zinc acetate dihydrate; Soya bean oil; Medium chain triglycerides; Isoleucine; Leucine; Lysine hydrochloride; Methionine; Phenylalanine; Threonine; Tryptophan; Valine; Arginine; Histidine hydrochloride monohydrate; Alanine; Aspartic acid; Glutamic acid; GLYCINE; Proline; Serine; Sodium hydroxide; Sodium chloride ; Sodium acetate; Potassium acetate; Magnesium Acetate Tetrahydrate; Calcium chloride dihydrate

MAH:

B. Braun Melsungen AG

ATC_code:

B05BA; B05BA10

INN:

Glucose monohydrate; Sodium dihydrogen phosphate dihydrate; Zinc acetate dihydrate; Soya bean oil; Medium chain triglycerides; Isoleucine; Leucine; Lysine hydrochloride; Methionine; Phenylalanine; Threonine; Tryptophan; Valine; Arginine; Histidine hydrochloride monohydrate; Alanine; Aspartic acid; Glutamic acid; GLYCINE; Proline; Serine; Sodium hydroxide; Sodium chloride ; Sodium acetate; Potassium acetate; Magnesium Acetate Tetrahydrate; Calcium chloride dihydrate

dosage:

Unknown

pharmaceutical_form:

Emulsion for infusion

prescription_type:

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

therapeutic_area:

Solutions for parenteral nutrition; combinations

authorization_status:

Marketed

authorization_date:

1999-11-26

PIL

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
NUTRIFLEX LIPID PERI
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 peri is and what it is used for
2.
What you need to know before you use NuTRIflex Lipid peri
3.
How to use NuTRIflex Lipid peri
4.
Possible side effects
5.
How to store NuTRIflex Lipid peri
6.
Contents of the pack and other information
1.
WHAT NUTRIFLEX LIPID PERI IS AND WHAT IT IS USED FOR
NuTRIflex Lipid peri contains fluids and substances called amino
acids, electrolytes 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 peri 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 PERI
DO NOT USE NUTRIFLEX LIPID PERI

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 medicine must not be given to newborn infants, infants and
toddlers under two years old.
Also, do not use NuTRIflex Lipid peri if you suffer from any of the
following:

Life threatening blood circulation problems such as

SPC

Health Products Regulatory Authority
27 August 2019
CRN008LK3
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
NuTRIflex Lipid peri 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
70.4 g
64.0 g
88.0 g
80.0 g
132.0 g
120.0 g
176.0 g
160.0 g
Sodium dihydrogen
phosphate dihydrate
0.936 g
1.170 g
1.755 g
2.340 g
Zinc acetate dihydrate
5.28 mg
6.600 mg
9.900 mg
13.20 mg
_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
1.87 g
2.34 g
3.51 g
4.68 g
Leucine
2.50 g
3.13 g
4.70 g
6.26 g
Lysine hydrochloride
equivalent to lysine
2.27 g
1.81 g
2.84 g
2.26 g
4.26 g
3.39 g
5.68 g
4.52 g
Methionine
1.57 g
1.96 g
2.94 g
3.92 g
Phenylalanine
2.81 g
3.51 g
5.27 g
7.02 g
Threonine
1.46 g
1.82 g
2.73 g
3.64 g
Tryptophan
0.46 g
0.57 g
0.86 g
1.14 g
Valine
2.08 g
2.60 g
3.90 g
5.20 g
Arginine
2.16 g
2.70 g
4.05 g
5.40 g
Histidine hydrochloride
monohydrate
equivalent to histidine
1.35 g
1.00 g
1.69 g
1.25 g
2.54 g
1.88 g
3.38 g
2.50 g
Alanine
3.88 g
4.85 g
7.28 g
9.70 g
Aspartic acid
1.20 g
1.50 g
2.25 g
3.00 g
Glutamic acid
2.80 g
3.50 g
5.25 g
7.00 g
Glycine
1.32 g
1.65 g
2.48 g
3.30 g
Proline
2.72 g
3.40 g
5.10 g
6.80 g
Serine
2.40 g
3.00 g
4.50 g
6.00 g
Sodium hydroxide
0.640 g
0.800 g
1.200 g
1.600 g
Sodium chloride
0.865 g
1.081 g
1.622 g
2.162 g
Sodium acetate trihydrate
0.435 g
0.544 g
0.816 g
1.088 g
Potassium acetate
2.354 g
2.943 g
4.415 g
5.886 g
Magnesium acetate
tetrahydrate
0.515 g
0.644 g
0.966 g
1.288 g
Calcium chloride dihydrate
0.353 g
0.441 g
0.662 g
0.882 g
ELECTROLYTES [MMOL]
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