NuTRIflex Lipid peri Emulsion for infusion

Country: Malta

Language: English

Source: Medicines Authority

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Patient Information leaflet (PIL)

26-06-2023

Summary of Product characteristics (SPC)

26-06-2023

Active ingredient:

CALCIUM CHLORIDE, DIHYDRATE, PHENYLALANINE, POTASSIUM ACETATE, HISTIDINE, ARGININE, ASPARTIC ACID, THREONINE, TRIGLYCERIDES MEDIUM, CHAIN, VALINE, ZINC ACETATE, GLUCOSE, GLUTAMIC ACID, GLYCINE, METHIONINE, ISOLEUCINE, TRYPTOPHAN, LYSINE, MAGNESIUM ACETATE, SERINE, PROLINE, SODIUM ACETATE, TRIHYDRATE, SODIUM CHLORIDE, SODIUM DIHYDROGEN, PHOSPHATE DIHYDRATE, SODIUM HYDROXIDE, SOYA OIL

Available from:

B Braun Melsungen AG Carl-Braun-Strasse 1, D34212 Melsungen, Germany

ATC code:

B05BA10

INN (International Name):

CALCIUM CHLORIDE DIHYDRATE 0.353 g/l PHENYLALANINE 2.81 g/l POTASSIUM ACETATE 2.354 g/l HISTIDINE 1 g/l ARGININE 2.16 g/l ASPARTIC ACID 1.2 g/l ALANINE 3.88 g/l THREONINE 1.46 g/l TRIGLYCERIDES MEDIUM CHAIN 20 g/l VALINE 2.08 g/l ZINC ACETATE DIHYDRATE 5.3 g/l GLUCOSE 64 g/l GLUTAMIC ACID 2.8 g/l GLYCINE 1.32 g/l METHIONINE 1.57 g/l ISOLEUCINE 1.87 g/l L-TRYPTOPHAN 0.46 g/l LYSINE 1.81 g/l MAGNESIUM ACETATE 0.515 g/l SERINE 2.4 g/l LEUCINE 2.5 g/l PROLINE 2.72 g/l SODIUM ACETATE TRIHYDRATE 0.435 g/l SODIUM CHLORIDE 0.865 g/l SODIUM DIHYDROGEN PHOSPHATE DIHYDRATE 0.936 g/l SODIUM HYDROXIDE 0.64 g/l SOYA OIL 20 g/l

Pharmaceutical form:

EMULSION FOR INFUSION

Composition:

Prescription type:

POM

Therapeutic area:

BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS

Authorization status:

Withdrawn

Authorization date:

2011-07-14

Patient Information leaflet

Page 1 of 8
PACKAGE LEAFLET: INFORMATION FOR THE USER
NUTRIFLEX LIPID PERI
EMULSION FOR INFUSION
READ ALL OF THIS LEAFLET CAREFULLY 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.
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 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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE NUTRIFLEX LIPID PERI
DO NOT USE NUTRIFLEX LIPID PERI

if you are allergic 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 those that can
occur if you are in a state of
collapse or shock

heart attack or stroke

severely impaired blood clotting function (bleeding risk)

blocking of b

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Summary of Product characteristics

Page 1 of 14
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
70.4 g
88.0 g
132.0 g
176.0 g
equivalent to anhydrous
glucose
64.0 g
80.0 g
120.0 g
160.0 g
Sodium dihydrogen phosphate
dihydrate
0.936 g
1.170 g
1.755 g
2.340 g
Zinc acetate dihydrate
5.30 mg
6.625 mg
9.938 mg
13.250 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
2.27 g
2.84 g
4.26 g
5.68 g
equivalent to lysine
1.81 g
2.26 g
3.39 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
1.35 g
1.69 g
2.54 g
3.38 g
equivalent to histidine
1.00 g
1.25 g
1.88 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
Page 2 of 14
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]
in 1000 ml
in 1250 ml
in 1875 ml

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