Nutriflex special Solution for infusion

Pajjiż: Irlanda

Lingwa: Ingliż

Sors: HPRA (Health Products Regulatory Authority)

Ixtrih issa

Ingredjent attiv:

Isoleucine; Leucine ; Lysine hydrochloride; Methionine; Phenylalanine; Threonine; Tryptophan; Valine; Arginine Monoglutamate ; Alanine; Aspartic Acid; Glutamic acid ; Glycine; Proline; Serine; Magnesium acetate tetrahydrate; Sodium acetate trihydrate ; Potassium dihydrogen phosphate; Potassium hydroxide; Sodium hydroxide ; Glucose monohydrate; Calcium chloride dihydrate; Histidine hydrochloride monohydrate

Disponibbli minn:

B. Braun Melsungen AG

Kodiċi ATC:

V06DE

INN (Isem Internazzjonali):

Isoleucine; Leucine ; Lysine hydrochloride; Methionine; Phenylalanine; Threonine; Tryptophan; Valine; Arginine Monoglutamate ; Alanine; Aspartic Acid; Glutamic acid ; Glycine; Proline; Serine; Magnesium acetate tetrahydrate; Sodium acetate trihydrate ; Potassium dihydrogen phosphate; Potassium hydroxide; Sodium hydroxide ; Glucose monohydrate; Calcium chloride dihydrate; Histidine hydrochloride monohydrate

Dożaġġ:

N/A

Għamla farmaċewtika:

Solution for infusion

Tip ta 'preskrizzjoni:

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

Żona terapewtika:

Amino acids/carbohydrates/minerals/vitamins, combinations

L-istatus ta 'awtorizzazzjoni:

Not marketed

Data ta 'l-awtorizzazzjoni:

2000-01-07

Fuljett ta 'informazzjoni

                                1
PACKAGE LEAFLET: INFORMATION FOR THE USER
NUTRIFLEX SPECIAL SOLUTION FOR INFUSION
Amino acids / Glucose / Electrolytes
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 further questions, ask your healthcare professional.
●
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 healthcare professional.
This includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Nutriflex special is and what it is used for
2.
What you need to know before you use Nutriflex special
3.
How to use Nutriflex special
4.
Possible side effects
5.
How to store Nutriflex special
6.
Contents of the pack and other information
1.
WHAT NUTRIFLEX SPECIAL IS AND WHAT IT IS USED FOR
The product contains substances (nutrients) called amino acids, salts
(electrolytes) and carbohydrates
(glucose) which are essential for the body to grow or to recover and
calories in the form of carbohydrates.
You are given this product by a vein drip (infusion) because you are
unable to eat adequately or cannot be
fed via a tube.
Nutriflex special is specifically indicated for adults and children
aged 2-17 years with moderate to severe
catabolism, a condition where patients are burning up their stores of
energy, protein, etc. faster than they can
be replaced.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE NUTRIFLEX SPECIAL
DO NOT USE NUTRIFLEX SPECIAL
●
if you are allergic to the active substances or any of the other
ingredients of this medicine (listed in
section 6)
●
if you have an inborn error of amino acid metabolism, where you need a
special protein diet
●
if you have abnormally high blood sugar levels that need more than 6
units of insulin per hour to be
controlled
●
if you have abnormally high levels of acidic substances in
                                
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Karatteristiċi tal-prodott

                                Health Products Regulatory Authority
20 June 2022
CRN00CZ81
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nutriflex special Solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Amounts of active substances in both the 1000 ml and 1500 ml sizes of
the product are given below.
COMPOSITION
IN 1000 ML
IN 1500 ML
FROM THE UPPER CHAMBER (500 ML)
FROM THE UPPER CHAMBER (750 ML )
Isoleucine
4.11 g
6.17 g
Leucine
5.48 g
8.22 g
Lysine hydrochloride
(equivalent to lysine:)
4.97 g
(3.98 g)
7.46 g
(5.97 g)
Methionine
3.42 g
5.13 g
Phenylalanine
6.15 g
9.23 g
Threonine
3.18 g
4.77 g
Tryptophan
1.00 g
1.50 g
Valine
4.54 g
6.81 g
Arginine monoglutamate
(equivalent to arginine:)
(equivalent to glutamic acid:)
8.72 g
(4.73 g)
(3.99 g)
13.08 g
(7.10 g)
(5.99 g)
Histidine hydrochloride monohydrate
(equivalent to histidine:)
2.96 g
(2.19 g)
4.44 g
(3.29 g)
Alanine
8.49 g
12.74 g
Aspartic acid
2.63 g
3.95 g
Glutamic acid
2.15 g
3.23 g
Glycine
2.89 g
4.34 g
Proline
5.95 g
8.93 g
Serine
5.25 g
7.88 g
Magnesium acetate tetrahydrate
1.08 g
1.62 g
Sodium acetate trihydrate
1.63 g
2.45 g
Potassium dihydrogenphosphate
2.00 g
3.00 g
Potassium hydroxide
0.62 g
0.93 g
Sodium hydroxide
1.14 g
1.71 g
FROM THE LOWER CHAMBER (500 ML)
FROM THE LOWER CHAMBER (750 ML)
Glucose monohydrate
(equivalent to glucose:)
264.0 g
(240.0 g)
396.0 g
(360.0 g)
Calcium chloride dihydrate
0.60 g
0.90 g
ELECTROLYTES:
IN 1000 ML
IN 1500 ML
Sodium
40.5 mmol
60.8 mmol
Potassium
25.7 mmol
38.6 mmol
Magnesium
5.0 mmol
7.5 mmol
Phosphate
14.7 mmol
22.1 mmol
Acetate
22.0 mmol
33.0 mmol
Chloride
49.5 mmol
74.3 mmol
Calcium
4.1 mmol
6.2 mmol
IN 1000 ML
IN 1500 ML
Amino acid content
70 g
105 g
Nitrogen content
10 g
15 g
Carbohydrate content
240 g
360 g
Health Products Regulatory Authority
20 June 2022
CRN00CZ81
Page 2 of 9
IN 1000 ML
IN 1500 ML
Energy in the form of amino acids [kJ (kcal)]
1172 (280)
1757 (420)
Energy in the form of carbohydrates [kJ (kcal)]
4017 (960)
6025 (1440)
Total energy [kJ (kcal)]
5198 (1240)
7782 (1860)
For
                                
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