Nutriflex basal Solution for Infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

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Patient Information leaflet (PIL)

04-07-2017

Summary of Product characteristics (SPC)

26-05-2018

Active ingredient:

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; Sodium chloride; Histidine hydrochloride monohydrate

Available from:

B. Braun Melsungen AG

ATC code:

B05BA; B05BA10

INN (International Name):

Dosage:

Unknown

Pharmaceutical form:

Solution for infusion

Prescription type:

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

Therapeutic area:

Solutions for parenteral nutrition; combinations

Authorization status:

Not marketed

Authorization date:

2000-01-07

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
NUTRIFLEX BASAL 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 any 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 basal is and what it is used for
2.
What you need to know before you use Nutriflex basal
3.
How to use Nutriflex basal
4.
Possible side effects
5.
How to store Nutriflex basal
6.
Contents of the pack and other information
1.
WHAT NUTRIFLEX BASAL 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 basal is specifically indicated for adults and children aged
2-17 years with mild to moderate
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 BASAL
DO NOT USE NUTRIFLEX BASAL
●
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 the blood
(acid

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Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nutriflex basal Solution for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Amounts of active substances in both the 1000 ml and 2000 ml sizes of
the product are given below.
COMPOSITION
IN 1000 ML
IN 2000 ML
FROM THE UPPER CHAMBER (400 ML)
FROM THE UPPER CHAMBER (800 ML )
Isoleucine
1.88 g
3.76 g
Leucine
2.50 g
5.00 g
Lysine hydrochloride
(equivalent to lysine:)
2.27 g
(1.82 g)
4.54 g
(3.64 g)
Methionine
1.56 g
3.12 g
Phenylalanine
2.81 g
5.62 g
Threonine
1.45 g
2.90 g
Tryptophan
0.46 g
0.92 g
Valine
2.08 g
4.16 g
Arginine monoglutamate
(equivalent to arginine:)
(equivalent to glutamic acid:)
3.98 g
(2.16 g)
(1.82 g)
7.96 g
(4.32 g)
(3.64 g)
Histidine hydrochloride
monohydrate
(equivalent to histidine:)
1.35 g
(1.00 g)
2.70 g
(2.00 g)
Alanine
3.88 g
7.76 g
Aspartic acid
1.20 g
2.40 g
Glutamic acid
0.98 g
1.96 g
Glycine
1.32 g
2.64 g
Proline
2.72 g
5.44 g
Serine
2.40 g
4.80 g
Magnesium acetate tetrahydrate
1.23 g
2.46 g
Sodium acetate trihydrate
3.20 g
6.40 g
Potassium dihydrogen phosphate
1.74 g
3.48 g
Potassium hydroxide
0.96 g
1.92 g
Sodium hydroxide
0.10 g
0.20 g
FROM THE LOWER CHAMBER (600 ML)
FROM THE LOWER CHAMBER (1200 ML)
Glucose monohydrate
(equivalent to glucose:)
137.5 g
(125.0 g)
275.0 g
(250.0 g)
Sodium chloride
1.40 g
2.80 g
Calcium chloride dihydrate
0.53 g
1.06 g
ELECTROLYTES:
IN 1000 ML
IN 2000 ML
Sodium
49.9 mmol
99.8 mmol
Potassium
30.0 mmol
60.0 mmol
Magnesium
5.7 mmol
11.4 mmol
Phosphate
12.8 mmol
25.6 mmol
Acetate
35.0 mmol
70.0 mmol
Chloride
50.0 mmol
100.0 mmol
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