Nutriflex plus Solution for Infusion

Страна: Ирландия

Език: английски

Източник: HPRA (Health Products Regulatory Authority)

Активна съставка:

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 ; Sodium dihydrogen phosphate dihydrate; Potassium hydroxide; Sodium hydroxide ; Glucose monohydrate; Calcium chloride dihydrate; Histidine hydrochloride monohydrate

Предлага се от:

B. Braun Melsungen AG

АТС код:

B05BA; B05BA10

INN (Международно Name):

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 ; Sodium dihydrogen phosphate dihydrate; Potassium hydroxide; Sodium hydroxide ; Glucose monohydrate; Calcium chloride dihydrate; Histidine hydrochloride monohydrate

дозиране:

Unknown

Лекарствена форма:

Solution for infusion

Вид предписание :

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

Терапевтична област:

Solutions for parenteral nutrition; combinations

Статус Оторизация:

Not marketed

Дата Оторизация:

2000-01-07

Листовка

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

Данни за продукта

Health Products Regulatory Authority
20 June 2022
CRN00CZ81
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nutriflex plus Solution for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Amounts of active substances in both the 1000 ml and 2000 ml sizes of
the are given below.
COMPOSITION
IN 1000 ML
IN 2000 ML
FROM THE UPPER CHAMBER (400 ML)
FROM THE UPPER CHAMBER (800 ML )
Isoleucine
2.82 g
5.64 g
Leucine
3.76 g
7.52 g
Lysine hydrochloride
(equivalent to lysine:)
3.41 g
(2.73 g)
6.82 g
(5.46 g)
Methionine
2.35 g
4.70 g
Phenylalanine
4.21 g
8.42 g
Threonine
2.18 g
4.36 g
Tryptophan
0.68 g
1.36 g
Valine
3.12 g
6.24 g
Arginine monoglutamate
(equivalent to arginine:)
(equivalent to glutamic acid:)
5.98 g
(3.24 g)
(2.74 g)
11.96 g
(6.48 g)
(5.48 g)
Histidine hydrochloride monohydrate
(equivalent to histidine:)
2.03 g
(1.50 g)
4.06 g
(3.00 g)
Alanine
5.82 g
11.64 g
Aspartic acid
1.80 g
3.60 g
Glutamic acid
1.47 g
2.94 g
Glycine
1.98 g
3.96 g
Proline
4.08 g
8.16 g
Serine
3.60 g
7.20 g
Magnesium acetate tetrahydrate
1.23 g
2.46 g
Sodium acetate trihydrate
1.56 g
3.12 g
Sodium dihydrogen phosphate dihydrate
3.12 g
6.24 g
Potassium hydroxide
1.40 g
2.80 g
Sodium hydroxide
0.23 g
0.46 g
FROM THE LOWER CHAMBER (600 ML)
FROM THE LOWER CHAMBER (1200 ML)
Glucose monohydrate
(equivalent to glucose:)
165.0 g
(150.0 g)
330.0 g
(300.0 g)
Calcium chloride dihydrate
0.53 g
1.06 g
ELECTROLYTES:
IN 1000 ML
IN 2000 ML
Sodium
37.2 mmol
74.4 mmol
Potassium
25.0 mmol
50.0 mmol
Magnesium
5.7 mmol
11.4 mmol
Phosphate
20.0 mmol
40.0 mmol
Acetate
22.9 mmol
45.8 mmol
Chloride
35.5 mmol
71.0 mmol
Calcium
3.6 mmol
7.2 mmol
IN 1000 ML
IN 2000 ML
Amino acid content
48 g
96 g
Nitrogen content
6.8 g
13.6 g
Health Products Regulatory Authority
20 June 2022
CRN00CZ81
Page 2 of 9
Carbohydrate content
150 g
300 g
IN 1000 ML
IN 2000 ML
Energy in the form of amino acids [kJ (kcal)]
803 (192)
1607 (384)
Energy in the form of carbohydrates [kJ (kcal)]
2510 (600)
5021 (1200)
Total energy [kJ (kcal)]
3313 (792)
6628 (1584)
For