Omeflex special without electrolytes emulsion for infusion

Страна: Ирландия

Език: английски

Източник: HPRA (Health Products Regulatory Authority)

Активна съставка:

Isoleucine; Leucine ; Lysine monohydrate; Methionine; Phenylalanine; Threonine; Tryptophan; Valine; Arginine ; Histidine; Alanine; Aspartic Acid; Glutamic acid ; Glycine; Proline; Serine; Glucose monohydrate; Triglycerides medium-chain ; SOYA BEAN OIL, REFINED PH. EUR.; Omega-3-acid triglycerides

Предлага се от:

B. Braun Melsungen AG

АТС код:

B05BA; B05BA10

INN (Международно Name):

Isoleucine; Leucine ; Lysine monohydrate; Methionine; Phenylalanine; Threonine; Tryptophan; Valine; Arginine ; Histidine; Alanine; Aspartic Acid; Glutamic acid ; Glycine; Proline; Serine; Glucose monohydrate; Triglycerides medium-chain ; SOYA BEAN OIL, REFINED PH. EUR.; Omega-3-acid triglycerides

дозиране:

0 millilitre(s)

Лекарствена форма:

Emulsion for infusion

Вид предписание :

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

Терапевтична област:

Solutions for parenteral nutrition; combinations

Статус Оторизация:

Marketed

Дата Оторизация:

2017-02-03

Листовка

PACKAGE LEAFLET: INFORMATION FOR THE USER
OMEFLEX SPECIAL WITHOUT ELECTROLYTES
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 Omeflex special without electrolytes is and what it is used for
2.
What you need to know before you use Omeflex special without
electrolytes
3.
How to use Omeflex special without electrolytes
4.
Possible side effects
5.
How to store Omeflex special without electrolytes
6.
Contents of the pack and other information
1.
WHAT OMEFLEX SPECIAL WITHOUT ELECTROLYTES IS AND WHAT IT IS USED FOR
Omeflex special without electrolytes contains fluids and substances
called amino acids 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.
Omeflex special without electrolytes is given to adults.
You are given Omeflex special without electrolytes 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 OMEFLEX SPECIAL WITHOUT
ELECTROLYTES
DO NOT USE OMEFLEX SPECIAL WITHOUT ELECTROLYTES
●
if you are allergic to any of the active substances, to egg, peanut,
soybean or fish 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

Данни за продукта

Health Products Regulatory Authority
05 January 2024
CRN009XSG
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Omeflex special without electrolytes emulsion for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
The ready-for-use emulsion for intravenous infusion contains after
mixing the chamber contents:
_FROM THE TOP CHAMBER _
_(GLUCOSE SOLUTION)_
IN 1000 ML
IN 625 ML
IN 1250 ML
IN 1875 ML
Glucose monohydrate
158.4 g
99.00 g
198.0 g
297.0 g
equivalent to glucose
144.0 g
90.00 g
180.0 g
270.0 g
_FROM THE MIDDLE CHAMBER _
_(FAT EMULSION)_
IN 1000 ML
IN 625 ML
IN 1250 ML
IN 1875 ML
Medium-chain triglycerides
20.00 g
12.50 g
25.00 g
37.50 g
Soya-bean oil, refined
16.00 g
10.00 g
20.00 g
30.00 g
Omega-3-acid triglycerides
4.000 g
2.500 g
5.000 g
7.500 g
_FROM THE BOTTOM CHAMBER _
_(AMINO ACID SOLUTION)_
IN 1000 ML
IN 625 ML
IN 1250 ML
IN 1875 ML
Isoleucine
3.284 g
2.053 g
4.105 g
6.158 g
Leucine
4.384 g
2.740 g
5.480 g
8.220 g
Lysine monohydrate
3.576 g
2.235 g
4.470 g
6.705 g
equivalent to lysine
3.184 g
1.990 g
3.979 g
5.969 g
Methionine
2.736 g
1.710 g
3.420 g
5.130 g
Phenylalanine
4.916 g
3.073 g
6.145 g
9.218 g
Threonine
2.540 g
1.588 g
3.175 g
4.763 g
Tryptophan
0.800 g
0.500 g
1.000 g
1.500 g
Valine
3.604 g
2.253 g
4.505 g
6.758 g
Arginine
3.780 g
2.363 g
4.725 g
7.088 g
Histidine
1.752 g
1.095 g
2.190 g
3.285 g
Alanine
6.792 g
4.245 g
8.490 g
12.73 g
Aspartic acid
2.100 g
1.313 g
2.625 g
3.938 g
Glutamic acid
4.908 g
3.068 g
6.135 g
9.203 g
Glycine
2.312 g
1.445 g
2.890 g
4.335 g
Proline
4.760 g
2.975 g
5.950 g
8.925 g
Serine
4.200 g
2.625 g
5.250 g
7.875 g
IN 1000 ML
IN 625
ML
IN 1250 ML
IN 1875 ML
Amino acid content [g]
56.0
35.0
70.1
105.1
Nitrogen content [g]
8
5
10
15
Carbohydrate content [g]
144
90
180
270
Lipid content [g]
40
25
50
75
Excipient(s) with known effect:
Sodium (from sodium oleate and sodium hydroxide) with max. 0.5 mmol/l
in the ready to use emulsion.
For the full list of excipients, see section 6.1.
Health Products Regulatory Authority
05 January 2024
CR