Omeflex special emulsion for infusion

Země: Irsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktivní složka:

Isoleucine; Leucine ; Lysine hydrochloride; Methionine; Phenylalanine; Threonine; Tryptophan; Valine; Arginine ; Histidine hyprochloride monohydrate; Alanine; Aspartic Acid; Glutamic acid ; Glycine; Proline; Serine; Sodium hydroxide ; Sodium chloride; Sodium acetate trihydrate ; Potassium acetate; Magnesium acetate tetrahydrate; Calcium chloride dihydrate; Glucose monohydrate; Sodium dihydrogen phosphate dihydrate; Zinc acetate dihydrate; Triglycerides, medium chain; Soya bean oil, refined; Omega-3-acid triglycerides

Dostupné s:

B. Braun Melsungen AG

ATC kód:

B05BA; B05BA10

INN (Mezinárodní Name):

Isoleucine; Leucine ; Lysine hydrochloride; Methionine; Phenylalanine; Threonine; Tryptophan; Valine; Arginine ; Histidine hyprochloride monohydrate; Alanine; Aspartic Acid; Glutamic acid ; Glycine; Proline; Serine; Sodium hydroxide ; Sodium chloride; Sodium acetate trihydrate ; Potassium acetate; Magnesium acetate tetrahydrate; Calcium chloride dihydrate; Glucose monohydrate; Sodium dihydrogen phosphate dihydrate; Zinc acetate dihydrate; Triglycerides, medium chain; Soya bean oil, refined; Omega-3-acid triglycerides

Dávkování:

Unknown

Léková forma:

Emulsion for infusion

Druh předpisu:

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

Terapeutické oblasti:

Solutions for parenteral nutrition; combinations

Stav Autorizace:

Marketed

Datum autorizace:

2017-02-03

Informace pro uživatele

PACKAGE LEAFLET: INFORMATION FOR THE USER
OMEFLEX SPECIAL
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 is and what it is used for
2.
What you need to know before you use Omeflex special
3.
How to use Omeflex special
4.
Possible side effects
5.
How to store Omeflex special
6.
Contents of the pack and other information
1.
WHAT OMEFLEX SPECIAL IS AND WHAT IT IS USED FOR
Omeflex special contains fluids and 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.
Omeflex special is given to adults.
You are given Omeflex special 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
DO NOT USE OMEFLEX SPECIAL
●
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 use Omeflex special 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
●
seve

Charakteristika produktu

Health Products Regulatory Authority
05 January 2024
CRN009XMN
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Omeflex special 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
Sodium dihydrogen phosphate dihydrate
2.496 g
1.560 g
3.120 g
4.680 g
Zinc acetate dihydrate
7.024 mg
4.390 mg
8.780 mg
13.17 mg
_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 hydrochloride
3.980 g
2.488 g
4.975 g
7.463 g
equivalent to lysine
3.186 g
1.991 g
3.982 g
5.973 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 hydrochloride monohydrate
2.368 g
1.480 g
2.960 g
4.440 g
equivalent to histidine
1.753 g
1.095 g
2.191 g
3.286 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
Sodium hydroxide
1.171 g
0.732 g
1.464 g
2.196 g
Sodium chloride
0.378 g
0.237 g
0.473 g
0.710 g
Sodium acetate trihydrate
0.250 g
0.157 g
0.313 g
0.470 g
Potassium acetate
3.689 g
2.306 g
4.611 g
6.917 g
Magnesium acetate tetrahydrate
0.910