Omeflex plus emulsion for infusion

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

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

Dostopno od:

B. Braun Melsungen AG

Koda artikla:

B05BA; B05BA10

INN (mednarodno ime):

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

Odmerek:

Unknown

Farmacevtska oblika:

Emulsion for infusion

Tip zastaranja:

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

Terapevtsko območje:

Solutions for parenteral nutrition; combinations

Status dovoljenje:

Marketed

Datum dovoljenje:

2017-02-03

Navodilo za uporabo

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

Lastnosti izdelka

Health Products Regulatory Authority
15 April 2021
CRN009ZXW
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Omeflex plus 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 1250 ML
IN 1875 ML
IN 2500 ML
Glucose monohydrate
132.0 g
165.0 g
247.5 g
330.0 g
equivalent to glucose
120.0 g
150.0 g
225.0 g
300.0 g
Sodium dihydrogen phosphate dihydrate
1.872 g
2.340 g
3.510 g
4.680 g
Zinc acetate dihydrate
5.264 mg
6.580 mg
9.870 mg
13.16 mg
_FROM THE MIDDLE CHAMBER _
_(FAT EMULSION)_
IN 1000 ML
IN 1250 ML
IN 1875 ML
IN 2500 ML
Medium-chain triglycerides
20.00 g
25.00 g
37.50 g
50.00 g
Soya-bean oil, refined
16.00 g
20.00 g
30.00 g
40.00 g
Omega-3-acid triglycerides
4.000 g
5.000 g
7.500 g
10.00 g
_FROM THE BOTTOM CHAMBER _
_(AMINO ACID SOLUTION)_
IN 1000 ML
IN 1250 ML
IN 1875 ML
IN 2500 ML
Isoleucine
2.256 g
2.820 g
4.230 g
5.640 g
Leucine
3.008 g
3.760 g
5.640 g
7.520 g
Lysine hydrochloride
2.728 g
3.410 g
5.115 g
6.820 g
equivalent to lysine
2.184 g
2.729 g
4.094 g
5.459 g
Methionine
1.880 g
2.350 g
3.525 g
4.700 g
Phenylalanine
3.368 g
4.210 g
6.315 g
8.420 g
Threonine
1.744 g
2.180 g
3.270 g
4.360 g
Tryptophan
0.544 g
0.680 g
1.020 g
1.360 g
Valine
2.496 g
3.120 g
4.680 g
6.240 g
Arginine
2.592 g
3.240 g
4.860 g
6.480 g
Histidine hydrochloride monohydrate
1.624 g
2.030 g
3.045 g
4.060 g
equivalent to histidine
1.202 g
1.503 g
2.254 g
3.005 g
Alanine
4.656 g
5.820 g
8.730 g
11.64 g
Aspartic acid
1.440 g
1.800 g
2.700 g
3.600 g
Glutamic acid
3.368 g
4.210 g
6.315 g
8.420 g
Glycine
1.584 g
1.980 g
2.970 g
3.960 g
Proline
3.264 g
4.080 g
6.120 g
8.160 g
Serine
2.880 g
3.600 g
5.400 g
7.200 g
Sodium hydroxide
0.781 g
0.976 g
1.464 g
1.952 g
Sodium chloride
0.402 g
0.503 g
0.755 g
1.006 g
Sodium acetate trihydrate
0.222 g
0.277 g
0.416 g
0.554 g
Potassium acetate
2.747 g
3.434 g
5.151 g
6.868 g
Magnesium acetate tetrahydrate