Nutriflex Omega Special Emulsion for infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Isoleucine; Leucine; Lysine hydrochloride; Methionine; Phenylalanine; Threonine; Tryptophan; Valine; Arginine; Histidine hyprochloride monohydrate; Alanine; GLYCINE; Aspartic acid; Glutamic acid; 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 triglycerid

Available from:

B. Braun Melsungen AG

ATC code:

B05BA; B05BA10

INN (International Name):

Isoleucine; Leucine; Lysine hydrochloride; Methionine; Phenylalanine; Threonine; Tryptophan; Valine; Arginine; Histidine hyprochloride monohydrate; Alanine; GLYCINE; Aspartic acid; Glutamic acid; 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 triglycerid

Pharmaceutical form:

Emulsion for infusion

Prescription type:

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

Therapeutic area:

Solutions for parenteral nutrition; combinations

Authorization status:

Marketed

Authorization date:

2011-06-23

Patient Information leaflet

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.
179/12609625/0120
WHAT IS IN THIS LEAFLET
1. What Nutriflex Omega special is and what it is used for
2. What you need to know before you use Nutriflex Omega special
3. How to use Nutriflex Omega special
4. Possible side effects
5. How to store Nutriflex Omega special
6. Contents of the pack and other information
1. WHAT NUTRIFLEX OMEGA SPECIAL IS AND WHAT IT IS USED
FOR
Nutriflex
Omega
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.
You are given Nutriflex Omega 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.
This solution is given to adults.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE NUTRIFLEX
OMEGA SPECIAL
DO NOT USE NUTRIFLEX OMEGA 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 Nutriflex Omega 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

Summary of Product characteristics

Health Products Regulatory Authority
29 January 2020
CRN0092SG
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nutriflex Omega 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 UPPER, LEFT-HAND CHAMBER (GLUCOSE SOLUTION)_
in 1000 ml
in 625 ml
in 1250 ml
in 1875 ml
in 2500 ml
Glucose monohydrate
158.4 g
99.00 g
198.0 g
297.0 g
396.0 g
equivalent to glucose
144.0 g
90.00 g
180.0 g
270.0 g
360.0 g
Sodium dihydrogen phosphate dihydrate
2.496 g
1.560 g
3.120 g
4.680g
6.240g
Zinc acetate dihydrate
7.024 mg
4.390 mg 8.780 mg
13.17 mg
17.56 mg
_FROM THE UPPER, RIGHT-HAND CHAMBER (FAT EMULSION)_
in 1000 ml
in 625 ml
in 1250 ml
in 1875 ml
in 2500 ml
Medium-chain triglycerides
20.00 g
12.50 g
25.00 g
37.50 g
50.00 g
Soya-bean oil, refined
16.00 g
10.00 g
20.00 g
30.00 g
40.00 g
Omega-3-acid triglycerides
4.000 g
2.500 g
5.000 g
7.500 g
10.00 g
_FROM THE LOWER CHAMBER _
_(AMINO ACID SOLUTION)_
in 1000 ml
in 625 ml
in 1250 ml
in 1875 ml
in 2500 ml
Isoleucine
3.284 g
2.053 g
4.105 g
6.158 g
8.210 g
Leucine
4.384 g
2.740 g
5.480 g
8.220 g
10.96 g
Lysine hydrochloride
3.980 g
2.488 g
4.975 g
7.463 g
9.950 g
equivalent to lysine
3.186 g
1.991 g
3.982 g
5.973 g
7.962 g
Methionine
2.736 g
1.710 g
3.420 g
5.130 g
6.840 g
Phenylalanine
4.916 g
3.073 g
6.145 g
9.218 g
12.29 g
Threonine
2.540 g
1.588 g
3.175 g
4.763 g
6.350 g
Tryptophan
0.800 g
0.500 g
1.000 g
1.500 g
2.000 g
Valine
3.604 g
2.253 g
4.505 g
6.758 g
9.010 g
Arginine
3.780 g
2.363 g
4.725 g
7.088 g
9.450 g
Histidine hydrochloride monohydrate
2.368 g
1.480 g
2.960 g
4.440 g
5.920 g
equivalent to histidine
1.753 g
1.095 g
2.191 g
3.286 g
4.381 g
Alanine
6.792 g
4.245 g
8.490 g
12.73 g
16.98 g
Aspartic acid
2.100 g
1.313 g
2.625 g
3.938 g
5.250 g
Glutamic acid
4.908 g
3.068 g
6.135 g
9.203 g
12.27 g
Glycine
2.312 g
1.445 g
2.890 g
4.335 g
5.780 g
Proline
4.760 g
2.975 g
5.950 g
8.925 g
11.90 g
Serine
4.200 g
2.625 g