Nutriflex Omega plus Emulsion for infusion

البلد: أيرلندا

اللغة: الإنجليزية

المصدر: HPRA (Health Products Regulatory Authority)

العنصر النشط:

Isoleucine; Leucine; Lysine hydrochloride; Methionine; Phenylalanine; Threonine; Tryptophan; Valine; Arginine; Histidine hydrochloride monohydrate; Alanine; GLYCINE PH. EUR; Aspartic acid; Glutamic acid; Proline; Serine; Sodium hydroxide; Sodium chloride; Sodium acetate trihydrate; Potassium acetate; Magnesium acetate trihydrate; Calcium chloride dihydrate; Glucose monohydrate; Sodium dihydrogen phosphate dihydrate; Zinc acetate dihydrate; Triglycerides, medium chain; SOYA BEAN OIL, REFINED PH. EUR.; Omega-

متاح من:

B. Braun Melsungen AG

ATC رمز:

B05BA; B05BA10

INN (الاسم الدولي):

Isoleucine; Leucine; Lysine hydrochloride; Methionine; Phenylalanine; Threonine; Tryptophan; Valine; Arginine; Histidine hydrochloride monohydrate; Alanine; GLYCINE PH. EUR; Aspartic acid; Glutamic acid; Proline; Serine; Sodium hydroxide; Sodium chloride; Sodium acetate trihydrate; Potassium acetate; Magnesium acetate trihydrate; Calcium chloride dihydrate; Glucose monohydrate; Sodium dihydrogen phosphate dihydrate; Zinc acetate dihydrate; Triglycerides, medium chain; SOYA BEAN OIL, REFINED PH. EUR.; Omega-

الشكل الصيدلاني:

Emulsion for infusion

نوع الوصفة الطبية :

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

المجال العلاجي:

Solutions for parenteral nutrition; combinations

الوضع إذن:

Marketed

تاريخ الترخيص:

2011-06-23

نشرة المعلومات

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.
170/12609620/0120
WHAT IS IN THIS LEAFLET
1. What Nutriflex Omega plus is and what it is used for
2. What you need to know before you use Nutriflex Omega plus
3. How to use Nutriflex Omega plus
4. Possible side effects
5. How to store Nutriflex Omega plus
6. Contents of the pack and other information
1. WHAT NUTRIFLEX OMEGA PLUS IS AND WHAT IT IS USED FOR
Nutriflex Omega 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.
You are given Nutriflex Omega 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.
This solution is given to adults.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE NUTRIFLEX
OMEGA PLUS
DO NOT USE NUTRIFLEX OMEGA 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 Nutriflex Omega 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 fun

خصائص المنتج

Health Products Regulatory Authority
29 January 2020
CRN0092SG
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nutriflex Omega 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 UPPER, LEFT-HAND CHAMBER _
_(GLUCOSE SOLUTION)_
IN 1000 ML
IN 1250 ML
IN 1875 ML
IN 2500 ML
Glucose monohydrate
equivalent to glucose
132.0 g
120.0g
165.0 g
150.0g
247.5 g
225.0 g
330.0 g 300.0g
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 UPPER, RIGHT-HAND 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 LOWER 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
equivalent to lysine
2.728 g
2.184 g
3.410 g
2.729 g
5.115 g
4.094 g
6.820 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
equivalent to histidine
1.624 g
1.202 g
2.030 g
1.503 g
3.045 g
2.254 g
4.060 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