SmofKabiven extra Nitrogen Electrolyte free, emulsion for infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Alanine; Arginine ; Glycine; Histidine; Isoleucine; Leucine ; Lysine acetate; Methionine; Phenylalanine; Proline; Serine; Taurine; Tryptophan; Tyrosine; Valine; Glucose monohydrate; Soya bean oil, refined; Triglycerides medium-chain ; Olive oil, refined; Fish oil, rich in omega-3 acids

Available from:

Fresenius Kabi Deutschland GmbH

ATC code:

B05BA; B05BA10

INN (International Name):

Alanine; Arginine ; Glycine; Histidine; Isoleucine; Leucine ; Lysine acetate; Methionine; Phenylalanine; Proline; Serine; Taurine; Tryptophan; Tyrosine; Valine; Glucose monohydrate; Soya bean oil, refined; Triglycerides medium-chain ; Olive oil, refined; Fish oil, rich in omega-3 acids

Pharmaceutical form:

Emulsion for infusion

Therapeutic area:

Solutions for parenteral nutrition; combinations

Authorization status:

Not marketed

Authorization date:

2017-08-25

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
SmofKabiven extra Nitrogen Electrolyte free 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.
-
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.
WHATS IS IN THIS LEAFLET
1.
What SmofKabiven extra Nitrogen Electrolyte Free is and what it is
used for
2.
What you need to know before you use SmofKabiven extra Nitrogen
Electrolyte free
3.
How to use SmofKabiven extra Nitrogen Electrolyte free
4.
Possible side effects
5.
How to store SmofKabiven extra Nitrogen Electrolyte free
6.
Contents of the pack and other information
1.
WHAT SMOFKABIVEN EXTRA NITROGEN ELECTROLYTE FREE IS AND WHAT IT IS
USED FOR
SmofKabiven extra Nitrogen Electrolyte free is an emulsion for
infusion given into your blood by a drip
(intravenous infusion). The product contains amino acids (components
used to build proteins), glucose
(carbohydrates) and lipids (fat) in a plastic bag and can be given to
adults and children aged 2 years and
above.
A healthcare professional will give you SmofKabiven extra Nitrogen
Electrolyte free when other forms of
feeding are not good enough or have not worked.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE SMOFKABIVEN EXTRA NITROGEN
ELECTROLYTE FREE
DO NOT USE SMOFKABIVEN EXTRA NITROGEN ELECTROLYTE FREE
-
if you are allergic (hypersensitive) to active substances or any of
the other ingredients of this medicine
(listed in section 6)
-
if you are allergic to fish or egg
-
if you are allergic to peanuts or soya you should not use this
product. SmofKabiven extra Nitrogen
Electrolyte free contains soya-bean oil
-
if you have too much lipids in the blood (hyperlipidemia)
-
if you have serious liver disorder
-
if you have blood clotting problems (coagulation disorder

Summary of Product characteristics

Health Products Regulatory Authority
23 June 2023
CRN00DJTT
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
SmofKabiven extra Nitrogen Electrolyte free, emulsion for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
SmofKabiven extra Nitrogen Electrolyte free consists of a three
chamber bag system. Each bag contains the following partial
volumes depending on the five pack sizes.
506 ML
1012 ML
1518 ML
2025 ML
2531 ML
PER 1000 ML
Amino acid solution 10%
331 ml
662 ml
993 ml
1325 ml
1656 ml
654 ml
Glucose 42%
102 ml
204 ml
306 ml
408 ml
510 ml
202 ml
Lipid emulsion 20%
73 ml
146 ml
219 ml
292 ml
365 ml
144 ml
This corresponds to the following total compositions:
ACTIVE INGREDIENTS
506 ML
1012 ML
1518ML
2025 ML
2531 ML
PER 1000 ML
Alanine
4.6 g
9.3 g
14 g
19 g
23 g
9.2 g
Arginine
4.0 g
7.9 g
12 g
16 g
20 g
7.9 g
Glycine
3.6 g
7.3 g
11 g
15 g
18 g
7.2 g
Histidine
1.0 g
2.0 g
3.0 g
4.0 g
5.0 g
2.0 g
Isoleucine
1.7 g
3.3 g
5.0 g
6.6 g
8.3 g
3.3 g
Leucine
2.4 g
4.9 g
7.3 g
9.8 g
12 g
4.8 g
Lysine (as acetate)
2.2 g
4.4 g
6.6 g
8.7 g
11 g
4.3 g
Methionine
1.4 g
2.8 g
4.3 g
5.7 g
7.1 g
2.8 g
Phenylalanine
1.7 g
3.4 g
5.1 g
6.8 g
8.4 g
3.3 g
Proline
3.7 g
7.4 g
11 g
15 g
19 g
7.3 g
Serine
2.2 g
4.3 g
6.5 g
8.6 g
11 g
4.3 g
Taurine
0.33 g
0.66 g
1.0 g
1.3 g
1.7 g
0.65 g
Threonine
1.5 g
2.9 g
4.4 g
5.8 g
7.3 g
2.9 g
Tryptophan
0.66 g
1.3 g
2.0 g
2.7 g
3.3 g
1.3 g
Tyrosine
0.13 g
0.26 g
0.40 g
0.53 g
0.66 g
0.26 g
Valine
2.1 g
4.1 g
6.2 g
8.2 g
10 g
4.1 g
Glucose monohydrate _corresponding to_
Glucose
43 g
86 g
129 g
171 g
214 g
85 g
Soya-bean oil, refined
4.4 g
8.8 g
13 g
18 g
22 g
8.7 g
Medium-chain triglycerides
4.4 g
8.8 g
13 g
18 g
22 g
8.7 g
Olive oil, refined
3.7 g
7.3 g
11 g
15 g
18 g
7.2 g
Fish oil, rich in omega-3-acids
2.2 g
4.4 g
6.6 g
8.8 g
11 g
4.3 g
Corresponding to
506 ML
1012 ML
1518ML
2025 ML
2531 ML
PER 1000 ML

Amino acids
33.1 g
66.3 g
99.4 g
133 g
166 g
65.5 g

Nitrogen
5.3 g
10.6 g
15.9 g
21.2 g
26.5 g
10.5 g

Carbohydrat
es
Health Products Regulatory Authority