SmofKabiven Nutribase emulsion for infusion

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Alanine; Arginine ; Glycine; Histidine; Isoleucine; Leucine ; Lysine acetate; Methionine; Phenylalanine; Proline; Serine; Taurine; Threonine; Tryptophan; Tyrosine; Valine; Calcium chloride dihydrate; Sodium glycerophosphate; Magnesium sulfate; Potassium chloride; Sodium acetate trihydrate ; Zinc sulphate heptahydrate; Glucose monohydrate; Soya-bean oil refined; Triglycerides medium-chain ; Olive oil, refined; Fish oil, rich in omega-3 acids

Tilgjengelig fra:

Fresenius Kabi Deutschland GmbH

ATC-kode:

B05BA10

INN (International Name):

Alanine; Arginine ; Glycine; Histidine; Isoleucine; Leucine ; Lysine acetate; Methionine; Phenylalanine; Proline; Serine; Taurine; Threonine; Tryptophan; Tyrosine; Valine; Calcium chloride dihydrate; Sodium glycerophosphate; Magnesium sulfate; Potassium chloride; Sodium acetate trihydrate ; Zinc sulphate heptahydrate; Glucose monohydrate; Soya-bean oil refined; Triglycerides medium-chain ; Olive oil, refined; Fish oil, rich in omega-3 acids

Legemiddelform:

Emulsion for infusion

Terapeutisk område:

combinations

Autorisasjon dato:

2022-05-06

Informasjon til brukeren

PACKAGE LEAFLET: INFORMATION FOR THE USER
SmofKabiven Nutribase 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 Nutribase is and what it is used for
2.
What you need to know before you use SmofKabiven Nutribase
3.
How to use SmofKabiven Nutribase
4.
Possible side effects
5.
How to store SmofKabiven Nutribase
6.
Contents of the pack and other information
1.
WHAT SMOFKABIVEN NUTRIBASE IS AND WHAT IT IS USED FOR
SmofKabiven Nutribase 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), lipids (fat)
and salts (electrolytes) in a plastic bag and can be given to adults
and children aged 2 years and above.
A healthcare professional will give you SmofKabiven Nutribase when
other forms of feeding are not good
enough or have not worked.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE SMOFKABIVEN NUTRIBASE
DO NOT USE SMOFKABIVEN NUTRIBASE
-
if you are allergic (hypersensitive) to the 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 Nutribase contains
soya-bean oil
-
if you have too much lipids in the blood (hyperlipidemia)
-
if you have serious liver disorder
-
if you have serious blood clotting problems (serious coagulation
disorder)
-
if your body has congenital problems with using amino acids
-
if you have serious kidney disease without access to dialysis or
hemofiltration
-
if you are in acute shock (severe blood circulation di

Preparatomtale

Health Products Regulatory Authority
06 May 2022
CRN009YJ5
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
SmofKabiven Nutribase emulsion for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
SmofKabiven Nutribase consists of a three-chamber bag system. Each bag
contains the following partial volumes depending
on the four pack sizes. 1026 ML
1539 ML
2052 ML
2565 ML
PER 1000 ML
Amino acid solution 10% with electrolytes
348 ml
522 ml
696 ml
870 ml
339 ml
Glucose 19%
478 ml
717 ml
956 ml
1195 ml
466 ml
Lipid emulsion 20%
200 ml
300 ml
400 ml
500 ml
195 ml
This corresponds to the following total compositions:
ACTIVE INGREDIENTS
1026 ML
1539 ML
2052 ML
2565 ML
PER 1000 ML
Alanine
4.9 g
7.3 g
9.7 g
12.2 g
4.7 g
Arginine
4.2 g
6.3 g
8.4 g
10.4 g
4.1 g
Glycine
3.8 g
5.7 g
7.7 g
9.6 g
3.7 g
Histidine
1.0 g
1.6 g
2.1 g
2.6 g
1.0 g
Isoleucine
1.7 g
2.6 g
3.5 g
4.4 g
1.7 g
Leucine
2.6 g
3.9 g
5.2 g
6.4 g
2.5 g
Lysine (as acetate)
2.3 g
3.4 g
4.6 g
5.7 g
2.2 g
Methionine
1.5 g
2.2 g
3.0 g
3.7 g
1.5 g
Phenylalanine
1.8 g
2.7 g
3.5 g
4.4 g
1.7 g
Proline
3.9 g
5.8 g
7.8 g
9.7 g
3.8 g
Serine
2.3 g
3.4 g
4.5 g
5.7 g
2.2 g
Taurine
0.35 g
0.52 g
0.70 g
0.87 g
0.34 g
Threonine
1.5 g
2.3 g
3.1 g
3.8 g
1.5 g
Tryptophan
0.70 g
1.0 g
1.4 g
1.7 g
0.68 g
Tyrosine
0.14 g
0.21 g
0.28 g
0.35 g
0.14 g
Valine
2.2 g
3.2 g
4.3 g
5.4 g
2.1 g
Calcium chloride dihydrate _corresponding to_
Calcium chloride
0.19 g
0.29 g
0.39 g
0.49 g
0.19 g
Sodium glycerophosphate (hydrate) _corresponding to_
Sodium glycerophosphate
1.5 g
2.2 g
2.9 g
3.6 g
1.4 g
Magnesium sulphate heptahydrate _corresponding to_
Magnesium sulphate
0.42 g
0.63 g
0.84 g
1.0 g
0.41 g
Potassium chloride
1.6 g
2.3 g
3.1 g
3.9 g
1.5 g
Sodium acetate trihydrate _corresponding to_
Sodium acetate
1.2 g
1.8 g
2.4 g
2.9 g
1.1 g
Zinc sulphate heptahydrate
_corresponding to_
Zinc sulphate
0.0045 g
0.0067 g
0.0090 g
0.0112 g
0.0044 g
Glucose monohydrate _corresponding to_
Glucose
91 g
136 g
182 g
227 g
89 g
Soya-bean oil, refined
12 g
18 g
24 g
30 g
12 g
Medium-ch