SmofKabiven Electrolyte Free Central emulsion for infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

L-alanine; L-arginine; Glycine; L-histidine; L-isoleucine; L-leucine; L-lysine acetate; L-methionine; L-phenylalanine; L-proline; L-serine; Taurine; L-threonine; L-tryptophan; L-tyrosine; L-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):

L-alanine; L-arginine; Glycine; L-histidine; L-isoleucine; L-leucine; L-lysine acetate; L-methionine; L-phenylalanine; L-proline; L-serine; Taurine; L-threonine; L-tryptophan; L-tyrosine; L-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:

Marketed

Authorization date:

2009-11-27

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
_SMOFKABIVEN _
_ELECTROLYTE _
_FREE _
_CENTRAL_
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.
What is in this leaflet:
1.
What SmofKabiven Electrolyte Free Central is and what it is used for
2.
What you need to know before you use SmofKabiven Electrolyte
Free
Central
3.
How to use SmofKabiven Electrolyte Free Central
4.
Possible side effects
5.
How to store SmofKabiven Electrolyte Free Central
6.
Contents of the pack and other information
SmofKabiven Electrolyte Free Central 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 Electrolyte
Free
Central when other forms of feeding are not good enough
or have not
worked.
2. What you need to know before you use SmofKabiven
Electrolyte Free Central
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 Electrolyte Free Central contains soybean oil
-
if you have too much lipids in the blood (hyperlipidaemia)
-
if you have serious liver disorder
-
if you have blood clotting problems (coagulation disorders)
-
if your body has problems using amino acids
-
if you have serious kidney disease without access to dialysis
-
if you are in acute shock
-
if you have too much sugar in your blood (hyperg

Summary of Product characteristics

Health Products Regulatory Authority
29 February 2024
CRN00D4WX
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
SmofKabiven Electrolyte Free Central emulsion for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
SmofKabiven Electrolyte Free consists of a three chamber bag system.
Each bag contains the following partial volumes
depending on the five pack sizes.
493 ML
986 ML
1477 ML
1970 ML
2463 ML
PER 1000 ML
Amino acid solution
250 ml
500 ml
750 ml
1000 ml
1250 ml
508 ml
Glucose 42%
149 ml
298 ml
446 ml
595 ml
744 ml
302 ml
Lipid emulsion
94 ml
188 ml
281 ml
375 ml
469 ml
190 ml
This corresponds to the following total compositions:
ACTIVE INGREDIENTS
493 ML
986 ML
1477ML
1970 ML
2463 ML
PER 1000 ML
Alanine
3.5 g
7.0 g
10.5 g
14.0 g
17.5 g
7.1 g
Arginine
3.0 g
6.0 g
9.0 g
12.0 g
15.0 g
6.1 g
Glycine
2.8 g
5.5 g
8.2 g
11.0 g
13.8 g
5.6 g
Histidine
0.8 g
1.5 g
2.2 g
3.0 g
3.7 g
1.5 g
Isoleucine
1.3 g
2.5 g
3.8 g
5.0 g
6.2 g
2.5 g
Leucine
1.9 g
3.7 g
5.6 g
7.4 g
9.4 g
3.8 g
Lysine (as acetate)
1.7 g
3.3 g
5.0 g
6.6 g
8.4 g
3.4 g
Methionine
1.1 g
2.2 g
3.2 g
4.3 g
5.4 g
2.2 g
Phenylalanine
1.3 g
2.6 g
3.8 g
5.1 g
6.4 g
2.6 g
Proline
2.8 g
5.6 g
8.4 g
11.2 g
14.0 g
5.7 g
Serine
1.6 g
3.2 g
4.9 g
6.5 g
8.1 g
3.3 g
Taurine
0.25 g
0.50 g
0.75 g
1.0 g
1.2 g
0.5 g
Threonine
1.1 g
2.2 g
3.3 g
4.4 g
5.4 g
2.2 g
Tryptophan
0.5 g
1.0 g
1.5 g
2.0 g
2.5 g
1.0 g
Tyrosine
0.10 g
0.20 g
0.30 g
0.40 g
0.49 g
0.20 g
Valine
1.6 g
3.1 g
4.6 g
6.2 g
7.6 g
3.1 g
Glucose (as monohydrate)
63 g
125 g
187 g
250 g
313 g
127 g
Soya-bean oil, refined
5.6 g
11.3 g
16.9 g
22.5 g
28.1 g
11.4 g
Medium-chain triglycerides
5.6 g
11.3 g
16.9 g
22.5 g
28.1 g
11.4 g
Olive oil, refined
4.7 g
9.4 g
14.1 g
18.8 g
23.4 g
9.5 g
Fish oil, rich in omega-3-acids
2.8 g
5.6 g
8.4 g
11.3 g
14.0 g
5.7 g
Corresponding to
493 ML
986 ML
1477 ML
1970 ML
2463 ML
PER 1000 ML

Amino acids
25 g
50 g
75 g
100 g
125 g
51 g

Nitrogen
4 g
8 g
12 g
16 g
20 g
8 g

Carbohydrates
- Glucose (anhydrous)
63 g
125 g
187 g
250 g
313 g
127 g
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