SmofKabiven extra Nitrogen Electrolyte free Infusionsvätska, emulsion

Riik: Rootsi

keel: rootsi

Allikas: Läkemedelsverket (Medical Products Agency)

Toimeaine:

alanin; arginin; fenylalanin; fiskolja, rik på omega-3-syror; glukosmonohydrat; glycin; histidin; isoleucin; leucin; lysinacetat; metionin; olivolja, raffinerad; prolin; serin; sojaolja, raffinerad; taurin; treonin; triglycerider, medellångkedjiga; tryptofan; tyrosin; valin

Saadav alates:

Fresenius Kabi AB

ATC kood:

B05BA10

INN (Rahvusvaheline Nimetus):

alanine; arginine; phenylalanine; fish oil, rich in omega-3 fatty acids; glukosmonohydrat; glycine; histidine; isoleucine; leucine; lysinacetat; methionine; olive oil, refined; proline; serine; soybean oil, refined; taurine; threonine; triglycerides, medellångkedjiga; tryptophan; tyrosine; valine

Ravimvorm:

Infusionsvätska, emulsion

Koostis:

valin 6,2 mg Aktiv substans; glycerol Hjälpämne; arginin 12 mg Aktiv substans; glycin 11 mg Aktiv substans; histidin 3 mg Aktiv substans; isoleucin 5 mg Aktiv substans; leucin 7,4 mg Aktiv substans; lysinacetat 9,3 mg Aktiv substans; metionin 4,3 mg Aktiv substans; fenylalanin 5,1 mg Aktiv substans; prolin 11,2 mg Aktiv substans; serin 6,5 mg Aktiv substans; taurin 1 mg Aktiv substans; treonin 4,4 mg Aktiv substans; tryptofan 2 mg Aktiv substans; tyrosin 0,4 mg Aktiv substans; alanin 14 mg Aktiv substans; glukosmonohydrat 462 mg Aktiv substans; sojaolja, raffinerad 60 mg Aktiv substans; triglycerider, medellångkedjiga 60 mg Aktiv substans; olivolja, raffinerad 50 mg Aktiv substans; fiskolja, rik på omega-3-syror 30 mg Aktiv substans

Retsepti tüüp:

Receptbelagt

Toote kokkuvõte:

Förpacknings: Trekammarpåse, 1 x 506 ml; Trekammarpåse, 1 x 1012 ml; Trekammarpåse, 1 x 1518 ml; Trekammarpåse, 1 x 2025 ml; Trekammarpåse, 1 x 2531 ml; Trekammarpåse, 6 x 506 ml; Trekammarpåse, 4 x 1012 ml; Trekammarpåse, 4 x 1518 ml; Trekammarpåse, 4 x 2025 ml; Trekammarpåse, 3 x 2531 ml

Volitamisolek:

Godkänd

Loa andmise kuupäev:

2017-07-07

Infovoldik

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

Toote omadused

1 (12)
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
•
Carbohydrates
- Glucose (anhydrous)
42.8 g
85.7 g
129 g
171 g
214 g
84.7 g
2 (12)
•
Lipids
14.6 g
29.2 g
43.8 g
5